Azitrolek 250

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
AzitroLEK 250 (Azitromycine Sandoz 250 mg)
250 mg, film-coated tablets
Azithromycinum
AzitroLEK 250 and Azitromycine Sandoz 250 mg are different trade names for the same
medicinal product.
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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 pack 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 bacterial infections.
This medicine is usually prescribed for the treatment of:

• chest infections, such as chronic bronchitis, pneumonia;
• tonsillitis, pharyngitis and sinus infections;
• ear infections (acute otitis media);
• skin and soft tissue infections (excluding burn wound infections);
• urinary tract and cervical infections caused by Chlamydia.

2. Important information before using AzitroLEK 250

Do not use this medicine 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 treatment with AzitroLEK 250, discuss the following with a doctor or pharmacist:

• liver function disorders: the doctor may need to assess liver function or discontinue treatment;
• kidney function disorders: if the patient has severe kidney function impairment, a dose adjustment may be necessary;
• neurological or psychiatric disorders;
• a specific type of muscle weakness called myasthenia gravis;
• if the patient has previously had infections caused by pathogens resistant to azithromycin, erythromycin, clindamycin and (or) lincomycin or methicillin-resistant staphylococci (possibility of cross-resistance).

Azithromycin may increase the risk of cardiac arrhythmias. Therefore, if the patient has any of the following conditions, the doctor must be informed before starting treatment:

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

If the patient develops diarrhoea or loose stools during or after treatment, they must immediately inform the doctor. Do not use any anti-diarrhoeal medication without first consulting a doctor. If diarrhoea persists, inform the doctor.
Inform the doctor if:

• the patient notices worsening of symptoms during or shortly after treatment [possible superinfection and (or) resistance].

Azithromycin is not suitable for the treatment of severe infections requiring rapid achievement of high antibiotic blood concentrations.
AzitroLEK 250 and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. This is particularly important before starting treatment with this medicine.

• Theophylline (used to treat bronchial asthma): the effect of theophylline may be enhanced.
• Warfarin or other similar anticoagulant medicines: concomitant use may increase the risk of bleeding.
• Ergotamine, dihydroergotamine (used to treat migraine): ergotism (tingling in limbs, painful muscle spasms, and gangrene of hands and feet due to poor blood circulation) may occur. Therefore, combined treatment is not recommended.
• Cyclosporine (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection): if combined treatment is necessary, the doctor will recommend regular blood tests and may adjust the dose.
• Digoxin (a medicine used for heart failure): blood digoxin levels may increase. The doctor will recommend monitoring these levels.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Medicines that neutralize gastric acid (used for indigestion): see section 3.
• Cisapride (used for stomach disorders), terfenadine (used for hay fever), pimozide (used to treat certain psychiatric disorders), citalopram (used to treat depression), fluoroquinolones (antibiotics used to treat bacterial infections, e.g. moxifloxacin and levofloxacin): concomitant use with azithromycin may cause heart rhythm disturbances; therefore, combined treatment is not recommended.
• Medicines used for irregular heartbeat (so-called antiarrhythmics).
• Zidovudine (used to treat HIV infections): concomitant use may increase the risk of adverse effects.
• Nelfinavir (used to treat HIV infections): concomitant use may intensify adverse effects of azithromycin.
• Alfentanil (used for anaesthesia) or astemizole (used for hay fever): concomitant use with azithromycin may enhance the effects of these medicines.
• Rifabutin (used to treat tuberculosis): the doctor may order regular blood tests and monitoring of blood drug levels.
• Statins (such as atorvastatin, used to reduce blood lipid levels): concomitant use with azithromycin may lead to muscle disorders.
• Certain medicines (such as hydroxychloroquine) known to cause heart rhythm disturbances, e.g. QT interval prolongation on electrocardiogram: concomitant use may increase the risk of arrhythmias.

AzitroLEK 250 with food and drink
Tablets can be taken independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy or breastfeeding unless specifically prescribed by a doctor.
This medicine passes into breast milk. If the patient is breastfeeding, she should consult a doctor before using this medicine.
Driving and operating machinery
It is unlikely that AzitroLEK 250 will impair the ability to drive or operate machinery. However, visual disturbances and blurred vision may affect the ability to drive or operate machinery. The medicine may cause adverse effects such as dizziness or seizures. These effects may impair the ability to perform certain activities, such as driving or operating machinery.
AzitroLEK 250 contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use AzitroLEK 250

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist. The dosages given below apply to adults and children with body weight greater than 45 kg. Tablets should not be given to children with lower body weight.
The following products are available: AzitroLEK 250 (250 mg) and AzitroLEK 500 (500 mg).
Recommended dosage:
AzitroLEK is administered in a 3- or 5-day regimen.

• 3-day regimen: 500 mg (2 tablets of 250 mg or 1 tablet of 500 mg) once daily.
• 5-day regimen:
• on day 1: 500 mg (2 tablets of 250 mg);
• on days 2, 3, 4, and 5: 250 mg (1 tablet of 250 mg).

For urethritis and cervicitis caused by Chlamydia, the medicine is administered in a single-day regimen.

• 1-day regimen: single dose of 1000 mg (4 tablets of 250 mg or 2 tablets of 500 mg). Tablets should be taken at once, on the same day.

Patients with impaired kidney or liver function
If the patient has impaired kidney or liver function, this should be reported to the doctor. The doctor may decide to adjust the dosage of the medicine.
Swallow the tablets with water.

• Tablets may be taken regardless of meals.
• AzitroLEK 250 tablets should be swallowed whole.

Concomitant use of AzitroLEK 250 with antacids
If antacids (medicines that neutralize gastric acid) are required, AzitroLEK 250 tablets should be taken at least 2 hours before or after taking the antacid.
Missed dose of AzitroLEK 250
If a dose is missed, take it as soon as possible and then continue taking the medicine according to the prescribed schedule. Do not take more than one dose per day.
Overdose of AzitroLEK 250
Taking too many tablets may cause malaise. Adverse effects such as transient deafness, nausea, vomiting, and diarrhea may also occur. In such a case, seek immediate medical attention or go to the nearest hospital. If possible, bring the tablets or the medicine packaging with you to show the doctor.
Discontinuation of AzitroLEK 250
The medicine should be taken for the full duration of the prescribed treatment course, even if the patient feels better. Stopping treatment too early may lead to recurrence of infection. Moreover, bacteria may become resistant to the medicine, which could cause difficulties in future treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following symptoms of a serious allergic reaction occur, stop taking the medicine and seek immediate medical advice or go to the nearest hospital:

• sudden difficulty in breathing, speaking or swallowing;
• swelling of the lips, tongue, face and neck;
• severe dizziness or fainting;
• severe or itchy skin rash, especially in the form of blisters, with pain in the eyes, mouth or genital organs;

If any of the following adverse reactions occur, seek medical advice as soon as possible:

• severe diarrhoea that lasts a long time or contains blood, accompanied by stomach pain or fever; this may be a sign of severe inflammation of the bowel, which rarely occurs after antibiotic treatment;
• yellowing of the skin or whites of the eyes, caused by liver function disorders;
• inflammation of the pancreas causing severe pain in the abdomen and back;
• increased or decreased urine output or blood in the urine, caused by kidney function disorders;
• skin rash caused by hypersensitivity to sunlight;
• unusual bruising or bleeding;
• irregular or rapid heartbeat.

These are serious adverse reactions and immediate medical help may be required. Serious adverse reactions occur uncommonly (may occur in less than 1 in 100 people), rarely (may occur in less than 1 in 1000 people), or their frequency cannot be determined from available data.
Other possible adverse reactions
Very common adverse reactions (may occur in more than 1 in 10 people):

• diarrhoea.

Common adverse reactions (may occur in less than 1 in 10 people):

• headache;
• vomiting, indigestion, abdominal cramps, nausea;
• low lymphocyte count (a type of white blood cell), increased eosinophil count (a type of white blood cell), low blood bicarbonate levels, increased basophil, monocyte and neutrophil counts (types of white blood cells).

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• fungal and bacterial infections, especially of the mouth, throat, nose, lungs, intestines and vagina;
• low leukocyte count (a type of white blood cell), low neutrophil count (a type of white blood cell), increased eosinophil count (a type of white blood cell);
• swelling, allergic reactions of varying severity;
• loss of appetite;
• nervousness, insomnia;
• dizziness, drowsiness, taste disturbances;
• visual disturbances;
• sensation of spinning;
• skin rash, sweating (hot flushes);
• difficulty in breathing, nosebleeds;
• constipation, flatulence, indigestion, gastritis, difficulty in swallowing, bloating, dry mouth, belching, oral ulceration, excessive salivation;
• hepatitis;
• itchy rash, skin inflammation, dry skin, sweating;
• joint inflammation, muscle, back and neck pain;
• difficulty and pain during urination, kidney pain;
• genital tract bleeding, testicular disorders;
• skin swelling, weakness, facial swelling, chest pain, fever, pain;
• abnormal laboratory test results (e.g. blood, liver and kidney function tests);
• complications following treatment.

Rare adverse reactions (may occur in less than 1 in 1000 people):

• restlessness, feeling of unreality;
• abnormal liver function;
• tingling or numbness in hands or feet;
• hearing impairment;
• palpitations;
• general malaise, fatigue;
• photosensitivity;
• skin eruption characterised by rapid appearance of red skin areas covered with small pustules (blisters 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, e.g. liver function tests and increased number of certain white blood cells (drug reaction with eosinophilia and systemic symptoms, DRESS).

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

• decreased platelet count, increasing the risk of bleeding or bruising;
• decreased red blood cell count, causing pale-yellow skin discoloration, weakness or shortness of breath;
• feelings of aggression, anxiety, severe confusion, hallucinations;
• seizures, fainting, reduced skin sensitivity to touch, hyperactivity, smell disturbances, loss of smell or taste, muscle weakness (myasthenia);
• hearing disturbances, deafness or tinnitus;
• abnormal ECG reading;
• low blood pressure;
• discoloured tongue;
• joint pain;
• vision problems (blurred vision).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store AzitroLEK 250

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What AzitroLEK 250 contains

• The active substance is azithromycin. Each coated tablet contains 250 mg of azithromycin in the form of azithromycin dihydrate.
• Other components are: tablet core: microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, 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.
Packaging contains 6 film-coated tablets.
For more detailed information about the medicine, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in the Netherlands, country of export:
Sandoz B.V., Veluwezoom 22, Almere, the 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, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorization number in the Netherlands, country of export: RVG 32491
Marketing authorization number for parallel import: 215/13
This medicinal product is authorized for sale 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