Azimicin

Leaflet attached to the packaging: patient information

Azimycin, 125 mg, film-coated tablets

Azithromycin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging and other information

1. What is Azimycin and what is it used for

Azimycin contains the active substance azithromycin, which is an azalide antibiotic from the macrolide group with a broad spectrum of activity. It has a bactericidal effect on susceptible microorganisms. Azimycin, 125 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 eczema; erythema migrans - the first sign of Lyme disease.

2. Important information before taking Azimycin

When not to take Azimycin

• If the patient is allergic to azithromycin, other macrolide antibiotics, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Azimycin, the patient should discuss it with their doctor or pharmacist if:

• the patient has conditions that may lead to disturbances in heart rhythm (especially in women and elderly patients):
• congenital or existing heart rhythm disturbances (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,
• the patient is taking other medicines that may cause prolongation of the QT interval in the ECG (see "Azimycin and other medicines");
• the patient has severe kidney problems;
• the patient has severe liver problems: the doctor may need to monitor liver function or discontinue treatment;
• the patient has a new infection (this may indicate an overgrowth of resistant microorganisms or a fungal infection);
• the patient has neurological or mental disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that the patient does not have a co-existing syphilis infection;
• the patient is taking ergotamine derivatives (ergot preparations);
• the patient has infected burn wounds.

The patient should also read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not disappear or new symptoms appear, e.g., fungal infection, the patient should consult their 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 diarrhea occurs, the patient should immediately report it to their doctor, as it may be a sign of pseudomembranous colitis - a complication that can occur during the use of macrolide antibiotics. This diagnosis should be considered in patients who develop diarrhea after starting azithromycin treatment. 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 azithromycin treatment, exacerbation of myasthenia symptoms or the occurrence of myasthenic syndrome (see "Possible side effects") has been observed.

Children and adolescents

Azimycin in the form of 125 mg film-coated tablets is recommended for use in children with a suitable body weight who can swallow the tablet. For the remaining group of children, the use of Azimycin in the form of an oral suspension is recommended. For children with a body weight over 45 kg, 250 mg or 500 mg film-coated tablets are recommended.

Azimycin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking any of the following medicines, it is especially important to inform their doctor or pharmacist:

• medicines that affect the QT interval, such as:
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat heart rhythm disturbances),
• 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 can cause ergotism (symptoms - constriction of peripheral blood vessels and ischemia) when used with azithromycin;
• 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 125 mg film-coated tablets can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if the doctor considers that the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during azithromycin treatment, 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 study results 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, the patient should take into account the possibility of side effects such as dizziness and seizures.

3. How to take Azimycin

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
Azimycin is also available in 250 mg and 500 mg film-coated tablets and in the form of a powder for oral suspension of 200 mg/5 mL and 100 mg/5 mL.
Azimycin, 125 mg film-coated tablets, is recommended for use in children with a suitable body weight (considering the dosage per kilogram of body weight), who can swallow the tablet. For the remaining group of children, the use of Azimycin in the form of an oral suspension is recommended. For children with a body weight over 45 kg, 250 mg or 500 mg film-coated tablets are recommended.
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans)
Dosage in children and adolescents with a body weight below 45 kg
The total dose is 30 mg/kg body weight, i.e., 10 mg/kg body weight once a day for 3 days.
Dosage in children and adolescents with a body weight over 45 kg
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 also 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 60 mg/kg body weight and should be administered as follows: 20 mg/kg body weight on the first day, and then 10 mg/kg body weight once a day from the second to the fifth day, in single daily doses.
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 disorders
If the patient has kidney or liver disorders, they should inform their 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 125 mg film-coated tablets can be taken independently of meals. 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 reported after administration of the correct doses. Characteristic symptoms of overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of overdose, the patient should immediately consult a doctor or pharmacist. In case of overdose, activated charcoal and symptomatic treatment, as well as supportive treatment if necessary, 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, the patient should stop taking Azimycin and immediately consult their doctor or go to the emergency department of the nearest hospital:

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

• Allergic reactions: severe allergic reaction leading to shock (unknown frequency) or sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially occurring all over the body (uncommon).

Severe skin reactions: skin rash characterized by rapid onset of areas of redness on the skin covered with small blisters; 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 may include fever, skin rash, swollen organs, increased number of a certain type of white blood cell (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms (DRESS); unknown frequency).

The patient should immediately consult their doctor if they 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, loss 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, 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 pointesdisturbances; unknown frequency).
• Decreased urine output, weakness, swelling, shortness of breath, loss of appetite, nausea, 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, oral thrush;
• change in white blood cell count (eosinophilia);
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, somnolence, taste disturbances, abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• visual disturbances;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• shortness of breath, epistaxis;
• constipation, flatulence, indigestion, gastritis, dysphagia, bloating, dry mouth, belching, oral ulcers, excessive salivation;
• skin rash, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary 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 1000 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.

Side effects possibly or probably related to the use of azithromycin in the treatment of infections caused by mycobacteria of the Mycobacterium aviumcomplex or prevention of them, 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;
• abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia):
• taste disturbances;
• visual disturbances;
• hearing loss;
• rash, itching;
• joint pain;
• fatigue.

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

• sensory disturbances (hypoesthesia);
• hearing disturbances, tinnitus;
• palpitations;
• hepatitis;
• blistering erythema multiforme (Stevens-Johnson syndrome - a severe skin reaction; ang. SJS), photosensitivity;
• weakness (asthenia), malaise.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Azimycin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date (EXP) is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Azimycin contains

The active substance of the medicine is azithromycin.
One film-coated tablet contains 125 mg of azithromycin in the form of azithromycin dihydrate.
The excipients 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:6 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, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: