Package leaflet: Information for the patient

Azimycin, 100 mg/5 mL, powder for oral suspension
Azimycin, 200 mg/5 mL, powder for oral suspension
Azithromycinum
Please read the entire leaflet carefully before using the medicine, because it contains important information for the patient.

Keep this leaflet, so you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Azimycin is and what it is used for
Important information before taking Azimycin
How to take Azimycin
Possible side effects
How to store Azimycin
Contents of the pack and other information

1. What Azimycin is and what it is used for

Azimycin contains azithromycin as the active substance, which is an azalide antibiotic from the macrolide group with a broad spectrum of activity. It acts bactericidally against susceptible microorganisms.
Azimycin in the form of powder for oral suspension is indicated for the treatment of the following infections caused by microorganisms sensitive to azithromycin.

Upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis (see also section 2).
Acute otitis media.
Lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, mild to moderate pneumonia, including interstitial pneumonia.
Skin and soft tissue infections: erysipelas, cellulitis, and secondary purulent skin infections; erythema migrans – the first sign of Lyme disease.

2. Important information before using Azimycin

When not to use Azimycin

If the patient is allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Azimycin, discuss with your doctor or pharmacist if:

the patient has conditions predisposing to cardiac rhythm disorders (particularly relevant in women and elderly patients):
- congenital or previous history of cardiac arrhythmias (visible on ECG – electrocardiogram),
- severe heart failure,
very slow heart rate (called bradycardia),
electrolyte imbalances in the blood, especially low levels of potassium and magnesium,
taking other medicines that may cause QT interval prolongation on ECG (see section "Azimycin with other medicines");
- the patient has severe kidney dysfunction;
- the patient has severe liver dysfunction: the doctor may monitor liver function or discontinue treatment;
- the patient develops a new infection (this may indicate overgrowth of resistant microorganisms or fungal infection);
- the patient has neurological or psychiatric disorders;
- the patient has a sexually transmitted disease: the doctor should confirm whether syphilis co-infection is excluded;
- the patient is taking ergot derivatives (ergot alkaloids);
- the patient has infected burn wounds.

Please also refer to the warnings in section 4.
If symptoms of infection do not improve despite treatment, or if symptoms of a new infection appear,
e.g. fungal infection, consult your doctor again.
Streptococcal infections
For the treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhoea occurs, it should be reported immediately to the doctor, as it may be a sign of
pseudomembranous colitis – a complication that may occasionally occur during treatment with
macrolide antibiotics. This diagnosis should be considered in patients who develop diarrhoea
after starting azithromycin therapy. In cases of pseudomembranous colitis due to azithromycin use,
discontinuation of Azimycin and initiation of appropriate treatment may be necessary.
Medicines that inhibit peristalsis are contraindicated.
Long-term use
There is lack of data on the safety and efficacy of long-term use of azithromycin for the indications
listed above. In cases of rapidly recurring infections, the doctor may consider treatment with another
antibacterial agent.
Myasthenia
Worsening of myasthenia symptoms or development of a myasthenic syndrome has been observed
during azithromycin treatment (see section "Possible side effects").
Treatment of Mycobacterium avium complex infections in children
The safety and efficacy of azithromycin for the treatment or prevention of Mycobacterium avium complex
infections in children have not been established.
Children and adolescents
Dosage is adjusted according to body weight (see section 3).
Azimycin with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
It is especially important to inform your doctor or pharmacist if the patient is taking any of the following medicines:

medicines affecting the QT interval, such as:
- quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat cardiac arrhythmias),
- cisapride (used for gastric disorders),
- hydroxychloroquine (used to treat rheumatological diseases or malaria),
- terfenadine (used to treat allergies),
- antipsychotic medicines, e.g. pimozide,
- antidepressants, e.g. citalopram,
- fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin;
antacids (Azimycin should be taken at least 1 hour before or 2 hours after antacids);
oral anticoagulants, e.g. warfarin;
ergot alkaloids (used for migraine or to reduce blood flow), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms include peripheral vasoconstriction and ischemia);
digoxin (used for heart rhythm disorders);
colchicine (used for gout and familial Mediterranean fever);
cyclosporine (used for skin diseases, rheumatoid arthritis, or after organ transplantation);
atorvastatin (a medicine used to lower cholesterol levels);
rifabutin (used in the treatment of HIV or tuberculosis).

Azimycin with food and drink
Azimycin can be taken independently of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the foetus.
Breastfeeding
Azithromycin passes into human milk. It is recommended not to breastfeed during azithromycin treatment unless otherwise advised by the doctor.
Fertility
In fertility studies conducted in rodents, a decreased pregnancy rate was observed after administration of azithromycin. The significance of these findings for humans is unknown.
Driving and using machines
There are no data on the effect of Azimycin on the ability to drive or operate machinery. However, when performing such activities, consider the possibility of side effects such as dizziness and convulsions.
Azimycin contains sucrose
Caution is advised in patients with diabetes.
Azimycin 100 mg/5 mL, powder for oral suspension: 5 mL of prepared suspension contains 2134.2 mg of sucrose.
Azimycin 200 mg/5 mL, powder for oral suspension: 5 mL of prepared suspension contains 2029.4 mg of sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, inform the doctor before starting treatment.
Azimycin contains sodium benzoate (E 211) (25 mg/5 mL)
Benzoic acid salts may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to use Azimycin

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
For upper and lower respiratory tract infections, otitis media, and skin and soft tissue infections (except erysipelas), the total dose is 30 mg/kg body weight, i.e. 10 mg/kg body weight once daily for 3 days.
Dosage for children and adolescents
Dosage for children depends on body weight, as follows:

Body weight	Azithromycin dose (volume of suspension)	Oral suspension concentration
5 kg	50 mg (2.5 mL)	100 mg/5 mL
6 kg	60 mg (3 mL)
7 kg	70 mg (3.5 mL)
8 kg	80 mg (4 mL)
9 kg	90 mg (4.5 mL)
10-14 kg	100 mg (5 mL)
10-14 kg	100 mg (2.5 mL)	200 mg/5 mL
15-24 kg	200 mg (5 mL)
25-34 kg	300 mg (7.5 mL)
35-44 kg	400 mg (10 mL)
≥45 kg	adult dose should be used	tablets should be administered

In the treatment of erythema migrans, the total dose is 60 mg/kg body weight administered as follows: 20 mg/kg body weight on the first day, followed by 10 mg/kg body weight once daily from day 2 to day 5 of treatment.
*Treatment of streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes
In the treatment of pharyngitis caused by Streptococcus pyogenes in children with body weight up to 13 kg, azithromycin can be administered either for 3 days at a dose of 20 mg/kg body weight once daily, or for 5 days at a dose of 12 mg/kg body weight once daily. In both the 3-day and 5-day regimens, the total amount of azithromycin received by the patient should amount to 60 mg/kg body weight.
The dosing of the 100 mg/5 mL suspension for children weighing 5–13 kg is shown in the table below:

Body weight in kg	Dosing 3-day regimen	Dosing 5-day regimen	Bottle content in mL
	Days 1–3 20 mg/kg body weight/day	Days 1–5 12 mg/kg body weight/day
	Azithromycin dose (suspension volume)	Azithromycin dose (suspension volume)
5 kg	100 mg (5 mL)	60 mg (3 mL)	20 mL
6 kg	120 mg (6 mL)	72 mg (3.6 mL)	20 mL
7 kg	140 mg (7 mL)	84 mg (4.2 mL)	2x20 mL
8 kg	160 mg (8 mL)	96 mg (4.8 mL)	2x20 mL
9 kg	180 mg (9 mL)	108 mg (5.4 mL)	2x20 mL
10 kg	200 mg (10 mL)	120 mg (6 mL)	2x20 mL
11 kg	220 mg (11 mL)	132 mg (6.6 mL)	2x20 mL
12 kg	240 mg (12 mL)	144 mg (7.2 mL)	2x20 mL
13 kg	260 mg (13 mL)	156 mg (7.8 mL)	2x20 mL

In the treatment of bacterial pharyngitis caused by Streptococcus pyogenes in patients with body weight up to 25 kg, azithromycin may be administered either for 3 days at a dose of 20 mg/kg body weight once daily, or for 5 days at a dose of 12 mg/kg body weight once daily. In both the 3-day and 5-day regimens, the total amount of azithromycin taken by the patient should amount to 60 mg/kg body weight. The maximum daily dose of azithromycin is 500 mg.

In adults and children with body weight above 25 kg, azithromycin is administered at a dose of 500 mg once daily for 3 days, or for 5 days with 500 mg on the first day and 250 mg from the second to the fifth day.

The dosing of the 200 mg/5 mL suspension for children weighing 10–25 kg is shown in the table below:

Body weight in kg	3-day dosing	5-day dosing	Bottle content in mL
	Days 1–3: 20 mg/kg body weight/day	Days 1–5: 12 mg/kg body weight/day
	Azithromycin dose (suspension volume)	Azithromycin dose (suspension volume)
10 kg	200 mg (5 mL)	120 mg (3 mL)	20 mL
11 kg	220 mg (5.5 mL)	132 mg (3.3 mL)	20 mL
12 kg	240 mg (6 mL)	144 mg (3.6 mL)	20 mL
13 kg	260 mg (6.5 mL)	156 mg (3.9 mL)	20 mL
14 kg	280 mg (7 mL)	168 mg (4.2 mL)	30 mL
15 kg	300 mg (7.5 mL)	180 mg (4.5 mL)	30 mL
16 kg	320 mg (8 mL)	192 mg (4.8 mL)	30 mL
17 kg	340 mg (8.5 mL)	204 mg (5.1 mL)	30 mL
18 kg	360 mg (9 mL)	216 mg (5.4 mL)	30 mL
19 kg	380 mg (9.5 mL)	228 mg (5.7 mL)	30 mL
20 kg	400 mg (10 mL)	240 mg (6 mL)	30 mL
21 kg	420 mg (10.5 mL)	252 mg (6.3 mL)	30 mL
22 kg	440 mg (11 mL)	264 mg (6.6 mL)	30 mL
23 kg	460 mg (11.5 mL)	276 mg (6.9 mL)	30 mL
24 kg	480 mg (12 mL)	288 mg (7.2 mL)	30 mL
25 kg	500 mg (12.5 mL)	300 mg (7.5 mL)	30 mL

Elderly patients
The same dosage is used in elderly patients as in other adult patients. Due to the risk of heart diseases, caution is recommended when administering the drug to elderly patients.

Patients with renal or hepatic impairment
If a patient has impaired kidney or liver function, this should be reported to the physician, as the physician may reduce the usual dose of the drug. The drug should not be used in patients with severe hepatic insufficiency.

Method of administration
Azithromycin should be administered orally, once daily.
The prepared oral suspension may be taken regardless of meals.
The prepared suspension should be administered orally using the measuring spoon or oral dosing syringe provided with the package.

The oral suspension must be shaken vigorously before each dose is taken.
After administering the medicine to a child, give the child some tea or juice to drink, to prevent the medicine from remaining in the mouth.

Preparation of the suspension
As specified in the enclosed instructions.

Use of a higher than recommended dose of Azimycin
Adverse effects observed after administration of doses higher than recommended were similar to those reported following correct doses. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhoea.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist. In the event of overdose, administration of activated charcoal is recommended, along with symptomatic treatment and, if necessary, supportive measures to maintain vital functions.

Missed dose of Azimycin
A missed dose should be taken as soon as possible, and subsequent doses should be administered according to the recommended dosing schedule. Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the medicine
Azimycin immediately and contact your doctor or go to the emergency department of the
nearest hospital:

Allergic reactions: sudden, severe allergic reaction leading to shock (frequency unknown) or sudden breathing and swallowing difficulties, swelling of lips, tongue, face and neck, itchy rash especially affecting the whole body (occurs not commonly).
Severe skin reactions: skin rash characterized by rapid appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding of lips, eyes, mouth, nose and genitals, associated with high fever and joint pain. This may be acute generalized pustular eruption (AGEP,
occurs rarely), erythema multiforme, bullous erythema multiforme (Stevens-Johnson syndrome) or toxic epidermal necrolysis (all occur with unknown frequency).
Severe hypersensitivity reaction which may include fever, skin rash, organ swelling, increase in a certain type of white blood cells (eosinophilia), and inflammation of internal organs (drug rash with eosinophilia and systemic symptoms [DRESS]; frequency unknown).

Contact your doctor immediately if you notice:

Severe or prolonged diarrhoea with blood or mucus. This symptom may occur during or after treatment and may indicate serious intestinal inflammation (frequency unknown).
Weakness, loss of appetite, yellowing of the skin and whites of the eyes, dark urine, pale stools, abdominal pain, especially in the right upper abdomen. These may be symptoms of severe liver disease (liver failure [rarely fatal], fulminant hepatitis, liver necrosis; frequency unknown).
Increased susceptibility to infections, especially of the mouth and upper respiratory tract, worsening despite treatment (symptoms of neutropenia, leukopenia; occur not commonly).
Unusual tendency to bruise or bleed – symptoms of thrombocytopenia (reduced platelet count).
Fainting, weakness and fatigue, paleness, shortness of breath, rapid heartbeat – symptoms of haemolytic anaemia (increased breakdown of red blood cells; frequency unknown).
Fast (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm on electrocardiogram (prolongation of QT interval and torsade de pointes-type arrhythmias; frequency unknown).
Decreased urine output, weakness, swelling, shortness of breath, loss of appetite, nausea and vomiting, itchy skin, small petechiae on the skin, pain in the lumbar region, haematuria (symptoms of acute kidney failure and interstitial nephritis; frequency unknown).

Other adverse reactions
Very common (may affect more than 1 in 10 patients):

Diarrhoea.

Common (may affect less than 1 in 10 patients):

Headache;
Vomiting, abdominal pain, nausea;
Changes in white blood cell count;
Decreased blood bicarbonate levels.

Uncommon (may affect less than 1 in 100 patients):

Fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis;
Changes in white blood cell count (eosinophilia);
Loss of appetite (anorexia);
Nervousness, insomnia; dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paraesthesia);
Visual disturbances;
Ear disorders, balance disorders;
Palpitations;
Hot flushes;
Dyspnoea, epistaxis;
Constipation, bloating with flatulence, dyspepsia, gastric mucosal inflammation, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation;
Dermatitis, dry skin, excessive sweating;
Osteoarthritis, muscle pain, back pain, neck pain;
Urinary disorders (dysuria), kidney pain;
Uterine haemorrhage, testicular disorders;
Oedema, weakness (asthenia), malaise, fatigue, facial oedema, chest pain, fever, pain, peripheral oedema;
Abnormal laboratory test results (e.g. blood tests, liver and kidney function parameters, glucose, electrolytes);
Post-procedural complications.

Rare (may affect less than 1 in 1000 patients):

Restlessness;
Liver function disorders;
Photophobia.

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

Aggressive behaviour, anxiety, delirium, hallucinations;
Loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disturbances of smell, rapid muscle fatigue (myasthenia);
Hearing disorders including deafness and (or) tinnitus;
Hypotension;
Pancreatitis, tongue discoloration;
Joint pain.

Adverse reactions probably or possibly related to the use of azithromycin
in the treatment of infections caused by Mycobacterium avium complex organisms
or prevention thereof, observed during clinical trials and post-marketing.
Very common (may affect more than 1 in 10 patients):

Diarrhoea;
Abdominal pain;
Nausea;
Bloating;
Abdominal discomfort;
Loose stools.

Common (may affect less than 1 in 10 patients):

Anorexia;
Dizziness;
Headache;
Unusual skin sensations, such as tingling and numbness of limbs (paraesthesia);
Taste disturbances;
Visual disturbances;
Deafness;
Rash, itching;
Joint pain;
Fatigue.

Uncommon (may affect less than 1 in 100 patients):

Sensory disturbances (hypoesthesia);
Hearing disorders, tinnitus;
Palpitations;
Hepatitis;
Bullous erythema multiforme (Stevens-Johnson syndrome – severe skin reaction; SJS), photophobia;
Sudden weakness (asthenia), malaise.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this
leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Azimycin

Keep the medicine out of the sight and reach of children.
Store the powder in the original packaging at a temperature below 25°C.
Store the prepared oral suspension at a temperature below 25°C and use within 5 days.
Do not use this medicine after the expiry date stated on the carton and label.
The expiry date (EXP) refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Azimycin contains
The active substance is azithromycin in the form of azithromycin dihydrate.
Azimycin, 100 mg/5 mL: 5 mL of reconstituted suspension contains 100 mg of azithromycin.
Azimycin, 200 mg/5 mL: 5 mL of reconstituted suspension contains 200 mg of azithromycin.
Other ingredients are: anhydrous sodium carbonate, sodium benzoate (E 211), sodium carboxymethylcellulose, glycine, titanium dioxide, anhydrous colloidal silicon dioxide, sodium lauryl sulfate, raspberry flavour, strawberry flavour, orange flavour, sucrose.

What Azimycin looks like and contents of the pack
White to slightly yellowish powder; after addition of water, a homogeneous white to slightly yellowish suspension is formed.

Packaging
Azimycin, 100 mg/5 mL: 1 bottle in a cardboard box containing 10 g of powder.
Azimycin, 200 mg/5 mL: 1 bottle in a cardboard box containing 10 g or 15 g of powder.
Each package includes a measuring spoon with graduations and a syringe dispenser.
Azimycin is also available in the form of film-coated tablets with strengths of 125 mg, 250 mg, and 500 mg.

Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: 22-811-18-14
For further information about this medicine, please contact the representative of the Marketing Authorisation Holder.

INSTRUCTIONS FOR PREPARING THE MEDICINE FOR USE

The graduated measuring spoon allows administration of 1.25 mL, 2.5 mL, and 5 mL of suspension.
The syringe dispenser allows administration of up to 5 mL of suspension with an accuracy of 0.1 mL.

Azimycin, 100 mg/5 mL
5 mL of suspension contains 100 mg of azithromycin;
2.5 mL of suspension contains 50 mg of azithromycin;
1.25 mL of suspension contains 25 mg of azithromycin;
0.1 mL of suspension contains 2 mg of azithromycin.

Azimycin, 200 mg/5 mL
5 mL of suspension contains 200 mg of azithromycin;
2.5 mL of suspension contains 100 mg of azithromycin;
1.25 mL of suspension contains 50 mg of azithromycin;
0.1 mL of suspension contains 4 mg of azithromycin.

Preparation of the oral suspension

Azimycin, 100 mg/5 mL
Bottle containing 10 g of powder (35 mL capacity)
Add 14 mL of boiled, cooled water to the bottle containing 10 g of powder, using the syringe dispenser. This yields 20 mL of suspension. Shake vigorously until a homogeneous suspension is obtained.

Azimycin, 200 mg/5 mL
Bottle containing 10 g of powder (35 mL capacity)
Add 14 mL of boiled, cooled water to the bottle containing 10 g of powder, using the syringe dispenser. This yields 20 mL of suspension. Shake vigorously until a homogeneous suspension is obtained.

Bottle containing 15 g of powder (60 mL capacity)
Add 21 mL of boiled, cooled water to the bottle containing 15 g of powder, using the syringe dispenser. This yields 30 mL of suspension. Shake vigorously until a homogeneous suspension is obtained.

Store the reconstituted oral suspension at a temperature not exceeding 25°C and use within 5 days.
Before each dose, shake the suspension vigorously.
After the child swallows the medicine, give them some tea or juice to drink, to ensure the medicine does not remain in the mouth.