Azitrolek 500

Leaflet attached to the packaging: patient information

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

AzitroLEK 500(Azithromycin Sandoz 500 mg)

500 mg, coated tablets

Azithromycin
AzitroLEK 500 and Azithromycin Sandoz 500 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using 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 specifically for you. 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 500 and what is it 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 packaging and other information

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

AzitroLEK 500 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 500

This medicine should 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 500, the patient should discuss it with their doctor or pharmacist:

• liver function disorders: it may be necessary for the doctor to examine the liver function or stop the treatment;
• kidney function disorders: if the patient has severe kidney function disorders, it may be necessary to change the dose of the medicine;
• neurological or psychiatric disorders;
• a specific 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 disorders, so if the patient has any of the following disorders, they should inform their doctor before starting to take the medicine:

• heart disorders, such as heart failure, very slow heart rate, irregular heart rate, or abnormal ECG (electrocardiogram) known as "long QT syndrome";
• low potassium or magnesium levels 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 exacerbation of symptoms during or shortly after treatment [possibility of superinfections and/or resistance].

Azithromycin is not suitable for the treatment of severe infections where it is necessary to quickly achieve a high concentration of the antibiotic in the blood.

AzitroLEK 500 and other medicines

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

• Theophylline(used to treat asthma): the effect of theophylline may be enhanced.
• Warfarinor other similar anticoagulant medicines: concurrent use may increase the risk of bleeding.
• Ergotamine, dihydroergotamine(used to treat migraines): there is a possibility of ergotism (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 to treat heart failure): the concentration of digoxin in the blood may increase. The doctor will recommend that this concentration be checked.
• Colchicine(used to treat gout and familial Mediterranean fever).
• Antacids(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 disorders), 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 disorders, 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 enhance the side effects of azithromycin.
• Alfentanil(used for anesthesia) or astemizole(used to treat hay fever): concurrent use with azithromycin may enhance the effect of these medicines.
• Rifabutin(used to treat tuberculosis): the doctor may recommend regular blood tests and check the concentration of the medicine in the blood.
• Statins(such as atorvastatin, used to reduce blood lipid levels): concurrent use with azithromycin may cause muscle disorders.
• Certain medicines (such as hydroxychloroquine) known to cause heart rhythm disorders, e.g., QT interval prolongation in the electrocardiogram: concurrent use may increase the risk of arrhythmias.

AzitroLEK 500 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 500 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 convulsions. These effects may impair the ability to perform certain activities, such as driving or using machines.

AzitroLEK 500 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 that the medicine is considered "sodium-free".

3. How to take AzitroLEK 500

This medicine should always be taken according to the doctor's recommendations. If there are any doubts, the patient 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 500 is used in a 3- or 5-day cycle.

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

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

• Single-day cycle: 1000 mg (4 x 250 mg tablets or 2 x 500 mg tablets) as a single dose. The tablets should be taken at the same time, on the same day.

Patients with kidney or liver function disorders

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

The tablets should be swallowed with water.

• The tablets can be taken independently of meals.
• The tablets of AzitroLEK 500 can be divided into two equal doses if necessary.

Using AzitroLEK 500 with antacids

If it is necessary to use antacids, such as medicines that neutralize stomach acid, the tablets of AzitroLEK 500 should be taken 2 hours before or after taking the antacid.

Missing a dose of AzitroLEK 500

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

Taking a higher dose of AzitroLEK 500 than recommended

Taking too many tablets may cause discomfort. The following side effects may also occur: transient hearing loss, nausea, vomiting, and diarrhea. 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 the packaging of the medicine with them and show it to the doctor.

Stopping the use of AzitroLEK 500

The medicine should be taken until the end of the recommended treatment cycle, even if the patient feels better. Stopping the 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 the use of 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 with eye pain, mouth, or genital area.

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

• severe diarrhea that lasts a long time or contains blood, with stomach pain and fever; this may be a sign of a severe intestinal infection, which occurs rarely after antibiotic treatment;
• yellowing of the skin or whites of the eyes, caused by liver function disorders;
• pancreatitis, causing severe stomach and back pain;
• 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 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 1,000 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, nausea, abdominal pain, diarrhea
• 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).

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

• fungal and 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 disorders
• vision disturbances
• vertigo
• skin rash, sweating (hot flashes)
• breathing difficulties, nosebleeds
• constipation, gas, nausea, 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, testicular disorders
• skin edema, weakness, facial edema, 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 1,000 people):

• agitation, feeling of strangeness
• abnormal liver function
• tingling or numbness of the hands or feet
• hearing impairment
• heart palpitations
• general malaise, fatigue
• hypersensitivity to sunlight
• skin rash characterized by rapid onset of areas of redness of the skin 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 edema, lymph node enlargement, and abnormal test results, e.g., liver function tests 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 disorders, loss of smell or taste, muscle weakness (myasthenia)
• hearing disorders, deafness, or ringing in the ears
• abnormal ECG
• low blood pressure
• tongue discoloration
• joint pain
• vision problems (blurred vision).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store AzitroLEK 500

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used 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 500 contains

• The active substance is azithromycin. Each coated tablet contains 500 mg of azithromycin (in the form of azithromycin dihydrate).
• The other ingredients are: tablet core: microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl cellulose (type A), colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 4000.

What AzitroLEK 500 looks like and what the packaging contains

White or almost white, elongated, coated tablets with a deep break line on one side and a notch on the other side. The tablets can be divided into equal doses.
The packaging contains 3 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:RVG 32492
Parallel import authorization number:214/13

This medicinal product is authorized in the Member States of 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
Ireland
Azithromycin 500 mg 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
Date of leaflet approval: 30.01.2023