Azitrolek 250

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

AzitroLEK 250(Azithromycin Sandoz 250 mg)

250 mg, film-coated tablets

Azithromycin
AzitroLEK 250 and Azithromycin Sandoz 250 mg are different trade names for the same medicine.

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 further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 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 AzitroLEK 250 and what is it used for
• 2. Important information before taking AzitroLEK 250
• 3. How to take AzitroLEK 250
• 4. Possible side effects
• 5. How to store AzitroLEK 250
• 6. Contents of the packaging and other information

1. What is AzitroLEK 250 and what is it used for

AzitroLEK 250 is an antibiotic belonging to a group called macrolides. It is used to treat infections caused by bacteria.
The medicine is usually prescribed to treat:

• infections in the chest, such as chronic bronchitis, pneumonia;
• infections of the tonsils, throat, and sinuses;
• ear infections (acute otitis media);
• skin and soft tissue infections (except for burn wound infections);
• urethra and cervix infections caused by chlamydia.

2. Important information before taking AzitroLEK 250

This medicine must not be taken if the patient is allergic (hypersensitive) to:

• azithromycin;
• erythromycin;
• any other macrolide or ketolide antibiotic;
• any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take AzitroLEK 250, the patient should discuss it with their doctor or pharmacist:

• liver problems: the doctor may need to check the liver function or stop the treatment;
• kidney problems: if the patient has severe kidney problems, the doctor may need to adjust the dose of the medicine;
• neurological or psychiatric disorders;
• a certain type of muscle weakness called myasthenia.
• if the patient has had infections with pathogens resistant to azithromycin, erythromycin, lincomycin, and/or clindamycin or methicillin-resistant staphylococci (possibility of cross-resistance).

Azithromycin may increase the risk of heart rhythm disturbances, so if the patient has any of the following conditions, they should inform their doctor before starting treatment:

• heart problems, such as heart failure, very slow heart rate, irregular heart rate, or abnormal ECG (electrocardiogram) known as "prolonged QT interval";
• low levels of potassium or magnesium in the blood.

If the patient experiences diarrhea or loose stools during or after treatment, they should immediatelyinform their doctor. The patient should not take any anti-diarrheal medicine without consulting their doctor first. If the diarrhea persists, the patient should tell their doctor.
The patient should inform their doctor if:

• they notice an increase in symptoms during treatment or soon after its completion [possibility of superinfections and/or resistance].

Azithromycin is not suitable for the treatment of severe infections where rapid achievement of high antibiotic levels in the blood is necessary.

AzitroLEK 250 and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, or have recently taken, and about any medicines they plan to take, including those obtained without a prescription. This is especially important before starting treatment with this medicine.

• Theophylline(used to treat asthma): the effect of theophylline may increase.
• Warfarinor other similar anticoagulant medicines: concurrent use may increase the risk of bleeding.
• Ergotamine, dihydroergotamine(used to treat migraines): ergotism may occur (with tingling of the limbs, painful muscle spasms, and gangrene of the hands and feet due to poor blood circulation). Therefore, combined treatment is not recommended.
• Cyclosporin(used to suppress the immune system in the prevention and treatment of organ or bone marrow transplant rejection): if combined treatment is necessary, the doctor will recommend regular blood tests and may adjust the dose of the medicine.
• Digoxin(a medicine used in heart failure): the level of digoxin in the blood may increase. The doctor will recommend checking this level.
• Colchicine(used to treat gout and familial Mediterranean fever).
• Antacids and other medicines that reduce stomach acid(used to treat heartburn): see section 3.
• Cisapride(used to treat stomach disorders), terfenadine(used to treat hay fever), pimozide(used to treat certain mental illnesses), citalopram(used to treat depression), fluoroquinolones(antibiotics used to treat bacterial infections, e.g., moxifloxacin and levofloxacin): concurrent use with azithromycin may cause heart rhythm disturbances, so combined treatment is not recommended.
• Medicines used to treat irregular heart rhythms(so-called anti-arrhythmic medicines).
• Zidovudine(used to treat HIV infections): concurrent use may increase the risk of side effects.
• Nelfinavir(used to treat HIV infections): concurrent use may increase the side effects of azithromycin.
• Alfentanil(used for anesthesia) or astemizole(used to treat hay fever): concurrent use with azithromycin may increase the effect of these medicines.
• Rifabutin(used to treat tuberculosis): the doctor may recommend regular blood tests and check the level of the medicine in the blood.
• Statins(such as atorvastatin, used to lower blood lipid levels): concurrent use with azithromycin may cause muscle disorders.
• Certain medicines (such as hydroxychloroquine) known to cause heart rhythm disturbances, e.g., QT interval prolongation: concurrent use may increase the risk of arrhythmias.

AzitroLEK 250 with food and drink

The tablets can be taken independently of meals.

Pregnancy and breastfeeding

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.
The medicine passes into breast milk. If the patient is breastfeeding, they should consult their doctor before taking this medicine.

Driving and using machines

It is unlikely that AzitroLEK 250 will affect the ability to drive or use machines. Vision disturbances and blurred vision may affect the ability to drive or use machines. The medicine may cause side effects such as dizziness or seizures. These effects may affect the ability to perform certain activities, such as driving or using machines.

AzitroLEK 250 contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take AzitroLEK 250

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The doses of the medicine listed below are for adults and children with a body weight of more than 45 kg. The tablets should not be given to children with a lower body weight.
AzitroLEK 250 (250 mg) and AzitroLEK 500 (500 mg) are available on the market.
Recommended dose:

• AzitroLEK 250 is taken in a 3- or 5-day cycle.
• 3-day cycle: 500 mg (2 tablets of 250 mg or 1 tablet of 500 mg) once a day.
• 5-day cycle:
• on the first day, 500 mg (2 tablets of 250 mg);
• on the second, third, fourth, and fifth days, 250 mg (1 tablet of 250 mg).

In the treatment of urethra and cervix infections caused by chlamydia, the medicine is taken in a single-day cycle.

• Single-day cycle: 1000 mg (4 tablets of 250 mg or 2 tablets of 500 mg) once. The tablets should be taken at the same time, on the same day.

Patients with kidney or liver problems

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

The tablets should be swallowed with water.

• The tablets can be taken independently of meals.
• The AzitroLEK 250 tablets should be swallowed whole.

Taking AzitroLEK 250 with antacids

If it is necessary to take antacids, such as medicines that neutralize stomach acid, the AzitroLEK 250 tablets should be taken 2 hours before or after taking the antacid.

Missing a dose of AzitroLEK 250

If a dose of the medicine is missed, it should be taken as soon as possible, and then the medicine should be taken as directed. The patient should not take more than one dose of the medicine in one day.

Taking more than the recommended dose of AzitroLEK 250

Taking too many tablets may cause discomfort. Side effects such as temporary hearing loss, nausea, vomiting, and diarrhea may also occur. In such a case, the patient should immediately consult their doctor or go to the nearest hospital. If possible, the patient should take the tablets or packaging of the medicine with them and show it to the doctor.

Stopping treatment with AzitroLEK 250

The medicine should be taken until the end of the prescribed treatment cycle, even if the patient feels better. Stopping treatment too early may cause the infection to recur. The bacteria may also 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, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If any of the following symptoms of a severe allergic reaction occur, the patient should stop taking the medicine and immediately contact their doctoror go to the nearest hospital:

• sudden difficulty breathing, speaking, or swallowing;
• swelling of the lips, tongue, face, and throat;
• severe dizziness or fainting;
• severe or itchy skin rash, especially with blisters, and possibly with fever, mouth sores, or genital sores;

If any of the following side effects occur, the patient should contact their doctor as soon as possible:

• severe diarrhea, which lasts a long time or contains blood, with stomach pain or fever; this may be a sign of a severe bowel inflammation, which occurs rarely after antibiotic treatment;
• yellowing of the skin or whites of the eyes, caused by liver problems;
• pancreatitis, causing severe stomach and back pain;
• increased or decreased urine output or blood in the urine, caused by kidney problems;
• skin rash caused by sensitivity to sunlight;
• unusual bruising or bleeding;
• irregular or rapid heart rate.

These are severe side effects and may require immediate medical attention. Severe side effects are uncommon (may occur in less than 1 in 100 people), rare (may occur in less than 1 in 1000 people), or their frequency cannot be estimated from the available data.

Other possible side effects

Very commonside effects (may occur in more than 1 in 10 people):

• diarrhea.

Commonside effects (may occur in less than 1 in 10 people):

• headache
• vomiting, heartburn, stomach cramps, nausea
• low lymphocyte count (a type of white blood cell), increased eosinophil count (a type of white blood cell), low bicarbonate level in the blood, increased basophil, monocyte, and neutrophil counts (types of white blood cells).

Uncommonside effects (may occur in less than 1 in 100 people):

• fungal or bacterial infections, especially of the mouth, throat, nose, lungs, intestines, and vagina
• low white blood cell count, low neutrophil count, increased eosinophil count
• edema, allergic reactions of varying severity
• loss of appetite
• nervousness, insomnia
• dizziness, drowsiness, taste disturbances
• vision disturbances
• feeling of spinning
• skin rash, sweating (hot flashes)
• breathing difficulties, nosebleeds
• constipation, gas, heartburn, stomach inflammation, swallowing difficulties, bloating, dry mouth, belching, mouth ulcers, increased salivation
• liver inflammation
• itchy skin rash, skin inflammation, dry skin, sweating
• joint inflammation, muscle pain, back and neck pain
• urination difficulties and pain, kidney pain
• genital bleeding, genital disorders
• skin swelling, weakness, facial swelling, chest pain, fever, pain
• abnormal laboratory test results (e.g., blood, liver, and kidney function)
• post-treatment complications

Rareside effects (may occur in less than 1 in 1000 people):

• agitation, feeling of strangeness
• abnormal liver function
• tingling or numbness of the hands or feet
• hearing impairment
• heart palpitations
• general malaise, fatigue
• sensitivity to sunlight
• skin rash characterized by rapid onset of areas of redness on the skin, covered with small blisters (pustules filled with white or yellow fluid)
• delayed allergic reaction (up to several weeks after exposure) with rash and other possible symptoms, such as facial swelling, enlarged lymph nodes, and abnormal test results,

such as liver function and increased eosinophil count (drug reaction with eosinophilia and systemic symptoms, DRESS)
Frequency not known(frequency cannot be estimated from the available data):

• decreased platelet count, which increases the risk of bleeding or bruising
• decreased red blood cell count, which causes pale yellow skin and weakness or shortness of breath
• feeling of aggression, anxiety, severe confusion, hallucinations
• seizures, fainting, decreased skin sensitivity to touch, excessive activity, smell disturbances, loss of smell or taste, muscle weakness (myasthenia)
• hearing disturbances, deafness, or ringing in the ears
• abnormal ECG
• low blood pressure
• discoloration of the tongue
• joint pain
• vision problems (blurred vision).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store AzitroLEK 250

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
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 AzitroLEK 250 contains

• The active substance is azithromycin. Each film-coated tablet contains 250 mg of azithromycin in the form of azithromycin dihydrate.
• The other ingredients are: tablet core: microcrystalline cellulose, pregelatinized starch, sodium carboxymethylcellulose (type A), colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 4000.

What AzitroLEK 250 looks like and contents of the pack

White or almost white, elongated, film-coated tablets, smooth on both sides.
The packaging contains 6 film-coated tablets.
For more detailed information on the medicine, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V., Veluwezoom 22, Almere, Netherlands

Manufacturer:

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
S.C. Sandoz S.R.L., Livezeni Street Nr. 7A, RO-540472 Targu-Mures, Romania

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Netherlands marketing authorization number, the country of export:RVG 32491
Parallel import authorization number:215/13

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Czech Republic
Azitromycin Sandoz
Denmark
Azitromycin "Sandoz"
Estonia
Azithromycin Sandoz 250 mg
Finland
Azithromycin Sandoz 250 mg, kalvopäällysteinen tabletti
Hungary
Azi Sandoz 250 mg filmtabletta
Italy
AZITROMICINA SANDOZ
Netherlands
Azitromycine Sandoz 250mg, filmomhulde tabletten
Poland
AZITROLEK 250
Portugal
AZITROMICINA SANDOZ
Sweden
Azithromycin Sandoz 250 mg filmdragerade tabletter
Slovenia
Azitromicin Sandoz 250 mg filmsko obložene tablete
Slovakia
Azithromycin Sandoz 250 mg filmom obalené tablety
Date of leaflet approval: 08.02.2023