AZIMYCIN 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. AZIMYCIN, 500 mg, film-coated tablets
   1. Table of contents of the leaflet
3. What is Azimycin and what is it used for
4. Important information before taking Azimycin
   1. When not to take Azimycin
   2. Warnings and precautions
   3. Children and adolescents
   4. Azimycin and other medicines
   5. Azimycin with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to take Azimycin
   1. Overdose of Azimycin
   2. Missed dose of Azimycin
6. Possible side effects
   1. 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:
   2. Azimycin and contact your doctor or go to the emergency department of the nearest hospital immediately:
   3. Contact your doctor immediately if you notice:
   4. Other side effects
   5. Reporting of side effects
7. How to store Azimycin
8. Contents of the pack and other information
   1. What Azimycin contains
   2. What Azimycin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

AZIMYCIN, 500 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 activity. It acts bactericidally on susceptible microorganisms. Azimycin, 500 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 bacterial infections of the skin; Lyme disease - the first sign of erythema migrans; moderate acne in adults only.
• 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 antibiotics, 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 arrhythmias (especially in women and elderly patients):
• congenital or documented arrhythmias (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,
• 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 monitor 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 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 (ergot preparations);
• you have infected burn wounds.

You should also read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not disappear or if symptoms of another infection appear, e.g. fungal infection, 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 during 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. The use of anti-peristaltic agents is contraindicated.
Long-term use
There is no data on the safety and efficacy of azithromycin used long-term in the above indications. In the case of rapidly 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 500 mg film-coated tablets is recommended for use in children only if their body weight is not less than 45 kg. For the rest of the pediatric population, it is recommended to use Azimycin in the form of an oral suspension or 125 mg film-coated tablets.

Azimycin and other medicines

Tell your doctor or pharmacist about all 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 arrhythmias),
• 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 taken 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 rhythm disorders);
• 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 500 mg film-coated tablets can be taken with or without food.

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 fertility 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 seizures.

3. How to take Azimycin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally.
Azimycin is also available in the form of 125 mg and 250 mg film-coated tablets and 200 mg/5 mL and 100 mg/5 mL oral suspension.
Dosage for adults, including the elderly, 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 and moderate acne)
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) 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 as follows: 1 g (2 film-coated tablets of 500 mg) on the first day, and then 500 mg (1 film-coated tablet) from the second to the fifth day, in single daily doses.
Moderate acne - only in adults
The total dose is 6 g and is recommended to be administered as follows: 1 film-coated tablet of 500 mg once a day for 3 days, then 1 film-coated tablet of 500 mg once a week for the next 9 weeks. In the second week of treatment, the medicine should be taken 7 days after the first dose, and the next eight doses should be taken at 7-day intervals.
Due to the use of a high dose of azithromycin in the above dosage regimen in patients with moderate acne, it is necessary to monitor liver enzyme activity before and during the treatment course with azithromycin.
The above cyclic treatment regimen for moderate acne (3 days + 9 weeks) can only be used once in a given patient, as there are no controlled clinical trials that have demonstrated the safety and efficacy of repeating this treatment regimen for moderate acne.
Uncomplicated infections caused by Chlamydia trachomatis1 g (2 film-coated tablets of 500 mg) in a single dose.
Patients with kidney or liver problems
If you have kidney or liver problems, you should 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 500 mg film-coated tablets can be taken with or without food. The 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 after 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, you should immediately consult a doctor or pharmacist. In case of overdose, it is recommended to administer activated charcoal and use symptomatic treatment, and if necessary, life-supporting treatment.

Missed dose of Azimycin

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

4. Possible side effects

Like all medicines, this medicine 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, sudden allergic reactions that can cause anaphylaxis (frequency not known) or sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially if it spreads over the whole body (uncommon).
• Severe skin reactions: skin rash characterized by rapid onset of areas of redness on the skin covered with small blisters (blisters 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, 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 cell (eosinophilia), and inflammation of internal organs (drug rash 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 upper respiratory tract, 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 inflammation;

change in white blood cell count (eosinophilia);

• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, drowsiness, taste disturbances, abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia);
• visual disturbances;
• hearing disturbances, balance disturbances;
• palpitations;
• flushing;
• shortness of breath, nosebleeds;
• constipation, bloating with gas, indigestion, stomach inflammation, swallowing difficulties (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 difficulties (dysuria), kidney pain;
• vaginal bleeding, testicular disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial swelling, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g. related to 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.

Unknown frequency(cannot be estimated from the available data)

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

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
Phone: +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 the month.
Medicines should 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.
One film-coated tablet contains 500 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 carboxymethylcellulose, 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:3 or 6 or 12 film-coated tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22-811-18-14
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: