Azithromycin Krka: detailed information

Package leaflet: Information for the patient

Azithromycin Krka 250 mg film-coated tablets, 500 mg film-coated tablets

Azithromycin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as 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 any not listed in this leaflet, tell your doctor or pharmacist. (See section 4).

Contents of this leaflet:

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

1. What Azitromicina Krka is and what it is used for

Azithromycin, the active substance of Azitromicina Krka, belongs to the group of antibiotics known as macrolides.
It is used to treat certain bacterial infections, including:

acute bacterial sinus infections,
acute bacterial ear infections,
tonsillitis, pharyngitis,
acute bacterial exacerbation of chronic bronchitis,
mild to moderately severe pneumonia,
mild to moderately severe skin and soft tissue infections, e.g. folliculitis, cellulitis, erysipelas,
infection of the tube that carries urine from the bladder (urethra) or of the cervix (cervix) caused by bacteria called Chlamydia trachomatis.

2. What you need to know before taking Azithromycin Krka

Do not take Azithromycin Krka:

if you are allergic to azithromycin or to other macrolides (such as erythromycin or clarithromycin), to ketolide antibiotics, 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 Azithromycin Krka:

if you have certain heart conditions (e.g. serious heart problems, “prolonged QT interval”) or if you are taking medicines that cause changes in the heart's electrical activity, such as cisapride (used to increase intestinal motility);
if you have a slow or irregular heartbeat;
if you have abnormal levels of electrolytes in your blood, especially low levels of magnesium and potassium;
if you are taking other medicines that cause abnormal changes in the ECG (see section “Other medicines and Azithromycin Krka”);
if you have severe kidney problems;
if you have severe liver problems: your doctor may need to monitor your liver function or discontinue treatment;
if you develop a new infection (which may be a sign of excessive growth of resistant organisms);
if you have neurological or psychiatric conditions.

Rarely, severe hypersensitivity reactions with swelling of the face, mouth, and throat (sometimes fatal) have been reported. If these symptoms occur, stop taking Azithromycin Krka and contact your doctor immediately.
Antibiotics may cause diarrhoea, which could be a sign of a serious intestinal inflammation. If you have watery or bloody diarrhoea, contact your doctor. Do not use medicines to stop diarrhoea unless your doctor has told you to do so.
Children and adolescents
Film-coated tablets of Azithromycin Krka are not suitable for neonates and children (under 2 years of age) and for children and adolescents (up to 17 years of age) with a body weight below 45 kg.
Information regarding the administration of Azithromycin Krka in children and adolescents above 45 kg is provided in section 3 “How to take Azithromycin Krka”.
Other medicines and Azithromycin Krka Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor or pharmacist if you are taking:

medicines known as ergot derivatives, e.g. ergotamine or dihydroergotamine (medicines used for migraine or to reduce blood flow), as these should not be taken together with Azithromycin Krka;
cyclosporine (a medicine used for skin conditions, rheumatoid arthritis, or after organ transplantation);
atorvastatin (for treatment of high cholesterol levels in the blood);
cisapride (used to treat stomach problems);
theophylline (for respiratory problems);
warfarin or other medicines used to thin the blood;
digoxin (for heart problems);
colchicine (used for gout and familial Mediterranean fever);
zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections);
rifabutin (for HIV infections or treatment of tuberculosis);
terfenadine (a medicine used to treat allergies);
fluconazole (for treatment of fungal infections);
medicines known as antacids (medicines that neutralize gastric acid). Your Azithromycin Krka tablets should be taken at least 1 hour before or 2 hours after taking antacids;
astemizole (a medicine used to treat allergies), alfentanil (a painkiller).

Azithromycin Krka with food and drink
The tablets should be taken with water.
You may take the medicine with or without food, as food does not affect the absorption of azithromycin.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy or breastfeeding unless you have discussed it with your doctor.
Driving and using machines
This medicine may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery.
Azithromycin Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to take Azithromycin Krka

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
For adults and children and adolescents with body weight equal to or greater than 45 kg:

Indication	Dosage
acute bacterial sinus infections, -acute bacterial ear infections, -tonsillitis, pharyngitis, -acute bacterial exacerbation of chronic bronchitis, -mild to moderately severe community-acquired pneumonia, -mild to moderately severe skin and soft tissue infections	500 mg once daily for three days, for a total dose of 1500 mg, or -500 mg as a single dose on day 1 and 250 mg once daily on days 2-5, for a total dose of 1500 mg
cervical and urethral infections caused by Chlamydia trachomatis	1000 mg as a single dose

Children and adolescents with body weight below 45 kg
The tablets are not recommended. Children and adolescents with a body weight of less than 45 kg
should use other pharmaceutical forms containing azithromycin.

Patients with kidney or liver problems
You must inform your doctor if you have liver or kidney problems, as your doctor may need
to adjust the usual dose.

Dosing for elderly patients
For elderly patients, the same dosage as for adults applies.

Administration
Swallow the tablets whole with some water.
You may take the medicine with or without food, as this does not affect the absorption
of azithromycin.

If you take more Azitromicina Krka than you should
It is important to follow the dose prescribed by your doctor. If you or someone else ingests more
tablets at the same time, or if you think a child has swallowed any tablets,
contact your doctor, pharmacist, or hospital emergency department immediately. Always bring
the remaining tablets and the packaging with you, as this will make identification easier. Symptoms of overdose may include severe nausea, vomiting and diarrhoea, and reversible hearing loss.

If you forget to take Azitromicina Krka
Do not take a double dose to make up for the missed dose. If you forget a dose, take it
as soon as you remember. However, if it is almost time for your next dose, skip the missed
dose and continue with the remaining medication as usual.

If you stop treatment with Azitromicina Krka
Do not stop treatment prematurely. Even if you start to feel better, it is important that you
continue taking your tablets for the full duration prescribed by your doctor.

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. These are usually mild to moderate and stop when treatment is discontinued.
If you experience any of the following side effects, stop taking the tablets and go immediately to your doctor or the nearest hospital emergency department. You may have developed a rare, severe allergic reaction to the tablets:

Swelling of the hands, feet, ankles, face, lips, mouth or throat
Difficulty swallowing or breathing
Severe skin reactions including Stevens-Johnson syndrome (a serious rash) and other severe rashes which may include blistering or peeling (toxic epidermal necrolysis)
Severe and persistent diarrhoea, especially if it contains blood or mucus (this could be pseudomembranous colitis, an inflammation of the intestine)

Other reported side effects are:
Very common (may affect more than 1 in 10 people):

Diarrhoea

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

Headache
Feeling unwell (vomiting), abdominal pain, feeling unwell (nausea)
Changes in the number of white blood cells
Changes in certain blood tests (reduced bicarbonate in the blood)

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

Oral or vaginal fungal infection (candidiasis)
Pneumonia, bacterial throat infection, gastrointestinal tract inflammation, respiratory disorders, inflammation of the mucous membrane inside the nose
Changes in white blood cells (leucopenia, neutropenia, eosinophilia)
Swelling of eyelids, face or lips (angioedema), allergic reactions
Loss of appetite (anorexia)
Nervousness, difficulty sleeping (insomnia)
Dizziness, drowsiness (somnolence), changes in taste sensation (dysgeusia), tingling or numbness (paraesthesia)
Visual disturbances
Ear disorders, sensation of spinning (vertigo)
Awareness of your heartbeat (palpitations)
Hot flushes
Sudden shortness of breath, nosebleeds
Constipation, flatulence, impaired digestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, release of gas from the stomach (eructation), mouth ulceration, increased salivation
Rash, itching, hives, dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
Degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
Difficulty urinating (dysuria), kidney pain
Irregular uterine bleeding (metrorrhagia), testicular disorders
Oedema, weakness, general malaise, facial oedema, chest pain, fever, pain, peripheral oedema
Abnormal laboratory test results (e.g. blood or liver tests)

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

Feeling irritable
Abnormal liver function, yellowing of the skin or eyes
Skin allergic reactions such as increased sensitivity to sunlight
Rash characterized by rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid)

Very rare (may affect up to 1 in 10,000 people):

Drug reaction with eosinophilia (increase in a certain type of white blood cells) and systemic symptoms such as fever and swollen lymph nodes (DRESS syndrome)

Not known (frequency cannot be estimated from available data):

Intestinal (colon) infection (pseudomembranous colitis)
Reduced number of red blood cells due to increased breakdown of cells (haemolytic anaemia); reduced number of platelets
Severe allergic reaction (anaphylactic reaction)
Feeling angry, aggressive, fear and worry (anxiety), acute confusional state (delirium), hallucinations
Fainting (syncope)
Seizures (convulsions)
Reduced sense of touch (hypoesthesia)
Feeling hyperactive
Changes in sense of smell (anosmia, parosmia)
Loss of taste sensation (ageusia)
Muscle weakness (myasthenia gravis)
Life-threatening irregular heartbeat (torsades de pointes), irregular heart ECG trace (prolonged QT interval)
Hearing impairment including deafness or ringing in the ears
Low blood pressure
Inflammation of the pancreas (pancreatitis)
Tongue changes colour
Liver disorders (liver failure, rarely leading to death, hepatic necrosis), inflammation of the liver (hepatitis)
Severe skin allergic reactions (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome)
Joint pain (arthralgia)
Inflammation of the kidneys (interstitial nephritis) and kidney failure

Adverse reactions possibly or probably related to Mycobacterium avium complex (MAC) prophylaxis and treatment (MAC):
Very common (may affect more than 1 in 10 people):

Diarrhoea
Abdominal pain
Feeling unwell (nausea)
Flatulence
Abdominal discomfort
Faecal incontinence

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

Loss of appetite (anorexia)
Dizziness
Headache
Tingling or numbness (paraesthesia)
Change in taste sensation (dysgeusia)
Visual impairment
Deafness
Rash, itching
Joint pain (arthralgia)
Fatigue

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

Reduced sense of touch (hypoesthesia)
Hearing impairment, ringing in the ears
Awareness of heartbeat (palpitations)
Inflammation of the liver (hepatitis)
Severe skin allergic reactions
Increased skin sensitivity to sunlight
Weakness
General malaise

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 Azithromycin Krka

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 packaging 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 Azithromycin Krka contains

The active substance is azithromycin. Azithromycin Krka 250 mg film-coated tablets

Each film-coated tablet contains 250 mg of azithromycin (as azithromycin
dihydrate).
Azithromycin Krka 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of azithromycin (as azithromycin
dihydrate).

The other ingredients (excipients) are microcrystalline cellulose (E460), pregelatinized potato starch, sodium lauryl sulfate, hypromellose (E464), sodium croscarmellose (E468), anhydrous colloidal silica (E551) and magnesium stearate (E470b) in the tablet core; and for the 250 mg tablets' coating: hypromellose 5 cP (E464), titanium dioxide (E171) and macrogol 400; for the 500 mg tablets' coating: poly(vinyl alcohol) graft copolymer, titanium dioxide (E171), talc, glycerol monocaprylocaprate, polyvinyl alcohol. See section 2 “Azithromycin Krka contains sodium”.

Description of the appearance of Azithromycin Krka and package contents
250 mg: film-coated tablets, white to almost white, capsule-shaped (length 13.8–14.2 mm, width: 6.3–6.7 mm), marked “S19” on one side and smooth on the other.
500 mg: film-coated tablets, white to almost white, capsule-shaped (length 16.7–17.3 mm, width: 8.2–8.8 mm), marked “S5” on one side and a score line on the other. The tablet can be divided into two equal doses.
250 mg:
Blister packs containing 4 or 6 film-coated tablets are available.
500 mg:
Blister packs containing 2, 3 or 30 film-coated tablets are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany
KRKA-FARMA d.o.o., DPC Jastrebarsko, Cvetković bb, 10450 Jastrebarsko, Croatia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorized in the European Economic Area Member States under the
following names:

Member State	Medicinal product name
Estonia, Hungary, Latvia, Poland, Sweden, Finland	Azithromycin Krka
Czech Republic, Slovakia	Azibiot NEO
Slovenia	Azitromicin Krka
Italy, Spain	Azitromicina Krka
Ireland	Azithromycin Krka 250 mg
Austria, Denmark	Azithromycin Krka 500 mg
Bulgaria	Azibiot 250 mg
Lithuania, Romania	Azibiot 250 mg

Package leaflet: information for the user

Azithromycin Krka 40 mg/ml powder for oral suspension

Azithromycin
Generic medicine
Please read this leaflet carefully before using this medicine 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 only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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:
1. What Azithromycin Krka is and what it is used for
2. What you need to know before taking Azithromycin Krka
3. How to take Azithromycin Krka
4. Possible side effects
5. How to store Azithromycin Krka
6. Contents of the pack and other information

1. What Azithromycin Krka is and what it is used for

Azithromycin, the active substance of Azithromycin Krka, belongs to the group of antibiotics known as macrolides. It is used to treat various infections such as:

acute bacterial infections of the upper respiratory tract,
acute bacterial infections of the ear,
tonsillitis, pharyngitis,
acute bacterial exacerbation of chronic bronchitis,
mild to moderate pneumonia,
mild to moderate skin and soft tissue infections such as folliculitis, cellulitis, erysipelas,
infections of the tube carrying urine from the bladder (urethra) or the neck of the uterus (cervix) caused by the bacterium Chlamydia trachomatis.

2. What you need to know before using Azithromycin Krka

Do not use Azithromycin Krka

if you are allergic to azithromycin, to other macrolides (such as erythromycin or clarithromycin), ketolide antibiotics, 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 Azithromycin Krka:

if you have certain heart problems (e.g. serious heart conditions, "prolonged QT interval") or if you are taking medicines that cause abnormal heart electrical activity, such as cisapride (used to increase intestinal motility);
if you have a slow or irregular heartbeat;
if your blood electrolyte levels are abnormal, particularly if you have low potassium or magnesium levels;
if you are taking other medicines that cause ECG changes (see section "Other medicines and Azithromycin Krka");
if you have severe kidney problems;
if you have severe liver problems: your doctor may need to monitor your liver function or discontinue treatment;
if you develop a new infection (which might be a sign of growth of resistant microorganisms);
if you have neurological or psychiatric conditions;
if you are administering the medicine to a newborn (less than 6 weeks of age) who vomits or becomes irritable after administration;
severe hypersensitivity reactions have rarely been reported, including difficulty breathing, dizziness, swelling of the face or throat, skin rashes, hives, and blisters (sometimes fatal). If you experience these symptoms, stop taking Azithromycin Krka immediately and contact your doctor. Antibiotics may cause diarrhoea, which could be a sign of serious intestinal inflammation. If you develop watery or bloody diarrhoea, contact your doctor. Do not take any medicine to stop the diarrhoea unless instructed by your doctor.

Other medicines and Azithromycin Krka
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
It is important that you inform your doctor or pharmacist if you are taking any of the following medicines:

Medicines known as ergot derivatives such as ergotamine or dihydroergotamine (used for migraine or to reduce blood flow), which must not be taken at the same time as Azithromycin Krka;
Cyclosporine (a medicine used for certain skin conditions, rheumatoid arthritis, or after organ transplantation);
Atorvastatin (to treat high cholesterol levels in the blood);
Cisapride (used to treat stomach problems);
Theophylline (for respiratory problems);
Warfarin or other blood-thinning medicines;
Digoxin (for heart problems);
Certain medicines for irregular heartbeat (called antiarrhythmics such as quinidine, amiodarone, sotalol). Concomitant use is not recommended;
Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections);
Rifabutin (for HIV infections or treatment of tuberculosis);
Terfenadine (a medicine used to treat allergies);
Fluconazole (to treat fungal infections);
Medicines known as antacids (medicines that neutralize gastric acid). You must take Azithromycin Krka at least one hour before or two hours after taking antacids;
Astemizole (a medicine for allergy treatment), alfentanil (a painkiller).

Azithromycin Krka with food and drinks
You may take this medicine with or without food, as food does not affect the absorption of azithromycin.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or breastfeeding unless your doctor has specifically recommended it.

Driving and using machines
This medicine may cause dizziness. If you feel dizzy, do not drive or operate machinery.

Azithromycin Krka contains sucrose and sodium
6.5 ml of suspension contains 5 g of sucrose. This should be taken into consideration in patients with diabetes mellitus. If your doctor has told you that you have an intolerance to certain sugars, inform your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per 12.5 ml of suspension (which is the maximum dose), i.e. essentially "sodium-free".

3. How to use Azithromycin Krka

Use this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and children with body weight greater than 45 kg:
Azithromycin is taken for a 3-day or 5-day treatment.
3-day treatment: Take 12.5 ml (500 mg) once daily.
5-day treatment:

Take 12.5 ml (500 mg) on Day 1
Take 6.25 ml (250 mg) on Days 2, 3, 4 and 5

For urethral and cervical infections caused by Chlamydia, the treatment is 1 day:
1-day treatment: 25 ml (1000 mg).
Children and adolescents with body weight less than 45 kg:
Azithromycin is taken for a 3-day or 5-day treatment. The daily dose is calculated based
on the child's body weight.
3-day treatment
Weight Day 1–3
10 kg 2.5 ml (100 mg)
12 kg 3 ml (120 mg)
14 kg 3.5 ml (140 mg)
16 kg 4 ml (160 mg)
17–25 kg 5 ml (200 mg)
26–35 kg 7.5 ml (300 mg)
36–45 kg 10 ml (400 mg)

45 kg 12.5 ml (500 mg)
5-day treatment
Weight Day 1 Day 2–5
10 kg 2.5 ml (100 mg) 1.25 ml (50 mg)
12 kg 3 ml (120 mg) 1.5 ml (60 mg)
14 kg 3.5 ml (140 mg) 1.75 ml (70 mg)
16 kg 4 ml (160 mg) 2 ml (80 mg)
17–25 kg 5 ml (200 mg) 2.5 ml (100 mg)
26–35 kg 7.5 ml (300 mg) 3.75 ml (150 mg)
36–45 kg 10 ml (400 mg) 5.0 ml (200 mg)
45 kg 12.5 ml (500 mg) 6.25 ml (250 mg)
Patients with liver or kidney problems:
Inform your doctor if you have kidney or liver problems, as the doctor may need to adjust the
usual dose.
Dose for elderly patients:
The same dosage as for adults is used in elderly patients.
Administration:
Shake well before use.
You may take this medicine with or without food, as food does not affect the absorption
of azithromycin.
Azithromycin Krka is administered once daily. In children, the total dose throughout the
treatment must not exceed 1500 mg.
How to measure the dose

A 10 ml syringe marked with notches every 0.25 ml is supplied in the package with the
medicine, together with an adapter that fits the bottle.
Shake the bottle before use and remove the child-resistant cap.
Attach the adapter to the neck of the bottle.
Attach the tip of the syringe to the adapter.
Invert the bottle.
Pull back the plunger of the syringe to draw up the required dose.
If large air bubbles are visible in the syringe, slowly push the plunger back into the syringe.
This will force the medicine back into the bottle. Repeat this step for 6.
Invert the bottle again, remove the syringe, leave the adapter attached to the bottle and close
it.
Consult your doctor or pharmacist for advice on how to dose the medicine.
Administration of the medicine using the syringe:
Ensure the child is held in an upright position.
Carefully insert the tip of the syringe into the child's mouth. Aim the tip of the syringe toward
the inside of the cheek.
Slowly push the plunger of the syringe. The medicine should not be expelled quickly from
the syringe, but should drip slowly into the child's mouth.
Allow the child time to swallow the medicine.
How to clean and store the syringe
Remove the plunger from the syringe and clean both parts under warm running water.
Dry both parts. Reinsert the plunger into the syringe. Store in a safe, dry place together with
the syringe.
How to prepare this medicine
Shake the container with the powder well.
Using a graduated pipette, graduated cylinder or graduated pipette (supplied in the
package), add the amount of water indicated below (X mL) to the powder. At home, freshly
boiled and cooled water may be used.
While adding water, hold the bottle at an angle so that most of the powder does not settle at
the bottom of the bottle, otherwise it may remain stuck to the bottom.
The correct amount of water depends on the size of the bottle and is indicated below:
Due to losses during administration, a larger volume of reconstituted suspension is prepared.
Azithromycin Krka 40 mg/ml

For 15 ml of suspension (600 mg), add 9.0 ml of water
For 22.5 ml of suspension (900 mg), add 12.5 ml of water
For 30 ml of suspension (1200 mg), add 16 ml of water
For 37.5 ml of suspension (1500 mg), add 19 ml of water

After adding the indicated amount of water, close the bottle tightly, immediately invert it so
that the powder mixes with the water, and shake vigorously. This helps to obtain a uniform
suspension. Check whether the powder is completely dispersed!
If you take more Azithromycin Krka than you should

If you/your child take too much Azithromycin Krka, you may feel unwell. Inform your
doctor immediately or go to the nearest hospital. Take the remaining medicine with you.
Symptoms of overdose may include severe nausea, vomiting, diarrhoea and reversible
hearing loss.
If you forget to take Azithromycin Krka
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose,
take it as soon as you remember. However, if it is almost time for the next dose, skip the
missed dose and continue with your regular dosing schedule.
If you stop treatment with Azithromycin Krka
Do not stop treatment early.
Even if you start to feel better, it is important that you continue taking your medicine for the
duration prescribed by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually these effects are mild to moderate and resolve once treatment is stopped.
If you experience any of the following side effects, stop taking this medicine and contact your doctor immediately or go to the nearest hospital. You may develop a rare, serious allergic reaction to the medicine:

Swelling of the hands, feet, ankles, face, lips, mouth or throat,
Difficulty swallowing or breathing,
Severe skin reactions such as Stevens-Johnson syndrome (a serious skin reaction) and other severe skin reactions that may involve blistering and peeling (toxic epidermal necrolysis),
Severe and persistent diarrhoea, especially with mucus or blood (this could be pseudomembranous colitis, an inflammation of the intestine).

Other side effects are:

Very common (may affect more than 1 in 10 people)

Diarrhoea

Common (may affect up to 1 in 10 people)

Headache
Feeling unwell (vomiting), abdominal pain, feeling sick (nausea)
Changes in the number of white blood cells in the blood
Changes in other blood parameters (decreased blood bicarbonate)

Uncommon (may affect up to 1 in 100 people)

Thrush (candidiasis) – a fungal infection of the mouth and vagina
Pneumonia, a bacterial throat infection, inflammation of the gastrointestinal tract, breathing problems, inflammation of the mucous membranes of the nose
Changes in the number of white blood cells (leucopenia, neutropenia, eosinophilia)
Swelling of the eyelids, face or lips (angioedema), allergic reactions
Loss of appetite (anorexia)
Nervousness, difficulty falling asleep (insomnia)
Dizziness, feeling of tiredness (drowsiness), change in taste sensation (dysgeusia), sensation of pins and needles, tingling or numbness (paraesthesia)
Vision problems
Ear disorders, dizziness (vertigo)
Awareness of heartbeat (palpitations)
Hot flushes
Sudden wheezing, nosebleeds
Constipation, gas, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, release of gas from the stomach (eructation), mouth ulcers, excessive salivation
Skin rash, itching, urticaria, dermatitis, dry skin, abnormal increase in sweating (hyperhidrosis)
Degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
Difficulty urinating (dysuria), kidney pain
Irregular uterine bleeding (metrorrhagia), testicular disorders
Oedema, weakness, general feeling of malaise, facial oedema, chest pain, fever, pain, peripheral oedema
Abnormal laboratory test results (e.g. blood and liver tests)
Post-procedural complications

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

Restlessness
Abnormal liver function, yellowing of the skin and eyes (jaundice)
Skin allergic reactions such as sensitivity to light
Skin rash characterised by the rapid appearance of red areas of skin with small pustules (small blisters filled with white/yellow fluid).

Very rare (may affect up to 1 in 10,000 people)

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Not known (frequency cannot be estimated from the available data)

Intestinal infections (of the colon) (pseudomembranous colitis)
Decrease in the number of red blood cells due to increased breakdown of cells (haemolytic anaemia); decrease in the number of platelets
Severe allergic reactions (anaphylactic reactions)
Feeling angry, aggression, feeling of fear and worry (anxiety), acute confusional state (delirium), hallucinations
Fainting (syncope)
Seizures (convulsions)
Reduced sense of touch (hypoesthesia)
Hyperactivity
Changes in the sense of smell (anosmia, parosmia)
Loss of taste sensation (ageusia)
Muscle weakness (myasthenia gravis)
Life-threatening irregular heartbeat (torsade de pointes), irregular ECG trace (QT prolongation)
Hearing impairment including deafness or ringing in the ears (tinnitus)
Low blood pressure
Inflammation of the pancreas (pancreatitis)
Change in tongue colour
Liver disorders (liver failure, which has rarely led to death, hepatic necrosis), inflammation of the liver (hepatitis)
Severe skin allergic reactions (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome)
Joint pain (arthralgia)
Kidney inflammation (interstitial nephritis) and kidney failure

Adverse reactions possibly or probably related to prophylaxis and treatment (MAC) of Mycobacterium avium complex (MAC)

Very common (may affect more than 1 in 10 people)

Diarrhoea
Abdominal pain
Feeling unwell (nausea)
Gas
Abdominal discomfort
Watery stools

Common (may affect up to 1 in 10 people)

Loss of appetite (anorexia)
Dizziness
Headache
Sensation of pins and needles, tingling or numbness (paraesthesia)
Changes in taste sensation (dysgeusia)
Visual impairment
Deafness
Skin rash, itching
Joint pain (arthralgia)
Fatigue

Uncommon (may affect up to 1 in 100 people)

Reduced sense of touch (hypoesthesia)
Hearing impairment or ringing in the ears
Awareness of heartbeat (palpitations)
Inflammation of the liver (hepatitis)
Severe skin allergic reactions
Increased sensitivity of the skin to light
Weakness
General feeling of malaise

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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azithromycin Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Bottles with 15 ml and 22.5 ml of suspension:
After reconstitution, the product must be used within 5 days. Do not store above 25°C.
Bottles with 30 ml and 37.5 ml of suspension:
After reconstitution, the product must be used within 10 days. Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Azitromicina Krka Contains

The active substance is azithromycin. 1 ml of oral suspension contains 40 mg of azithromycin (as azithromycin dihydrate).
The other components (excipients) are sucrose, hydroxypropylcellulose, trisodium phosphate, anhydrous (E339), xanthan gum, colloidal anhydrous silica, banana flavour (sucrose, maltodextrin, acacia gum, flavouring), wild cherry flavour (sucrose, maltodextrin, acacia gum, flavouring), and vanilla flavour (maltodextrin, flavouring, natural flavouring substance). See section 2 "Azitromicina Krka contains sucrose and sodium".

Description of the Appearance of Azitromicina Krka and Contents of the Package
The powder for oral suspension is white to almost white. After reconstitution with water, it forms a homogeneous suspension ranging from pale yellow to brownish yellow, with a characteristic banana and wild cherry flavour.
Azitromicina Krka 40 mg/ml is available in boxes containing:

12.6 g of powder for reconstitution into 15 ml of oral suspension (containing 600 mg of azithromycin), in one bottle,
18.9 g of powder for reconstitution into 22.5 ml of oral suspension (containing 900 mg of azithromycin), in one bottle,
25.2 g of powder for reconstitution into 30 ml of oral suspension (containing 1200 mg of azithromycin), in one bottle,
31.5 g of powder for reconstitution into 37.5 ml of oral suspension (containing 1500 mg of azithromycin), in one bottle.

The packages are supplied with a graduated 10 ml oral polyethylene/polypropylene (PE/PP) syringe and an adapter.
The reconstituted suspension contains an overfill of 5 ml to ensure complete dose administration.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative in Italy
KRKA Farmaceutici Milano S.r.l. – Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State Name	Medicinal Product Name
Lithuania, Poland, Romania	Azibiot
Slovenia	Azitromicin Krka
Italy, Portugal, Spain	Azitromicina Krka
Estonia, Latvia	Azithromycin Krka
Bulgaria	Aзибиот
Slovakia, Czech Republic	Azibiot NEO