Azithromycin

Package leaflet: Information for the patient

AZIMYCIN, 500 mg, coated tablets
Azithromycinum
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that 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, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Azimycin is and what it is used for
2. Important information before taking Azimycin
3. How to take Azimycin
4. Possible side effects
5. How to store Azimycin
6. 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 belonging to the macrolide group with broad-spectrum activity. It acts bactericidally against susceptible microorganisms.
Azimycin 500 mg 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 disease; moderate acne vulgaris, in adults only.
• Sexually transmitted infections: uncomplicated infections caused by Chlamydia trachomatis.

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 disturbances (particularly relevant in women and elderly patients):
  • congenital or previous history of cardiac arrhythmias (visible on ECG – electrocardiogram, a test measuring the electrical activity of the heart),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte imbalances in the blood, especially low potassium or magnesium levels,
• taking other medicines that may cause QT interval prolongation on ECG (see section "Azimycin with other medicines"),
• the patient has severe kidney function disorders,
• the patient has severe liver function disorders: 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 ergot derivatives (ergot alkaloids),
• 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 infections (e.g. fungal) appear, 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, inform your doctor immediately, as this may be a sign of pseudomembranous colitis – a complication that may occur occasionally 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 no 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 gravis
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 in the form of 500 mg film-coated tablets is recommended for use in children only if their body weight is at least 45 kg. For other children, use of Azimycin oral suspension or 125 mg film-coated tablets is recommended.

Azimycin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
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 gastrointestinal 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 administered 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: peripheral vasoconstriction and ischemia);
• digoxin (used for cardiac 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 500 mg film-coated tablets can be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may 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 doctor's opinion, the benefit to the mother outweighs the risk to the foetus.
Breastfeeding
Azithromycin passes into human milk. Breastfeeding is not recommended during azithromycin treatment unless otherwise advised by a doctor.
Fertility
In fertility studies conducted in rodents, a decreased pregnancy rate was observed after administration of azithromycin. The relevance of these findings to 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.

3. How to use Azimycin

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Azimycin is taken orally.
Azimycin is also available as coated tablets with strengths of 125 mg and 250 mg, and as a powder for oral suspension with strengths of 200 mg/5 mL and 100 mg/5 mL.

Dosage in adults, including elderly, and in children and adolescents with body weight above 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except erythema migrans and acne vulgaris)
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 from the second to the fifth day.

Erythema migrans
The total dose is 3 g, administered as follows: 1 g (2 coated tablets of 500 mg) on the first day, followed by 500 mg (1 coated tablet) once daily from the second to the fifth day.

Moderate acne vulgaris – adults only
The total dose is 6 g, administered as follows: one 500 mg coated tablet once daily for 3 days, followed by one 500 mg coated tablet once weekly for the next 9 weeks. In the second week of treatment, the dose should be taken 7 days after the first dose, and the subsequent eight doses should be administered at 7-day intervals.

Due to the high dose of azithromycin used in the above regimen for moderate acne vulgaris, monitoring of liver enzyme activity is required before starting and during the course of treatment with azithromycin.

The above cyclic regimen for moderate acne vulgaris (3 days + 9 weeks) may be used only once in a given patient, as there are currently no controlled clinical trials demonstrating the safety and efficacy of repeating this treatment regimen for acne vulgaris.

Uncomplicated infections caused by Chlamydia trachomatis: a single dose of 1 g (2 coated tablets of 500 mg).

Patients with renal or hepatic impairment
If a patient has impaired kidney or liver function, this should be reported to the doctor, as a dose reduction may be necessary. Azimycin should not be used in patients with severe hepatic insufficiency.

Method of administration
Azithromycin should be taken orally, once daily.
Azimycin 500 mg coated tablets may be taken with or without food. Tablets should be swallowed whole.

Use of a higher than recommended dose of Azimycin
Adverse effects observed after administration of doses higher than recommended were similar to those reported with correct dosing. Characteristic symptoms of macrolide antibiotic overdose include transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of ingestion of a dose higher than recommended, 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. Subsequent doses should be taken according to the prescribed schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.

If any of the following adverse reactions occur, discontinue use of the medicine Azimycin immediately and contact a doctor or go to the emergency department of the nearest hospital:

• Allergic reactions: sudden, severe allergic reaction leading to anaphylactic shock (frequency unknown) or sudden breathing and swallowing difficulties, swelling of the lips, tongue, face and neck, itchy rash especially affecting the whole body (occurs not frequently).
• Severe skin reactions: skin eruption characterized by rapidly appearing 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 the 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 levels of a certain type of white blood cells (eosinophilia), and inflammation of internal organs (drug reaction 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 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; occurs not frequently).
• Unusual tendency to bruising or bleeding – symptoms of thrombocytopenia (reduced 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).
• Reduced urine output, weakness, oedema, shortness of breath, loss of appetite, nausea and vomiting, itchy skin, petechiae (small skin haemorrhages), flank pain, 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, gastrointestinal disorders, respiratory disorders, rhinitis, fungal infection of the mouth;

• 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 the limbs (paraesthesiae);

• 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 of gastric contents, oral ulcers, excessive salivation;

• Skin inflammation, 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 swelling, chest pain, fever, pain, peripheral oedema;

• Abnormal laboratory test results (e.g. blood tests, liver function tests, kidney function tests, glucose, electrolytes);

• Post-procedural complications.

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

• Restlessness;
• Liver function disorders;
• Photosensitivity.

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

• Aggressive behaviour, anxiety, delirium, hallucinations;
• Loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, smell disturbances, 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 post-marketing experience.

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

• Diarrhoea;
• Abdominal pain;
• Nausea;
• Bloating;
• Discomfort in the abdominal cavity;
• Loose stools.

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

• Anorexia;
• Dizziness;
• Headache;
• Unusual skin sensations, such as tingling and numbness of the limbs (paraesthesiae);
• Taste disturbances;
• Visual disturbances;
• Deafness;
• Rash, itching;
• Joint pain;
• Feeling of 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), 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 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Azimycin

Keep this medicine out of the 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 refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Azimycin contains
The active substance is azithromycin.
One coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
Excipients: pregelatinized corn starch, povidone, microcrystalline cellulose type 101, microcrystalline cellulose type 102, sodium carboxymethyl starch, magnesium stearate; coating: hypromellose, macrogol 6000, titanium dioxide.

What Azimycin looks like and contents of the pack
White or cream, oval, biconvex tablets.
Pack size: 3, 6 or 12 coated tablets.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
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.