Azimicin

Leaflet attached to the packaging: patient information

AZIMYCIN, 250 mg, film-coated tablets

Azithromycin
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azimycin and what is it 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 is Azimycin and what is it used for

Azimycin contains the active substance azithromycin, which is an azalide antibiotic belonging to the macrolide group with a broad spectrum of action. It has a bactericidal effect on susceptible microorganisms. Azimycin, 250 mg, film-coated tablets, is indicated for the treatment of the following infections caused by microorganisms susceptible 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 community-acquired pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erythema, impetigo, and secondary infected dermatitis; erythema migrans - the first sign of Lyme disease.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Azimycin

When not to take Azimycin

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

Warnings and precautions

Before taking Azimycin, discuss with your doctor or pharmacist if:

• you have conditions that may lead to heart rhythm disorders (especially in women and elderly patients):
• congenital or existing heart rhythm disorders (visible in the ECG - a test of the heart's electrical activity),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• you are taking other medicines that may cause prolongation of the QT interval in the ECG (see "Azimycin and other medicines");
• you have severe kidney problems;
• you have severe liver problems: your doctor may need to monitor your liver function or stop treatment;
• you have a new infection (this may indicate an overgrowth of resistant microorganisms or a fungal infection);
• you have neurological (nervous system) or psychiatric disorders;
• you have a sexually transmitted disease: your doctor should ensure that you do not have a co-existing syphilis infection;
• you are taking ergotamine derivatives (for migraine or to reduce blood flow);
• you have infected burn wounds;

Also, read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not disappear or if the symptoms of another infection appear, e.g., fungal, you should consult your doctor again.
Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, penicillin is usually the drug of choice.
Pseudomembranous colitis
If you experience diarrhea, you should report it to your doctor immediately, as it may be a sign of pseudomembranous colitis - a complication that can occur with the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting treatment with azithromycin. In the case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Azimycin and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents.
Long-term use
There is no data on the safety and efficacy of long-term use of azithromycin in the indications listed above. In the case of frequently recurring infections, the doctor will consider treatment with another antibacterial agent.
Myasthenia
During treatment with azithromycin, exacerbation of myasthenia symptoms or the occurrence of a myasthenic syndrome (see "Possible side effects") has been observed.

Children and adolescents

Azimycin in the form of 250 mg film-coated tablets is recommended for use in children only with a body weight of 45 kg or more. For the remaining group of children, Azimycin is recommended in the form of an oral suspension or 125 mg film-coated tablets.

Azimycin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
If you are taking any of the following medicines, it is especially important to tell your doctor or pharmacist:

• medicines that affect the QT interval, such as:
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat heart rhythm disorders),
• cisapride (used to treat stomach disorders),
• hydroxychloroquine (used to treat rheumatologic diseases or malaria),
• terfenadine (used to treat allergies),
• antipsychotic medicines, e.g., pimozide,
• antidepressant medicines, e.g., citalopram,
• fluoroquinolones (used to treat infections), e.g., moxifloxacin, levofloxacin;
• antacids (Azimycin should be administered at least 1 hour before or 2 hours after taking antacids);
• oral anticoagulants, e.g., warfarin;
• ergot alkaloids (used to treat migraine or reduce blood flow), e.g., ergotamine, which, when used with azithromycin, may cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia);
• digoxin (used to treat heart function disorders);
• colchicine (used to treat gout or familial Mediterranean fever);
• cyclosporin (used to treat skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (a medicine used to lower cholesterol levels);
• rifabutin (used to treat HIV or tuberculosis).

Azimycin with food and drink

Azimycin in the form of 250 mg film-coated tablets can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The medicine should only be used during pregnancy if the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during treatment with azithromycin unless the doctor recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in the fertility index was observed after administration of azithromycin. The significance of these findings for humans is unknown.

Driving and using machines

There is no data on the effect of Azimycin on the ability to drive and use machines. However, when performing such activities, you should take into account the possibility of side effects such as dizziness and convulsions.

3. How to take Azimycin

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The medicine should be taken orally.
Azimycin is also available in the form of 125 mg and 500 mg film-coated tablets and as a powder for oral suspension 200 mg/5 mL and 100 mg/5 mL.
Dosage for adults and children and adolescents with a body weight over 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans)
The total dose of azithromycin is 1.5 g over 3 days (500 mg in a single daily dose).
Alternatively, the same total dose (1500 mg) can be administered over 5 days: 500 mg on the first day of treatment and 250 mg from the second to the fifth day of treatment.
Erythema migrans
The total dose is 3 g and should be taken in the following regimen: 1 g (4 tablets of 250 mg) on the first day, and then 500 mg (2 tablets) from the second to the fifth day, in single daily doses.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (4 tablets of 250 mg) in a single dose.
Elderly patients
In elderly patients, the same dose is used as in other adult patients. Due to the risk of heart disease, caution is recommended when using the medicine in these patients.
Patients with kidney or liver problems
If you have kidney or liver problems, tell your doctor, as it may be necessary to reduce the usual dose of the medicine. The medicine should not be used in patients with severe liver failure.
Method of administration
Azithromycin should be taken orally, once a day.
Azimycin in the form of 250 mg film-coated tablets can be taken independently of meals.
Tablets should be swallowed whole.

Overdose of Azimycin

Side effects that occurred after taking the medicine in doses higher than recommended were similar to those described after taking the correct doses. Characteristic symptoms of overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
If you have taken more than the recommended dose of the medicine, seek medical attention immediately. In case of overdose, activated charcoal and symptomatic treatment, and if necessary, life-supporting treatment, are recommended.

Missed dose of Azimycin

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

4. Possible side effects

Like all medicines, Azimycin can cause side effects, although not everybody gets them.

In case of the following side effects, stop taking Azimycin and contact your doctor or go to the emergency department of the nearest hospital immediately:

Azimycin and contact your doctor or go to the emergency department of the nearest hospital immediately:

• Allergic reactions: severe, life-threatening allergic reaction leading to shock (frequency not known) or sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially on the whole body (uncommon).
• Severe skin reactions: skin rash characterized by rapid appearance of areas of redness of the skin covered with small blisters (blisters filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding from the lips, eyes, mouth, nose, and genitals, associated with high fever and joint pain. This may be acute generalized exanthematous pustulosis (AGEP, rare), erythema multiforme, blistering erythema multiforme (Stevens-Johnson syndrome), or toxic epidermal necrolysis (all with unknown frequency).
• Severe hypersensitivity reaction that can include fever, skin rash, swollen organs, increased number of a certain type of white blood cells (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms (DRESS); unknown frequency).

Contact your doctor immediately if you notice:

• Severe or persistent diarrhea with blood or mucus. This symptom may occur during or after treatment and may indicate a serious bowel inflammation (unknown frequency).
• Weakness, lack of appetite, yellowing of the skin and whites of the eyes, dark urine, pale stools, abdominal pain, especially in the right upper quadrant. These may be symptoms of severe liver disease (liver failure [rarely leading to death], fulminant hepatitis, liver necrosis; unknown frequency).
• Susceptibility to infections, especially of the mouth and throat, worsening despite treatment (symptoms of neutropenia, leukopenia; uncommon).
• Unusual tendency to bruise or bleed - symptoms of thrombocytopenia (decreased platelet count).
• Fainting, weakness, and fatigue, pallor, shortness of breath, rapid heartbeat - symptoms of hemolytic anemia (increased breakdown of red blood cells; unknown frequency).
• Rapid (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm in the electrocardiogram (prolongation of the QT interval and torsade de pointesarrhythmia; unknown frequency).
• Decreased urine output, weakness, swelling, shortness of breath, lack of appetite, nausea, and vomiting, itching, small hemorrhages on the skin, back pain, hematuria (symptoms of acute kidney failure and interstitial nephritis; unknown frequency).

Other side effects

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

• diarrhea.

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

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decrease in blood bicarbonate levels.

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal disorders, respiratory disorders, rhinitis, fungal infection of the mouth;
• change in white blood cell count (eosinophilia);
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, somnolence, taste disorders, unusual skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• shortness of breath, nosebleeds;
• constipation, bloating with gas, indigestion, gastritis, swallowing disorders (dysphagia), bloated abdomen, dry mouth, belching, oral ulcers, excessive salivation;
• skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urination disorders (dysuria), kidney pain;
• menstrual bleeding, testicular disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial edema, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g., blood, liver function, kidney function, glucose, electrolytes);
• post-procedural complications.

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

• agitation;
• liver function disorders;
• photosensitivity.

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

• aggressive behavior, anxiety, hallucinations, delirium;
• loss of consciousness (syncope), convulsions, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, smell disorders, rapid muscle fatigue (myasthenia);
• hearing disorders, including deafness and/or tinnitus;
• decreased blood pressure;
• pancreatitis, tongue discoloration;
• joint pain.

Side effects possibly or probably related to the use of azithromycin in the treatment of infections caused by Mycobacterium aviumcomplex or for the prevention of such infections, observed during clinical trials and after marketing authorization.

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

• diarrhea;
• abdominal pain;
• nausea;
• bloating;
• abdominal discomfort;
• loose stools.

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

• loss of appetite;
• dizziness;
• headache;
• unusual skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• taste disorders;
• vision disorders;
• hearing loss;
• rash, itching;
• joint pain;
• fatigue.

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

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• liver inflammation;
• blistering erythema multiforme (Stevens-Johnson syndrome), photosensitivity;
• weakness (asthenia), malaise.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azimycin

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Azimycin contains

The active substance is azithromycin.
One film-coated tablet contains 250 mg of azithromycin in the form of azithromycin dihydrate.
The other ingredients are: maize starch pre-gelatinized, povidone, microcrystalline cellulose type 101, microcrystalline cellulose type 102, sodium carboxymethyl cellulose, magnesium stearate;
coating: hypromellose, macrogol 6000, titanium dioxide.

What Azimycin looks like and contents of the pack

White or cream-colored, oval, biconvex tablets.
Packaging:6 film-coated tablets

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Poland. Phone: 22-811-18-14. For more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: