Azitrolek

Leaflet attached to the packaging: patient information

AzitroLEK, 100 mg/5 ml, powder for oral suspension

AzitroLEK, 200 mg/5 ml, powder for oral suspension

Azithromycin

You should carefully read the contents of this 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.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. 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 not listed in this leaflet, they should tell their 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 using Azitro
• 3. How to use Azitro
• 4. Possible side effects
• 5. How to store Azitro
• 6. Package contents and other information

1. What is Azitro and what is it used for

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

2. Important information before using Azitro

This medicine should not be used in patients who are allergic (hypersensitive) to:

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

Warnings and precautions

Before starting treatment with Azitro, the patient should discuss the following with their doctor or pharmacist:
allergic reactions (itching, rash) may occur due to the use of Azitro.
If a severe allergic reaction occurs, the patient will experience rapid swelling of the face and throat (angioedema) that causes shortness of breath, or a sudden severe feeling of unwellness (anaphylaxis). High fever, rash, blisters on the skin, peeling of the skin, 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, the patient should contact their doctor immediately.
if the patient has liver function disorders, they should inform their doctor before starting treatment with 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.
if the patient has kidney function disorders: if they are severe, it may be necessary to modify the dose of the medicine.
if the patient has neurological or psychiatric disorders.
if the patient has heart disease, such as

• -heart failure (heart failure)
• very slow heart rate
• irregular heartbeat or
• disorders referred to as "prolonged QT interval" (detected in the ECG) because azithromycin may increase the risk of heart rhythm disturbances. if the patient has low potassiumor magnesiumlevels in the blood if the patient has myasthenia- a type of muscle weakness if the patient has had infections with pathogens resistant to azithromycin, erythromycin, lincosamides, and (or) methicillin-resistant staphylococci (possibility of cross-resistance).

If the patient experiences diarrhea or loose stools during or after treatment, they should immediatelyinform their doctor. The patient should not use any anti-diarrheal medication 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 treatment or soon after its completion [possibility of superinfections and (or) resistance].
Azithromycin is not suitable for the treatment of severe infections that require rapid achievement of high antibiotic concentrations in the blood.

Children and adolescents up to 18 years of age

If the patient is a newborn (under 6 weeks of age) and experiences vomiting or irritability during feeding, they should immediately inform their doctor.

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.
If the patient is taking any of the following medicines, it is especially important to inform their doctor before starting treatment:
Theophylline(used to treat asthma): the effect of theophylline may be enhanced.
Anticoagulant medicines, such as warfarin, phenprocoumon: concurrent use may increase the risk of bleeding. During concurrent use with Azitro, it may be necessary to monitor blood clotting parameters more frequently.
Ergotamine, dihydroergotamine(used to treat migraines): ergot alkaloid poisoning may occur (with itching of the limbs, muscle cramps, and gangrene due to poor blood circulation). For this reason, concurrent treatment is not recommended.
Cyclosporin(used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection): if concurrent treatment is necessary, the doctor will monitor cyclosporin blood levels and may adjust the dose of the medicine.
Digoxin(a medicine used to treat heart failure): digoxin levels may increase, so the doctor will order blood tests.
Colchicine(used to treat gout and familial Mediterranean fever): it may be necessary to monitor colchicine blood levels more frequently and adjust the dose of colchicine.
Antacids(used to relieve heartburn): they may reduce the effectiveness of azithromycin, 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): concurrent use with azithromycin may cause heart rhythm disturbances, so concurrent treatment is not recommended.
Medicines used to treat heart rhythm disorders(so-called anti-arrhythmic medicines, i.e., quinidine, amiodarone, sotalol). Concurrent treatment with azithromycin is not recommended.
Zidovudine(used to treat HIV infections): concurrent use may increase the risk of side effects.
Nelfinavir(used to treat HIV infections): concurrent use may increase the risk of side effects.
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 order control tests and blood level tests.
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 disturbances, e.g., QT interval prolongation detected in the electrocardiogram: concurrent use may increase the risk of arrhythmia.
Anticoagulant medicines of the coumarin type(blood-thinning medicines that prevent blood clots); although it seems that Azitro does not affect the blood-thinning effect of coumarin-type medicines, it may be necessary to monitor blood clotting parameters more frequently and adjust the dose.

Azitro with food and drink

Azitro can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

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 using this and any other medicine.
Pregnancy
The doctor will decide whether the patient should take this medicine during pregnancy, only after determining that the benefits outweigh the potential risks.
Breastfeeding
Azithromycin has been reported to be 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, 100 mg/5 ml and Azitro, 200 mg/5 ml contain sucrose, sodium, benzyl alcohol, aspartame, and sulfites
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 taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 its improper excretion.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means 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. It should not be given to newborns (under 4 weeks of age), unless prescribed by a doctor. It should not be used for more than a week in young children (under 3 years of age), unless prescribed by a doctor or pharmacist. The patient should consult their doctor or pharmacist for advice if they are pregnant or breastfeeding or have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (known as "metabolic acidosis").
Sulfites
This medicine contains up to 85 nanograms of sulfites per 5 ml of suspension
The medicine can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Azitro

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Azitro, 200 mg/5 ml

Adults and children with a body weight over 45 kg

Azithromycin is used in a 3- or 5-day cycle.
3-day cycle: 12.5 ml (500 mg) once a day
5-day cycle
12.5 ml (500 mg) on day 1
6.25 ml (250 mg) on days 2, 3, 4, and 5
In chlamydia-induced urethral and cervical infections, the medicine is used in a 1-day cycle:
1-day cycle: 25 ml (1000 mg).
Exception is dosing in the treatment of throat pain. The doctor may prescribe a different dosage.
Azitro, 100 mg/5 ml and 200 mg/5 ml

Children with a body weight under 45 kg

Azithromycin is not a suitable medicine for children under 1 year of age.
Azithromycin is used in a 3- or 5-day cycle. The daily dose is determined based on the child's body weight.
The following tables show the usual 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, they should inform their doctor, as it may be necessary to adjust the dose of the medicine.

Dosing in elderly patients

The patient should use the same dosing as adults.

The medicine should be taken once a day. It can be taken independently of meals.

The patient can avoid the bitter taste of the suspension by drinking it with fruit juice.

Using Azitro with antacids

If the patient needs to use another medicine for heartburn, e.g., an antacid, they should take AzitroLEK at least 2 hours before or after taking the antacid.

with antacids.

How to measure the dose of the medicine

A measuring syringe with a capacity of 10 ml, graduated every 0.25 ml, and a connector adapted to the bottle are attached to the packaging of the medicine. To measure the dose of the medicine, the patient should:
shake the bottle
place the connector in the bottle neck
insert the end of the syringe into the connector
turn the bottle upside down
pull out the plunger to measure the required dose of the medicine
turn the bottle back to its original position, remove the syringe, leaving the connector, and close the bottle.
If the patient is unsure how to measure the dose of the medicine, they should consult their doctor or pharmacist.

Administering the medicine to a child with a syringe

The patient should ensure that the child is supported in an upright position.
The patient should carefully insert the tip of the syringe into the child's mouth, directing it to the inside of the cheek.
The patient should slowly press the syringe plunger. The patient should not inject the medicine too quickly. The suspension will flow into the child's mouth in a thin stream.
The patient should allow the child time to swallow the medicine.

How to prepare the suspension

It is possible that the oral suspension will be prepared by the doctor, nurse, or pharmacist.
To open the bottle, the patient should press the child-resistant cap and turn it.
If the patient is preparing the oral suspension themselves, they should shake the bottle to make the powder loose and pour the measured amount of cold, boiled water into the bottle with the powder.
The appropriate volume of water can be measured with the attached measuring syringe with a capacity of 10 ml.
The amount of water depends on the capacity of the medicine bottle and is as follows:
Azitro, 100 mg/5 ml:
to prepare 20 ml of suspension (400 mg), the patient should pour 10.5 ml of water into the bottle
Azitro, 200 mg/5 ml:
to prepare 20 ml of suspension (800 mg), the patient should pour 10.5 ml of water into the bottle
to prepare 30 ml of suspension (1200 mg), the patient should pour 15 ml of water into the bottle
to prepare 37.5 ml of suspension (1500 mg), the patient should pour 18.5 ml of water into the bottle
Immediately after adding water, the patient should shake the bottle. The suspension is prepared only once, at the beginning of treatment.

Taking a higher dose of Azitro than recommended

Taking too much of the medicine may cause nausea or vomiting. Other side effects, such as transient hearing loss, nausea, vomiting, and diarrhea, may also occur. In case of overdose, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital. If possible, the patient should take the medicine packaging with them to show the doctor what they have taken.

Missing a dose of Azitro

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

Stopping treatment with Azitro

The oral suspension should always be taken to the end of the treatment cycle, even if the patient feels better. Stopping treatment too early may cause the infection to recur. It may also lead to the development of bacterial resistance to the medicine, making treatment more difficult.
In case of any further doubts about using this medicine, the patient 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 the patient experiences any of the following symptoms of a severe allergic reaction, they should stop using the medicine and immediately contact their doctor or go to the emergency department of the nearest hospital:

• sudden difficulty breathing, speaking, or swallowing
• swelling of the lips, tongue, face, and throat
• severe dizziness or fainting
• severe or itchy rash, especially with blisters, and pain in the eyes, mouth, or genitals.

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

• severe, prolonged, or bloody diarrhea with abdominal pain or fever; this may be a sign of severe colitis, which occurs rarely after antibiotic treatment
• yellowing of the skin or whites of the eyes, indicating liver function disorders
• pancreatitis, causing severe abdominal and back pain
• increased or decreased urine output, blood in the urine
• skin rash caused by hypersensitivity to sunlight
• bruising or bleeding
• irregular heartbeat.

All the above side effects are severe 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 with an unknown 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
abdominal pain
nausea
bloating
Commonside effects ( may occur in less than 1 in 10 people):
headache
vomiting
changes in taste (dysgeusia)
dizziness
drowsiness
feeling of tingling, itching, or numbness without reason (paresthesia)
vision disturbances
hearing loss
indigestion and heartburn (dyspepsia)
rash, itching (pruritus)
joint pain (arthralgia)
fatigue
changes in white blood cell count (low lymphocyte count, increased eosinophil, basophil, monocyte, and neutrophil count)
decreased bicarbonate levels in the blood (indicating excessive levels of acidic substances in the blood)
Uncommonside effects ( may occur in less than 1 in 100 people):
infections with fungi or bacteria, especially in the mouth, throat, nose, lungs, stomach, intestines, and vagina
low white blood cell count (a type of white blood cell), low neutrophil count (a type of white blood cell), high eosinophil count (a type of white blood cell),
swelling, allergic reactions of varying severity (angioedema)
loss of appetite (anorexia)
nervousness, insomnia, feeling of tingling or numbness in the hands and (or) feet
hearing disturbances, ringing in the ears (tinnitus), feeling of spinning (vertigo)
palpitations
feeling of heat with sweating and rapid heartbeat (hot flashes)
breathing difficulties, nosebleeds
constipation, gas, indigestion, stomach inflammation, difficulty swallowing, bloating, dry mouth, mouth ulcers, increased salivation
hives, skin inflammation, dry skin, sweating
Stevens-Johnson syndrome
bone and joint inflammation, muscle pain, back and neck pain
urinary tract problems, kidney pain
genital bleeding, testicular disorders
skin swelling, weakness, general malaise, fatigue, facial swelling, chest pain, fever, pain, limb swelling
abnormal laboratory test results (e.g., blood, liver, and kidney function)
post-marketing side effects
pharyngitis
hypersensitivity to light or sunlight, with possible skin changes (hypersensitivity to light)
abnormal liver function
decreased sensitivity (hypoesthesia)
Rareside effects ( may occur in less than 1 in 1000 people):
irritability
jaundice
agitation
acute generalized exanthematous pustulosis (AGEP), a skin rash characterized by rapid onset of areas of redness on the skin, covered with small blisters (pustules) 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 count of certain white blood cells (drug rash with eosinophilia and systemic symptoms, DRESS)
Frequency not known, cannot be estimated from the available data):
low red blood cell count, which may cause pale skin, weakness, or shortness of breath
decreased platelet count, which increases the risk of bleeding or bruising
severe allergic reaction
feeling of aggression, anxiety, severe confusion, hallucinations
fainting, seizures, excessive activity, smell disturbances, loss of sense of smell or taste, muscle weakness (myasthenia)
heart rhythm disturbances, abnormal electrocardiogram (ECG)
low blood pressure
discoloration of the tongue, tooth discoloration
liver failure, severe liver inflammation
kidney failure, kidney inflammation
toxic epidermal necrolysis
erythema multiforme

The following side effects have been reported during the use of the medicine for the prevention and treatment of Mycobacterium avium complex (MAC) infection:

Very commonside effects ( may occur in more than 1 in 10 people):
diarrhea
abdominal pain
nausea
bloating with gas passage
feeling of discomfort in the abdominal cavity
loose stools
Commonside effects ( may occur in less than 1 in 10 people):
loss of appetite (anorexia)
dizziness
headache
feeling of tingling or numbness
taste disturbances
vision disturbances
hearing loss
rash
itching (pruritus)
joint pain (arthralgia)
feeling of fatigue
Uncommonside effects ( may occur in less than 1 in 100 people):
decreased sensitivity (hypoesthesia)
hearing disturbances or ringing in the ears (tinnitus)
heart rhythm disturbances and feeling of heartbeat (palpitations)
liver disease, such as liver inflammation
skin reactions, such as hypersensitivity to sunlight, with possible skin redness, peeling, or swelling
weakness
general malaise

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Azitro

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 expiration date stated on the packaging and bottle after EXP. The expiration date refers to the last day of the specified month.
Bottle with powder before first opening: do not store above 30°C.
Prepared suspension: do not store above 25°C.
The prepared suspension should not be used for more than 10 days.
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. Package contents and other information

What Azitro contains

The active substance of the medicine is azithromycin.
Azitro, 100 mg/5 ml:
Each 5 ml of prepared suspension contains 104.80 mg of azithromycin dihydrate, equivalent to 100 mg of azithromycin.
Azitro, 200 mg/5 ml:
Each 5 ml of prepared suspension contains 209.6 mg of azithromycin dihydrate, equivalent to 200 mg of azithromycin.
The other ingredients are: sucrose, xanthan gum (E 415), hydroxypropyl cellulose, anhydrous disodium phosphate, colloidal silicon dioxide (E 551), aspartame (E 951), banana flavor (contains sulfites), cream-vanilla flavor (contains benzyl alcohol), and cherry flavor (contains sulfites).

What Azitro looks like and contents of the pack

Azitro is a white to off-white crystalline powder.
The prepared suspension is white to off-white, 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 packaging also includes a measuring syringe with a capacity of 10 ml, graduated every 0.25 ml, for measuring the dose.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovśkova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz S.R.L.
Str. Livezeni nr 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:

100 mg/5 ml
Netherlands
Azithromycin Sandoz 100 mg/5 ml, powder for oral suspension
Poland:
AzitroLEK
Romania:
AZITROMICINĂ SANDOZ 100 mg/5 ml powder for oral suspension
200 mg/5 ml
Austria:
Azithromycin Sandoz 200 mg/5 ml - powder for oral suspension
Belgium:
Azithromycin Sandoz 200mg/5ml powder for oral suspension
Finland:
Azithromycin Sandoz 40 mg/ml powder for oral suspension
Hungary:
Azithromycin Sandoz 40 mg/ml powder for oral suspension
Italy:
AZITROMICINA Sandoz GmbH
Netherlands:
Azithromycin Sandoz 200 mg/5 ml, powder for oral suspension
Poland:
AzitroLEK
Romania:
AZITROMICINĂ SANDOZ 200 mg/5 ml powder for oral suspension
Slovakia:
Azithromycin Sandoz 200 mg/5 ml powder for oral suspension
Spain:
Azitromicina Sandoz 200 mg 5 ml powder for oral suspension EFG
United Kingdom (Northern Ireland):
Azithromycin 200 mg/5 ml Powder for Oral Suspension
Date of last revision of the leaflet:12/2024
(logo of the marketing authorization holder)