Macrozit

Package leaflet: Information for the patient

MACROZIT

“500 mg film-coated tablets”
Azithromycin dihydrate
Generic medicine
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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MACROZIT is and what it is used for
2. What you need to know before taking MACROZIT
3. How to take MACROZIT
4. Possible side effects
5. How to store MACROZIT
6. Contents of the pack and other information

1. What MACROZIT is and what it is used for

MACROZIT contains azithromycin, an antibiotic used to treat infections caused by susceptible bacteria.

• Sinus infections (sinusitis),
• Ear infections (otitis media),
• Tonsil and throat infections (tonsillitis and pharyngitis),
• Lower respiratory tract infections (including bronchitis and pneumonia),
• Mouth and dental infections (odontostomatological),
• Skin and soft tissue infections, sexually transmitted infections (urethritis due to Chlamydia trachomatis and chancroid due to Haemophilus ducreyi).

2. What you need to know before taking MACROZIT

Do not take MACROZIT
If you are allergic to azithromycin, erythromycin, antibiotics similar to these (macrolides or ketolides), 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 MACROZIT:

• 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 MACROZIT”). In such cases, caution is required before starting treatment with MACROZIT;
• if you are being treated with ergotamine or its derivatives (see section “Other medicines and MACROZIT”);
• if you have kidney problems (severe renal failure);
• if you suffer from heart rhythm disorders. MACROZIT may also cause mild changes 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 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 antiallergic medicine), 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 MACROZIT (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 MACROZIT 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 brain-related symptoms (e.g., mental confusion, altered level of consciousness, or coma). Stop treatment with MACROZIT immediately and contact your doctor, who will perform medical tests to evaluate 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 your child’s doctor immediately;
• symptoms of new infections or persistence of symptoms from the current infection. This situation could be caused by bacteria not sensitive to MACROZIT (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, which may be mild but in some cases may lead to death (fatal colitis). Diarrhea may occur with the use of almost all antibiotics, including MACROZIT, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If diarrhea 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.

Other medicines and MACROZIT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
In particular, inform your doctor if you are taking:

• Cimetidine and antacids (medicines used to treat stomach disorders). If you are taking both antacids and MACROZIT, do not take these two medicines at the same time.
• Cetirizine and terfenadine (antihistamines, used to treat allergies).
• Didanosine, Zidovudine, Efavirenz, Indinavir, Nelfinavir (used in HIV therapy).
• Rifabutin (an antibiotic used to treat tuberculosis).
• Digoxin (used to treat heart problems). If taken together with MACROZIT, the digoxin dose must be carefully monitored.
• Ergotamine (used to treat migraine headaches). Concomitant use with MACROZIT is not recommended, as it may cause disturbances in blood circulation, especially in the fingers and toes (ergotism crisis);
• Statins (used to lower blood cholesterol levels). Concomitant use with MACROZIT is not recommended, as it may cause muscle cell breakdown (rhabdomyolysis).
• Carbamazepine (used in the treatment of epilepsy).
• Oral anticoagulants of the coumarin type (e.g., warfarin). Concomitant use with MACROZIT may increase the anticoagulant effect of these medicines. Cyclosporine (used to regulate immune system function in transplant patients). If taken together with MACROZIT, the cyclosporine dose must be carefully monitored.
• Methylprednisolone (used to regulate immune system function).
• Fluconazole (used to treat fungal infections).
• Midazolam and Triazolam (sedatives).
• Hydroxychloroquine (used to treat certain diseases such as rheumatoid arthritis and malaria).
• Sildenafil (used to treat erectile dysfunction).
• Theophylline (used to treat asthma).
• Trimethoprim/sulfamethoxazole (a combination of antibiotics).
• Colchicine (used for gout and familial Mediterranean fever).

MACROZIT with food and drink
MACROZIT can be taken with or without food. However, it is preferable to take this medicine with food.

Fertility, pregnancy, and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.

Fertility
Fertility studies conducted in rats showed a reduced number of pregnancies
after administration of azithromycin. The relevance of these findings to humans is unknown.

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

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

Driving and using machines
There are no data indicating that azithromycin may affect the ability of patients to
drive vehicles or operate machinery.

MACROZIT contains lactose
This medicine contains lactose (milk sugar). If your doctor has diagnosed you with an
intolerance to certain sugars, contact them before taking this medicine.

MACROZIT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take MACROZIT

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• infections of the mouth and teeth (odontostomatological),
• skin and soft tissue infections,
• sexually transmitted infections (urethritis due to Chlamydia trachomatis and chancroid due to Haemophilus ducreyi).

Adults
For the treatment of sinus infections (sinusitis), ear infections (otitis media), tonsil infections (tonsillitis), throat infections (pharyngitis), lower respiratory tract infections (bronchitis and pneumonia), and skin and soft tissue infections: 500 mg once daily for three consecutive days.
For the treatment of sexually transmitted infections (urethritis due to Chlamydia trachomatis and chancroid due to Haemophilus ducreyi): a single oral dose of 1000 mg taken once.

Children
For children weighing 45 kg or more, the same adult dosage may be used (500 mg/day for three consecutive days).
The maximum recommended total dose for any pediatric treatment is 1500 mg.
The medicine should always be administered as a single daily dose.

Special patients
If you are elderly or have mild to moderate liver problems or kidney problems, your doctor may prescribe the same doses indicated above.
MACROZIT can be taken regardless of food intake, either on an empty stomach or after meals. Taking food before administration of the medicine may reduce any gastrointestinal side effects.
The tablets must be swallowed whole.

If you take more MACROZIT than you should
In case of accidental ingestion or overdose of MACROZIT, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use MACROZIT, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, MACROZIT may cause side effects, although not everyone experiences them.
The following side effects have occurred after taking MACROZIT.
STOP MACROZIT 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 final part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
• severe skin reactions:
• severe skin reaction 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), which may occasionally 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 (cephalalgia)
• Vomiting
• Abdominal pain
• Nausea
• 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
• Decrease in the amount of bicarbonate in the blood

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

• Vaginal and/or oral infections caused by Candida (a fungus)
• Vaginal infection
• Pneumonia
• Infection caused by microorganisms called "fungi"
• Infection caused by microorganisms called "bacteria"
• Pharyngitis
• Gastroenteritis
• Respiratory disorders
• Rhinitis
• Oral candidiasis (oral candidiasis)
• Reduction in the number of white blood cells in the blood (leucopenia)
• Reduction in the number of a type of white blood cells called neutrophils (neutropenia)
• Reduction in the number of a type of white blood cells called eosinophils (eosinophilia)
• Swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing (angioedema)
• Allergy (hypersensitivity)
• Reduced or absent appetite
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Distortion or reduction in the ability to taste
• Sensory disturbances in various parts of the body
• Visual disturbances
• Ear disorders
• Vertigo
• Palpitations (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 bloating
• Dry mouth
• Belching
• 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
• Abnormal, heavy and prolonged vaginal bleeding
• Testicular disorders
• Fluid retention (oedema)
• Weakness
• Malaise
• Fatigue
• Facial swelling
• Chest pain
• Fever
• Pain
• Swelling of legs and feet
• Abnormal liver function tests
• Increased blood bilirubin levels (a substance produced by the liver)
• Increased blood urea levels (a substance produced by the liver)
• Increased blood creatinine levels (a substance produced by the muscles)
• Changes in blood potassium and sodium levels
• Increased blood alkaline phosphatase levels (a substance produced in various body tissues)
• Increased blood chloride levels (a mineral salt)
• Increased blood glucose levels (a sugar)
• Increased number of platelets in the blood
• Decreased number of red blood cells in the blood
• Increased blood bicarbonate levels
• Complications following medical or surgical procedures

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

• Agitation
• Altered liver function
• Yellowish discoloration of the skin and mucous membranes (jaundice)
• Increased sensitivity of the skin to sunlight (photosensitivity)
• Severe allergic reaction (DRESS)
• Acute generalised exanthematous pustulosis (AGEP)

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

• Severe diarrhoea caused by antibiotics (pseudomembranous colitis)
• Reduced number of platelets in the blood
• Destruction of red blood cells (haemolytic anaemia)
• Severe allergic reaction (anaphylactic reaction)
• Aggressiveness
• Anxiety
• Delirium
• Hallucinations
• Loss of consciousness (syncope)
• Seizures
• Reduced sensitivity of any body area to stimuli
• Excessive motor activity and restlessness (psychomotor agitation)
• Loss of the ability to smell
• Complete loss of the ability to taste
• Disturbance of smell (parosmia)
• Severe muscle weakness (myasthenia gravis)
• Hearing disorders including deafness
• Ringing in the ears (tinnitus)
• Increased heart rate due to a specific cardiac rhythm abnormality (arrhythmia) called "torsades de pointes"
• Disorders of 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)
• Inflammation of the pancreas (pancreatitis)
• Change in tongue colour
• Severe allergic reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• Severe kidney problems
• Acute kidney failure
• Interstitial nephritis
• Liver failure (rarely fatal)
• Severe liver disorder (fulminant hepatitis)
• Death of liver cells (hepatic necrosis)
• Joint pain (arthralgia)

Reporting of side effects
If you 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 MACROZIT

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 the wording
EXP.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any signs of deterioration.
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 MACROZIT contains
The active substance is azithromycin dihydrate 524.1 mg, equivalent to azithromycin 500 mg.
The other components are:
Tablet core: anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, magnesium stearate.
Coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), monohydrate lactose.
Description of the appearance of MACROZIT and package contents
Film-coated tablets.
Blister pack containing 3 film-coated tablets of 500 mg.
MARKETING AUTHORISATION HOLDER
S.F. GROUP S.r.l.
Via Tiburtina, n. 1143 - 00156 Roma
MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, n° 1 - 03012 Anagni (FR)
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino
S.S. Zona Industriale - 73010 – Zollino (Lecce)