Azithromycin krka

Package leaflet: Information for the patient

Azithromycin Krka, 250 mg, film-coated tablets
Azithromycin Krka, 500 mg, film-coated tablets
Azithromycinum
Please read the entire leaflet carefully before using this 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Azithromycin Krka is and what it is 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 pack and other information

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

The active substance in Azithromycin Krka is azithromycin, an antibiotic belonging to the macrolide class.
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, e.g. folliculitis, cellulitis, erysipelas;
• Urethral and cervical infections caused by bacteria called Chlamydia trachomatis.

2. Information before using Azithromycin Krka

When not to use Azithromycin Krka
Do not use Azithromycin Krka:

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

Warnings and precautions
Before starting treatment, discuss with a doctor or pharmacist if:

• the patient has a specific type of heart disorder (e.g. severe heart problems, "prolonged QT interval") or is taking medicines that affect the heart's electrical activity, such as cisapride (used to increase intestinal motility); or hydroxychloroquine or chloroquine (used in the treatment of malaria);
• the patient has a slow or irregular heartbeat;
• the patient has abnormal blood electrolyte levels, especially low potassium or magnesium levels;
• the patient is taking other medicines that cause changes in the ECG (see section "Azithromycin Krka and other medicines");
• the patient has severe kidney problems;
• the patient has severe liver problems: the doctor may monitor liver function or discontinue treatment;
• the patient has a new infection (which may indicate overgrowth of resistant microorganisms);
• the patient has neurological or psychiatric disorders.

Severe allergic reactions, including swelling of the face, mouth and throat (sometimes fatal), have been rarely reported. If the patient experiences such symptoms, the use of Azithromycin Krka must be stopped immediately and medical advice must be sought.
Antibiotics may cause diarrhoea, which could be a sign of a serious bowel infection. If the patient develops watery diarrhoea or bloody diarrhoea, medical advice must be sought. Do not take medicines to stop diarrhoea unless directed by a doctor.
Children and adolescents
Azithromycin Krka tablets are not suitable for infants and young children (under 2 years of age) or for children and adolescents (under 17 years of age) weighing less than 45 kg.
Information on the use of Azithromycin Krka in children and adolescents weighing over 45 kg can be found in section 3 "How to take Azithromycin Krka".
Azithromycin Krka and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If the patient is taking any of the following medicines, it is especially important to inform the doctor or pharmacist:

• medicines known as ergot derivatives, e.g. ergotamine or dihydroergotamine (used for migraine or reducing blood flow), as these should not be used together with Azithromycin Krka;
• cyclosporine (used in skin diseases, rheumatoid arthritis or after organ transplantation);
• atorvastatin (used to treat high blood cholesterol);
• cisapride (used for stomach disorders);
• theophylline (used for breathing problems);
• warfarin or other anticoagulants;
• digoxin (used for 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 infections);
• terfenadine (used to treat allergies);
• fluconazole (used for fungal infections);
• antacids (acid-neutralizing medicines); Azithromycin Krka should be taken at least 1 hour before or 2 hours after taking antacids;
• astemizole (used to treat allergies);
• alfentanil (a painkiller);
• hydroxychloroquine and chloroquine (used to treat malaria).

Azithromycin Krka with food and drink
Take tablets with water.
This medicine may be taken with or without food, as food does not affect the absorption of azithromycin.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breastfeeding, unless specifically advised by a doctor.
Driving and using machines
This medicine may cause dizziness. If the patient experiences dizziness, he/she should not drive or operate machinery.
Azithromycin Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Azithromycin Krka

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

Children and adolescents with body weight below 45 kg
The use of tablets is not recommended. In children and adolescents with body weight less than 45 kg, another pharmaceutical form of azithromycin is recommended.
Patients with renal or hepatic impairment
If the patient has renal or hepatic impairment, this should be reported to the physician, as the physician may adjust the dose of the medication.
Dosing in elderly patients
Dosing in elderly patients is the same as in other adult patients.
Method of administration
The tablets should be taken with half a glass of water.
This medicine may be taken with or without food, as food does not affect the absorption of azithromycin.
Taking more Azithromycin Krka than prescribed
It is important to take the medicine exactly as prescribed by the doctor.
If the patient or someone else has swallowed several tablets, or if it is suspected that a child may have swallowed any of the tablets, contact a doctor, pharmacist, or the emergency department of the nearest hospital immediately. Bring any remaining tablets or the packaging along, as this will help identify the medicine. Symptoms of overdose may include nausea, vomiting, diarrhea, and transient hearing loss.
Missed dose of Azithromycin Krka
Do not take a double dose to make up for a missed dose. If the patient forgets to take a dose, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken at the usual time.
Stopping Azithromycin Krka treatment prematurely
Do not stop taking the medicine early.
Even if the patient feels better, it is important to continue taking the tablets for as long as prescribed by the doctor.
If there are any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate in severity and resolve after discontinuation of the medicine.
If any of the symptoms listed below occur, stop taking the medicine immediately and contact your doctor or the emergency department of your nearest hospital without delay. 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 (serious skin rash) and other severe rashes, which may include blisters or peeling (toxic epidermal necrolysis);
• severe, persistent diarrhoea, especially if blood or mucus is present in the stool (this may be a sign of an inflammatory bowel disease called pseudomembranous colitis).

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

• diarrhoea.

Common (may affect less than 1 in 10 people):

• headache;
• vomiting, abdominal pain, nausea;
• changes in white blood cell count;
• changes in results of other blood tests (decreased blood bicarbonate levels).

Uncommon (may affect less than 1 in 100 people):

• fungal infections (candidiasis) – oral or vaginal thrush;
• pneumonia, bacterial throat infection, gastrointestinal infection, breathing disorders, nasal mucosal inflammation (rhinitis);
• changes in white blood cell count (leukopenia, neutropenia, eosinophilia);
• eyelid, facial or lip swelling (angioedema), allergic reactions;
• loss of appetite (anorexia);
• nervousness, sleep problems (insomnia);
• dizziness, drowsiness, taste disturbance, tingling, prickling or numbness sensations (paraesthesiae);
• visual disturbances;
• ear disorders, sensation of spinning (vertigo);
• palpitations;
• hot flushes;
• sudden shortness of breath, nosebleeds;
• constipation, flatulence, indigestion, inflammation of the stomach lining (gastritis), difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, excessive salivation;
• skin rash, itchy rash (urticaria), skin inflammation, dry skin, excessive sweating;
• bone and joint inflammation, muscle, back and neck pain;
• difficulty or pain during urination, kidney pain;
• irregular vaginal bleeding, testicular disorders;
• swelling, weakness, general malaise, facial swelling, chest pain, fever, pain, peripheral oedema;
• abnormal laboratory test results (e.g. blood tests and liver function tests).

Rare (may affect less than 1 in 1,000 people):

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

Very rare (may affect less than 1 in 10,000 people):

• drug rash with eosinophilia and systemic symptoms (DRESS syndrome), including fever, swollen lymph nodes and increased levels of a certain type of white blood cells.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
­ intestinal inflammation (pseudomembranous colitis);
­ decreased number of red blood cells (haemolytic anaemia), decreased platelet count;
­ hypersensitivity reactions (anaphylactic reaction);
­ feelings of aggression, anxiety, severe confusion, hallucinations;
­ fainting;
­ seizures;
­ reduced skin sensitivity to touch;
­ excessive activity;
­ disturbances in smell;
­ loss of smell or taste;
­ muscle weakness (myasthenia);
­ life-threatening heart rhythm disorders (torsade de pointes), abnormal ECG (prolonged QT interval);
­ hearing disorders, including deafness or tinnitus;
­ low blood pressure;
­ pancreatitis;
­ tongue discoloration;
­ liver disorders (liver failure, rarely fatal, liver necrosis), hepatitis;
­ severe allergic skin reactions (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome);
­ joint pain (arthritis);
­ acute kidney failure and interstitial nephritis.

Adverse reactions possibly or probably related to the use of azithromycin for the prevention and treatment of Mycobacterium avium complex infection
Very common (may affect more than 1 in 10 people):

• diarrhoea;
• abdominal pain, nausea;
• bloating;
• discomfort in the abdominal cavity;
• loose stools.

Common (may affect less than 1 in 10 people):

• anorexia;
• dizziness;
• headache;
• tingling, prickling or numbness sensations (paraesthesiae);
• taste disturbances;
• visual disturbances;
• deafness;
• rash, itching;
• joint pain (arthritis);
• feeling of fatigue.

Uncommon (may affect less than 1 in 100 people):

• reduced sensitivity to touch (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• severe allergic skin reactions;
• increased skin sensitivity to sunlight;
• weakness;
• malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 4921301
Fax: +48 22 4921309
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 this medicine.

5. How to store Azithromycin Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box following: EXP. The expiry date refers to the last day of the stated month. The batch number is indicated on the packaging by the abbreviation "Lot".
No special storage instructions are required for this medicine.
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 Azithromycin Krka contains

• The active substance 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.

The other ingredients are:
tablet core: microcrystalline cellulose, pregelatinized potato 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 5 cP, titanium dioxide (E 171),
polyethylene glycol 400]
coating of the 500 mg tablet: Opadry QX321A180025 White [grafted copolymer of polyethylene glycol and polyvinyl alcohol, titanium dioxide (E 171), talc, glycerol monocaprylocapronate, polyvinyl alcohol]

See section 2, "Azithromycin Krka contains sodium".

What Azithromycin Krka looks like and contents of the pack
250 mg: white or almost white, capsule-shaped film-coated tablets (length: 13.8–14.2 mm,
width: 6.3–6.7 mm), marked “S19” on one side and smooth on the other; the pack contains 4 or 6 film-coated tablets.
500 mg: white or almost white, capsule-shaped film-coated tablets (length: 16.7–17.3 mm,
width: 8.2–8.8 mm), marked “S5” on one side and smooth on the other; the pack contains 2, 3 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation Holder:
KRKA - Polska Sp. z o.o.,
ul. Równoległa 5,
02-235 Warszawa,
Poland
Tel.: 22 57 37 500