Zitromax: detailed information

Package leaflet: Information for the user

Zitromax 100 mg powder for oral suspension, 150 mg powder for oral suspension, 200 mg powder for oral suspension, 300 mg powder for oral suspension, 400 mg powder for oral suspension

Azithromycin
Please read this leaflet carefully before you or your child take this medicine
because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you/your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
Contents of this leaflet

What Zitromax is and what it is used for
What you need to know before taking/giving Zitromax to your child
How to take/give Zitromax to your child
Possible side effects
How to store Zitromax
Contents of the pack and other information

1. What Zitromax is and what it is used for

Zitromax contains the active substance azithromycin, an azalide antibiotic belonging to the group of antibiotics known as "macrolides". Azithromycin inhibits the growth of susceptible bacteria.
Zitromax is indicated in adults and children for the treatment of the following infections (caused by microorganisms susceptible to azithromycin):

upper respiratory tract infections, including inflammation of the sinuses (sinusitis), inflammation of the tonsils (tonsillitis) and inflammation of the throat (pharyngitis),
lower respiratory tract infections, including bronchitis and pneumonia,
ear infections (acute otitis media),
infections of the mouth and oesophagus (odontostomatological infections),
skin and soft tissue infections.

2. What you should know before taking/giving Zitromax to the child

Do not take/give Zitromax to the child
if the child is allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to the doctor or pharmacist before taking/giving Zitromax to the child:

if the child has or has ever had liver problems, or if they are currently taking or have recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax”). In such cases, caution is required before starting treatment with Zitromax;
if the child is being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax”);
if the child has kidney problems (renal insufficiency);
if the child has heart rhythm disorders. Zitromax may cause mild disturbances in heart rhythm, but in some cases these may be fatal (see section 4 “Possible side effects”).

Therefore, this medicine should be used with caution:

in patients with congenital heart rhythm abnormalities, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm disorders), cisapride (medicine for gastric reflux into the oesophagus), terfenadine (medicine for allergies), pimozide (medicine for mental disorders), citalopram (medicine for depression), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low blood levels of potassium or magnesium;
in elderly patients and in women.

Inform the doctor immediately if any of the following conditions occur or worsen during treatment with Zitromax (see also section 4 “Possible side effects”):

severe allergic reactions, including severe skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, immediately stop treatment with Zitromax and consult a doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark urine, easy bruising or bleeding, or neurological symptoms (e.g. confusion, altered consciousness, or coma). Immediately stop treatment with Zitromax and consult a doctor, who will perform medical tests to assess liver function;
vomiting or irritability in the child (if a newborn within the first 42 days of life) occurring after feeding. This medicine may cause narrowing of a portion of the stomach. If these symptoms occur, immediately consult the child’s doctor;
signs of new infections or persistence of symptoms from the current infection. This may be due to bacteria not sensitive to Zitromax (resistant bacteria) or to microorganisms other than bacteria (fungal infection);
onset of diarrhoea, which may be mild but in some cases may be fatal (fatal colitis). Diarrhoea may occur with the use of almost all antibiotics, including Zitromax, and is due to disruption of the normal intestinal bacterial flora, allowing overgrowth of a bacterium called Clostridium difficile. In case of diarrhoea, the doctor will closely monitor the patient, as Clostridium difficile infection may occur up to two months after stopping treatment with this medicine;
onset or worsening of muscle weakness and easy fatigability, i.e. symptoms of myasthenia gravis.

Children
Zitromax may be used in children and adolescents.

Other medicines and Zitromax
Inform the doctor or pharmacist if the child is taking, has recently taken, or might take any other medicine.
Inform the doctor if the child is taking any of the following medicines, as caution is required:

antacids (medicines for stomach acidity). If the child is taking both antacids and Zitromax, these two medicines should not be taken at the same time;
digoxin (used to treat heart failure). If taken together with Zitromax, the dose of digoxin must be carefully monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (medicine for HIV infections);
ergotamine (medicine for migraine). Concomitant use with Zitromax is not recommended, as it may cause disturbances in blood circulation, especially in the fingers and toes (ergotism crisis);
statins (medicines to lower blood fat levels). Concomitant use with Zitromax may cause breakdown of muscle cells (rhabdomyolysis);
cyclosporine (medicine to prevent organ transplant rejection). If taken together with Zitromax, the dose of cyclosporine must be carefully monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax may increase the anticoagulant effect of these medicines.

Zitromax must not be taken together with other medicines that may affect heart rhythm
(see section “Warnings and precautions”).

Zitromax with food and drink
Zitromax may be taken either with or without food. It is preferable to take this medicine with food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The doctor will decide whether you may take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.

Breastfeeding
Zitromax passes into breast milk. Therefore, if you are breastfeeding, the doctor will prescribe this medicine only if strictly necessary.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.

This medicine contains a vanilla cream flavouring which includes butter-derived acids containing traces of milk proteins that may cause allergic reactions.

Zitromax contains sucrose
Each sachet of Zitromax 100 mg powder for oral suspension contains 1.93 g of sucrose (sugar).
Each sachet of Zitromax 150 mg powder for oral suspension contains 2.90 g of sucrose (sugar).
Each sachet of Zitromax 200 mg powder for oral suspension contains 3.87 g of sucrose (sugar).
Each sachet of Zitromax 300 mg powder for oral suspension contains 5.82 g of sucrose (sugar).
Each sachet of Zitromax 400 mg powder for oral suspension contains 7.75 g of sucrose (sugar).
This should be taken into account in patients with diabetes mellitus.

Zitromax 100 mg powder for oral suspension contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.
Zitromax 150 mg powder for oral suspension contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.
Zitromax 200 mg powder for oral suspension contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.
Zitromax 300 mg powder for oral suspension contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.
Zitromax 400 mg powder for oral suspension contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.

3. How to take/give Zitromax to the child

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
A 45

For the treatment of upper and lower respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis, bronchitis and pneumonia), skin and soft tissue infections, and odontostomatological infections: the recommended dose is 500 mg once daily for 3 consecutive days.

For children and adolescents weighing less than 45 kg, the recommended dose is 10 mg per kg of body weight once daily for 3 consecutive days.

For the treatment of streptococcal pharyngitis in children: the recommended dose is 10 mg/kg or 20 mg/kg, given as a single daily dose for 3 consecutive days; however, the daily dose must not exceed 500 mg. The maximum total recommended dose for any pediatric therapy is 1500 mg.

Special patients
If you are elderly or have mild to moderate liver problems or kidney problems, your doctor may prescribe the same dosages indicated above.
How to take the oral suspension powder

Pour the contents of the sachet into half a glass of water;
Stir well before use;
Take/give the child this medicine immediately after dilution.

If you take/give the child more Zitromax than you should
If you take/give the child an excessive dose of this medicine, the possible side effects will be the same as those that may occur after taking a correct dose of the medicine. If you have taken more medicine than you should, inform your doctor immediately.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have occurred after taking Zitromax.
STOP taking Zitromax immediately if you or the child experience any of the following side effects:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the final part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
severe skin reactions:
severe rash associated with increased number of a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with formation of pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
severe liver problems (severe hepatic failure), as they may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you or the child experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea
Common (may affect up to 1 in 10 people):
headache
vomiting
abdominal pain
nausea
decreased level of bicarbonate in the blood
decreased number of a type of white blood cells called lymphocytes
increased number of a type of white blood cells called eosinophils
increased number of a type of white blood cells called basophils
increased number of a type of white blood cells called monocytes
increased number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection by Candida (a fungus)
infection by microorganisms called "fungi"
infection by microorganisms called "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decrease in the number of white blood cells in the blood (leucopenia)
decrease in the number of a type of white blood cells called neutrophils (neutropenia)
increase in a type of white blood cells called eosinophils (eosinophilia)
decreased or absent appetite
nervousness
insomnia
dizziness
somnolence
altered sensation in various parts of the body
distortion or decreased ability to taste
visual disturbances
ear disorders
vertigo
heightened perception of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleed (epistaxis)
constipation
gas production in the intestine
stomach disturbances
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
burping
mouth ulcers
increased saliva production
skin rashes
itching
urticaria
dermatitis
dry skin
excessive sweating
arthrosis
muscle pain
back pain
neck pain
pain when urinating
kidney pain
atypical, heavy and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
fatigue
facial swelling
chest pain
fever
pain
swelling of legs and feet
abnormal laboratory tests assessing liver function
increased level of bilirubin in the blood (a substance produced by the liver)
increased level of urea in the blood (a substance produced by the liver)
increased level of creatinine in the blood (a substance produced by muscles)
changes in potassium and sodium levels in the blood (mineral salts)
increased level of alkaline phosphatase in the blood (a substance produced in various body tissues)
increased level of chloride in the blood (a mineral salt)
increased level of glucose (a sugar) in the blood
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased level of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

restlessness
altered liver function
yellowish discoloration of the skin and mucous membranes (jaundice)
increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known (frequency cannot be estimated from the available data):

decreased number of platelets in the blood
seizures
decreased sensitivity of any body area to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
complete or partial loss of the ability to smell
complete loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
ringing in the ears
increased heart rate due to a specific heart rhythm abnormality (arrhythmia) called "torsades de pointes"
disturbances in normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by a test called "electrocardiogram"
decreased blood pressure (hypotension)
change in tongue colour
joint pain
severe kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zitromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the sachet after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax contains
The active substance is azithromycin (as azithromycin dihydrate).
Each sachet of Zitromax 100 mg oral suspension powder contains 100 mg of azithromycin
(equivalent to 104.8 mg of azithromycin dihydrate).
Each sachet of Zitromax 150 mg oral suspension powder contains 150 mg of azithromycin
(equivalent to 157.2 mg of azithromycin dihydrate).
Each sachet of Zitromax 200 mg oral suspension powder contains 200 mg of azithromycin
(equivalent to 209.6 mg of azithromycin dihydrate).
Each sachet of Zitromax 300 mg oral suspension powder contains 300 mg of azithromycin
(equivalent to 314.4 mg of azithromycin dihydrate).
Each sachet of Zitromax 400 mg oral suspension powder contains 400 mg of azithromycin
(equivalent to 419.2 mg of azithromycin dihydrate).
The other components are: anhydrous trisodium phosphate, hydroxypropylcellulose, xanthan gum, cherry flavour, vanilla cream flavour (containing dairy-derived acids with traces of milk proteins), banana flavour, sucrose (see section “Zitromax contains sucrose”).

Description of the appearance of Zitromax and the contents of the pack
Zitromax oral suspension powder is available in aluminium sachets, externally coated with paper and internally with polyethylene. Each pack contains 3 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47.600 – Borgo San Michele
04100 Latina

Package leaflet: information for the user

Zitromax 200 mg/5 ml powder for oral suspension

Azithromycin
Please read this leaflet carefully before taking/administering this medicine to your child
as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you/your child only. Do not give it to other people,
even if their symptoms are the same as yours, as it could be harmful.
If any adverse reaction occurs, including those not listed in this
leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What Zitromax is and what it is used for
What you need to know before taking/giving Zitromax to your child
How to take/give Zitromax to your child
Possible side effects
How to store Zitromax
Contents of the pack and other information

1. What Zitromax is and what it is used for

upper respiratory tract infections, including sinus inflammation (sinusitis), tonsil inflammation (tonsillitis) and throat inflammation (pharyngitis),
lower respiratory tract infections, including bronchitis and pneumonia,
ear infections (acute otitis media),
mouth and oesophagus infections (odontostomatological infections),
skin and soft tissue infections.

2. What you should know before taking/giving Zitromax to your child

Do not take/give your child Zitromax
if he/she is allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Zitromax to your child:

if he/she has or has ever had liver problems, or if he/she is taking or has recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax”). In these cases, caution is required before starting treatment with Zitromax;
if he/she is being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax”);
if he/she has kidney problems (renal failure);
if he/she has heart rhythm disorders. Zitromax may cause mild, but in some cases even fatal, disturbances in heart rhythm (see section 4 “Possible side effects”). Therefore, this medicine should be used with caution:
in patients with congenital heart rhythm abnormalities, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm disorders), cisapride (medicine for stomach acid reflux), terfenadine (antihistamine), pimozide (medicine for mental disorders), citalopram (medicine for depression), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low blood levels of potassium or magnesium;
in elderly patients and women.

Inform your doctor if any of the following conditions occur or worsen during treatment with Zitromax (also see section 4 “Possible side effects”):

severe allergic reactions, including severe skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, immediately stop treatment with Zitromax and contact your doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark-colored urine, easy bleeding, or neurological symptoms (e.g. confusion, altered consciousness, or coma). Immediately stop treatment with Zitromax and contact your doctor, who will perform medical tests to evaluate liver function;
vomiting or irritability in your infant (if a newborn within the first 42 days of life) occurring after feeding. This medicine may cause narrowing of a part of the stomach. If these symptoms occur, contact immediately your child’s doctor;
symptoms of new infections or persistence of current infection symptoms. This may be due to bacteria not sensitive to Zitromax (resistant bacteria) or to microorganisms other than bacteria (fungal infections);
onset of diarrhoea, which may be mild but in some cases may be fatal (fatal colitis). Diarrhoea may occur with the use of almost all antibiotics, including Zitromax, due to disruption of the normal intestinal bacterial flora, allowing overgrowth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will closely monitor you, as Clostridium difficile infection may occur up to two months after stopping treatment with this medicine;
onset or worsening of muscle weakness and easy fatigability, i.e. symptoms of myasthenia gravis.

Children
Zitromax can be used in children and adolescents.

Other medicines and Zitromax
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Inform your doctor if your child is taking any of the following medicines, as caution is required:

antacids (medicines for stomach acidity). If your child is taking both antacids and Zitromax, do not take these two medicines at the same time;
digoxin (used to treat heart failure). If taken together with Zitromax, the digoxin dose must be carefully monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (medicine for HIV infections);
ergotamine (medicine for migraine). Concomitant use with Zitromax is not recommended, as it may cause disturbances in blood circulation, especially in fingers and toes (ergotism crisis);
statins (medicines to lower blood fat levels). Concomitant use with Zitromax may cause breakdown of muscle cells (rhabdomyolysis);
cyclosporine (medicine to prevent organ transplant rejection). If taken together with Zitromax, the cyclosporine dose must be carefully monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax may increase the anticoagulant effect of these medicines.

Zitromax must not be taken together with other medicines that may affect heart rhythm (see section “Warnings and precautions”).

Zitromax with food and drink
Zitromax can be taken with or without food. It is preferable to take this medicine with food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.

Breastfeeding
Zitromax passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe this medicine only if strictly necessary.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.

This medicine contains vanilla cream flavouring, which includes butter-derived acids containing traces of milk proteins that may cause allergic reactions.

Zitromax contains sucrose
This medicine contains 3.87 g of sucrose (sugar) in 5 ml of reconstituted suspension.
This should be taken into account in patients with diabetes mellitus.

Zitromax contains sodium
Zitromax 200 mg/5 ml powder for oral suspension contains less than 1 mmol (23 mg) of sodium in 5 ml of oral suspension, i.e. essentially 'sodium-free'.

3. How to take/give Zitromax to the child

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
A 45

For the treatment of upper and lower respiratory tract infections (sinusitis, tonsillitis, pharyngitis, bronchitis, and pneumonia), skin and soft tissue infections, and odontostomatological infections: the recommended dose is 500 mg once daily for 3 consecutive days.

For children and adolescents weighing less than 45 kg, the dose must be determined according to body weight. Exact recommendations are provided in the following table:

Weight (kg)	Dosing regimen
<15	10 mg/kg/day for 3 days
15-25	200 mg (5 ml) daily for 3 days
26-35	300 mg (7.5 ml) daily for 3 days
36-45	400 mg (10 ml) daily for 3 days
>45	500 mg daily for 3 days (same adult dosage)

For the treatment of acute otitis media in children: the recommended dose is 10 mg/kg daily for 3 consecutive days or 30 mg/kg as a single dose (see also below "How to take the oral suspension powder").
For the treatment of streptococcal pharyngitis in children: the recommended dose is 10 mg/kg or 20 mg/kg as a single dose administered for 3 consecutive days; however, the daily dose must not exceed 500 mg.

The maximum total recommended dose for any pediatric treatment is 1500 mg.
Special patients
If you are elderly, or have mild to moderate liver problems or kidney problems, your doctor may prescribe the same dosages indicated above.
How to take the oral suspension powder

Shake the bottle containing the powder before adding water.
Use the measuring device provided in the closure cap of the package and fill it with water up to the mark (corresponding to 9 ml), only once.
Pour the water from the measuring device into the bottle.
Shake well until all the powder is suspended.

Each milliliter of the reconstituted suspension contains 40 mg of azithromycin (equivalent to 200 mg per 5 ml dose).
Always shake the suspension before use.
Zitromax may be taken with or without food. Taking food before administration may reduce any gastrointestinal or intestinal side effects caused by this medicine.
Administer the reconstituted suspension using one of the two graduated dosing devices supplied in the package:

"Double spoon" graduated dosing device to be used for children weighing between 15 kg and 45 kg. The dosing device consists of a small spoon (capacity 5 ml) on one side and a large spoon (capacity 10 ml) on the other side.

CHILD'S WEIGHT	ONCE DAILY FOR 3 DAYS	AMOUNT OF MEDICINE
from 15 kg to 25 kg	Small spoonful filled to the brim	200 mg
from 26 kg to 35 kg	Large spoonful up to the mark	300 mg
from 36 kg to 45 kg	Large spoonful filled to the brim	400 mg

2. Graduated dosing "syringe" to be used for children weighing less than 15 kg

Sequence of five numbered illustrations showing the

The syringe is graduated in mg and ml of drug and in kg of child's body weight
Unscrew the plastic cap and insert the syringe, with the adapter, into the bottle
Draw up the prescribed amount of suspension
Remove the syringe from the adapter
Administer the suspension directly into the child's mouth using the syringe

Close the bottle with the original cap and thoroughly rinse the graduated dosing device used

WARNING
For the treatment of acute otitis media in children, the dosage of 30 mg/kg may also be administered
as a single dose, by filling the graduated "syringe" dosing device as many times as necessary
to achieve the prescribed dose.

If you take/give more Zitromax than you should
If you take/give an excessive dose of this medicine, the possible side effects will be the same
as those that may occur after taking a correct dose of the medicine. If you have taken more
medicine than you should, inform your doctor immediately.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have occurred after taking Zitromax.
STOP using Zitromax immediately if you or the child experience any of the following side effects:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue, and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the final part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
severe skin reactions:
severe rash associated with an increase in a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with formation of pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
severe liver problems (severe hepatic failure), as these may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you or the child experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea

Common (may affect up to 1 in 10 people):

headache
vomiting
abdominal pain
nausea
decreased levels of bicarbonate in the blood
decreased number of a type of white blood cells called lymphocytes
increased number of a type of white blood cells called eosinophils
increased number of a type of white blood cells called basophils
increased number of a type of white blood cells called monocytes
increased number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection caused by Candida (a fungus)
infection by microorganisms called "fungi"
infection by microorganisms called "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decreased number of white blood cells in the blood (leucopenia)
decreased number of a type of white blood cells called neutrophils (neutropenia)
increased number of a type of white blood cells called eosinophils (eosinophilia)
decreased or absent appetite
nervousness
insomnia
dizziness
somnolence
altered sensation in various parts of the body
distortion or decreased ability to taste
visual disturbances
ear disorders
vertigo
heightened perception of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleed (epistaxis)
constipation
gas production in the intestine
stomach discomfort
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
belching
mouth ulcers
increased saliva production
skin rashes
itching
urticaria
dermatitis
dry skin
excessive sweating
arthralgia
muscle pain
back pain
neck pain
pain when urinating
kidney pain
abnormal, heavy, and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
fatigue
facial swelling
chest pain
fever
pain
swelling of legs and feet
abnormal liver function tests
increased levels of bilirubin in the blood (a substance produced by the liver)
increased levels of urea in the blood (a substance produced by the liver)
increased levels of creatinine in the blood (a substance produced by the muscles)
changes in blood levels of potassium and sodium (electrolytes)
increased levels of alkaline phosphatase in the blood (a substance produced in various body tissues)
increased levels of chloride in the blood (an electrolyte)
increased levels of glucose (a sugar) in the blood
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased levels of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

restlessness
altered liver function
yellowing of the skin and mucous membranes (jaundice)
increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known (frequency cannot be estimated from the available data):

decreased number of platelets in the blood
seizures
decreased sensitivity of any body area to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
complete or partial loss of the ability to smell
complete loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
tinnitus
increased heart rate due to a specific heart rhythm disorder (arrhythmia) called "torsades de pointes"
disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by an examination called "electrocardiogram"
decreased blood pressure (hypotension)
change in tongue colour
joint pain
severe kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zitromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Zitromax, after reconstitution, is stable for 10 days at room temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax contains
The active substance is azithromycin (as azithromycin dihydrate).
100 g of powder contain 4.78 g of azithromycin (equivalent to 5.01 g of azithromycin dihydrate).
The other ingredients are: anhydrous trisodium phosphate, hydroxypropylcellulose, xanthan gum, cherry flavour, vanilla cream flavour (includes butter-derived acids containing traces of milk proteins), banana flavour, sucrose (see section “Zitromax contains sucrose”).

Description of the appearance of Zitromax and contents of the pack
Zitromax oral suspension powder is available in a polyethylene bottle containing 600 mg of azithromycin, equipped with a child-resistant closure and an appropriate dosing device. After reconstitution, the suspension will contain 200 mg/5 ml.

Package leaflet: information for the user

Zitromax 200 mg/5 ml powder for oral suspension

Azithromycin
Please read all of this leaflet carefully before taking/giving this medicine to your child
because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you/your child only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What Zitromax is and what it is used for
What you need to know before taking/giving Zitromax to your child
How to take/give Zitromax to your child
Possible side effects
How to store Zitromax
Contents of the pack and other information

1. What Zitromax is and what it is used for

Zitromax contains the active substance azithromycin, an azalide antibiotic belonging to a group of antibiotics called "macrolides". Azithromycin inhibits the growth of susceptible bacteria.
Zitromax is indicated in adults and children for the treatment of the following infections (caused by organisms sensitive to azithromycin):

upper respiratory tract infections, including sinus inflammation (sinusitis), tonsil inflammation (tonsillitis) and throat inflammation (pharyngitis),
lower respiratory tract infections, including bronchitis and pneumonia,
ear infections (acute otitis media),
mouth and oesophagus infections (odontostomatological infections),
skin and soft tissue infections.

2. What you should know before taking/giving Zitromax to the child

Do not take/give Zitromax to the child
if he/she is allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Zitromax to the child:

if he/she has or has ever had liver problems, or if he/she is currently taking or has recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax”). In such cases, caution is required before starting treatment with Zitromax;
if he/she is being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax”);
if he/she has kidney problems (renal failure);
if he/she has heart rhythm disorders. Zitromax may cause mild disturbances in heart rhythm, but in some cases these may be fatal (see section 4 “Possible side effects”). Therefore, this medicine should be used with caution:
in patients with congenital heart rhythm abnormalities, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm disorders), cisapride (a medicine for stomach acid reflux into the oesophagus), terfenadine (an antihistamine), pimozide (a medicine for mental disorders), citalopram (an antidepressant), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low blood levels of potassium or magnesium;
in elderly patients and women.

Inform the doctor if any of the following conditions occur or worsen during treatment with Zitromax (see also section 4 “Possible side effects”):

severe allergic reactions, including severe skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, immediately stop treatment with Zitromax and contact your doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark-coloured urine, easy bruising or bleeding, or neurological symptoms (e.g. confusion, altered consciousness or coma). Immediately stop treatment with Zitromax and contact your doctor, who will perform medical tests to assess liver function;
vomiting or irritability in your child (if a newborn within the first 42 days of life) occurring after feeding. This medicine may cause narrowing of a part of the stomach. If these symptoms occur, contact your child’s doctor immediately;
signs of new infections or persistence of symptoms from the current infection. This may be due to bacteria not sensitive to Zitromax (resistant bacteria) or to microorganisms other than bacteria (fungal infection);
onset of diarrhoea, which may be mild but in some cases may be fatal (fatal colitis). Diarrhoea may occur with the use of almost all antibiotics, including Zitromax, due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will carefully monitor you, as Clostridium difficile infection may occur up to two months after completion of treatment with this medicine;
onset or worsening of muscle weakness and easy fatigue, i.e. symptoms of myasthenia gravis.

Children
Zitromax may be used in children and adolescents.

Other medicines and Zitromax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines, as caution is required:

antacids (medicines for stomach acidity). If you are taking both antacids and Zitromax, do not take these two medicines at the same time;
digoxin (used to treat heart failure). If taken together with Zitromax, the digoxin dose must be closely monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (an antiviral medicine for HIV infection);
ergotamine (a medicine for migraine). Concomitant use with Zitromax is not recommended, as it may cause disturbances in blood circulation, especially in the fingers and toes (ergotism crisis);
statins (medicines to lower blood fat levels). Concomitant use with Zitromax may cause breakdown of muscle cells (rhabdomyolysis);
cyclosporine (a medicine to prevent organ transplant rejection). If taken together with Zitromax, the cyclosporine dose must be closely monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax may increase the anticoagulant effect of these medicines.

Zitromax must not be taken together with other medicines that may affect heart rhythm
(see section “Warnings and precautions”).

Zitromax with food and drink
Zitromax may be taken with or without food. It is preferable to take this medicine with food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will decide whether you may take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.

Breastfeeding
Zitromax passes into breast milk. Therefore, your doctor will prescribe this medicine only if strictly necessary while breastfeeding.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.

This medicine contains vanilla cream flavouring, which includes butter-derived acids containing traces of milk proteins that may cause allergic reactions.

Zitromax contains sucrose
This medicine contains 3.87 g of sucrose in 5 ml of reconstituted suspension.
This should be taken into account in patients with diabetes mellitus.

Zitromax contains sodium
Zitromax 200 mg/5 ml powder for oral suspension contains less than 1 mmol (23 mg) of sodium per 5 ml of oral suspension, i.e. essentially 'sodium-free'.

3. How to take/give Zitromax to a child

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
A 45

For the treatment of upper and lower respiratory tract infections (sinusitis, tonsillitis, pharyngitis, bronchitis, and pneumonia), skin and soft tissue infections, and odontostomatological infections: the recommended dose is 500 mg once daily for 3 consecutive days.

For children and adolescents weighing less than 45 kg, the dose must be determined according to body weight. Exact recommendations are provided in the following table:

Weight (kg)	Dosage regimen
<15	10 mg/kg daily for 3 days
15-25	200 mg (5 ml) daily for 3 days
26-35	300 mg (7.5 ml) daily for 3 days
36-45	400 mg (10 ml) daily for 3 days
>45	500 mg daily for 3 days (same adult dosage)

For the treatment of acute otitis media in children: the recommended dose is 10 mg/kg/day for 3 consecutive days or 30 mg/kg as a single dose (see also below "How to take the oral suspension powder").
For the treatment of streptococcal pharyngitis in children: the recommended dose is 10 mg/kg or 20 mg/kg as a single dose administered for 3 consecutive days; however, the daily dose must not exceed 500 mg.

The maximum total recommended dose for any pediatric treatment is 1500 mg.
Special patients
If you are elderly, or have mild or moderate liver problems, or have kidney problems, your doctor may
prescribe the same dosages indicated above.
How to take the oral suspension powder

Shake the bottle containing the powder before adding water.
Use the measuring device provided with the closure cap of the package and fill it with water up to the mark, once only. The mark corresponds to:
- 12 ml of water for the 900 mg bottle
- 15 ml of water for the 1200 mg bottle
Pour the water from the measuring device into the bottle.
Shake well until all the powder is suspended.

Each millilitre of reconstituted suspension contains 40 mg of azithromycin (equivalent to 200 mg per 5 ml dose).
Always shake the suspension before use.
Zitromax may be taken regardless of meals, either on an empty stomach or after eating. Taking food
before administration may reduce any gastrointestinal or intestinal side effects possibly caused by this
medicinal product.
Administer the reconstituted suspension using one of the two graduated dosing devices supplied in the
package:

"Double spoon" graduated dosing device to be used for children weighing between 15 kg and 45 kg. The dosing device consists of a small spoon (capacity 5 ml) on one side and a large spoon (capacity 10 ml) on the other side.

CHILD'S WEIGHT	ONCE DAILY FOR 3 DAYS	AMOUNT OF MEDICINE
from 15 kg to 25 kg	Small spoonful filled to the brim	200 mg
from 26 kg to 35 kg	Large spoonful up to the mark	300 mg
from 36 kg to 45 kg	Large spoonful filled to the brim	400 mg

4. Graduated dosing "syringe" to be used for children weighing less than 15 kg

The syringe is graduated in mg and ml of medication and in kg of child's weight
Unscrew the plastic cap and insert the syringe, with the adapter, into the bottle
Draw up the prescribed amount of suspension
Remove the syringe from the adapter
Administer the suspension directly into the child's mouth using the syringe

Reseal the bottle with the original cap and thoroughly rinse the graduated dosing device after use
WARNING
For the treatment of acute otitis media in children, the dosage of 30 mg/kg may also be administered
as a single dose, by filling the graduated dosing "syringe" as many times as necessary to reach the prescribed dose.
If you take/give more Zitromax than you should
If an excessive dose of this medicine is taken/given to the child, the possible side effects will be
the same as those that could occur after taking a correct dose of the medicine. If you have taken more
medicine than you should, contact your doctor immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have occurred after taking Zitromax.
STOP using Zitromax immediately if you/your child experience any of the following side effects:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue, and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the final part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
severe skin reactions:
severe rash associated with an increase in a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with formation of pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
severe liver problems (severe hepatic failure), as these may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you/your child experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea

Common (may affect up to 1 in 10 people):

headache
vomiting
abdominal pain
nausea
decrease in the amount of bicarbonate in the blood
decrease in the number of a type of white blood cells called lymphocytes
increase in the number of a type of white blood cells called eosinophils
increase in the number of a type of white blood cells called basophils
increase in the number of a type of white blood cells called monocytes
increase in the number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection by Candida (a fungus)
infection by microorganisms called "fungi"
infection by microorganisms called "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decrease in the number of white blood cells in the blood (leucopenia)
decrease in the number of a type of white blood cells called neutrophils (neutropenia)
increase in a type of white blood cells called eosinophils (eosinophilia)
decreased or absent appetite
nervousness
insomnia
dizziness
somnolence
disturbances in sensation in various parts of the body
distortion or reduction in the ability to taste
visual disturbances
ear disorders
vertigo
heightened perception of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleed (epistaxis)
constipation
gas production in the intestine
stomach disorders
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
burping
mouth ulcers
increased saliva production
skin rashes
itching
hives
dermatitis
dry skin
excessive sweating
arthralgia
muscle pain
back pain
neck pain
pain when urinating
kidney pain
abnormal, heavy, and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
fatigue
facial swelling
chest pain
fever
pain
swelling of legs and feet
abnormal laboratory tests assessing liver function
increased amount of bilirubin in the blood (a substance produced by the liver)
increased amount of urea in the blood (a substance produced by the liver)
increased amount of creatinine in the blood (a substance produced by muscles)
changes in the levels of potassium and sodium in the blood (mineral salts)
increased level of alkaline phosphatase in the blood (a substance produced in various body tissues)
increased level of chloride in the blood (a mineral salt)
increased level of glucose (a sugar) in the blood
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased level of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

agitation
altered liver function
yellowing of the skin and mucous membranes (jaundice)
increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known (frequency cannot be estimated from the available data):

decreased number of platelets in the blood
seizures
reduced sensitivity of any body area to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
complete or partial loss of the ability to smell
complete loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
ringing in the ears
increased heart rate due to a specific cardiac rhythm abnormality (arrhythmia) called "torsades de pointes"
disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by a test called "electrocardiogram"
decrease in blood pressure (hypotension)
change in tongue colour
joint pain
severe kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you/your child experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zitromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After reconstitution, Zitromax is stable for 10 days at room temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax contains
The active substance is azithromycin (as azithromycin dihydrate).
100 g of powder contain 4.78 g of azithromycin (equivalent to 5.01 g of azithromycin dihydrate).
The other components are: anhydrous trisodium phosphate, hydroxypropylcellulose, xanthan gum, cherry flavour, vanilla cream flavour (includes butter-derived acids containing traces of milk proteins), banana flavour, sucrose (see section “Zitromax contains sucrose”).

Description of the appearance of Zitromax and contents of the pack
Zitromax oral suspension powder is available in packs containing 1 polyethylene bottle with 900 mg or 1200 mg of azithromycin, child-resistant closure, and appropriate dosing device. After reconstitution, the suspension will contain 200 mg/5 ml.
Not all pack sizes may be marketed.

Package leaflet: information for the user

Zitromax 500 mg film-coated tablets, 200 mg/5 ml powder for oral suspension

Azithromycin
Please read this leaflet carefully before taking/giving the child this medicine
because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for you/your child. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If any side effect occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What Zitromax is and what it is used for
What you need to know before taking/giving the child Zitromax
How to take/give the child Zitromax
Possible side effects
How to store Zitromax
Contents of the pack and other information

1. What Zitromax is and what it is used for

Zitromax contains the active substance azithromycin, an azalide antibiotic belonging to the group of antibiotics known as “macrolides”. Azithromycin inhibits the growth of susceptible bacteria.
Zitromax is indicated in adults and children for the treatment of the following infections (caused by microorganisms sensitive to azithromycin):

upper respiratory tract infections, including sinus inflammation (sinusitis), tonsil inflammation (tonsillitis) and throat inflammation (pharyngitis),
lower respiratory tract infections, including bronchitis and pneumonia,
ear infections (acute otitis media),
mouth and oesophagus infections (odontostomatological infections),
skin and soft tissue infections,
genital infections caused by Chlamydia trachomatis and Haemophilus ducreyi (sexually transmitted infections).

2. What you should know before taking/giving Zitromax to the child

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Zitromax to the child:

if he/she has or has ever had liver problems, or if he/she is currently taking or has recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax”). In such cases, caution is required before starting treatment with Zitromax;
if he/she is being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax”);
if he/she has kidney problems (renal insufficiency);
if he/she has heart rhythm disorders. Zitromax may also cause mild disturbances in heart rhythm, which in some cases may be fatal (see section 4 “Possible side effects”). Therefore, this medicine must be used with caution:
in patients with congenital heart rhythm disorders, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm abnormalities), cisapride (a medicine for gastric reflux), terfenadine (an antihistamine), pimozide (a medicine for mental disorders), citalopram (an antidepressant), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low levels of potassium or magnesium in the blood;
in elderly patients and women.

Inform your doctor if any of the following conditions occur or worsen during treatment with Zitromax (see also section 4 “Possible side effects”):

severe allergic reactions, including severe skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, immediately stop treatment with Zitromax and contact your doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark urine, easy bruising or bleeding, or neurological symptoms (e.g. mental confusion, altered consciousness, or coma). Immediately stop treatment with Zitromax and contact your doctor, who will perform medical tests to assess liver function;
vomiting or irritability in your child (if a newborn within the first 42 days of life) occurring after feeding. This medicine may cause narrowing of a portion of the stomach. If these symptoms occur, contact your child’s doctor immediately;
onset of new infections or persistence of symptoms from the current infection. This may be due to bacteria not sensitive to Zitromax (resistant bacteria) or to microorganisms other than bacteria (fungal infections);
onset of diarrhoea, which may be mild but in some cases may be fatal (fatal colitis). Diarrhoea may occur with the use of almost all antibiotics, including Zitromax, due to disruption of the normal intestinal bacterial flora, allowing overgrowth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will closely monitor you, as Clostridium difficile infection may occur up to two months after stopping treatment with this medicine;
onset or worsening of muscle weakness and easy fatigue, i.e. symptoms of myasthenia gravis.

Children
Zitromax can be used in children and adolescents.

Other medicines and Zitromax
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicine.
Inform your doctor if the child is taking any of the following medicines, as caution is required:

antacids (medicines for stomach acidity). If the child is taking both antacids and Zitromax, these two medicines should not be taken at the same time;
digoxin (used to treat heart failure). If taken together with Zitromax, the digoxin dose must be carefully monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (an antiviral medicine for HIV infection);
ergotamine (a medicine for migraine). Concomitant use with Zitromax is not recommended, as it may cause disturbances in blood circulation, especially in the fingers and toes (ergotism crisis);
statins (medicines to lower blood lipid levels). Concomitant use with Zitromax may cause breakdown of muscle cells (rhabdomyolysis);
cyclosporine (a medicine to prevent organ transplant rejection). If taken together with Zitromax, the cyclosporine dose must be carefully monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax may increase the anticoagulant effect of these medicines.

Zitromax must not be taken together with other medicines that may affect heart rhythm
(see section “Warnings and precautions”).

Zitromax with food and drink
Zitromax can be taken with or without food. It is preferable, however, to take this medicine with food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring that the benefits outweigh any potential risks.

Breastfeeding
Zitromax passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe this medicine only if strictly necessary.

Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.

Zitromax 500 mg film-coated tablets contain lactose
Zitromax contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Zitromax 200 mg/5 ml oral suspension powder contains vanilla cream flavouring, which includes butter-derived acids containing traces of milk proteins that may cause allergic reactions.

Zitromax 200 mg/5 ml oral suspension powder contains sucrose
Zitromax 200 mg/5 ml oral suspension powder contains 3.87 g of sucrose per 5 ml of suspension. This should be taken into account in patients with diabetes mellitus.

Zitromax 200 mg/5 ml oral suspension powder contains sodium
Zitromax 200 mg/5 ml oral suspension powder contains less than 1 mmol (23 mg) of sodium per 5 ml of oral suspension, i.e. essentially 'sodium-free'.

Zitromax 500 mg film-coated tablets contain sodium
Zitromax 500 mg tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take/give Zitromax to a child

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
A 45

For the treatment of upper and lower respiratory tract infections (sinusitis, tonsillitis, pharyngitis, bronchitis, and pneumonia), skin and soft tissue infections, and odontostomatological infections: the recommended dose is 500 mg once daily for 3 consecutive days.
For the treatment of sexually transmitted infections caused by susceptible strains of Chlamydia trachomatis or Haemophilus ducreyi: the recommended dose is 1000 mg as a single oral dose.

For children and adolescents weighing less than 45 kg, the dose must be determined according to body weight. Exact dosing instructions are provided in the following table:

Weight (kg)	Dosage regimen
<15	10 mg/kg daily for 3 days
15-25	200 mg (5 ml) daily for 3 days
26-35	300 mg (7.5 ml) daily for 3 days
36-45	400 mg (10 ml) daily for 3 days
>45	500 mg daily for 3 days (same adult dosage)

For the treatment of acute otitis media in children: the recommended dose is 10 mg/kg/day for 3 consecutive days or 30 mg/kg as a single dose (see also below, “How to take the oral suspension powder”).
For the treatment of streptococcal pharyngitis in children: the recommended dose is 10 mg/kg or 20 mg/kg as a single dose given for 3 consecutive days; however, the daily dose must not exceed 500 mg.

The maximum total recommended dose for any pediatric treatment is 1500 mg.
Special patients
If you are elderly or have mild to moderate liver problems or kidney problems, your doctor may
prescribe the same dosages listed above.
How to take the tablets
Swallow the tablets whole. Take the tablets with a glass of water as a single daily dose. The tablets may be taken regardless of food intake, either on an empty stomach or after meals.
Taking food before administration of the tablet may reduce any potential gastrointestinal side effects caused by this medicine.
How to take the oral suspension powder

Shake the bottle containing the powder before adding water.
Use the dedicated measuring device provided with the closure cap of the container and fill it with water up to the mark, only once: For 37.5 ml of oral suspension (1500 mg of azithromycin), add 19 ml of water.
Pour the water from the measuring device into the bottle.
Shake well until all the powder is completely suspended. One millilitre of the reconstituted oral suspension contains 40 mg of azithromycin (equivalent to 200 mg in a 5 ml dose).

Always shake the suspension well before use.
Administer the reconstituted suspension using one of the two graduated dosing devices supplied with the package:

Double-ended graduated dosing spoon to be used for children weighing between 15 kg and 45 kg. The dosing spoon consists of a small spoon (capacity 5 ml) on one end and a large spoon (capacity 10 ml) on the other end.

CHILD'S WEIGHT	ONCE DAILY FOR 3 DAYS	AMOUNT OF MEDICINE
from 15 kg to 25 kg	Small spoonful filled to the rim	200 mg
from 26 kg to 35 kg	Large spoonful up to the mark	300 mg
from 36 kg to 45 kg	Large spoonful filled to the rim	400 mg

6. Graduated dosing "syringe" to be used for children weighing less than 15 kg

Sequence of five numbered illustrations showing how to aspirate medication from a vial with a syringe and administer it to a child

The syringe is graduated in mg and ml of medication and in kg of child's weight
Unscrew the plastic cap and insert the syringe, with the adapter, into the bottle
Draw up the prescribed amount of suspension
Remove the syringe from the adapter
Administer the suspension directly into the child's mouth using the syringe. Close the bottle with the proper cap and thoroughly rinse the graduated dosing device after use

WARNING
For the treatment of acute otitis media in children, the dosage of 30 mg/kg may also be administered
as a single dose, by filling the graduated dosing "syringe" as many times as necessary
to reach the prescribed dose.

If you take/give the child more Zitromax than you should
If you take/give the child an excessive dose of this medicine, the possible side effects will be
the same as those that may occur after taking a correct dose of the medicine. If you have taken more
medicine than you should, inform your doctor immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have occurred after taking Zitromax.
STOP taking Zitromax immediately if you/your child experience any of the following side effects:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the final part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
severe skin reactions:
severe rash associated with an increase in a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with formation of pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
serious liver problems (severe hepatic failure), as it may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you/your child experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea

Common (may affect up to 1 in 10 people):

headache
vomiting
abdominal pain
nausea
decreased levels of bicarbonate in the blood
decreased number of a type of white blood cells called lymphocytes
increased number of a type of white blood cells called eosinophils
increased number of a type of white blood cells called basophils
increased number of a type of white blood cells called monocytes
increased number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection caused by Candida (a fungus)
infection caused by microorganisms called "fungi"
infection caused by microorganisms called "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decreased number of white blood cells in the blood (leucopenia)
decreased number of a type of white blood cells called neutrophils (neutropenia)
increased number of a type of white blood cells called eosinophils (eosinophilia)
decreased or absent appetite
nervousness
insomnia
dizziness
drowsiness
disturbances in sensation in various parts of the body
distortion or reduction in the ability to taste
visual disturbances
ear disorders
vertigo
increased awareness of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleeds (epistaxis)
constipation
gas production in the intestine
stomach discomfort
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
burping
mouth ulcers
increased saliva production
skin rashes
itching
urticaria
dermatitis
dry skin
excessive sweating
arthralgia
muscle pain
back pain
neck pain
pain when urinating
kidney pain
abnormal, heavy and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
fatigue
facial swelling
chest pain
fever
pain
swelling of legs and feet
abnormal laboratory tests assessing liver function
increased levels of bilirubin in the blood (a substance produced by the liver)
increased levels of urea in the blood (a substance produced by the liver)
increased levels of creatinine in the blood (a substance produced by muscles)
changes in blood levels of potassium and sodium (mineral salts)
increased levels of alkaline phosphatase in the blood (a substance produced in various body tissues)
increased levels of chloride in the blood (a mineral salt)
increased levels of glucose (a sugar) in the blood
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased levels of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

restlessness
impaired liver function
yellowing of the skin and mucous membranes (jaundice)
increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known (the frequency cannot be estimated from the available data):

decreased number of platelets in the blood
seizures
reduced sensitivity of any part of the body to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
complete or partial loss of the ability to smell
complete loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
ringing in the ears
increased heart rate due to a specific heart rhythm abnormality (arrhythmia) called "torsades de pointes"
disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by an electrocardiogram
low blood pressure (hypotension)
change in tongue colour
joint pain
serious kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you/your child experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zitromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, bottle, and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Zitromax 200 mg/5 ml powder for oral suspension, after reconstitution, is stable for 10 days at room temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax contains
Zitromax 500 mg film-coated tablets
The active substance is azithromycin (as azithromycin dihydrate).
Each film-coated tablet contains 500 mg of azithromycin (equivalent to 524.11 mg of azithromycin dihydrate).
The other ingredients are: pregelatinized starch, anhydrous calcium hydrogen phosphate, sodium carmellose, magnesium stearate, sodium lauryl sulfate.
Coating film: titanium dioxide, lactose (see section “Zitromax 500 mg film-coated tablets contains lactose”), hypromellose, triacetin.

Zitromax 200 mg/5 ml powder for oral suspension
The active substance is azithromycin (as azithromycin dihydrate).
100 g of powder contain 4.78 g of azithromycin (equivalent to 5.01 g of azithromycin dihydrate).
The other ingredients are: anhydrous trisodium phosphate, hydroxypropylcellulose, xanthan gum, cherry flavor, vanilla cream flavor (contains butter-derived acids with traces of milk proteins), banana flavor, sucrose (see section “Zitromax 200 mg/5 ml powder for oral suspension contains sucrose”).

Description of the appearance of Zitromax and contents of the pack
Zitromax tablets are available in PVC/Al blisters, pack containing 3 tablets of 500 mg.
Zitromax oral suspension powder is available in a polyethylene bottle containing 1500 mg of azithromycin, with child-resistant closure and appropriate dosing device. After reconstitution, the suspension will contain 200 mg/5 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47.600 – Borgo San Michele
04100 Latina
Italy

Patient Information Leaflet

Zitromax 250 mg hard capsules

Azithromycin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist. See section 4.
Contents of this leaflet

What Zitromax is and what it is used for
What you need to know before taking Zitromax
How to take Zitromax
Possible side effects
How to store Zitromax
Contents of the pack and other information

1. What Zitromax is and what it is used for

Zitromax contains the active substance azithromycin, an azalide antibiotic belonging to the group of antibiotics known as "macrolides". Azithromycin inhibits the growth of susceptible bacteria.
Zitromax is indicated in adults for the treatment of the following infections (caused by microorganisms sensitive to azithromycin):

upper respiratory tract infections, including sinus inflammation (sinusitis), tonsil inflammation (tonsillitis), and throat inflammation (pharyngitis),
lower respiratory tract infections, including bronchitis and pneumonia,
ear infections (acute otitis media),
mouth and oesophageal infections (odontostomatological infections),
skin and soft tissue infections,
genital infections caused by Chlamydia trachomatis and Haemophilus ducreyi (sexually transmitted infections).

2. What you need to know before taking Zitromax

Do not take Zitromax
if you are allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", or to
any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Zitromax:

if you have or have ever had liver problems, or if you are taking or have recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax”). In such cases, caution is required before starting treatment with Zitromax;
if you are being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax”);
if you have kidney problems (renal failure);
if you suffer from heart rhythm disorders. Zitromax may cause mild disturbances in heart rhythm, which in some cases may be fatal (see section 4 “Possible side effects”). Therefore, this medicine should be used with caution:
in patients with congenital heart rhythm abnormalities, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm disorders), cisapride (medicine for gastric reflux into the oesophagus), terfenadine (medicine for allergies), pimozide (medicine for mental disorders), citalopram (medicine for depression), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low levels of potassium or magnesium in the blood;
in elderly patients and in women. Inform your doctor if any of the following conditions occur or worsen during treatment with Zitromax (also see section 4 “Possible side effects”):
severe allergic reactions, including severe skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, stop treatment with Zitromax immediately and contact your doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark urine, easy bleeding, or brain-related symptoms (e.g. mental confusion, altered level of consciousness, or coma). Stop treatment with Zitromax immediately and contact your doctor, who will perform medical tests to assess your liver function;
vomiting or irritability in your infant (if a newborn within the first 42 days of life) occurring after breastfeeding. This medicine may cause narrowing of a portion of the stomach. If these symptoms occur, contact your child’s doctor immediately;
signs of new infections or persistence of symptoms of the current infection. This situation could be caused by bacteria not sensitive to Zitromax (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
onset of diarrhoea, which may be mild but in some cases may be fatal (fatal colitis). Diarrhoea may occur with the use of almost all antibiotics, including Zitromax, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will carefully monitor you, as Clostridium difficile infection may occur up to two months after stopping treatment with this medicine;
onset or worsening of muscle weakness and easy fatigability, i.e. symptoms of myasthenia gravis.

Other medicines and Zitromax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Inform your doctor if you are taking any of the following medicines, as caution is required:

antacids (medicines for stomach acidity). If you are taking both antacids and Zitromax, do not take these two medicines at the same time;
digoxin (used to treat heart failure). If taken together with Zitromax, the digoxin dose must be closely monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (medicine for HIV virus infections);
ergotamine (medicine for migraine). Concomitant use with Zitromax is not recommended, as it may cause disturbances in blood circulation, especially in the fingers and toes (ergotism crisis);
statins (medicines to lower blood lipid levels). Concomitant use with Zitromax may cause breakdown of muscle cells (rhabdomyolysis);
ciclosporin (medicine to prevent organ transplant rejection). If taken together with Zitromax, the ciclosporin dose must be closely monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax may increase the anticoagulant effect of these medicines. Zitromax must not be taken together with other medicines that may affect heart rhythm (see section “Warnings and precautions”).

Zitromax with food and drink
Take this medicine at least 1 hour before or 2 hours after meals.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding
with breast milk, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring
that the benefits outweigh the potential risks.
Breastfeeding
Zitromax passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe this
medicine only if strictly necessary.
Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.
Zitromax contains lactose
Zitromax contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.
Zitromax contains sodium
Zitromax 250 mg hard capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e.
essentially 'sodium-free'.

3. How to take Zitromax

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

For the treatment of infections of the upper and lower respiratory tract (sinusitis, tonsillitis, pharyngitis, bronchitis, and pneumonia), skin and soft tissue infections, and odontostomatological infections: the recommended dose is 500 mg once daily, for 3 consecutive days.
For the treatment of sexually transmitted infections caused by susceptible strains of Chlamydia trachomatis or Haemophilus ducreyi: the recommended dose is 1000 mg, taken as a single oral dose.

Special patients
If you are elderly or have mild to moderate liver problems or kidney problems, your doctor may prescribe the same dosages indicated above.

How to take the capsules
Swallow the capsules whole with a glass of water. Take the capsules at least 1 hour before or 2 hours after meals.

If you take more Zitromax than you should
If you take an excessive dose of this medicine, the possible side effects will be the same as those you might experience after taking a correct dose. If you have taken more medicine than you should, inform your doctor immediately.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the final part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
serious skin reactions:
severe rash associated with an increase in a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with formation of pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
serious liver problems (severe hepatic failure), as they may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea

Common (may affect up to 1 in 10 people):

headache
vomiting
abdominal pain
nausea
decrease in the amount of bicarbonate in the blood
decrease in the number of a type of white blood cells called lymphocytes
increase in the number of a type of white blood cells called eosinophils
increase in the number of a type of white blood cells called basophils
increase in the number of a type of white blood cells called monocytes
increase in the number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection caused by Candida (a fungus)
infection by microorganisms called "fungi"
infection by microorganisms called "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decrease in the number of white blood cells in the blood (leucopenia)
decrease in the number of a type of white blood cells called neutrophils (neutropenia)
increase in a type of white blood cells called eosinophils (eosinophilia)
decreased or loss of appetite
nervousness
insomnia
dizziness
drowsiness
altered sensation in various parts of the body
distortion or decreased ability to taste
vision disorders
ear disorders
vertigo
heightened perception of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleed (epistaxis)
constipation
gas production in the intestine
stomach disorders
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
belching
mouth ulcers
increased saliva production
skin rashes
itching
urticaria
dermatitis
dry skin
excessive sweating
arthralgia
muscle pain
back pain
neck pain
pain when urinating
kidney pain
abnormal, heavy and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
fatigue
facial swelling
chest pain
fever
pain
swelling of legs and feet
abnormal laboratory tests assessing liver function
increased amount of bilirubin in the blood (a substance produced by the liver)
increased amount of urea in the blood (a substance produced by the liver)
increased amount of creatinine in the blood (a substance produced by muscles)
changes in the levels of potassium and sodium in the blood (mineral salts)
increased amount of alkaline phosphatase in the blood (a substance produced in various body tissues)
increased amount of chloride in the blood (a mineral salt)
increased amount of glucose (a sugar) in the blood
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased amount of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

restlessness
altered liver function
yellowish discoloration of the skin and mucous membranes (jaundice)
increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known (frequency cannot be estimated from the available data):

decrease in the number of platelets in the blood
seizures
reduced sensitivity of any body area to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
total or partial loss of the ability to smell
total loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
ringing in the ears
increased heart rate caused by a specific heart rhythm abnormality (arrhythmia) called "torsades de pointes"
disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation) which can be detected by an examination called "electrocardiogram"
decrease in blood pressure (hypotension)
change in tongue colour
joint pain
serious kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zitromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax contains
The active substance is azithromycin (as azithromycin dihydrate).
Each hard capsule contains 250 mg of azithromycin (equivalent to 262.05 mg of azithromycin dihydrate).
The other components are: anhydrous lactose (see section “Zitromax contains lactose”), maize starch, magnesium stearate, sodium lauryl sulfate.
Hard capsules: gelatin, titanium dioxide.

Description of the appearance of Zitromax and contents of the pack
The hard capsules of Zitromax are available in PVC blisters, pack containing 6 capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47.600 – Borgo San Michele
04100 Latina

Patient Information Leaflet

Zitromax 500 mg powder for solution for infusion

Azithromycin
Please read this leaflet carefully before this medicine is administered because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Zitromax is and what it is used for
What you need to know before Zitromax is administered to you
How Zitromax will be administered to you
Possible side effects
How to store Zitromax
Contents of the pack and other information

1. What Zitromax is and what it is used for

Zitromax contains the active substance azithromycin, an azalide antibiotic belonging to a group of
antibiotics called "macrolides". Azithromycin inhibits the growth of susceptible bacteria.
Zitromax is indicated in adults and children aged over 16 years who require initial
intravenous (into a vein) therapy for the treatment of the following infections (caused by organisms
susceptible to azithromycin):

Pneumonia (inflammation of the lungs), including community-acquired Legionnaires' disease (caused by Legionella pneumophila)
Inflammation of the ovary

2. What you should know before being given Zitromax

You must not be given Zitromax
if you are allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
This medicine is only available in a hospital setting. Therefore, it will be administered to you
exclusively under close supervision by qualified medical personnel.

In particular, before you are given Zitromax, inform your doctor:

if you have or have ever had liver problems, or if you are currently taking or have recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax”). In such cases, caution is required before starting treatment with Zitromax;
if you are being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax”);
if you have kidney problems (renal insufficiency);
if you suffer from heart rhythm disorders. Zitromax may cause mild disturbances in heart rhythm, which in some cases may be fatal (see section 4 “Possible side effects”). Therefore, this medicine must be used with caution:
in patients with congenital heart rhythm disorders, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients receiving other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm abnormalities), cisapride (a medicine for gastroesophageal reflux), terfenadine (an antihistamine), pimozide (a medicine for mental disorders), citalopram (an antidepressant), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low levels of potassium or magnesium in the blood;
in elderly patients and in women. Inform your doctor if any of the following conditions appear or worsen during treatment with Zitromax (also see section 4 “Possible side effects”):
severe allergic reactions, including serious skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, stop treatment with Zitromax immediately and contact your doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark-colored urine, easy bruising or bleeding, or neurological symptoms (e.g. confusion, altered consciousness, or coma). Stop treatment with Zitromax immediately and contact your doctor, who will perform medical tests to assess your liver function;
vomiting or irritability in your infant (if a newborn within the first 42 days of life) occurring after breastfeeding. This medicine may cause narrowing of a portion of the stomach. If these symptoms occur, contact your child’s doctor immediately;
signs of new infections or persistence of symptoms from the current infection. This may be due to bacteria not sensitive to Zitromax (resistant bacteria) or to non-bacterial microorganisms (fungal infection);
onset of diarrhoea, which may be mild but in some cases can be fatal (fatal colitis). Diarrhoea may occur with the use of almost all antibiotics, including Zitromax, and is due to disruption of the normal intestinal bacterial flora, allowing overgrowth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will closely monitor you, as Clostridium difficile infection may occur up to two months after completion of treatment with this medicine;
onset or worsening of muscle weakness and easy fatigability, i.e. symptoms of myasthenia gravis.

Children and adolescents
Currently, there is no information available on the efficacy and safety of Zitromax powder for solution
for infusion in children under 16 years of age.

Other medicines and Zitromax
Inform your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines.
Inform your doctor if you/your child are taking any of the following medicines, as caution is required:

digoxin (used to treat heart failure). If taken together with Zitromax, the digoxin dose must be carefully monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (a medicine for HIV infections);
ergotamine (used for migraine). Concomitant use with Zitromax is not recommended, as it may cause circulatory disturbances, especially in the fingers and toes (ergotism crisis);
statins (medicines to lower blood lipid levels). Concomitant use with Zitromax may cause muscle cell breakdown (rhabdomyolysis);
cyclosporine (a medicine to prevent organ transplant rejection). If taken together with Zitromax, the cyclosporine dose must be carefully monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax may increase the anticoagulant effect of these medicines.

Zitromax must not be taken together with other medicines that may affect heart rhythm
(see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will decide whether to administer this medicine during pregnancy, only after confirming
that the benefits outweigh the potential risks.

Breastfeeding
Zitromax passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe this
medicine only if strictly necessary.

Driving and using machines
It is not known whether this medicine affects the ability to drive vehicles or operate machinery.

Zitromax contains sodium
This medicine contains 114 mg of sodium (a main component of table salt) per vial. This corresponds to 5.7% of the maximum daily dietary intake recommended for an adult.
This medicine may be prepared with a solution containing sodium. This should be further considered if you are on a low-salt (low-sodium) diet.

3. How Zitromax will be administered to you

This medicine is available only in hospital. Therefore, this medicine will be administered intravenously under the strict supervision of qualified medical personnel.
The appropriate dose will be determined by your doctor depending on the illness, but the recommended doses are generally:

For the treatment of pneumonia: The recommended dose is 500 mg of powder for infusion solution once daily for at least 2 days. After completion of intravenous treatment, your doctor will prescribe 500 mg of azithromycin orally once daily until a total treatment duration of 7–10 days is reached. Your doctor will decide the best time to switch from intravenous to oral administration.
For the treatment of ovarian inflammation: The recommended dose is 500 mg of powder for infusion solution once daily for 1–2 days.

After completion of intravenous treatment, your doctor will prescribe 250 mg of azithromycin orally once daily for up to 7 days of treatment.
Your doctor will decide the best time to switch from intravenous to oral administration.

Use in children and adolescents
Currently, there is no information available on the efficacy and safety of Zitromax powder for infusion solution in children under 16 years of age.
For children above 16 years of age, the same doses as for adults should be used.

Special patient populations
If you are elderly or have mild to moderate liver problems or kidney problems, your doctor may prescribe the same dosages as listed above.

If more Zitromax is administered than intended
It is highly unlikely that an excessive dose of Zitromax will be administered, as your doctor will monitor you/your child during treatment.
However, if an overdose of Zitromax is administered, your doctor will initiate appropriate supportive therapy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have occurred after taking Zitromax.
STOP using Zitromax immediately if you experience any of the following side effects:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the last part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
severe skin reactions:
severe skin rash associated with an increase in a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
severe liver problems (severe hepatic failure), as these may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea

Common (may affect up to 1 in 10 people):

headache
vomiting
abdominal pain
nausea
pain at injection site
inflammation at injection site
decrease in the amount of bicarbonate in the blood
decrease in the number of a type of white blood cells called lymphocytes
increase in the number of a type of white blood cells called eosinophils
increase in the number of a type of white blood cells called basophils
increase in the number of a type of white blood cells called monocytes
increase in the number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection caused by Candida (a fungus)
infection caused by microorganisms known as "fungi"
infection caused by microorganisms known as "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decrease in the number of white blood cells in the blood (leucopenia)
decrease in the number of a type of white blood cells called neutrophils (neutropenia)
increase in a type of white blood cells called eosinophils (eosinophilia)
decreased or absent appetite
nervousness
insomnia
dizziness
somnolence
altered sensation in various parts of the body
distortion or reduction in the ability to taste
visual disturbances
ear disorders
vertigo
increased awareness of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleed (epistaxis)
constipation
gas production in the intestine
stomach disorders
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
belching
mouth ulcers
increased saliva production
skin rashes
itching
urticaria
dermatitis
dry skin
excessive sweating
arthralgia
muscle pain
back pain
neck pain
pain when urinating
kidney pain
abnormal, heavy and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
fatigue
facial swelling
chest pain
fever
swelling of legs and feet
abnormal liver function tests
increased amount of bilirubin in the blood (a substance produced by the liver)
increased amount of urea in the blood (a substance produced by the liver)
increased amount of creatinine in the blood (a substance produced by the muscles)
changes in the levels of potassium and sodium in the blood (mineral salts)
increased amount of chloride in the blood (mineral salt)
increased amount of glucose (a sugar) in the blood
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased amount of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

restlessness
altered liver function
yellowing of the skin and mucous membranes (jaundice)
increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known (frequency cannot be estimated from the available data):

decreased number of platelets in the blood
seizures
reduced sensitivity of any body area to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
complete or partial loss of the ability to smell
complete loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
ringing in the ears
increased heart rate due to a specific heart rhythm abnormality (arrhythmia) called "torsades de pointes"
disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by a test called "electrocardiogram"
decrease in blood pressure (hypotension)
change in tongue colour
joint pain
severe kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zithromax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax contains
The active substance is azithromycin (as azithromycin dihydrate).
Each vial contains 500 mg of azithromycin (equivalent to 524.1 mg of azithromycin dihydrate).
The other components are: anhydrous citric acid, sodium hydroxide.

Description of the appearance of Zitromax and contents of the pack
The powder is contained in a single-use 10 ml glass vial sealed with a butyl rubber stopper and an aluminum cap.
Each pack contains 1 vial.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Fareva Amboise
Zone Industrielle - 29 route des Industries
37530 Pocé-sur-Cisse
France

The following information is intended exclusively for healthcare professionals or medical personnel:
Instructions for administration
ZITROMAX powder for solution for infusion must be administered intravenously after reconstitution and dilution.
The concentration of the solution and duration of infusion should be: 1 mg/ml over 3 hours or 2 mg/ml over 1 hour.
ZITROMAX powder for solution for infusion must not be administered as an intravenous bolus or by intramuscular injection.

Reconstitution
The initial solution should be prepared by adding 4.8 ml of water for injections to the vial containing the powder. Shake the vial until the powder is completely dissolved. It is recommended to use a standard 5 ml syringe to accurately withdraw 4.8 ml of sterile water for injection. Each 1 ml of reconstituted solution contains 100 mg of azithromycin.

Parenteral medications should be carefully inspected for particulate matter in the solution. If particles are visible, the solution must be discarded.

The reconstituted solution must be diluted before administration according to the instructions below.

Dilution
To obtain a final azithromycin concentration of 1.0–2.0 mg/ml, withdraw 5 ml of the reconstituted solution (concentration 100 mg/ml) from the vial and add it to the appropriate volume of one of the following infusion solutions:

Sodium chloride 0.9% solution (normal saline)
Sodium chloride 0.45% solution
Ringer Lactate
5% Dextrose in water
5% Dext游戏副本

Zitromax Avium 600 mg film-coated tablets

Azithromycin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their
symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this
leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What Zitromax Avium is and what it is used for
What you need to know before taking Zitromax Avium
How to take Zitromax Avium
Possible side effects
How to store Zitromax Avium
Contents of the pack and other information

1. What Zitromax Avium is and what it is used for

Zitromax Avium contains the active substance azithromycin, an azalide antibiotic belonging to a group
of antibiotics known as "macrolides". Azithromycin inhibits the growth of susceptible bacteria.
Zitromax Avium is indicated in adults and elderly patients with advanced HIV (AIDS) infection for:

preventing infections caused by the bacterium Mycobacterium avium complex (MAC). Zitromax Avium can be used alone or in combination with rifabutin, another antibiotic;
treating disseminated systemic infections caused by the bacterium Mycobacterium avium complex (MAC). Zitromax Avium must be used in combination with ethambutol, another antibiotic.

2. What you need to know before taking Zitromax Avium

Do not take Zitromax Avium
if you are allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", or to
any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Zitromax Avium:

if you have or have ever had liver problems, or if you are taking or have recently taken other medicines that may cause liver problems (see section “Other medicines and Zitromax Avium”). In these cases, caution is required before starting treatment with Zitromax Avium;
if you are being treated with ergotamine or its derivatives (see section “Other medicines and Zitromax Avium”);
if you have kidney problems (renal failure);
if you suffer from heart rhythm disorders. Zitromax Avium may also cause mild disturbances in heart rhythm, but in some cases these may be fatal (see section 4 “Possible side effects”). Therefore, this medicine should be used with caution:
in patients with congenital heart rhythm abnormalities, very slow heart rate (bradycardia), heart rhythm disorders (arrhythmias), or severe heart problems (severe heart failure);
in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm disorders), cisapride (a medicine for gastroesophageal reflux), terfenadine (an antihistamine), pimozide (a medicine for mental disorders), citalopram (a medicine for depression), moxifloxacin, levofloxacin, chloroquine (antibiotics);
in patients with low levels of potassium and magnesium in the blood;
in elderly patients and women. Inform your doctor if any of the following conditions occur or worsen during treatment with Zitromax Avium (also see section 4 “Possible side effects”):
severe allergic reactions, including serious skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, stop immediately taking Zitromax Avium and contact your doctor;
symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark-colored urine, easy bleeding, or neurological symptoms (e.g. mental confusion, altered consciousness, or coma). Stop immediately taking Zitromax Avium and contact your doctor, who will perform medical tests to assess your liver function;
vomiting or irritability in your infant (if it is a newborn within the first 42 days of life) occurring after breastfeeding. This medicine may cause narrowing of a part of the stomach. If these symptoms occur, contact immediately the doctor treating your baby;
symptoms of new infections or persistence of symptoms from the current infection. This situation could be caused by bacteria not sensitive to Zitromax Avium (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
onset of diarrhea, which may be mild but in some cases can be fatal (fatal colitis). Diarrhea may occur with the use of nearly all antibiotics, including Zitromax Avium, and is due to disruption of the normal intestinal bacterial flora, allowing overgrowth of a bacterium called Clostridium difficile. If diarrhea occurs, your doctor will carefully monitor you, as Clostridium difficile infection may occur up to two months after stopping treatment with this medicine;
onset or worsening of muscle weakness and easy fatigability, i.e. symptoms of myasthenia gravis.

Children
Currently, there is no information available on the efficacy and safety of Zitromax Avium in children.
Other medicines and Zitromax Avium
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Inform your doctor if you are taking any of the following medicines, as caution is required:

antacids (medicines for stomach acidity). If you are taking both antacids and Zitromax Avium, you should not take these two medicines at the same time;
digoxin (used for treatment of heart failure). If taken together with Zitromax Avium, the dose of digoxin must be carefully monitored;
colchicine (used for gout and familial Mediterranean fever);
zidovudine (a medicine for HIV infections);
ergotamine (a medicine for migraine). Concomitant use with Zitromax Avium is not recommended, as it may cause disturbances in blood circulation, especially in the fingers of the hands and feet (ergotism crisis);
statins (medicines to lower blood lipid levels). Concomitant use with Zitromax Avium may cause breakdown of muscle cells (rhabdomyolysis);
cyclosporine (a medicine to prevent organ transplant rejection). If taken together with Zitromax Avium, the dose of cyclosporine must be carefully monitored;
oral anticoagulants of the coumarin type (e.g. warfarin). Concomitant use with Zitromax Avium may increase the anticoagulant effect of these medicines.

Zitromax Avium should not be taken together with other medicines that may affect heart rhythm (see section “Warnings and precautions”).
Zitromax Avium with food and drink
Zitromax Avium can be taken either with or without food. It is preferable to take this medicine with food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.
Breastfeeding
Zitromax Avium passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe this medicine only if strictly necessary.
Driving and using machines
It is not known whether this medicine affects the ability to drive or use machinery.
Zitromax Avium contains lactose
Zitromax Avium contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Zitromax Avium contains sodium
Zitromax Avium contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Zitromax Avium

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

To prevent infections caused by the bacterium Mycobacterium avium complex (MAC) in adult and elderly patients infected with HIV virus

The recommended dose is 2 tablets taken together once a week.

To treat disseminated infections caused by the bacterium Mycobacterium avium complex (MAC) in adult and elderly patients affected by HIV virus

The recommended dose is 1 tablet once daily.

How to take the tablets
Swallow the tablets whole, or split them in half if you have difficulty swallowing. Take the tablets with a glass of water as a single daily dose. The tablets may be taken with or without food. Taking food before taking the tablet may reduce any stomach or intestinal side effects caused by this medicine.

Special patient groups
If you are elderly, or have mild or moderate liver problems, or have kidney problems, your doctor may prescribe the same doses indicated above.

If you take more Zitromax Avium than you should
If you take an excessive dose of this medicine, the possible side effects will be the same as those you might experience after taking a correct dose. If you have taken more medicine than you should, inform your doctor immediately.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have occurred after taking Zitromax Avium.
STOP the use of Zitromax Avium immediately if you experience the following side effect:

severe acute hypersensitivity reaction affecting the skin and mucous membranes (Stevens-Johnson syndrome)

Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea
abdominal pain
abdominal discomfort
nausea
intestinal gas production
faecal incontinence

Common (may affect up to 1 in 10 people):

decreased or loss of appetite
dizziness
headache
altered sensation in various parts of the body
distortion or reduced ability to taste
visual disturbances
deafness
skin rash
itching
joint pain
fatigue

Uncommon (may affect up to 1 in 100 people):

decreased sensitivity of any body area to stimuli
hearing disorders
ringing in the ears (tinnitus)
heightened awareness of heartbeat
inflammation of the liver (hepatitis)
increased skin sensitivity to sunlight (photosensitivity)
weakness
malaise

The following side effects have occurred after taking other azithromycin-containing medicines,
the same active substance as Zitromax Avium. Therefore, it cannot be ruled out that you may
experience the following side effects after taking Zitromax Avium.
STOP the use of Zitromax Avium immediately if you experience the following side effect:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue, and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
severe inflammation of the last part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
severe skin reactions:
severe rash associated with increased number of a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)
red, scaly rash with pustules and blisters (exanthematous pustulosis) (rare frequency)
severe acute hypersensitivity reactions affecting the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
severe liver problems (severe hepatic failure), which may sometimes lead to death
sudden and massive death of liver cells (fulminant hepatitis)
toxic liver reaction with cell death
anaemia due to destruction of red blood cells
sudden loss of consciousness (syncope)
inflammation of the pancreas (pancreatitis)

Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

diarrhoea

Common (may affect up to 1 in 10 people):

headache
vomiting
abdominal pain
nausea
decreased level of bicarbonate in the blood
decreased number of a type of white blood cells called lymphocytes
increased number of a type of white blood cells called eosinophils
increased number of a type of white blood cells called basophils
increased number of a type of white blood cells called monocytes
increased number of a type of white blood cells called neutrophils

Uncommon (may affect up to 1 in 100 people):

vaginal and/or oral infection with Candida (a fungus)
infection by microorganisms known as "fungi"
infection by microorganisms known as "bacteria"
respiratory disorders
pneumonia
pharyngitis
gastroenteritis
rhinitis
decreased number of white blood cells in the blood (leucopenia)
decreased number of a type of white blood cells called neutrophils (neutropenia)
increased number of a type of white blood cells called eosinophils (eosinophilia)
decreased or loss of appetite
nervousness
insomnia
dizziness
drowsiness
altered sensation in various parts of the body
distortion or reduced ability to taste
visual disturbances
ear disorders
vertigo
heightened awareness of heartbeat
hot flushes
difficulty breathing (dyspnoea)
nosebleed (epistaxis)
constipation
intestinal gas production
stomach discomfort
gastritis
difficulty or pain when swallowing
abdominal swelling
dry mouth
belching
mouth ulcers
increased saliva production
skin eruptions
itching
urticaria
dermatitis
dry skin
excessive sweating
arthrosis
muscle pain
back pain
neck pain
pain when urinating
kidney pain
abnormal, heavy, and prolonged vaginal bleeding
testicular disorders
swelling
weakness
malaise
tiredness
facial swelling
chest pain
fever
pain
swelling of legs and feet
abnormal liver function tests
increased level of bilirubin in the blood (a substance produced by the liver)
increased level of urea in the blood (a substance produced by the liver)
increased level of creatinine in the blood (a substance produced by muscles)
changes in blood levels of potassium and sodium (electrolytes)
increased level of alkaline phosphatase in the blood (a substance produced in various body tissues)
increased level of chloride in the blood (an electrolyte)
increased blood glucose level (a sugar)
increased number of platelets in the blood
decreased number of red blood cells in the blood
increased level of bicarbonate in the blood
complications following medical or surgical procedures

Rare (may affect up to 1 in 1,000 people):

restlessness
altered liver function
yellowing of the skin and mucous membranes (jaundice)
increased skin sensitivity to sunlight (photosensitivity)

Frequency not known (frequency cannot be estimated from the available data):

decreased number of platelets in the blood
seizures
decreased sensitivity of any body area to stimuli
aggression
anxiety
delirium
hallucinations
excessive motor activity and restlessness (psychomotor agitation)
complete or partial loss of the ability to smell
complete loss of the ability to taste
severe muscle weakness (myasthenia gravis)
hearing disorders
deafness
ringing in the ears (tinnitus)
increased heart rate due to a specific heart rhythm abnormality (arrhythmia) called "torsades de pointes"
disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by an electrocardiogram
low blood pressure (hypotension)
change in tongue colour
joint pain
severe kidney problems (acute renal failure, interstitial nephritis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zitromax Avium

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zitromax Avium contains
The active substance is azithromycin (as azithromycin dihydrate).
Each film-coated tablet contains 600 mg of azithromycin (equivalent to 628.93 mg of
azithromycin dihydrate).
The other components are: pregelatinized starch, anhydrous calcium hydrogen phosphate, sodium carmellose,
magnesium stearate, sodium lauryl sulfate.
Coating film: titanium dioxide, lactose (see section “Zitromax Avium contains lactose”),
hypromellose, triacetin.
Description of the appearance of Zitromax Avium and pack contents
Zitromax Avium tablets are oval, film-coated, white to off-white tablets, engraved with “ZTM 600” on one side and “PFIZER” on the other.
Zitromax Avium tablets are available in PVC/Al blisters, in packages containing 8 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47.600 – Borgo San Michele
04100 Latina