Azithromycin

Package leaflet: Information for the patient

AZIMYCIN, 250 mg, film-coated tablets
Azithromycinum
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm others, even if their symptoms are identical.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Azimycin is and what it is used for
2. Important information before taking Azimycin
3. How to take Azimycin
4. Possible adverse reactions
5. How to store Azimycin
6. Contents of the package 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 broad-spectrum activity. It acts bactericidally against susceptible microorganisms.
Azimycin 250 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 disease.
• Sexually transmitted diseases: 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, consult a doctor or pharmacist if:

• the patient has conditions predisposing to cardiac rhythm disorders (particularly relevant in women and elderly patients):
• congenital or previous episodes of cardiac arrhythmia (visible on ECG – a test measuring the heart's electrical activity),
• severe heart failure,
• very slow heart rate (known as 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 fungal infection);
  • the patient has neurological or psychiatric disorders;
  • the patient has a sexually transmitted disease: the doctor should ensure that syphilis is not co-existing;
  • the patient is taking ergot derivatives (ergot alkaloids);
  • the patient has infected burn wounds.

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 infection), consult a 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 a doctor, as it may be a sign 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 lack of data on the safety and efficacy of long-term azithromycin use 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 250 mg film-coated tablets are recommended for use in children only if body weight is at least 45 kg. For other paediatric patients, Azimycin oral suspension or 125 mg film-coated tablets are recommended.
Azimycin with other medicines
Inform the 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 especially 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 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 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: peripheral vasospasm 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 for HIV or tuberculosis treatment).

Azimycin with food and drink
Azimycin 250 mg film-coated tablets can be taken independently of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 azithromycin treatment unless otherwise advised by a doctor.
Fertility
Fertility studies in rodents showed reduced pregnancy rates 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 adverse 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 500 mg, and as a powder for oral suspension with strengths of 200 mg/5 mL and 100 mg/5 mL.

Dosage in adults 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)
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, followed by 250 mg daily from the second to the fifth day.

Erythema migrans
The total dose is 3 g, to be taken according to the following regimen: 1 g (4 tablets of 250 mg) on the first day, followed by 500 mg (2 tablets) daily from the second to the fifth day, as single daily doses.

Uncomplicated infections caused by Chlamydia trachomatis
1 g (4 tablets of 250 mg) as a single dose.

Elderly patients
The same dosage as in other adult patients should be used in elderly patients. However, due to the increased risk of heart disease, caution is recommended when administering this medicine to elderly patients.

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

Administration method
Azithromycin should be taken orally, once daily.
Azimycin 250 mg coated tablets may be taken with or without food.
Tablets should be swallowed whole.

Taking more Azimycin than prescribed
Adverse effects observed after taking higher than recommended doses 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 overdose, 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.

If you forget to take Azimycin
If a dose is missed, take it as soon as possible, then continue with the prescribed dosing schedule.
Do not take 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, discontinue use of the medicine
Azimycin immediately and contact a doctor or go to the emergency department of the
nearest hospital:

• Allergic reactions: rapidly progressing severe allergic reaction leading to shock (frequency unknown) or sudden breathing and swallowing difficulties, swelling of lips, tongue, face and neck, itchy rash, especially when occurring all over the body (occurs uncommonly).
• 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 genital organs, 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, increased levels 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-coloured 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).
• Increased susceptibility to infections, especially of the mouth and upper respiratory tract, worsening despite treatment (symptoms of neutropenia, leukopenia; occur uncommonly).
• 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).
• 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).
• Reduced urine output, weakness, swelling, shortness of breath, loss of appetite, nausea and vomiting, itchy skin, small skin hemorrhages, 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, 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, nosebleeds;
• 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;
• Dermatitis, dry skin, excessive sweating;
• Osteoarthritis, muscle pain, back pain, neck pain;
• Urinary disorders (dysuria), kidney pain;
• Uterine bleeding, 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 parameters, kidney function, 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 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 organisms
or prevention thereof, observed during clinical trials and post-marketing surveillance.
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 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), 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 responsible entity.
Reporting adverse reactions helps to gather more information on the
safety of medicine use.

5. How to store Azimycin

Keep the 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 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 packaging and other information

What Azimycin contains
The active substance is azithromycin.
One coated tablet contains 250 mg of azithromycin in the form of 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 tablets.
Pack: 6 coated tablets
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22-811-18-14
For further information on this medicinal product, please contact the representative of the Marketing Authorisation Holder.