Abiazit

Leaflet attached to the packaging: patient information

ABIAZYT, 500mg, coated tablets

Azithromycin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Abiazyt and what is it 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 packaging and other information

1. What is Abiazyt and what is it used for

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

• acute sinusitis;
• acute otitis media;
• streptococcal pharyngitis, tonsillitis, in cases where therapy with first-line beta-lactam antibiotics is not possible and the streptococcus is susceptible to azithromycin treatment;
• in exacerbations of chronic bronchitis of bacterial origin;
• mild to moderate pneumonia,
• mild to moderate skin and soft tissue infections;
• uncomplicated Chlamydia trachomatis infections

2. Important information before taking Abiazyt

When not to take Abiazyt

• If the patient is 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, the patient should discuss it with their doctor if:

• the patient has been diagnosed with heart disorders, known as "prolonged QT interval" or is taking antiarrhythmic drugs (drugs used to treat heart rhythm disorders, such as quinidine, procainamide, dofetilide, amiodarone, sotalol); cisapride (a drug used to treat stomach disorders) and terfenadine (an antihistamine drug); antipsychotic drugs, such as pimozide; antidepressant drugs, such as citalopram; fluoroquinolones (bacterial chemotherapeutic agents), such as moxifloxacin and levofloxacin
• the patient has been diagnosed with slowed or irregular heart rhythm
• there are disturbed electrolyte levels, especially potassium or magnesium levels in the blood;
• the patient has liver disease
• the patient has kidney disease
• the patient has nervous system (neurological) or mental (psychiatric) disorders.
• there are symptoms of new bacterial or fungal infections that are not susceptible to azithromycin

Before starting treatment with Abiazyt, the patient should discuss it with their doctor:

• if the patient has liver function disorders: it may be necessary to monitor liver function or discontinue treatment;

Severe allergic reactions, causing swelling of the face and throat, with possible difficulty breathing, have been reported during azithromycin therapy. If such symptoms occur, the patient should stop taking Abiazyt and contact their doctor immediately. Antibiotics can cause diarrhea, which can be a sign of intestinal inflammation (associated with infection by Clostridium difficile bacteria). The patient should contact their doctor if they experience prolonged diarrhea, with blood or mucus in the stool, during or after antibiotic therapy. Cases of diarrhea have been reported to occur more than two months after the administration of antibacterial drugs. The patient should not take any medication to stop diarrhea without consulting their doctor. Worsening of myasthenia symptoms (muscle disease) and the occurrence of myasthenic syndrome (muscle weakness making it difficult to walk and raise arms) have been observed in patients during azithromycin therapy.

Children and adolescents

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

Abiazyt 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, they should inform their doctor or pharmacist before starting treatment with Abiazyt:

• 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 drugs, such as pimozide,
• antidepressant drugs, such as citalopram,
• fluoroquinolones (used to treat infections), such as moxifloxacin, levofloxacin;
• medicines known as ergot derivatives, such as ergotamine or dihydroergotamine (used to treat migraines or reduce blood flow); these medicines should not be taken at the same time as Abiazyt;
• atorvastatin and statins (used to treat high cholesterol levels in the blood)
• cyclosporine (used to treat skin diseases, rheumatoid arthritis, or after organ transplantation),
• theophylline (used to treat respiratory disorders),
• warfarin or other anticoagulant medicines,
• digoxin (used to treat heart function disorders),
• zidovudine (used to treat HIV infections), Abiazyt may decrease zidovudine levels in the blood 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 stomach acid), Abiazyt should be taken at least 1 hour before or 2 hours after taking antacids;
• astemizole (used to treat allergies), triazolam and midazolam (sedative drugs), alfentanil (pain reliever);

Taking Abiazyt with food and drink

The medicine 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. The medicine should not be taken during pregnancy or breastfeeding, unless the doctor specifically recommends it.

Driving and using machines

The medicine may cause side effects such as dizziness or seizures. These effects may impair the ability to perform certain activities, such as driving or operating machines.

Abiazyt contains sodium

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

3. How to take Abiazyt

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dosage is presented in the table:

For children and adolescents over 45kg body weight,

Adults and elderly patients

Indication Dosage

• upper and lower respiratory tract infections
• otitis media
• skin and soft tissue infections
• 500 mg (1 tablet) 1x daily for 3 days or
• 500 mg on the first day, then 250 mg (half a tablet) from the second to the fifth day, daily

1000 mg (2 tablets) as a single dose

• uncomplicated Chlamydia trachomatis infections

Elderly patients

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

Use in children and adolescents

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

Patients with kidney or liver function disorders

If the patient has kidney or liver function disorders, they should inform their doctor. The doctor may decide to change the dose of the medicine.

Tablets should be swallowed with water.

Tablets can be taken independently of meals. The tablet can be divided into 2 equal parts.

Taking a higher dose of Abiazyt than recommended

In case of taking a higher dose of Abiazyt than recommended, the patient should immediately contact their doctor or go to the nearest hospital emergency department. The patient should take the medicine in its original packaging, so that the medical staff can check exactly which medicine was taken. Taking a higher dose of Abiazyt than recommended by the doctor may cause symptoms such as: transient hearing loss, severe nausea, vomiting, diarrhea.

Missing a dose of Abiazyt

If the patient misses a dose, they should take it as soon as possible, and then continue taking the medicine according to the recommended dosage. The patient should not take more than one dose of the medicine in one day.

Stopping treatment with Abiazyt

The medicine should be taken until the end of the recommended treatment cycle, even if the patient feels better. Stopping treatment too early may cause the infection to recur. Also, bacteria may become resistant to the medicine, which may cause difficulties in treatment later on. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Abiazyt can cause side effects, although not everybody gets them. If any of the following symptoms of a severe allergic reaction occur, the patient should stop taking the medicine and contact their doctor immediately or go to the nearest hospital:

• swelling of the lips, tongue, face, and throat;
• sudden difficulty breathing, speaking, or swallowing;
• severe or itchy skin rash, especially with blisters, and possible eye, mouth, or genital pain;
• frequent, prolonged diarrhea, especially with mucus and blood in the stool (may indicate pseudomembranous colitis or intestinal inflammation);

Side effects
Very common(may occur more frequently than in 1 in 10 patients):

• diarrhea.

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

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decrease in blood bicarbonate levels.

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal upset, respiratory disorders, rhinitis, fungal infection of the mouth;
• 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, drowsiness, taste disorders, abnormal skin sensations, such as tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• hot flashes;
• shortness of breath, nosebleeds;
• constipation, bloating with gas, indigestion, gastritis, swallowing disorders (dysphagia), bloated stomach, dry mouth, belching, oral ulcers, excessive salivation;
• rash, itching, urticaria, skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urination disorders (dysuria), kidney pain;
• menstrual bleeding, testicular disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial swelling, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g., blood, liver function, glucose, electrolytes);
• post-procedure complications.

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

• agitation;
• liver function disorders, cholestatic jaundice;
• photosensitivity;
• skin rash characterized by rapid onset of areas of redness on the skin studded with small blisters (pustules filled with white or yellow fluid);

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

• pseudomembranous colitis;
• thrombocytopenia (decreased platelet count), decreased red blood cell count (hemolytic anemia);
• 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 difficulty breathing, skin rash or urticaria);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), seizures, sensory disorders (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, taste disorders, rapid muscle fatigue (myasthenia);
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsades de pointes and ventricular tachycardia), QT interval prolongation in the electrocardiogram;
• decreased blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS);
• arthritis;
• acute kidney failure, interstitial nephritis.

Side effects probably or possibly related to the use of azithromycin in the treatment of Mycobacterium avium complex infections or prevention of them, based on clinical trials and post-marketing observations

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

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

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

• loss of appetite;
• dizziness;
• headache;
• abnormal skin sensations, such as tingling and numbness of limbs (paresthesia);
• taste disorders;
• vision disorders;
• deafness;
• rash, itching;
• arthritis;
• fatigue.

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Abiazyt

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month. The medicine does not require special storage conditions. 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 Abiazyt contains

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

What Abiazyt looks like and what the packaging contains

Coated tablets, white or almost white, capsule-shaped, marked "S5" on one side and with a dividing line on the other side. The tablets are packaged in blisters, in cardboard boxes. The packaging contains 3 tablets.

Marketing authorization holder

Artespharm Sp. z o.o., Solec 81 B, lok. A-51, 00-382 Warsaw, Poland

Name and address of the importer who releases the series:

Mako Pharma Sp z o.o., ul. Wiśniowa 9, 05-092 Kiełpin, Poland. For more detailed information, please contact the marketing authorization holder.

Date of the last update of the leaflet: