Azithromycin Krka 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Azithromycin Krka 500 mg Film-coated Tablets EFG

Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Azithromycin Krka is and what it is used for
2. What you need to know before taking Azithromycin Krka
3. How to take Azithromycin Krka
4. Possible side effects
5. Storage of Azithromycin Krka
6. Contents of the pack and other information

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

Azithromycin, the active substance in Azithromycin Krka, belongs to a group of medicines called macrolide antibiotics.

Antibiotics are used to treat bacterial infections and are not effective against viral infections, such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or with household waste.

It is used to treat a number of infections including:

• acute bacterial infections of the sinuses
• acute bacterial infections of the ears
• tonsillitis, pharyngitis
• acute bacterial exacerbation of chronic bronchitis
• mild to moderate pneumonia
• mild to moderate infections of the skin and soft tissues, e.g. folliculitis, cellulitis, erysipelas
• urinary tract infections originating in the bladder (urethra) or cervix caused by a bacterium called Chlamydia trachomatis.

2. What you need to know before starting to take Azithromycin Krka

Do not take Azithromycin:

• if you are allergic to azithromycin or to other macrolide antibiotics (such as erythromycin or clarithromycin) or ketolides, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Azithromycin:

• if you have severe liver problems: your doctor may need to monitor your liver function or discontinue treatment;
• if you have certain heart conditions (e.g. serious heart problems, "prolongation of the QT interval") or if you are taking medicines that cause disturbances in the electrical activity of your heart, such as cisapride (used to increase intestinal movement) or hydroxychloroquine or chloroquine (used in the treatment of malaria);
• if you have irregular or slow heartbeat;
• if you have abnormal electrolyte levels in your blood, especially low levels of potassium and magnesium;
• if you are taking other medicines that cause abnormal changes in the ECG (see section "Other medicines and Azithromycin Krka");
• if you are being treated with ergot derivatives (see section "Other medicines and Azithromycin Krka"), as these medicines must not be taken together with azithromycin;
• if you have severe kidney problems;
• if you have myasthenia gravis (localized muscle weakness);
• if you have neurological or psychiatric conditions.

During treatment, inform your doctor immediately:

• if you experience severe hypersensitivity reactions with difficulty breathing, dizziness, swelling of the face or throat, skin rash, redness, burning sensation (sometimes fatal). If these symptoms occur, stop taking azithromycin and contact your doctor immediately.
• if you notice signs of liver problems during treatment (such as dark urine, severe loss of appetite, or yellowing of the skin or whites of the eyes): Stop taking this medicine and seek urgent medical advice.
• if you develop diarrhoea, which may be a sign of severe intestinal inflammation. If you have watery or bloody diarrhoea, call your doctor. Do not take any medicine to stop the diarrhoea unless instructed by your doctor.
• if you feel your heart beating in your chest or experience an abnormal heartbeat, feel dizzy or faint, or suffer muscle weakness while taking azithromycin.
• if you develop a new infection (which may be a sign of excessive growth of resistant microorganisms);

Children and adolescents

Azithromycin film-coated tablets are not suitable for infants and young children (under 2 years of age) and adolescents and children (up to 17 years of age) with a body weight below 45 kg.

Information on the administration of azithromycin in children and adolescents weighing 45 kg or more can be found in section 3 "How to take Azithromycin Krka".

Other medicines and Azithromycin Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor or pharmacist if you are taking:

• Medicines known as ergot derivatives, e.g. ergotamine or dihydroergotamine (medicines used for migraine or to reduce blood flow), as these medicines must not be taken simultaneously with azithromycin;
• Cyclosporine (a medicine used for skin conditions, rheumatoid arthritis, or after organ transplants);
• Atorvastatin (for treating high cholesterol levels in the blood);
• Cisapride (used to treat stomach problems);
• Theophylline (for respiratory problems);
• Warfarin or other medicines to thin your blood;
• Digoxin (for heart problems);
• Colchicine (used for gout and familial Mediterranean fever);
• Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections);
• Rifabutin (for HIV infections or treatment of tuberculosis);
• Terfenadine (a medicine used to treat allergies);
• Fluconazole (to treat fungal infections);
• Medicines known as antacids (medicines that neutralize stomach acid). Your azithromycin tablets should be taken at least one hour before or two hours after taking antacids.
• Astemizole (a medicine used to treat allergies), alfentanil (a painkiller);
• Hydroxychloroquine and chloroquine (for the treatment of malaria).

Use of Azithromycin with food and alcohol

The tablets should be taken with water.

You may take your medicine with or without food, as it does not affect the absorption of azithromycin.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy or breastfeeding unless discussed with your doctor.

Driving and using machines

This medicine may make you feel dizzy. If you feel dizzy, do not drive or operate any tools or machinery.

Azithromycin Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to take Azithromycin Krka

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For adults and children and adolescents with a body weight of 45 kg or more:

Children and adolescents weighing less than 45 kg:

The tablets are not recommended. Children and adolescents weighing less than 45 kg should use other pharmaceutical forms of medications containing azithromycin.

Patients with renal or hepatic impairment:

You must inform your doctor if you have kidney or liver problems, as the doctor may need to adjust the usual dose.

Dosing for elderly patients:

The same dose as for adults applies to elderly patients.

Administration:

Swallow the film-coated tablets without chewing, with a little water.

You may take your medication with or without food, as this does not affect the absorption of azithromycin.

If you take more Azithromycin than you should

It is important that you follow the dose prescribed by your doctor. If you or someone else takes several tablets together, or if you think a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. Always carry some tablets with you, as well as the outer carton, since this will allow easier identification of the medication. Symptoms of an overdose may include severe nausea, vomiting, diarrhea, and reversible hearing loss.

If you forget to take Azithromycin

Do not take a double dose to make up for a missed dose. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.

If you stop Azithromycin treatment early

Do not interrupt the treatment prematurely.

It is important that you continue taking your tablets for the length of time prescribed by your doctor, even if you start to feel better.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. These are usually mild to moderate and resolve when treatment is stopped.

If you experience any of the following symptoms of a serious allergic reaction, stop taking your tablets and contact your doctor immediately or go to the nearest emergency department:

• low blood pressure, rapid or irregular heartbeat (anaphylactic reaction);
• swelling of the hands, feet, ankles, face, lips, mouth or throat (angioedema);
• difficulty swallowing or breathing;
• severe skin reactions including Stevens-Johnson syndrome (a serious skin rash) and other serious skin rashes which may include blisters or peeling (toxic epidermal necrolysis).

If you experience any of the following adverse effects, contact your doctor as soon as possible:

• severe, prolonged diarrhoea, especially if it contains blood or mucus (this may be pseudomembranous colitis, an inflammation of the intestine);
• dark urine, profound loss of appetite, or yellowing of the skin or whites of the eyes, which are signs of liver problems (liver failure, rarely resulting in death, hepatic necrosis), inflammation of the liver (hepatitis).

These are all serious adverse effects. You may require urgent medical attention. Serious adverse effects are uncommon (may affect up to 1 in 100 people), or the frequency cannot be estimated from the available data.

Other reported adverse effects are:

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

• diarrhoea

Common (may affect up to 1 in 10 people)

• headache
• feeling sick (vomiting), abdominal pain, feeling unwell (nausea)
• changes in white blood cell count
• changes in other blood parameters (decreased blood bicarbonate)

Uncommon (may affect up to 1 in 100 people)

• mouth or vaginal thrush (candidiasis) – a fungal infection of the mouth and vagina
• pneumonia, bacterial throat infection, gastrointestinal tract inflammation, respiratory disorder, inflammation of the mucous membrane inside the nose
• changes in white blood cells (leucopenia, neutropenia, eosinophilia)
• allergic reactions
• loss of appetite (anorexia)
• nervousness, difficulty sleeping (insomnia)
• dizziness, drowsiness, altered sense of taste (dysgeusia), tingling or numbness sensation (paraesthesia)
• visual disturbances
• deafness, vertigo
• awareness of your heartbeat (palpitations)
• hot flushes
• sudden wheezing, nosebleeds
• constipation, gas, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, release of gas from the stomach (belching), mouth ulceration, increased salivation
• rash, itching, urticaria, dermatitis, dry skin, abnormal increase in sweating (hyperhidrosis)
• degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
• difficulty urinating (dysuria), kidney pain
• irregular uterine bleeding (metrorrhagia), testicular disorder
• oedema, weakness, general malaise, facial oedema, chest pain, fever, pain, peripheral oedema
• abnormal laboratory test results (e.g. blood or liver tests)

Rare (may affect up to 1 in 1,000 people)

• feeling irritable
• abnormal liver function, yellowing of the skin or eyes
• allergic skin reactions such as photosensitivity
• skin rash characterised by the sudden appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid)
• skin rash with eosinophilia (increase in a type of white blood cells) and systemic symptoms such as fever or swollen lymph nodes (DRESS syndrome)

Not known (cannot be estimated from available data)

• reduced number of red blood cells due to increased cell breakdown (haemolytic anaemia), reduced platelet count
• feeling angry, aggressive, fear and worry (anxiety), acute confusional state (delirium), hallucinations
• fainting (syncope)
• seizures (convulsions)
• reduced sense of touch (hypoesthesia)
• feeling hyperactive
• change in sense of smell (anosmia, parosmia)
• loss of sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• life-threatening irregular heartbeat (arrhythmia, torsades de pointes), abnormal ECG trace (prolongation of QT interval)
• hearing problems including deafness or ringing in the ears
• low blood pressure
• inflammation of the pancreas (pancreatitis)
• change in the colour of your tongue
• joint pain (arthralgia)
• inflammation of the kidney (interstitial nephritis) and kidney failure

Adverse reactions possibly or probably related to prophylaxis and treatment of Mycobacterium Avium complex (MAC):

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

• diarrhoea
• abdominal pain
• feeling unwell (nausea)
• flatulence
• abdominal distension
• loose stools

Common (may affect up to 1 in 10 people)

• loss of appetite (anorexia)
• dizziness
• headache
• tingling or numbness sensation (paraesthesia)
• altered sense of taste (dysgeusia)
• visual disturbances
• deafness
• skin rash, itching
• joint pain (arthralgia)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• reduced sense of touch (hypoesthesia)
• hearing impairment, ringing in the ears
• awareness of your heartbeat (palpitations)
• inflammation of the liver (hepatitis)
• severe skin allergic reactions (Stevens-Johnson syndrome)
• skin more sensitive than normal to sunlight
• weakness
• general feeling of malaise

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Azithromycin

• The active substance is azithromycin.

Each film-coated tablet contains 500 mg of azithromycin (as azithromycin dihydrate).

• The other components (excipients) are microcrystalline cellulose (E460), pregelatinized potato starch, sodium lauryl sulfate, hypromellose (E464), sodium croscarmellose (E468), colloidal anhydrous silica (E551), and magnesium stearate (E470b) in the tablet core; and graft copolymer of polyethylene glycol and poly(vinyl alcohol), titanium dioxide (E171), talc, glycerol monocaprylocaprate, and poly(vinyl alcohol) in the film coating. See section 2 “Azithromycin Krka contains sodium”.

Appearance of the product and contents of the pack

The film-coated tablets are white or almost white, capsule-shaped (length: 16.7–17.3 mm, width: 8.2–8.8 mm), marked with "S5" on one side and scored on the other. The tablet can be divided into equal doses.

Boxes containing 2, 3 and 30 film-coated tablets in blisters are available.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer responsible

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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: August 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/