Azithromicin Krka

Leaflet attached to the packaging: patient information

Azithromycin Krka, 250 mg, film-coated tablets

Azithromycin Krka, 500 mg, film-coated tablets

Azithromycin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Azithromycin Krka and what is it used for

The active substance of Azithromycin Krka is azithromycin, an antibiotic from the macrolide group.
Azithromycin Krka is indicated for the treatment of the following infections:

• acute bacterial sinusitis;
• acute bacterial otitis media;
• tonsillitis, pharyngitis;
• exacerbation of chronic bronchitis;
• mild to moderate pneumonia;
• mild to moderate skin and soft tissue infections, such as furunculosis, cellulitis, erysipelas;
• urethral and cervical infections caused by Chlamydia trachomatis.

2. Important information before taking Azithromycin Krka

When not to take Azithromycin Krka

Azithromycin Krka should not be taken:

• if the patient is allergic to azithromycin or other macrolide antibiotics, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist if:

• the patient has a certain type of heart disorder (e.g. severe heart rhythm disorders, "QT interval prolongation") or is taking medicines that change the heart's electrical activity, such as cisapride (used to increase bowel movement); or hydroxychloroquine or chloroquine (used to treat malaria);
• the patient has slowed or irregular heart rhythm;
• the patient has changed electrolyte levels in the blood, especially low potassium and magnesium levels;
• the patient is taking other medicines that cause changes in the ECG (see "Azithromycin Krka and other medicines");
• the patient has severe kidney disorders;
• the patient has severe liver disorders: the doctor may monitor liver function or stop treatment;
• the patient has a new infection (which may indicate excessive growth of resistant microorganisms);
• the patient has neurological (neurological) or mental (psychic) disorders.

Rarely, severe allergic reactions, facial swelling, oral and pharyngeal edema (sometimes fatal) have been reported. If the patient notices such symptoms, they should stop taking Azithromycin Krka immediately and consult a doctor.
Antibiotics can cause diarrhea, which can be a sign of a serious intestinal inflammation. If the patient experiences watery diarrhea or bloody diarrhea, they should contact a doctor.
Do not take medicines to stop diarrhea, unless the doctor recommends it.

Children and adolescents

Azithromycin Krka film-coated tablets are notsuitable for infants and young children (under 2 years of age) or for children and adolescents (under 17 years of age) with a body weight of less than 45 kg.
Information on the use of Azithromycin Krka in children and adolescents with a body weight of 45 kg or more can be found in section 3 "How to take Azithromycin Krka".

Azithromycin Krka and other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or plan to take.
If the patient is taking any of the following medicines, it is especially important to tell their doctor or pharmacist:

• medicines known as ergot derivatives, e.g. ergotamine or dihydroergotamine (used in migraine or to reduce blood flow), as they should not be taken at the same time as Azithromycin Krka;
• cyclosporin (used in skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (used to treat high blood cholesterol);
• cisapride (used in stomach disorders);
• theophylline (used in respiratory disorders);
• warfarin or other anticoagulant medicines;
• digoxin (used in heart disorders);
• colchicine (used to treat gout and familial Mediterranean fever);
• zidovudine, efavirenz, indinavir, nelfinavir, didanosine (used in HIV infections);
• rifabutin (used in HIV or tuberculosis treatment);
• terfenadine (used to treat allergies);
• fluconazole (used in fungal infections);
• so-called antacids (medicines that neutralize stomach acid); Azithromycin Krka should be taken at least 1 hour before taking antacids or 2 hours after taking them;
• astemizole (used to treat allergies);
• alfentanil (a pain reliever);
• hydroxychloroquine and chloroquine (used to treat malaria).

Azithromycin Krka with food and drink

Tablets should be taken with a glass of water.
This medicine can be taken with or without food, as it does not affect the absorption of azithromycin.

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 a doctor or pharmacist before taking this medicine .
This medicine should not be taken during pregnancy and breastfeeding, unless it has been recommended by a doctor.

Driving and using machines

This medicine may cause dizziness. If the patient feels dizzy, they should not drive or operate machinery.

Azithromycin Krka contains sodium

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

3. How to take Azithromycin Krka

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Adults, adolescents, and children with a body weight of at least 45 kg

Children and adolescents with a body weight below 45 kg
Taking tablets is not recommended. For children and adolescents with a body weight below 45 kg, another pharmaceutical form of azithromycin is recommended.
Patients with kidney or liver disorders
If the patient has kidney or liver disorders, they should tell their doctor, as the doctor may change the dose of the medicine.
Dosage in elderly patients
In elderly patients, the dosage is the same as in other adult patients.
Method of administration
Tablets should be taken with a glass of water.
This medicine can be taken with or without food, as it does not affect the absorption of azithromycin.

Taking a higher dose of Azithromycin Krka than recommended

It is important to take the dose of the medicine as recommended by the doctor.
If the patient or someone else has swallowed several tablets or if it is suspected that a child has swallowed any of the tablets, they should contact a doctor, pharmacist, or the emergency department of the nearest hospital. They should take the remaining tablets or packaging with them, which will allow the medicine to be identified. Symptoms of overdose may include nausea, vomiting, diarrhea, and transient hearing loss.

Missing a dose of Azithromycin Krka

A double dose should not be taken to make up for a missed dose. If the patient forgets to take a dose of the medicine, they should do so as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose and take the next dose at the usual time.

Stopping Azithromycin Krka

The patient should not stop taking the medicine prematurely.
Even if the patient feels better, it is important to take the tablets for as long as the doctor has recommended.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Azithromycin Krka can cause side effects, although not everybody gets them .
These effects are usually mild or moderate and disappear after stopping the medicine.

If any of the following symptoms occur, the medicine should be stopped and a doctor or the emergency department of the nearest hospital should be contacted immediately. These may be symptoms of a rare, severe allergic reaction to these tablets:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat;
• difficulty breathing or swallowing;
• severe skin reactions, including Stevens-Johnson syndrome (severe skin rash) and other severe skin rashes, which may include blisters or peeling (toxic epidermal necrolysis);
• severe, prolonged diarrhea, especially if there is blood or mucus in the stool (this may be a sign of a serious intestinal inflammation).

Other reported side effects

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

• diarrhea.

Common (may affect up to 1 in 10 people):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• change in other blood test results (decrease in blood bicarbonate levels).

Uncommon (may affect up to 1 in 100 people):

• fungal infections (candidiasis) - oral and vaginal thrush;
• pneumonia, bacterial pharyngitis, gastrointestinal infection, respiratory disorders, rhinitis;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• swelling of the eyelids, face, or lips (angioedema), allergic reactions;
• loss of appetite (anorexia);
• nervousness, sleep disorders (insomnia);
• dizziness, drowsiness, taste disturbance, feeling of tingling, numbness, or prickling (paresthesia);
• vision disorders;
• hearing disorders, feeling of spinning;
• palpitations;
• flushing;
• sudden shortness of breath, nosebleeds;
• constipation, gas, indigestion, gastritis, difficulty swallowing, bloating, dry mouth, belching, oral ulcers, increased salivation;
• rash, itching, urticaria, skin dryness, excessive sweating;
• joint or muscle pain (arthritis);
• urination disorders, kidney pain;
• abnormal vaginal bleeding, genital disorders;
• edema, weakness, general malaise, facial swelling, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g. blood and liver function tests).

Rare (may affect up to 1 in 1000 people):

• agitation;
• abnormal liver function, yellowing of the skin and eyes (jaundice);
• allergic reactions, such as increased sensitivity to sunlight;
• skin rash characterized by rapid onset of areas of red skin with small blisters (small blisters filled with white-yellow fluid).

Very rare (may affect up to 1 in 10,000 people):

• drug rash with eosinophilia and systemic symptoms, such as fever and lymph node swelling (DRESS syndrome).

Side effects with unknown frequency (cannot be estimated from available data):

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intestinal inflammation (pseudomembranous colitis);
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decrease in red blood cell count (hemolytic anemia), decrease in platelet count;
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allergic reactions (anaphylactic reaction);
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feeling of aggression, anxiety, severe confusion, hallucinations;
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fainting;
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seizures;
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decreased skin sensitivity to touch;
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excessive activity;
­
disorders of smell;
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loss of smell or taste;
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muscle weakness (myasthenia);
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life-threatening heart rhythm disorders (torsades de pointes), abnormal ECG (QT interval prolongation);
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hearing disorders, including deafness or ringing in the ears;
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low blood pressure;
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pancreatitis;
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discoloration of the tongue;
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liver disorders (liver failure, rarely ending in death, liver necrosis), hepatitis;
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severe skin allergic reactions (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome);
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joint pain (arthritis);
­
acute kidney failure and interstitial nephritis.

Side effects whose connection to the use of azithromycin in the prevention and treatment of Mycobacterium avium complex infection is possible or probable

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

• diarrhea;
• abdominal pain, nausea;
• bloating;
• feeling of discomfort in the abdominal cavity;
• loose stools.

Common (may affect up to 1 in 10 people):

• loss of appetite;
• dizziness;
• headache;
• feeling of tingling, numbness, or prickling (paresthesia);
• taste disturbance;
• vision disorders;
• hearing loss;
• rash, itching;
• joint pain (arthritis);
• feeling of fatigue.

Uncommon (may affect up to 1 in 100 people):

• decreased skin sensitivity to touch (hypoesthesia);
• hearing disorders, ringing in the ears;
• palpitations;
• hepatitis;
• severe skin allergic reactions;
• increased sensitivity to sunlight;
• weakness;
• general malaise.

Reporting side effects

If side effects occur, including those 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
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 Azithromycin Krka

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
The abbreviation "Lot" on the packaging means batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Azithromycin Krka contains

• The active substance of the medicine is azithromycin.

Azithromycin Krka, 250 mg, film-coated tablets: each film-coated tablet contains 250 mg of azithromycin in the form of azithromycin dihydrate.
Azithromycin Krka, 500 mg, film-coated tablets: each film-coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
Other ingredients are:
tablet core:microcrystalline cellulose, maize starch, sodium lauryl sulfate, hypromellose 4,0-6,0 mPa s, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate
coating of the 250 mg tablet:Opadry Y-1-7000 [hypromellose 5cP, titanium dioxide (E 171), macrogol 400]
coating of the 500 mg tablet:Opadry QX321A180025 White [copolymer of methacrylic acid and acrylic acid esters, titanium dioxide (E 171), talc, glycerol monocaprylocaprate, polyvinyl alcohol]
See section 2 "Azithromycin Krka contains sodium".

What Azithromycin Krka looks like and contents of the packaging

250 mg: white or almost white film-coated tablets in the shape of capsules (length: 13.8–14.2 mm, width: 6.3–6.7 mm), marked with "S19" on one side and smooth on the other; the packaging contains 4 or 6 film-coated tablets
500 mg: white or almost white film-coated tablets in the shape of capsules (length: 16.7–17.3 mm, width: 8.2–8.8 mm), marked with "S5" on one side and smooth on the other; the packaging contains 2, 3, or 30 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
KRKA - Polska Sp. z o.o.,
ul. Równoległa 5,
02-235 Warsaw,
Poland
phone: 22 57 37 500

Date of last revision of the leaflet: 08.08.2022