Azicina

Leaflet accompanying the packaging: patient information

Azycyna, 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.
• In case of 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 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 from the macrolide group with a broad spectrum of action. It has a bactericidal effect on susceptible microorganisms. Azycyna in the form of 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: erysipelas, impetigo, and secondary infected dermatitis; Lyme disease - the first sign of erythema migrans.
• Sexually transmitted diseases: uncomplicated chlamydial infections caused by Chlamydia trachomatis.

2. Important information before taking Azycyna

When not to take Azycyna

• If the patient is hypersensitive 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, the patient should discuss with their doctor or pharmacist if:

• the patient has conditions that may lead to arrhythmias (especially in women and elderly patients):
• congenital or documented QT interval prolongation (visible on the ECG - a test of the heart's electrical activity),
• severe heart failure,
• very slow heart rate (bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• taking other medicines that may cause QT interval prolongation (see "Azycyna and other medicines");
• the patient has severe kidney impairment;
• the patient has severe liver impairment: the doctor may need to monitor liver function or discontinue treatment;
• the patient has a new infection (this may indicate excessive growth of resistant microorganisms or a fungal infection);
• the patient has neurological or psychiatric 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 has signs of superinfection (e.g., fungal infections);
• the patient is taking ergotamine derivatives (for migraine or to reduce blood flow);
• the patient has 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
In case of diarrhea, the patient should immediately report it to their doctor, as it may be a sign of pseudomembranous colitis - a complication that can occur with the use of macrolide antibiotics. The doctor should consider this diagnosis in patients who develop diarrhea after starting treatment with azithromycin. In 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 are no data on the safety and efficacy of long-term use of azithromycin in the indications listed above. In 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.
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 250 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

The patient should tell their doctor 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 arrhythmias),
• 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 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 rhythm 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).

Azycyna with food and drink

See section 3.

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 treatment with azithromycin, unless the doctor recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in the conception rate was observed after administration of azithromycin. The significance of these findings for humans is unknown.

Driving and using machines

There are no data on the effect of Azycyna 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.

Azycyna contains sodium

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

3. How to take Azycyna

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
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 film-coated tablets of 250 mg) on the first day, and then 500 mg (2 film-coated tablets) from the second to the fifth day, in single daily doses.
Uncomplicated chlamydial 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 renal or hepatic impairment
If the patient has renal or hepatic impairment, 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 hepatic impairment.
Method of administration
Azycyna in the form of 250 mg film-coated tablets should be administered orally, once a day, at least 1 hour before meals or 2 hours after a meal. The tablets should be swallowed whole.

Overdose of Azycyna

Side effects that occurred after taking the medicine in doses higher 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.
In case of overdose, the patient should immediately consult their doctor or pharmacist. In case of overdose, it is recommended to administer activated charcoal and use symptomatic treatment, and if necessary, life-supporting treatment.

Missing a 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. A double dose should not be taken 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, the medicine should be discontinued and the patient should immediately contact their doctor or the emergency department of the nearest hospital:

• 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 fever), acute generalized exanthematous pustulosis (skin rash characterized by rapid onset of areas of redness on the skin studded with small pustules [blisters filled with white or yellow fluid]);
• severe and prolonged diarrhea, especially if there is blood or mucus in the stool (this may be a sign of inflammatory bowel disease, known as pseudomembranous colitis);
• vaginal bleeding

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, genital infections, urinary tract infections;
• change 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 disturbances, abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• visual disturbances;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• dyspnea, epistaxis;
• constipation, flatulence, indigestion, gastritis, dysphagia, bloating, dry mouth, belching, oral ulcers, excessive salivation;
• rash, pruritus, urticaria, skin inflammation, dry skin, excessive sweating;
• arthrosis, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• vaginal bleeding, genital 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 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 (decrease in platelet count), hemolytic anemia (decrease in red blood cell count);
• anaphylactic reaction (generalized allergic reaction, which 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, confusion, hallucinations;
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disturbances of smell, tinnitus;
• hearing disorders, including deafness and/or tinnitus;
• arrhythmias (including torsades de pointes and ventricular tachycardia), QT interval prolongation;
• hypotension;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme;
• arthritis;
• acute renal failure, interstitial nephritis.

Side effects probably or possibly 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 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, pruritus;
• arthritis;
• fatigue.

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

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• Stevens-Johnson syndrome (severe skin reaction), 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 Azycyna

The medicine should be stored out of 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. 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 pack and other information

What Azycyna contains

• The active substance of the medicine is azithromycin. Each film-coated tablet contains 250 mg of azithromycin in the form of azithromycin dihydrate.
• The 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 smooth surface.
The tablets are packaged in PVC/Aluminum blisters with a leaflet, in a cardboard box.
The pack contains 3 or 6 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 last revision of the leaflet: