Abiazyt

Package leaflet: Information for the patient

ABIAZYT, 500 mg, coated tablets
Azithromycinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Abiazyt is and what it is used for

The active substance in Abiazyt is azithromycin. Abiazyt belongs to the group of macrolide antibiotics. Azithromycin is indicated for the treatment of the following conditions:

• Acute sinusitis;
• Acute otitis media;
• Streptococcal pharyngitis, tonsillitis when therapy with first-line beta-lactam antibiotics is not possible and Streptococcus pyogenes is susceptible to azithromycin;
• Exacerbations of chronic bacterial bronchitis;
• Mild to moderate pneumonia;
• Mild to moderate skin and soft tissue infections;
• Uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Abiazyt
When not to take Abiazyt

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

Warnings and precautions
Before starting treatment with Abiazyt, discuss with your doctor if:

• You have been diagnosed with heart disorders known as "long QT syndrome" or you are taking antiarrhythmic drugs (medicines used to treat heart rhythm disorders), such as quinidine, procainamide, dofetilide, amiodarone, sotalol; cisapride (a medicine used to treat gastrointestinal disorders); terfenadine (an antihistamine); antipsychotic drugs such as pimozide; antidepressants such as citalopram; fluoroquinolones (antibacterial chemotherapeutic agents) such as moxifloxacin and levofloxacin;
• You have been diagnosed with slowed or irregular heart rhythm;
• You have electrolyte imbalances, especially low blood potassium or magnesium levels;
• You have liver disease;
• You have kidney disease;
• You have neurological or psychiatric disorders.
• Symptoms of a new infection caused by bacteria or fungi resistant to azithromycin occur.

Before starting treatment with Abiazyt, discuss with your doctor:

• If you have impaired liver function: monitoring of liver function or discontinuation of treatment may be necessary.

Severe allergic reactions causing facial and throat swelling, possibly accompanied by breathing difficulties, have been reported during azithromycin therapy. If such symptoms occur, discontinue Abiazyt immediately and contact your doctor without delay.
Antibiotics may cause diarrhea, which may be a sign of intestinal inflammation (associated with infection by Clostridium difficile). Contact your doctor if prolonged diarrhea occurs during or after antibiotic therapy, especially if stools contain blood or mucus.
Cases of diarrhea occurring more than two months after administration of antibacterial agents have been reported. Do not use any anti-diarrheal medicines until advised by a doctor.
Exacerbation of myasthenia gravis symptoms and occurrence of myasthenic syndrome (muscle weakness making walking and lifting arms difficult) have been observed in patients during azithromycin therapy.

Children and adolescents
Abiazyt is not indicated for children and adolescents with body weight below 45 kg.
Information on dosing for children and adolescents above 45 kg body weight can be found in section 3.

Abiazyt with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
If you are taking any of the following medicines, you must inform your doctor or pharmacist before starting Abiazyt:

• Medicines affecting the QT interval, such as:
  • quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat heart rhythm disorders),
  • cisapride (used for gastrointestinal disorders),
  • terfenadine (used to treat allergies),
  • antipsychotics, e.g. pimozide,
  • antidepressants, e.g. citalopram,
  • fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin;
• Ergot derivatives, e.g. ergotamine or dihydroergotamine (medicines used for migraine or reducing blood flow); these medicines should not be used concomitantly with Abiazyt;
• Atorvastatin and statins (used to treat high blood cholesterol levels);
• Cyclosporine (used for skin diseases, rheumatoid arthritis, or after organ transplantation);
• Theophylline (used to treat respiratory disorders);
• Warfarin or other anticoagulants;
• Digoxin (used to treat heart function disorders);
• Zidovudine (used to treat HIV infections); Abiazyt may reduce zidovudine blood levels and should be taken 1–2 hours before or after zidovudine;
• Efavirenz, indinavir, nelfinavir, didanosine (used to treat HIV infections);
• Rifabutin (used to treat HIV infections or tuberculosis);
• Antacids (medicines that neutralize gastric acid); Abiazyt should be taken at least 1 hour before or 2 hours after antacids;
• Astemizole (for allergy treatment), triazolam and midazolam (sedatives), alfentanil (an analgesic).

Taking Abiazyt with food and drink
Abiazyt may be taken with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy or breastfeeding unless specifically prescribed by a doctor.

Driving and operating machinery
This medicine may cause side effects such as dizziness or seizures. These effects may impair your ability to perform certain activities, such as driving or operating machinery.

Abiazyt contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free."

3. How to take Abiazyt
Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosing is shown in the table below:
For children and adolescents above 45 kg body weight,
Adults and elderly patients
Indication Dosage

• Upper and lower respiratory tract infections – 500 mg (1 tablet) once daily for 3 days or
• Otitis media – 500 mg on the first day, then 250 mg (half a tablet) daily from the second to the fifth day
• Skin and soft tissue infections
• Uncomplicated infections caused by Chlamydia trachomatis – 1000 mg (2 tablets) as a single dose

Elderly patients
Due to increased risk of heart rhythm disturbances and severe forms of tachycardia in elderly patients, the doctor will exercise particular caution.

Use in children and adolescents
Abiazyt is not indicated for children and adolescents with body weight below 45 kg.

Patients with impaired kidney or liver function
If you have impaired kidney or liver function, inform your doctor. The doctor may decide to adjust the dose.

Swallow the tablets with water.
The tablets may be taken with or without food.
The tablet may be divided into two equal parts.

Taking more Abiazyt than prescribed
If you take more Abiazyt than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine in its original packaging so that the medical staff can identify exactly which medicine was taken.
Taking more Abiazyt than prescribed may cause symptoms such as transient hearing loss, severe nausea, vomiting, and diarrhea.

If you miss a dose of Abiazyt
If you miss a dose, take it as soon as possible, then continue taking the medicine as prescribed. Do not take more than one dose per day.

Stopping Abiazyt treatment
Continue taking the medicine for the full prescribed duration, even if you feel better. Stopping treatment too early may lead to recurrence of infection. Also, bacteria may become resistant to the medicine, making future treatment more difficult.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms of a severe allergic reaction occur, stop taking the medicine and contact a doctor immediately or go to the nearest hospital:

• swelling of the lips, tongue, face, and neck;
• sudden difficulty breathing, speaking, or swallowing;
• severe or itchy skin rash, especially in the form of blisters, accompanied by eye pain, mouth pain, or genital pain;
• frequent, prolonged diarrhoea, especially if it contains mucus and blood (may indicate pseudomembranous colitis or intestinal inflammation);

Adverse reactions
Very common (may occur in more than 1 in 10 patients):

• diarrhoea.

Common (may occur in less than 1 in 10 patients):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decreased concentration of bicarbonate in blood.

Uncommon (may occur in less than 1 in 100 patients):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, sore throat, gastritis, gastrointestinal disorders, respiratory disorders, rhinitis, oral candidiasis;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling of the face and throat, possibly causing breathing difficulties), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paresthesia);
• visual disturbances;
• ear disorders, balance disorders;
• palpitations;
• hot flushes;
• shortness of breath, nosebleeds;
• constipation, bloating with flatulence, indigestion, inflammation of the gastric mucosa, difficulty swallowing (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting of gastric contents, oral ulcers, excessive salivation;
• rash, itching, urticaria, skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• uterine bleeding, testicular disorders;
• oedema, weakness (asthenia), malaise (apathy), feeling of fatigue, facial swelling, chest pain, fever, pain, peripheral oedema;
• abnormal laboratory test results (e.g. blood tests, liver function parameters, glucose, electrolytes);
• post-procedural complications.

Rare (may occur in less than 1 in 1000 patients):

• restlessness;
• liver function disorders, cholestatic jaundice (cholestatic jaundice);
• photosensitivity;
• skin eruption characterized by rapid appearance of red skin areas covered with small blisters filled with clear or yellow fluid;

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

• pseudomembranous colitis;
• thrombocytopenia (reduced platelet count), reduced number of red blood cells (hemolytic anaemia);
• anaphylactic reaction (generalized allergic reaction rarely leading to death; may present with symptoms such as swelling of lips, face or neck leading to severe breathing difficulties, skin rash or urticaria);
• aggressive behaviour, anxiety, delirium, hallucinations;
• loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, olfactory disturbances, rapid muscle fatigue (myasthenia);
• hearing disorders including deafness and (or) tinnitus;
• cardiac arrhythmias (including torsade de pointes and ventricular tachycardia), QT interval prolongation on electrocardiogram;
• hypotension;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, hepatic necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS);
• joint pain;
• acute kidney failure, interstitial nephritis.

Adverse reactions probably or possibly related to the use of azithromycin in the treatment or prevention of Mycobacterium avium complex infections, based on clinical trials and post-marketing surveillance
Very common (may occur in more than 1 in 10 patients):

• diarrhoea;
• abdominal pain;
• nausea;
• bloating;
• discomfort in the abdominal cavity;
• loose stools.

Common (may occur in less than 1 in 10 patients):

• anorexia;
• dizziness;
• headache;
• unusual skin sensations such as tingling and numbness of limbs (paresthesia);
• taste disturbances;
• visual disturbances;
• deafness;
• rash, itching;
• joint pain;
• feeling of fatigue.

Uncommon (may occur in less than 1 in 100 patients):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Email: [email protected]
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Abiazyt

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Abiazyt contains

• The active substance is azithromycin. Each coated tablet contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin.
• The other ingredients are: microcrystalline cellulose, pregelatinized potato starch, sodium lauryl sulfate, hypromellose 4.0-6.0 mPa·s., sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
  Coating: Opadry White Y-1-7000[3] containing: hypromellose 4.0-6.0 mPa·s., titanium dioxide (E171), polyethylene glycol 400.

What Abiazyt looks like and contents of the pack
Film-coated tablets, white or almost white, capsule-shaped, marked "S5" on one side and a breakline on the other side. The tablets are packed in blisters, placed in cardboard boxes.
Pack size: 3 tablets.
Marketing Authorisation Holder
Artespharm Sp. z o.o.
Solec 81 B, lok. A-51,
00-382 Warszawa, Poland
Name and address of the importer where batch release takes place:
Mako Pharma Sp. z o.o.
Wiśniowa 9
05-092 Kiełpin
Poland
For more detailed information, please contact the Marketing Authorisation Holder.