Azicina

Package Leaflet: Information for the Patient

Azycyna, 500 mg, Film-Coated Tablets

Azithromycin

Read the package 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Azycyna and what is it used for
• 2. Important information before taking Azycyna
• 3. How to take Azycyna
• 4. Possible side effects
• 5. How to store Azycyna
• 6. Contents of the pack and other information

1. What is Azycyna and what is it used for

Azycyna 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. Azycyna in the form of 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: erysipelas, impetigo, and secondary bacterial infections of the skin; erythema migrans (the first symptom of Lyme disease); moderate acne in adults only.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Azycyna

When not to take Azycyna

• 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 starting treatment with Azycyna, 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 documented QT interval prolongation (visible on the ECG - a test of heart 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 QT interval prolongation (see "Azycyna 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 have signs of superinfection (e.g., fungal infections);
• you are taking ergotamine derivatives (for migraine or to reduce blood flow);
• you have infected burn wounds.

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, it should be reported to the 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 Azycyna 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 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 myasthenic syndrome (see "Possible side effects") has been observed.
Treatment of infections caused by Mycobacterium avium complex in children
The safety and efficacy of azithromycin in the treatment of infections caused by Mycobacterium avium complex or in the prevention of such infections in children have not been established.

Children and adolescents

Azycyna 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 remaining group of children, it is recommended to use Azycyna in the form of an oral suspension or 125 mg film-coated tablets.

Azycyna and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
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),
• 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 (Azycyna 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 to reduce blood flow), e.g., ergotamine, which can cause ergotism (symptoms - spasm 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)
• ciclosporin (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).

Azycyna with food and drink

See section 3.

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 be used during pregnancy only if the doctor considers it necessary for the mother and the potential risk to the fetus is acceptable.
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 Azycyna 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.

Azycyna contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Azycyna

This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Dosage for adults and children 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 in the following regimen: 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 in the following regimen: 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 high dose of azithromycin in the above regimen for moderate acne, it is necessary to monitor liver enzyme activity before starting and during the course of treatment with azithromycin.
The above regimen of cyclic treatment of moderate acne (3 days + 9 weeks) can be used in a given patient only once, as there are no controlled clinical trials that have shown the safety and efficacy of repeating this regimen for moderate acne.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (4 film-coated 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 disorders
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
Azycyna in the form of 500 mg film-coated tablets should be administered orally, once a day, at least 1 hour before meals or 2 hours after meals. The tablets should be swallowed whole.

Overdose of Azycyna

Side effects that occurred after taking the medicine in higher doses than recommended were similar to those reported 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, it is recommended to administer activated charcoal and provide symptomatic treatment, and if necessary, life-supporting treatment.

Missed dose of Azycyna

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

4. Possible side effects

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

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

• allergic reactions: rash, urticaria, swelling of hands, feet, ankles, face, lips, mouth, or throat, difficulty breathing or swallowing;
• severe skin reactions, including erythema multiforme (circular red and swollen patches), Stevens-Johnson syndrome (blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain), toxic epidermal necrolysis (large blisters under the skin, extensive erosions on the skin, and shedding of large skin patches, as well as fever), acute generalized exanthematous pustulosis (a skin rash characterized by rapid onset of areas of redness on the skin, studded with small pustules [blisters or bumps filled with white or yellow fluid]);
• severe and persistent diarrhea, especially if there is blood or mucus in the stool. (this may be a sign of inflammatory bowel disease, called pseudomembranous colitis)
• vaginal bleeding Częstości of the above side effects are listed below.

The following side effects have been reported:
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;
• changes in white blood cell count;
• decreased bicarbonate levels in the blood.

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;
• changes in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling in the face and throat, which can cause difficulty breathing), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia; dizziness, somnolence, taste disorders, abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• dyspnea, epistaxis;
• constipation, bloating with gas, indigestion, gastritis, dysphagia, abdominal distension, dry mouth, eructation, oral ulcers, excessive salivation;
• rash, pruritus, urticaria, skin inflammation, dry skin, excessive sweating;
• osteoarthrosis, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• vaginal 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, glucose, electrolytes);
• post-procedural complications.

Rare side effects(may affect up to 1 in 10,000 people):

• agitation;
• liver function disorders, cholestatic jaundice;
• photosensitivity
• severe skin reactions: acute generalized exanthematous pustulosis

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

• pseudomembranous colitis;
• thrombocytopenia (decreased platelet count), decreased red blood cell count (hemolytic anemia);
• anaphylactic reaction (a generalized allergic reaction that can rarely be fatal; may occur with symptoms such as: swelling of the lips, face, or throat, leading to severe breathing difficulties, rash on the skin or urticaria);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disturbances of smell;
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsades de pointes and ventricular tachycardia), QT interval prolongation on the electrocardiogram;
• hypotension;
• pancreatitis, tongue discoloration;
• liver failure (rarely fatal), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme;
• arthritis;
• acute kidney failure, interstitial nephritis.

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

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

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

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

• loss of appetite;
• dizziness;
• headache;
• abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• taste disorders;
• vision disorders;
• hearing loss;
• rash, pruritus;
• arthritis;
• fatigue.

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

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• Stevens-Johnson syndrome (severe skin reaction), photosensitivity;
• weakness (asthenia), malaise.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, 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 Azycyna

Keep the medicine out of the sight and reach of children.
Store in the original packaging, at a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Azycyna contains

• The active substance of the medicine is azithromycin. Each film-coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
• Other ingredients are: microcrystalline cellulose (101), microcrystalline cellulose (102), povidone
• (90), croscarmellose sodium, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate. Coating:hypromellose (E 15), hypromellose (E 5), hydroxypropylcellulose, Macrogol (8000), Opaspray K-1R-4210A, indigo carmine.

What Azycyna looks like and contents of the pack

Blue, round, biconvex film-coated tablets with a uniform surface.
The tablets are packaged in PVC/Aluminum blisters with a leaflet, in a cardboard box.
The pack contains 2, 3, 6, or 12 film-coated tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of the last revision of the leaflet: