Azitrolek 500

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
AzitroLEK 500 (Azitromycine Sandoz)
500 mg, film-coated tablets
Azithromycinum
AzitroLEK 500 and Azitromycine Sandoz are different brand names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The 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 of the leaflet:

1. What AzitroLEK 500 is and what it is used for
2. Important information before taking AzitroLEK 500
3. How to take AzitroLEK 500
4. Possible side effects
5. How to store AzitroLEK 500
6. Contents of the pack and other information

1. What AzitroLEK 500 is and what it is used for

AzitroLEK 500 is an antibiotic belonging to a group called macrolides. It is used to treat bacterial infections.
This medicine is usually prescribed to treat:

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

2. Important information before using AzitroLEK 500

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 500, 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 heart rhythm disturbances. Therefore, inform the doctor if the patient has any of the following conditions:

• heart disorders, such as heart failure, very slow heart rate, irregular heartbeat, or abnormal electrocardiogram (ECG) findings known as "long QT syndrome";
• 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 antidiarrhoeal 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 required.
AzitroLEK 500 and other medicines
Tell the doctor or pharmacist about all medicines currently used, recently taken, or planned for use, including over-the-counter medicines. This is especially 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 (with tingling in limbs, painful muscle cramps, 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 in heart failure): digoxin blood levels may increase. The doctor will recommend monitoring these levels.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Medicines that neutralize stomach acid (used for indigestion): see section 3.
• Cisapride (used for stomach disorders), terfenadine (used for 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): 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 cause muscle disorders.
• Certain medicines (such as hydroxychloroquine) known to cause heart rhythm disturbances, e.g. QT prolongation observed on electrocardiogram: concomitant use may increase the risk of arrhythmias.

AzitroLEK 500 with food and drink
Tablets may be taken regardless 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 advised 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 using machines
It is unlikely that AzitroLEK 500 will impair the ability to drive or operate machinery. However, visual disturbances and blurred vision may affect this ability. This medicine may cause adverse effects such as dizziness or convulsions.
These effects may impair the ability to perform certain activities, such as driving or operating machinery.
AzitroLEK 500 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 500

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The following products are available on the market: AzitroLEK 250 (250 mg) and AzitroLEK 500 (500 mg).
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.
Recommended dosage:
AzitroLEK is administered in a 3- or 5-day treatment 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 urethritis and cervicitis caused by Chlamydia, the medicine is administered in a
single-day cycle.

• 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 impaired kidney or liver function
If the patient has impaired kidney or liver function, this should be reported to the
physician. The physician may decide to adjust the dosage of the medicine.
Tablets should be swallowed with water.

• Tablets may be taken independently of meals.
• AzitroLEK 500 tablets may be divided into halves if necessary.

Concomitant use of AzitroLEK 500 with antacids
If antacids (medicines that neutralize gastric acid) are required, AzitroLEK 500 tablets should be taken at least 2 hours before or after administration of the antacid.
Missed dose of AzitroLEK 500
If a dose is missed, take it as soon as possible, then continue treatment according to the recommended dosing schedule. Do not take more than one dose of the medicine per day.
Overdose of AzitroLEK 500
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 and show it to the doctor.
Discontinuation of AzitroLEK 500
The medicine should be taken for the entire prescribed duration of treatment, even if the patient feels better. Premature discontinuation of treatment 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 regarding 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.

Severe 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 if blistering, accompanied by eye pain, mouth sores or genital pain.

If any of the following side effects occur, contact a doctor 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 intestinal inflammation, which rarely occurs after antibiotic treatment;
• yellowing of the skin or whites of the eyes, caused by liver function disorders;
• pancreatitis causing severe pain in the abdomen and back;
• reduced or increased urine output, or blood in the urine, caused by kidney function disorders;
• skin rash caused by photosensitivity (increased sensitivity to sunlight);
• unusual bruising or bleeding;
• irregular or rapid heartbeat.

These are serious side effects and may require immediate medical attention. Severe side effects 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 side effects

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

• diarrhoea.

Common side effects (may affect 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 bicarbonate levels in blood, increased basophil, monocyte and neutrophil counts (types of white blood cells).

Uncommon side effects (may affect less than 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);
• 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 breathing, nosebleeds;
• constipation, flatulence, indigestion, gastritis, difficulty swallowing, bloating, dry mouth, burping, oral ulceration, excessive salivation;
• hepatitis (liver inflammation);
• itchy rash, skin inflammation, dry skin, sweating;
• joint inflammation, muscle pain, 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 tests, liver and kidney function tests);
• complications following treatment.

Rare side effects (may affect less than 1 in 1000 people):

• restlessness, feeling of detachment;
• abnormal liver function;
• tingling or numbness in hands or feet;
• hearing impairment;
• palpitations;
• general malaise, fatigue;
• photosensitivity (increased sensitivity to sunlight);
• skin eruption characterized by rapid appearance of red skin areas covered with small blisters filled with white or yellow fluid;
• delayed allergic reaction (occurring 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 counts of certain white blood cells (drug reaction with eosinophilia and systemic symptoms, DRESS).

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

• reduced platelet count, increasing the risk of bleeding or bruising;
• reduced 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 findings;
• low blood pressure;
• tongue discoloration;
• joint pain;
• vision problems (blurred vision).

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department for 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 side effects helps provide more information on the safety of this medicine.

5. How to store AzitroLEK 500

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.
There are no special storage requirements for this medicinal product.
Medicines should 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 500 contains

• The active substance in AzitroLEK 500 is azithromycin. Each coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
• 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.

What AzitroLEK 500 looks like and contents of the pack
White or almost white, elongated coated tablets, with a deep score line on one side and an indentation on the other side. The tablets can be divided into equal doses.
The tablets are packed in blisters and placed in a cardboard box.
Pack sizes of AzitroLEK 500 contain 3 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 by:
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 32492
Parallel Import Licence Number: 592/12
This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria Azithromycin Sandoz 500 mg – Filmtabletten
Czech Republic Azitromycin Sandoz
Denmark Azitromycin „Sandoz”
Estonia Azithromycin Sandoz 500 mg
Finland Azithromycin Sandoz 500 mg, kalvopäällysteinen tabletti
United Kingdom Azithromycin 500mg Tablets
Hungary Azi Sandoz 500 mg filmtabletta
Italy AZITROMICINA SANDOZ
Lithuania Azithromycin Sandoz 500 mg plėvele dengtos tabletės
Latvia Azithromycin Sandoz 500 mg apvalkotās tabletes
Netherlands Azitromycine Sandoz 500 mg, filmomhulde tabletten
Poland AZITROLEK 500
Portugal AZITROMICINA SANDOZ
Sweden Azithromycin Sandoz 500 mg filmdragerade tabletter
Slovenia Azitromicin Sandoz 500 mg filmsko obložene tablete
Slovakia Azithromycin Sandoz 500 mg filmom obalené tablety