Azitrolek 250

Patient Information Leaflet: Package Insert

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
AzitroLEK 250 (Azitromycine Sandoz)
250 mg, film-coated tablets
Azithromycinum
AzitroLEK 250 and Azitromycine Sandoz are different brand 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, as you may need to read it again.
• 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

1. What AzitroLEK 250 is and what it is 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 AzitroLEK 250 is and what it is 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 and pneumonia;
• infections of the tonsils, throat, and sinuses;
• ear infections (acute otitis media);
• skin and soft tissue infections (excluding burn wound infections);
• urethral 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: it may be necessary for the doctor to assess liver function or discontinue treatment; Page 1 of 8
• kidney function disorders: if the patient has severe kidney impairment, a dose adjustment may be required;
• 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, inform the doctor before starting treatment:

• heart disorders, such as heart failure, very slow heart rate, irregular heartbeat, or an abnormal electrocardiogram (ECG) reading 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 medicine 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 treating severe infections where rapid achievement of high antibiotic blood concentrations is necessary.
AzitroLEK 250 and other medicines
Tell the doctor or pharmacist about all medicines currently used or 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 in the treatment of 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 in the treatment of migraine): ergotism (tingling in limbs, painful muscle cramps, and necrosis of hands and feet due to poor blood circulation) may occur. Therefore, combined treatment is not recommended.
• Cyclosporine (used to suppress immune system function in preventing and treating 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 in heart failure): blood digoxin levels may increase. The doctor will recommend monitoring these levels.
• Colchicine (used in the treatment of 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 in the treatment of certain psychiatric disorders), citalopram (used in the treatment of depression), fluoroquinolones (antibiotics used to treat bacterial infections, e.g. moxifloxacin and levofloxacin): concomitant use with azithromycin may cause cardiac disturbances, therefore combined treatment is not recommended.
• Medicines used for irregular heartbeats (so-called antiarrhythmics).
• Zidovudine (used in HIV infections): concomitant use may increase the risk of adverse effects.

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• Nelfinavir (used in 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 in the treatment of 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 cause muscle disorders.
• Certain medicines (such as hydroxychloroquine) known to cause cardiac arrhythmias, e.g. QT interval prolongation observed on electrocardiogram: concomitant use may increase the risk of arrhythmias.

AzitroLEK 250 with food and drink
Tablets may 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 recommended by a doctor.
This medicine passes into human 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, they 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 used as directed by the physician. If in doubt, consult a doctor or pharmacist. The dosages given below are intended for adults and children with body weight greater than 45 kg. Tablets should not be administered to children with lower body weight.
Available in the market are: AzitroLEK 250 (250 mg) and AzitroLEK 500 (500 mg).
Recommended dosage:
AzitroLEK is administered in a 3- or 5-day cycle.

• 3-day cycle: 500 mg (2 tablets of 250 mg or 1 tablet of 500 mg) once daily.
• 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).

For chlamydia-induced urethritis and cervicitis, the medicine is used in a single-day cycle.
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• 1-day cycle: 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 renal or hepatic impairment
If the patient has impaired kidney or liver function, inform the physician. The physician may decide to adjust the dosage.
Swallow the tablets with water.

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

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 administration of the antacid.
Missed dose of AzitroLEK 250
If a dose is missed, take it as soon as possible, then continue treatment according to the recommended 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 advice or go to the nearest hospital. If possible, bring the tablets or the packaging to show the doctor.
Discontinuation of AzitroLEK 250
The medicine should be taken for the full duration of the prescribed treatment cycle, even if the patient feels better. Stopping treatment too early may lead to recurrence of infection. Moreover, bacteria may become resistant to the antibiotic, which could make future treatment more difficult.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Serious side effects
If any of the following symptoms of a severe 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 with blisters, accompanied by pain in the eyes, mouth or genitals.

If any of the following side effects occur, consult a doctor as soon as possible:

• severe diarrhoea that lasts a long time or contains blood, with stomach pain or fever; this may be a sign of a serious intestinal inflammation, 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 side effects and immediate medical help may be required. Serious side effects occur uncommonly (may occur in fewer than 1 in 100 people), rarely (may occur in fewer than 1 in 1000 people), or their frequency cannot be determined from available data.

Other possible side effects
Very common side effects (may affect more than 1 in 10 people):

• diarrhoea.

Common side effects (may affect up to 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 side effects (may affect up to 1 in 100 people):

• fungal and bacterial infections, especially in 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);
• oedema, 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 breathing, nosebleeds;
• constipation, flatulence, indigestion, gastritis, difficulty swallowing, bloating, dry mouth, belching, oral ulceration, increased salivation;
• hepatitis;
• itchy rash, skin inflammation, dry skin, sweating;
• joint inflammation, muscle, back and neck pain;
• difficulty and pain during urination, kidney pain;
• genital 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 side effects (may affect up to 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 blisters (vesicles 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, which increases the risk of bleeding or bruising;
• decreased red blood cell count, causing pale-yellow skin discoloration and 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 recording;
• low blood pressure;
• discoloured tongue;
• joint pain;
• vision problems (blurred vision).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also 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
Tel: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store AzitroLEK 250

Keep this medicine out of the 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 specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AzitroLEK 250 contains

• The active substance in AzitroLEK 250 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 carboxymethyl starch (type A), anhydrous colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 4000. Page 6 of 8

What AzitroLEK 250 looks like and contents of the pack
White or almost white, elongated, film-coated tablets, smooth on both sides.
The tablets are packed in blisters in a cardboard box.
Pack sizes of AzitroLEK 250 contain 6 film-coated tablets.
For further information about this medicinal product, please contact the marketing
authorisation holder or parallel importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
Sandoz B.V.
Veluwezoom 22
1327 AH 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in the Netherlands, the country of export: RVG 32491
Parallel Import Licence Number: 591/12
This medicinal product is authorised in the European Economic Area member states 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 250 mg, filmomhulde tabletten
Poland AZITROLEK 250
Portugal AZITROMICINA SANDOZ
Sweden Azithromycin Sandoz 250 mg filmdragerade tabletter
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Slovenia Azitromicin Sandoz 250 mg filmsko obložene tablete
Slovakia Azithromycin Sandoz 250 mg filmom obalené tablety
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