Package leaflet: Information for the patient

Azimycin, 125 mg, film-coated tablets
Azithromycinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical to yours.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Azimycin and what is it 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 is Azimycin and what is it used for

Azimycin contains azithromycin as the active substance, which is an azalide antibiotic belonging to the macrolide group with a broad spectrum of activity. It acts bactericidally against susceptible microorganisms.
Azimycin 125 mg film-coated tablets are 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 bacterial skin infections; erythema migrans—the first sign of Lyme borreliosis.

2. Important Information Before Using Azimycin

When not to use Azimycin

If the patient is allergic to azithromycin, other macrolide 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 the development of cardiac rhythm disorders (particularly relevant in women and elderly patients):
- congenital or previously occurring heart rhythm disorders (visible on ECG – a test measuring the heart's electrical activity),
- 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 function impairment;
- the patient has severe liver function impairment: the doctor may monitor liver function or discontinue treatment;
- the patient develops a new infection (this may indicate overgrowth of resistant microorganisms or a fungal infection);
- the patient has neurological or psychiatric disorders;
- the patient has a sexually transmitted disease: the doctor should ensure that syphilis is not present;
- the patient is taking ergotamine derivatives (ergot preparations);
- the patient has infected burn wounds.

Please also refer to the warnings contained in section 4.
If, despite treatment, symptoms of infection do not improve or new infection symptoms appear (e.g. fungal), 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 to the doctor immediately, as it may be a symptom of pseudomembranous colitis—a complication that may occasionally occur during treatment with macrolide antibiotics. Physicians should consider this diagnosis 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. Antiperistaltic agents are contraindicated.
Long-term use
There is a 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").
Children and adolescents
Azimycin 125 mg film-coated tablets are recommended for children of appropriate body weight who are able to swallow tablets. For other children, Azimycin oral suspension is recommended. For children weighing over 45 kg, 250 mg or 500 mg film-coated tablets are recommended.
Azimycin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
If the patient is taking any of the following medicines, it is particularly important to inform the doctor or pharmacist:

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 vasoconstriction), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms include peripheral vasoconstriction and ischemia);
- digoxin (used for cardiac disorders);
- colchicine (used to treat 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 125 mg film-coated tablets can be taken independently of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning 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. Breastfeeding is not recommended during treatment with azithromycin unless otherwise advised by a doctor.
Fertility
Fertility studies in rodents showed a decreased pregnancy rate after administration of azithromycin. The relevance of these findings to humans is unknown.
Driving and operating machinery
There are no data on the effect of Azimycin on the ability to drive vehicles or operate machinery. However, when performing such activities, consider the possibility of side effects such as dizziness and convulsions.

3. How to use Azimycin

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Azimycin is taken orally.
Azimycin is also available as film-coated tablets with strengths of 250 mg and 500 mg, and as a powder for oral suspension with strengths of 200 mg/5 mL and 100 mg/5 mL.
Azimycin 125 mg film-coated tablets are recommended for use in children of appropriate body weight (considering dosing based on kg of body weight) who are able to swallow tablets. In all other children, Azimycin oral suspension is recommended.
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except erythema migrans)
Dosage in children and adolescents with body weight below 45 kg
The total dose is 30 mg/kg body weight, i.e. 10 mg/kg body weight once daily for 3 days.
Dosage in children and adolescents with body weight above 45 kg
The total dose of azithromycin is 1.5 g over 3 days (500 mg as a single daily dose).
Alternatively, the same total dose (1500 mg) may be administered over 5 days: 500 mg on the first day of treatment and 250 mg daily from the second to the fifth day of treatment.
Erythema migrans
The total dose is 60 mg/kg body weight, administered according to the following regimen: 20 mg/kg body weight on the first day, followed by 10 mg/kg body weight once daily from the second to the fifth day, as single daily doses.
Elderly patients
The same dose as in other adult patients should be used in elderly patients. Caution is recommended in these patients due to the risk of cardiac disorders.
Patients with renal or hepatic impairment
If a patient has impaired renal or hepatic function, this should be reported to the doctor, as dose reduction may be necessary. This medicine should not be used in patients with severe hepatic impairment.
Administration method
Azithromycin should be taken orally, once daily.
Azimycin 125 mg film-coated tablets may be taken independently of food. Tablets should be swallowed whole.
Use of a higher than recommended dose of Azimycin
Adverse effects observed after administration of higher than recommended doses were similar to those reported with correct dosing. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhea.
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
If a dose is missed, it should be taken as soon as possible, and subsequent doses should be taken according to the prescribed schedule. A double dose should not be taken to make up for the 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 using the medicine Azimycin immediately and contact a doctor or go to the emergency department of the nearest hospital:

Allergic reactions: a rapidly progressing severe allergic reaction leading to shock (frequency unknown) or sudden difficulty breathing and swallowing, swelling of the lips, tongue, face and neck, itchy rash, especially when occurring all over the body (occurs not very often).
Severe skin reactions: skin eruption 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 from lips, eyes, mouth, nose and genitals, associated with high fever and joint pain. This may be acute generalized exanthematous pustulosis (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, increased number of a certain type of white blood cells (eosinophilia) and inflammation of internal organs (drug rash with eosinophilia and systemic symptoms (DRESS); frequency unknown).

Contact a doctor immediately if any of the following are observed:

Severe or prolonged diarrhoea with blood or mucus. This symptom may occur during or after treatment and may indicate a 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 leading to death], fulminant hepatitis, liver necrosis; frequency unknown).
Susceptibility to infections, especially of the mouth and upper respiratory tract, worsening despite treatment (symptoms of neutropenia, leukopenia; occur not very often).
Unusual tendency to bruising or bleeding – symptoms of thrombocytopenia (decreased number of blood platelets).
Fainting, weakness and fatigue, paleness, shortness of breath, rapid heartbeat – symptoms of haemolytic anaemia (increased breakdown of red blood cells; frequency unknown).
Rapid (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 amount of urine, weakness, swelling, shortness of breath, loss of appetite, nausea and vomiting, itchy skin, petechiae (small skin haemorrhages), pain in the lumbar region, haematuria (symptoms of acute kidney failure and interstitial nephritis; frequency unknown).

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

Diarrhoea.

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

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

Uncommon (may occur in 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 (paresthesia);
Visual disturbances;
Ear disorders, balance disorders;
Palpitations;
Hot flushes;
Shortness of breath, nosebleeds;
Constipation, bloating with flatulence, dyspepsia, inflammation of the gastric mucosa, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation;
Skin inflammation, dry skin, excessive sweating;
Osteoarthritis, muscle pain, back pain, neck pain;
Urinary disorders (dysuria), kidney pain;
Uterine bleeding, testicular disorders;
Swelling, weakness (asthenia), malaise, fatigue, facial swelling, 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 occur in less than 1 in 1000 patients):

Restlessness;
Liver function disorders;
Photosensitivity.

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 or for prevention of such infections, observed during clinical trials and after market introduction.
Very common (may occur in more than 1 in 10 patients):

Diarrhoea;
Abdominal pain;
Nausea;
Bloating;
Feeling of discomfort in the abdominal cavity;
Loose stools.

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

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

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 to gather more information on the safety of medicine use.

5. How to store Azimycin

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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. Following this advice helps protect the environment.

6. Contents of the packaging and other information

What Azimycin contains
The active substance is azithromycin.
One coated tablet contains 125 mg of azithromycin as azithromycin dihydrate.
Excipients: pregelatinized corn starch, povidone, microcrystalline cellulose type 101,
microcrystalline cellulose type 102, sodium carboxymethylstarch, magnesium stearate;
coating: hypromellose, polyethylene glycol 6000, titanium dioxide.
What Azimycin looks like and contents of the pack
White or cream, oval, biconvex coated tablets.
Packaging: 6 coated tablets
Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: 22-811-18-14
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder.