Azitrolek 500

Leaflet attached to the packaging: patient information

AzitroLEK 250, 250 mg, coated tablets

AzitroLEK 500, 500 mg, coated tablets

Azithromycin

You should carefully read the contents of the leaflet before taking 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 questions, you should ask your 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Azitro and what is it used for

Azitro 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);

infections of the urethra and cervix caused by chlamydia.

2. Important information before taking Azitro

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 taking Azitro, you should discuss with your doctor or pharmacist:

sometimes, taking Azitro can cause allergic reactions (itching, rash). However, if a serious allergic reaction occurs, the patient will quickly develop swelling of the face and throat (angioedema), which can cause shortness of breath, or a sudden severe feeling of illness (anaphylaxis). High fever, skin rash, blisters on the skin, peeling of the skin, joint pain, and (or) eye inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, or acute generalized exanthematous pustulosis) may also be symptoms of severe allergic reactions.

if the patient has liver function disorders, they should inform their doctor before taking Azitro. During treatment with Azitro, there have been cases of very severe liver inflammation, which can potentially lead to life-threatening liver dysfunction. The patient should immediately inform their doctor if they experience symptoms such as rapidly progressing physical weakness (asthenia) accompanied by jaundice, dark urine, bleeding tendency, or decreased level of consciousness (hepatic encephalopathy). The doctor will assess liver function and may advise the patient to stop taking Azitro.

kidney function disorders: if the patient has severe kidney function disorders, a dose adjustment may be necessary;

neurological or psychiatric disorders;

a specific type of muscle weakness called myasthenia

if the patient has had infections with pathogens resistant to azithromycin, erythromycin, lincosamides, and (or) methicillin-resistant staphylococci (possibility of cross-resistance).

Azithromycin may increase the risk of heart rhythm disturbances, so if the patient has any of the following heart disorders, they should inform their doctor before taking Azitro:

heart disorders, such as heart failure, very slow heart rate, irregular heart rate, or abnormal ECG (QT interval prolongation);

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 medication without consulting their doctor. If the diarrhea persists, the patient should tell their doctor.

The patient should inform their doctor if:

they notice an increase in symptoms during treatment or soon after its completion [possibility of superinfections and (or) resistance].

Azithromycin is not suitable for the treatment of severe infections where rapid achievement of high blood antibiotic levels is necessary.

Children and adolescents up to 18 years of age

In case of difficulties with swallowing tablets, for example, in young children, the use of Azitro suspension may be considered. Azitro tablets are not suitable for children with a body weight below 45 kg.

If, after administration of the medicine to a newborn (under 6 weeks of age), vomiting or irritability during feeding occurs, the doctor should be informed immediately.

Azitro and other medicines

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

Theophylline(used to treat asthma): the effect of theophylline may be enhanced.

Warfarinor other similar anticoagulant medicines: concomitant use may increase the risk of bleeding.

Ergotamine, dihydroergotamine(used to treat migraines): ergotism (with tingling of the limbs, painful muscle spasms, and gangrene of the hands and feet due to poor blood circulation) is possible. 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 in heart failure): the level of digoxin in the blood may increase. The doctor will recommend checking this level.

Colchicine(used to treat gout and familial Mediterranean fever): it is necessary to more frequently check the level of colchicine in the blood and, if necessary, adjust the dose of colchicine.

Antacids (used to neutralize stomach acid): see section 3.

Cisapride(used to treat stomach disorders), terfenadine(used to treat 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, so combined treatment is not recommended.

Medicines used to treat irregular heart rhythm (so-called anti-arrhythmic medicines).

Zidovudine(used to treat HIV infections): concomitant use may increase the risk of side effects.

Nelfinavir(used to treat HIV infections): concomitant use may enhance the side effects of azithromycin.

Alfentanil(used for anesthesia) or astemizole(used to treat hay fever): concomitant 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 level of the medicine in the blood.

Statins (such as atorvastatin, used to reduce blood lipid levels): concomitant use with azithromycin may cause muscle disorders.

Some medicines (such as hydroxychloroquine) known to cause heart rhythm disturbances, e.g., QT interval prolongation: concomitant use may increase the risk of arrhythmia.

Anticoagulant medicines from the coumarin group (blood-thinning medicines that prevent blood clots): although it seems that Azitro does not affect the blood-thinning effect of coumarin medicines, it may be necessary to more frequently check blood clotting and adjust the dose of the medicine.

Azitro 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.

Pregnancy

The doctor will decide whether the patient should take this medicine during pregnancy, only after assessing that the benefits outweigh the potential risks.

Breastfeeding

It has been reported that azithromycin is excreted into human milk. No serious side effects of azithromycin have been observed in infants.

Driving and using machines

This medicine may cause side effects such as vision disturbances, blurred vision, dizziness, and drowsiness. This may affect the ability to drive and use machines.

Azitro 250 contains lactose 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 the medicine is considered "sodium-free".

Azitro 500 contains lactose 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 the medicine is considered "sodium-free".

3. How to take Azitro

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The doses of the medicine listed below are intended for adults and children with a body weight over 45 kg. The tablets should not be given to children with a lower body weight. A suspension is available, which allows for accurate dosing in milliliters.

Recommended dose:

Azitro is taken in a 3- or 5-day cycle.

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

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).

In the treatment of urethritis and cervicitis caused by chlamydia, the medicine is taken in a single-day cycle.

Single-day cycle: 1000 mg (4 tablets of 250 mg or 2 tablets of 500 mg) once. The tablets should be taken at the same time, on the same day.

Elderly patients

In the case of elderly patients, the doctor will prescribe the same dose as for adults.

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 adjust the dose of the medicine.

The tablets should be swallowed with water.

The tablets can be taken independently of meals.

Azitro 250 tablets should be swallowed whole.

Azitro 500 tablets can be divided into two equal doses if necessary.

Taking Azitro with antacids

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

Missing a dose of Azitro

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

Taking more than the recommended dose of Azitro

Taking too many tablets may cause discomfort. Side effects such as temporary hearing loss, nausea, vomiting, and diarrhea may also occur. In this case, the patient should immediately consult their doctor or go to the nearest hospital. If possible, the patient should take the tablets or packaging of the medicine with them and show it to the doctor.

Stopping treatment with Azitro

The medicine should be taken until the end of the prescribed treatment cycle, even if the patient feels better. Stopping treatment too early may cause the infection to recur. Additionally, bacteria may become resistant to the medicine, which can cause difficulties in treatment later on.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Azitro 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 eye, mouth, or genital inflammation;

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 or fever; this may be a sign of severe colitis, which can occur rarely after antibiotic treatment;

jaundice or liver function disorders;

pancreatitis, causing severe stomach and back pain;

increased or decreased urine output or blood in the urine, due to kidney function disorders;

skin rash caused by sensitivity to sunlight;

unusual bruising or bleeding;

irregular or rapid heart rhythm.

These are severe side effects, and the patient may need 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 1000 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, stomach pain, nausea, bloating

Commonside effects (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 level in the blood, increased basophil, monocyte, and neutrophil counts (types of white blood cells)

changes in taste (dysgeusia)

dizziness

drowsiness

tingling, itching, or numbness without cause (paresthesia)

vision disturbances

hearing loss

rash, itching (pruritus)

indigestion and heartburn (dyspepsia)

joint pain (arthralgia)

fatigue

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

fungal or bacterial infections, especially of the mouth, throat, nose, lungs, intestines, and vagina

low white blood cell count (leukopenia), low neutrophil count (a type of white blood cell), increased eosinophil count (a type of white blood cell)

swelling, allergic reactions of varying severity (angioedema)

loss of appetite (anorexia)

nervousness, insomnia, tingling or numbness of the hands or feet

vertigo (dizziness of inner ear origin)

palpitations

sweating (hot flushes)

breathing difficulties, nosebleeds

constipation, gas, indigestion, stomach inflammation, swallowing difficulties, bloating, dry mouth, belching, oral ulcers, increased salivation

liver inflammation, abnormal liver function

skin inflammation, dry skin, sweating

Stevens-Johnson syndrome

joint inflammation, muscle pain, back and neck pain

urination difficulties or pain, 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)

post-treatment complications

throat inflammation

hearing disturbances, ringing in the ears (tinnitus)

sensitivity to light or sunlight, with possible skin changes (photosensitivity reaction)

decreased sensitivity (hypoesthesia)

Rareside effects (may occur in less than 1 in 1000 people):

irritability

jaundice

agitation

exanthematous pustulosis (a skin rash characterized by the rapid appearance of areas of redness on the skin, studded with small pustules or blisters)

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 and increased white blood cell count) (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, excessive activity, disturbances of smell, loss of smell or taste, muscle weakness (myasthenia)

abnormal ECG, arrhythmia

low blood pressure

discoloration of the tongue, tooth discoloration

liver failure, severe liver inflammation

kidney failure, kidney inflammation

toxic epidermal necrolysis

erythema multiforme

severe allergic reaction

The following side effects have been reported in the prevention and treatment of Mycobacterium Avium Complex (MAC) infections:

Very commonside effects (may occur in more than 1 in 10 people):

diarrhea

stomach pain

nausea

bloating

abdominal discomfort

loose stools

Commonside effects (may occur in less than 1 in 10 people):

loss of appetite (anorexia)

dizziness

headache

tingling or numbness (paresthesia)

changes in taste (dysgeusia)

vision disturbances

hearing loss

rash

itching (pruritus)

joint pain (arthralgia)

fatigue

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

decreased sensitivity (hypoesthesia)

hearing disturbances, ringing in the ears (tinnitus)

heart rhythm or frequency disturbances and awareness of heartbeat (palpitations)

liver diseases, such as liver inflammation

allergic skin reactions, such as sensitivity to sunlight, with redness, peeling, and swelling of the skin

weakness (asthenia)

general malaise

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Jerozolimskie Avenue 181C, 02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Azitro

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.

There are no special precautions for the storage of the medicinal product.

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 Azitro contains

The active substance is azithromycin.

• Each coated tablet contains 250 mg of azithromycin (in the form of dihydrate).
• Each coated tablet contains 500 mg of azithromycin (in the form of dihydrate). The other ingredients are: tablet core: microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 4000.

What Azitro looks like and contents of the pack

Azitro 250: white or almost white, elongated, coated tablets, smooth on both sides.

Azitro 500: 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 two equal doses.

Blisters:

Azitro 250 packaging contains 6 coated tablets.

Azitro 500 packaging contains 3 or 6 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl, Austria

Manufacturer/Importer

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana, Slovenia

S.C. Sandoz S.R.L.

Livezeni Street no 7A

540472 Targu Mures, Romania

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.

Domaniewska 50 C

02-672 Warsaw

phone: 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria Azithromycin Sandoz 500 mg – Filmtabletten

Czech Republic Azitromycin Sandoz

Denmark Azitromycin Sandoz

Estonia Azithromycin Sandoz 250 mg/500 mg

Finland Azithromycin Sandoz 250 mg/500 mg, kalvopäällysteinen tabletti

Ireland Azithromycin 500mg Tablets

Hungary Azi Sandoz 250 mg/500 mg filmtabletta

Italy AZITROMICINA SANDOZ

Lithuania Azithromycin Sandoz 500 mg plėvele dengtos tabletės

Latvia Azithromycin Sandoz 500 mg apvalkotās tabletes

Netherlands Azitromycine Sandoz 250mg/500 mg, filmomhulde tabletten

Poland AZITROLEK 250/500

Portugal AZITROMICINA SANDOZ

Sweden Azithromycin Sandoz 250 mg/500 mg filmdragerade tabletter

Slovenia Azitromicin Sandoz 250 mg/500 mg filmsko obložene tablete

Slovakia Azithromycin Sandoz 250 mg/500 mg filmom obalené tablety

Date of last revision of the leaflet:12/2024

(logo of the marketing authorization holder)