Azithromycin lek

Package leaflet: Information for the patient

AzitroLEK, 100 mg/5 ml, powder for oral suspension
AzitroLEK, 200 mg/5 ml, powder for oral suspension
Azithromycinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet,
inform the doctor or pharmacist. See section 4.
Table of contents:

1. What Azitro is and what it is 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 pack and other information

1. What Azitro is and what it is used for

Azithromycin is an antibiotic belonging to the macrolide group. It is used to treat bacterial infections.
This medicine is usually prescribed for the treatment of:
respiratory tract infections, such as chronic bronchitis, pneumonia;
tonsillitis, pharyngitis and sinusitis;
ear infections (acute otitis media);
skin and soft tissue infections, excluding infected burn wounds;
urethral and cervical infections caused by Chlamydia.

2. Information before using Azitro

Do not use this medicine in patients allergic (hypersensitive) to:

azithromycin,
erythromycin,
any other macrolide or ketolide antibiotic,
or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Azitro, discuss the following with your doctor or pharmacist:

• Allergic reactions (itching, rash) may occur during treatment with Azitro. However, if a serious allergic reaction occurs, the patient may experience rapidly developing swelling of the face and throat (angioedema), causing breathlessness, or sudden severe malaise (shock). High fever, skin rash, blisters, skin peeling, joint pain and/or eye inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, or acute generalized exanthematous pustulosis) may also be symptoms of severe allergic reactions. If any of these symptoms occur, contact a doctor immediately.

• If the patient has liver function disorders, they should inform the doctor before starting treatment with Azitro. Cases of very severe hepatitis have been reported during treatment with Azitro, which may potentially lead to life-threatening deterioration of liver function. The patient should contact the doctor immediately if symptoms such as rapidly progressing physical weakness (asthenia) accompanied by jaundice, dark urine, tendency to bleeding, or decreased level of consciousness (hepatic encephalopathy) occur. The doctor will assess liver function and may recommend discontinuation of Azitro.

• If the patient has kidney function disorders: dose adjustment may be necessary in cases of severe impairment.

• If the patient has neurological or psychiatric disorders.

• If the patient has heart diseases, such as:

  • heart failure
  • very slow heart rate
  • irregular heartbeat, or
  • conditions known as "prolonged QT interval syndrome" (detected on ECG), as azithromycin may increase the risk of cardiac arrhythmias.

• If the patient has low blood potassium or magnesium levels.

• If the patient has myasthenia gravis – a condition causing muscle weakness.

• If the patient has previously had infections caused by pathogens resistant to azithromycin, erythromycin, lincomycin, and/or clindamycin, or methicillin-resistant staphylococci (risk of cross-resistance).

If diarrhoea or loose stools occur during or after treatment, the patient should immediately inform the doctor. Do not use any anti-diarrhoeal medication without first consulting a doctor. If diarrhoea persists, inform the doctor.

Inform the doctor if:

• Symptoms worsen during or shortly after treatment [possible superinfection and/or resistance].

Azithromycin is not suitable for treating severe infections requiring rapid achievement of high antibiotic blood concentrations.

Children and adolescents under 18 years of age

If vomiting or irritability occurs in a newborn (under 6 weeks of age) after administration of the medicine, inform the doctor immediately.

Azitro 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.

It is especially important to inform the doctor before starting treatment if the patient is taking any of the following medicines:

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

• Anticoagulant medicines, such as warfarin, phenprocoumon: concomitant use may increase the risk of bleeding. When used together with Azitro, more frequent monitoring of blood clotting parameters by the doctor may be necessary.

• Ergotamine, dihydroergotamine (used to treat migraine): ergotism (tingling in limbs, muscle cramps, and tissue necrosis in hands and feet due to poor blood circulation) may occur. Therefore, concomitant treatment is not recommended.

• Cyclosporine (used to suppress the immune system to prevent and treat rejection of transplanted organs or bone marrow): if combined treatment is necessary, the doctor will monitor blood cyclosporine levels and may adjust the dose.

• Digoxin (used to treat heart failure): digoxin levels may increase; therefore, the doctor may order appropriate blood tests.

• Colchicine (used to treat gout and familial Mediterranean fever): more frequent monitoring of colchicine blood levels and possible dose adjustment may be required.

• Medicines that neutralize stomach acid (used to relieve indigestion): may reduce the effectiveness of concomitantly administered azithromycin; see section 3.

• Cisapride (used to treat stomach disorders), terfenadine (used to treat hay fever), pimozide (used to treat certain psychiatric conditions), citalopram (used to treat depression), fluoroquinolones (antibiotics used to treat bacterial infections, e.g. moxifloxacin and levofloxacin): concomitant use with azithromycin may cause heart problems; therefore, combined treatment is not recommended.

• Medicines used to treat heart rhythm disorders (so-called antiarrhythmics, e.g. quinidine, amiodarone, sotalol): combined treatment with azithromycin is not recommended.

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

• Nelfinavir (used to treat HIV infections): concomitant use may increase the risk of adverse effects.

• Alfentanil (used in anaesthesia) or astemizole (used to treat 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 drug blood levels.

• Statins (e.g. atorvastatin, used to lower blood lipid levels): concomitant use with azithromycin may cause muscle disorders.

• Some medicines (such as hydroxychloroquine) known to cause heart rhythm disorders, e.g. QT interval prolongation observed on electrocardiogram: concomitant use may increase the risk of arrhythmias.

• Anticoagulant coumarin-type medicines (blood thinners that prevent blood clots); although Azitro appears not to affect the action of coumarin anticoagulants, more frequent monitoring of blood coagulation by the doctor managing anticoagulant therapy and possible dose adjustment may be necessary.

Azitro with food and drink

Azitro can be taken independently of meals.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this or any other medicine.

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

This medicine may cause adverse effects such as visual disturbances, blurred vision, dizziness, and drowsiness. This may affect the ability to drive or operate machinery.

Azitro, 100 mg/5 ml and Azitro, 200 mg/5 ml contain sucrose, sodium, benzyl alcohol, aspartame and sulphites

Sucrose

• Azitro, 100 mg/5 ml: 5 ml of suspension contains 3.82 g of sucrose.
• Azitro, 200 mg/5 ml: 5 ml of suspension contains 3.71 g of sucrose.

This should be considered in patients with diabetes. If intolerance to certain sugars has previously been diagnosed, the patient should consult a doctor before taking the medicine.

Aspartame

The medicine contains 0.030 g of aspartame in 5 ml of suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

Benzyl alcohol

This medicine contains up to 410 nanograms of benzyl alcohol per 5 ml of suspension.
Benzyl alcohol may cause allergic reactions. Do not administer to newborns (under 4 weeks of age) unless directed by a doctor. Do not use for longer than one week in young children (under 3 years of age) unless directed by a doctor or pharmacist. Consult a doctor or pharmacist for advice if the patient is pregnant or breastfeeding, or has liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and may cause adverse effects (called "metabolic acidosis").

Sulphites

This medicine contains up to 85 nanograms of sulphites per 5 ml of suspension.
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Azitro

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Azitro, 200 mg/5 ml
Adults and children with body weight greater than 45 kg
Azithromycin is administered in a 3-day or 5-day regimen.
3-day regimen: 12.5 ml (500 mg) once daily
5-day regimen:
• 12.5 ml (500 mg) on Day 1
• 6.25 ml (250 mg) on Days 2, 3, 4 and 5
For urethral and cervical infections caused by Chlamydia, the medicine is administered in a 1-day regimen:
1-day regimen: 25 ml (1000 mg).
Exception: dosing for treatment of sore throat. The doctor may recommend a different dosage.
Azitro, 100 mg/5 ml and 200 mg/5 ml
Children with body weight less than 45 kg
Azithromycin is not an appropriate medicine for children under 1 year of age.
Azithromycin is administered in a 3-day or 5-day regimen. The daily dose is determined based on the child's body weight.
The tables below show the usual recommended doses.
Azitro, 100 mg/5 ml
3-day treatment

5-day treatment

Azitro, 200 mg/5 ml
3-day treatment

5-day treatment

Patients with kidney or liver function disorders
If the patient has kidney or liver function disorders, this should be reported to the physician, as
a dose adjustment of the medicine may be necessary.

Dosage in elderly patients
Dosage should be the same as for adults.

The medicine should be taken once daily. It can be taken regardless of meals.
The bitter taste of the suspension may be avoided by taking the medicine with fruit juice.

Use of AzitroLEK together with medicines for indigestion
If the patient needs to take another medicine for indigestion, e.g. an antacid, AzitroLEK should be taken at least two hours before or after taking the antacid.

How to measure the dose of the medicine
An oral syringe with a capacity of 10 ml and graduations every 0.25 ml, as well as a bottle adapter, are supplied with the medicine. To measure the dose:

• shake the bottle
• place the adapter into the neck of the bottle
• insert the tip of the syringe into the adapter
• turn the bottle upside down
• pull back the plunger to measure the required dose
• turn the bottle back to its original position, remove the syringe, leaving the adapter in place, and close the bottle.

If in doubt about how to measure the dose, consult a physician or pharmacist.

Administering the medicine to a child using the syringe
Ensure the child is supported in an upright position.
Carefully insert the tip of the syringe into the child's mouth, directing it towards the inside of the cheek.
Slowly depress the plunger of the syringe. Do not administer the medicine too quickly. The suspension will flow slowly into the child's mouth.
Allow the child time to swallow the medicine.

How to prepare the suspension
The oral suspension may be prepared by a physician, nurse, or pharmacist.
To open the bottle, press down on the child-resistant cap and turn it.
If preparing the oral suspension independently, shake the bottle to loosen the powder, then add the measured amount of cold, boiled water to the bottle containing the powder.
The appropriate volume of water can be measured using the provided 10 ml oral syringe.
The amount of water required depends on the bottle size and is as follows:

Azitro, 100 mg/5 ml:
To prepare 20 ml of suspension (400 mg), add 10.5 ml of water to the bottle.

Azitro, 200 mg/5 ml:
To prepare 20 ml of suspension (800 mg), add 10.5 ml of water to the bottle.
To prepare 30 ml of suspension (1200 mg), add 15 ml of water to the bottle.
To prepare 37.5 ml of suspension (1500 mg), add 18.5 ml of water to the bottle.

Immediately after adding water, shake the bottle. The suspension should be prepared only once, at the beginning of treatment.

Accidental overdose of AzitroLEK
Taking too high a dose may cause nausea or vomiting. Other adverse effects may also occur, such as transient hearing loss, nausea, vomiting, and diarrhea. In case of overdose, seek immediate medical advice from a physician or go to the nearest hospital emergency department. If possible, bring the medicine packaging along to show the physician what the patient has taken.

Missed dose of AzitroLEK
If the patient forgets to take a dose, they should take it as soon as possible, then continue as before. Do not take more than one dose per day.

Stopping treatment with AzitroLEK
The oral suspension should always be taken for the full duration of treatment, even if the patient feels better. Stopping treatment early may result in recurrence of infection. It may also lead to the development of bacterial resistance to the medicine, making future treatment more difficult.

If you have any further questions about the use of this medicine, consult your physician 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 the patient experiences any of the symptoms of a severe allergic reaction listed below, stop taking the medicine immediately and contact a doctor or go to the emergency department of the nearest hospital without delay:

• sudden difficulty in breathing, speaking or swallowing
• swelling of the lips, tongue, face and neck
• severe dizziness or fainting
• severe or itchy rash, especially in the form of blisters, with eye, mouth or genital pain

If the patient experiences any of the adverse reactions listed below, seek medical advice as soon as possible:

• severe, prolonged or bloody diarrhoea with abdominal 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
• pancreatitis causing severe abdominal and back pain
• increased or decreased urine output, blood in the urine
• skin rash caused by photosensitivity
• appearance of bruises or bleeding
• irregular heartbeat

All the adverse reactions described above are serious and may require urgent medical attention. Serious adverse reactions occur uncommonly (may affect fewer than 1 in 100 people), rarely (may affect fewer than 1 in 1,000 people), or at a frequency that cannot be determined from available data.

Other possible adverse reactions
Very common adverse reactions (may affect more than 1 in 10 people):

• diarrhoea
• abdominal pain
• nausea
• bloating

Common adverse reactions (may affect no more than 1 in 10 people):

• headache
• vomiting
• changes in taste sensation (dysgeusia)
• dizziness
• drowsiness
• unexplained prickling, itching or tingling sensations (paraesthesia)
• visual disturbances
• hearing loss
• belching and burning in the stomach (dyspepsia)
• rash, itching (pruritus)
• joint pain (arthralgia)
• fatigue
• changes in white blood cell count (low lymphocyte count, increased eosinophils, basophils, monocytes and neutrophils)
• decreased blood bicarbonate levels (indicating excess acid in the blood)

Uncommon adverse reactions (may affect fewer than 1 in 100 people):

• fungal and bacterial infections, especially in the mouth, throat, nose, lungs, stomach, intestine and vagina
• low white blood cell count (leukopenia), low neutrophil count (neutropenia), high eosinophil count (eosinophilia)
• oedema, allergic reactions of varying severity (angioedema)
• loss of appetite (anorexia)
• nervousness, insomnia, tingling or numbness in hands and (or) feet
• hearing disturbances, ringing in the ears (tinnitus), sensation of spinning (vestibular dizziness)
• palpitations
• hot flushes with sweating and rapid heartbeat
• breathing difficulties, nosebleeds
• constipation, gas, indigestion, inflammation of the stomach lining, difficulty swallowing, bloating, dry mouth, belching, mouth ulcers, excessive salivation
• urticaria, skin inflammation, dry skin, sweating
• Stevens-Johnson syndrome
• inflammation of bones and joints, muscle, back and neck pain
• painful or difficult urination, kidney pain
• genital bleeding, testicular disorders
• skin swelling, weakness, general malaise, fatigue, facial swelling, chest pain, fever, pain, swelling of limbs
• abnormal laboratory test results (e.g. blood, liver and kidney function tests)
• complications following administration of the medicine
• sore throat
• photosensitivity or sun sensitivity, possibly with skin lesions (photosensitivity reaction)
• abnormal liver function
• reduced sensory sensitivity (hypoesthesia)

Rare adverse reactions (may affect fewer than 1 in 1,000 people):

• irritability
• jaundice
• restlessness
• skin eruption characterised by rapid appearance of red skin areas covered with small blisters filled with white or yellow fluid (acute generalised exanthematous pustulosis [AGEP])
• delayed allergic reaction (within several weeks of 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 numbers of certain white blood cells (drug rash with eosinophilia and systemic symptoms, DRESS)

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

• low red blood cell count, which may cause pale-yellow skin, weakness or shortness of breath
• reduced platelet count, increasing the risk of bleeding or bruising
• severe allergic reaction
• feelings of aggression, anxiety, severe confusion, hallucinations
• fainting, seizures, excessive activity, smell disturbances, loss of smell or taste, muscle weakness (myasthenia)
• heart rhythm disorders, abnormal electrocardiogram (ECG)
• low blood pressure
• tongue discoloration, tooth discoloration
• liver failure, severe hepatitis
• kidney failure, kidney inflammation
• toxic epidermal necrolysis
• erythema multiforme

The following adverse reactions have been reported during use of the medicine in the prevention and treatment of Mycobacterium avium complex (MAC) infection:

Very common adverse reactions (may affect more than 1 in 10 people):

• diarrhoea
• abdominal pain
• nausea
• bloating with gas release
• abdominal discomfort
• loose stools

Common adverse reactions (may affect no more than 1 in 10 people):

• loss of appetite (anorexia)
• dizziness
• headache
• tingling or numbness
• taste disturbances
• visual disturbances
• deafness
• skin rash
• itching
• joint pain
• feeling of fatigue

Uncommon adverse reactions (may affect fewer than 1 in 100 people):

• reduced sense of touch (hypoesthesia)
• hearing disturbances or ringing in the ears (tinnitus)
• heart rhythm disorders and palpitations
• liver disorders, such as hepatitis
• blistering and (or) bleeding affecting lips, eyes, nose, mouth and genital organs (e.g. due to Stevens-Johnson syndrome)
• skin allergic reactions, such as sensitivity to sunlight, redness, peeling or swelling of the skin
• weakness
• general malaise

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store AzitroLEK

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the specified month.
Bottle with powder before first opening: do not store above 30 °C.
Reconstituted suspension: do not store above 25 °C.
Do not use the reconst uted suspension for more than 10 days.
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 Azitro contains
The active substance is azithromycin.
Azitro, 100 mg/5 ml:
Each 5 ml of reconstituted suspension contains 104.80 mg of azithromycin dihydrate, corresponding to
100 mg of azithromycin.
Azitro, 200 mg/5 ml:
Each 5 ml of reconstituted suspension contains 209.6 mg of azithromycin dihydrate, corresponding to
200 mg of azithromycin.
The other ingredients are: sucrose, xanthan gum (E 415), hydroxypropylcellulose, anhydrous
trisodium phosphate, colloidal anhydrous silica (E 551), aspartame (E 951), banana flavour (contains sulphites), cream-vanilla flavour (contains benzyl alcohol), and cherry flavour (contains sulphites).

What Azitro looks like and contents of the pack
Azitro is a white to off-white crystalline powder.
The reconstituted suspension is white to off-white and homogeneous.
Azitro, 100 mg/5 ml
HDPE bottles: 20 ml (400 mg).
Azitro, 200 mg/5 ml
HDPE bottles: 20 ml (800 mg), 30 ml (1200 mg), and 37.5 ml (1500 mg).
The pack also contains a PE/PP dosing syringe (10 ml) for measuring the dose, graduated every 0.25 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Novartis Pharmaceuticals S.R.L.
Str. Livezeni nr 7a
540472 Targu Mures, Romania

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

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

100 mg/5 ml
Netherlands: Azitromycine Sandoz 100 mg/5 ml, poeder voor orale suspensie
Poland: AzitroLEK
Romania: AZITROMICINĂ SANDOZ 100 mg/5 ml pulbere pentru suspensie orală

200 mg/5 ml
Austria: Azithromycin Sandoz 200 mg/5 ml - Pulver zur Herstellung einer Suspension zum Einnehmen
Belgium: Azithromycine Sandoz 200mg/5ml poeder voor orale suspensie
Finland: Azithromycin Sandoz 40 mg/ml jauhe oraalisuspensiota varten
Hungary: Azithromycin Sandoz 40 mg/ml por belsőleges szuszpenzióhoz
Italy: AZITROMICINA Sandoz GmbH
Netherlands: Azitromycine Sandoz 200 mg/5 ml, poeder voor orale suspensie
Poland: AzitroLEK
Romania: AZITROMICINĂ SANDOZ 200 mg/5 ml pulbere pentru suspensie orală
Slovakia: Azithromycin Sandoz 200 mg/5 ml prášok na perorálnu suspenziu
Spain: Azitromicina Sandoz 200 mg 5 ml polvo para suspensión oral EFG
United Kingdom (Northern Ireland): Azithromycin 200 mg/5 ml Powder for Oral Suspension

(logo of the Marketing Authorisation Holder)