Azitrolek 250

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
AzitroLEK 250 (Azithromycin 250 – 1 A Pharma)
250 mg, film-coated tablets
Azithromycinum
AzitroLEK 250 and Azithromycin 250 – 1 A Pharma are different brand names of the
same medicine.
Please read this leaflet carefully before using the 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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 package 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.
The medicine is usually prescribed to treat:

• chest infections, such as chronic bronchitis and pneumonia;
• infection of the tonsils, throat and sinuses;
• ear infection (acute otitis media);
• skin and soft tissue infections (excluding burn wound infections);
• urethral and cervical infections caused by chlamydia.

2. 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 with your doctor or pharmacist if the patient has:

• liver function disorders: liver function tests may be required or treatment may need to be discontinued;
• kidney function disorders: if the patient has severe kidney impairment, a dose adjustment may be necessary;
• neurological or psychiatric disorders;
• a specific type of muscle weakness called myasthenia gravis;
• a history of 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, 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 an abnormal electrocardiogram (ECG) reading known as "long QT syndrome";
• low blood potassium or magnesium levels.

If the patient develops diarrhoea or loose stools during or after treatment, 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 the treatment of severe infections requiring rapid achievement of high antibiotic blood concentrations.
AzitroLEK 250 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take. 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 anticoagulants: concomitant use may increase the risk of bleeding.
• Ergotamine, dihydroergotamine (used in the treatment of migraine): ergotism (with tingling of extremities, 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 in heart failure): digoxin blood levels may increase. The doctor will recommend monitoring of digoxin 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 in 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 disorders; therefore, combined treatment is not recommended.
• Medicines used for irregular heart rhythm (so-called antiarrhythmics).
• Zidovudine (used in HIV infections): concomitant use may increase the risk of adverse effects.
• Nelfinavir (used in HIV infections): concomitant use may enhance the adverse effects of azithromycin.
• Alfentanil (used in anaesthesia) or astemizole (used in 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 drug blood 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 in 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 her 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 convulsions. 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 the physician. If in doubt, consult your
doctor or pharmacist. The dosages provided below are intended for adults and children with a body
weight greater than 45 kg. Do not administer tablets to children with a lower body weight.
The following products are available: AzitroLEK 250 (250 mg) and AzitroLEK 500 (500 mg).
Recommended dosage:
AzitroLEK 250 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 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 all 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 independently of meals.
• AzitroLEK 250 tablets should be swallowed whole.

Concomitant use of AzitroLEK 250 with antacids
If antacids or acid-neutralizing medicines 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, then continue taking the medicine 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 hearing loss, 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 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 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 severe allergic reaction occur,
you must stop taking the medicine and contact a doctor immediately or go to the nearest
hospital:

• sudden difficulty 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 genital organs.

If any of the following adverse reactions occur, you should 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 a serious intestinal inflammation, which may rarely occur after antibiotic treatment;
• yellowing of the skin or whites of the eyes, caused by impaired liver function;
• pancreatitis causing severe pain in the abdomen and back;
• increased or decreased urine output or blood in the urine, caused by impaired kidney function;
• skin rash caused by increased sensitivity 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 bicarbonate levels in the blood, 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 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, belching, mouth ulcers, excessive salivation;
• hepatitis;
• itchy rash, skin inflammation, dry skin, sweating;
• joint inflammation, muscle, back and neck pain;
• difficulty or pain when urinating, 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);
• 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;
• increased sensitivity to sunlight;
• skin eruption characterised by rapid appearance of red skin areas covered with small pimples (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 counts of certain white blood cells (drug reaction with eosinophilia and systemic symptoms, DRESS).

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

• decreased platelet count, increasing 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 ringing in the ears;
• abnormal ECG reading;
• low blood pressure;
• discolouration of the tongue;
• joint pain;
• eye problems (blurred vision).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, you should 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 conditions are required.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number / expiry date – see embossing.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What AzitroLEK 250 contains

• The active substance is azithromycin. Each film-coated tablet contains 250 mg of azithromycin (as azithromycin dihydrate).
• Other ingredients are:
  Tablet core: microcrystalline cellulose, maize 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, elongated film-coated tablet with a breakline on both sides and an imprint “A 250”. The breakline
is intended for splitting the tablet to facilitate swallowing and not for dividing into equal doses.
Packaging contains 6 film-coated tablets.
For further detailed information about the medicinal product, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Germany, the country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany
Manufacturer:
S.C. SANDOZ S.R.L.
7A “Livezeni” Street, 540472
Târgu Mureş, Mureş County, Romania
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
German Marketing Authorisation Number (country of export): 60506.00.00
Parallel Import Authorisation Number: 445/22
This medicinal product is authorised for marketing in the European Economic Area countries under the following trade names:
Austria Azithromycin Sandoz 250 mg – Filmtabletten
Czech Republic Azitromycin Sandoz
Denmark Azitromycin "Sandoz"
Estonia Azithromycin Sandoz 250 mg
Finland Azithromycin Sandoz 250 mg, kalvopäällysteinen tabletti
Ireland Pn Azithromycin 250mg Tablets
Hungary Azi Sandoz 250 mg filmtabletta
Italy AZITROMICINA SANDOZ
Lithuania Azithromycin Sandoz 250 mg plėvele dengtos tabletės
Latvia Azithromycin Sandoz 250 mg apvalkotās tabletes
Netherlands Azitromycine Sandoz 250 mg, 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