Clarithromycin Krka 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clarithromycin Krka 500 mg film-coated tablets EFG

Read the 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 only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Clarithromycin belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria that cause infections.

Clarithromycin is used in the treatment of the following infections:

• Respiratory tract infections, such as bronchitis and pneumonia.
• Throat infections and sinusitis.
• Skin and tissue infections.
• Infections caused by Helicobacter pylori associated with duodenal ulcer.

2. What you need to know before taking Clarithromycin Krka

Do not take Clarithromycin Krka

• If you are allergic to clarithromycin or to other macrolide antibiotics (such as erythromycin or azithromycin), or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called ergot alkaloids, for example ergotamine tablets or dihydroergotamine, or using ergotamine inhalers for migraine. Consult your doctor about other treatment options.
• If you are taking medicines called simvastatin or lovastatin (known as statins, used to reduce blood lipids such as cholesterol or triglycerides).
• If you are taking a medicine containing lomitapide.
• If you are taking medicines called terfenadine or astemizole (commonly used to treat hay fever or allergies), or cisapride or domperidone (to treat stomach disorders), or pimozide (to treat mental disorders), as combining these medicines may occasionally cause serious disturbances in the heart's rhythm. Consult your doctor about other treatment options.
• If you are taking other medicines known to cause serious disturbances in the heart's rhythm.
• If you are taking medicines called ticagrelor, ivabradine, or ranolazine (for angina or to prevent stroke or heart attack).
• If you are taking a medicine called colchicine (for gout).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
• If you are taking midazolam orally (a sedative).
• If you have any liver or kidney problems.
• If you or a family member has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsade de pointes) or an abnormality on the electrocardiogram (ECG, electrical recording of the heart) called "long QT syndrome".

Clarithromycin Krka 500 mg film-coated tablets EFG is not suitable for children under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clarithromycin Krka:

• if you have heart problems;
• if you are pregnant or breastfeeding;
• if you require intravenous midazolam.

Inform your doctor immediately if you experience severe or persistent diarrhoea during or after taking Clarithromycin Krka, as this may be a symptom of a more serious condition such as pseudomembranous colitis or Clostridium difficile-associated diarrhoea.

Stop taking Clarithromycin Krka and inform your doctor immediately if you develop any symptoms of liver dysfunction such as anorexia (loss of appetite), yellowing of the skin or whites of the eyes, dark urine, itching, or abdominal pain.

If you have kidney problems, consult your doctor before taking Clarithromycin Krka.

Prolonged use of Clarithromycin Krka may lead to infections resistant to bacteria and fungi.

Children and adolescents

Clarithromycin Krka is not suitable for children under 12 years of age.

Other medicines and Clarithromycin Krka

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

This is especially important if you are taking medicines called:

• digoxin, quinidine, or disopyramide (medicines for treating various heart conditions). Your heart may need to be monitored (ECG), or you may need blood tests if you take clarithromycin with any medicine used for heart problems.
• warfarin, or any other anticoagulant such as dabigatran, rivaroxaban, apixaban, or edoxaban (used to make blood less likely to clot). Blood tests may be needed to check that your blood clots properly.
• omeprazole (a medicine for treating indigestion and stomach ulcers), unless prescribed by your doctor for the treatment of Helicobacter pylori infection associated with duodenal ulcer.
• ergot alkaloids such as ergotamine or dihydroergotamine (medicines for treating migraine).
• colchicine (a medicine for treating gout). Your doctor may wish to monitor you.
• theophylline (a medicine for treating respiratory problems such as asthma).
• terfenadine or astemizole (medicines for treating hay fever or allergies).
• triazolam, alprazolam, or intravenous or oromucosal midazolam (sedatives).
• cilostazol (a medicine for treating poor blood circulation).
• cisapride, domperidone, or cimetidine (medicines for treating digestive problems).
• carbamazepine, valproate, phenytoin, or phenobarbital (medicines for treating epilepsy).
• methylprednisolone (a corticosteroid).
• vinblastine (a medicine for treating cancer).
• cyclosporine, tacrolimus, or sirolimus (immunosuppressants used for organ transplantation and severe eczema).
• pimozide or St. John’s wort (hypericum) (medicines for treating mental health problems).
• rifabutin, rifampicin, rifapentine, fluconazole, or itraconazole (medicines used to treat certain infectious diseases).
• verapamil, amlodipine, or diltiazem (a medicine for treating high blood pressure).
• tolterodine (a medicine for treating overactive bladder).
• simvastatin or lovastatin (medicines known as HMG-CoA reductase inhibitors, used to treat hypercholesterolaemia).
• ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, etravirine, and zidovudine (antiviral or anti-HIV medicines).
• sildenafil, vardenafil, and tadalafil (for treating erectile dysfunction in adult men or for treating pulmonary arterial hypertension —high blood pressure in the blood vessels of the lungs—).
• insulin, repaglinide, rosiglitazone, pioglitazone, or nateglinide (medicines for treating diabetes).
• aminoglycosides (a type of antibiotic) such as gentamicin, streptomycin, tobramycin, amikacin, or netilmicin.

It is also important if you are taking medicines called:

• hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse effects affecting the heart.
• corticosteroids, administered orally, by injection, or by inhalation to suppress the immune system; this is useful in the treatment of a wide range of diseases.

Inform your doctor if you are taking oral contraceptive pills and experience diarrhoea or vomiting, as you may need to take additional contraceptive precautions, such as using a condom.

Taking Clarithromycin Krka with food and drink

Clarithromycin Krka may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. The safety of clarithromycin during pregnancy and breastfeeding has not been established. Therefore, its use is not recommended during pregnancy and breastfeeding without carefully weighing the benefits against the risks. Clarithromycin is excreted in breast milk.

Driving and using machines

Clarithromycin Krka may cause dizziness, vertigo, confusion, and disorientation. Do not drive or operate machinery if you experience these symptoms.

Clarithromycin Krka contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit; i.e., essentially "sodium-free".

3. How to take Clarithromycin Krka

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

For respiratory tract, skin and soft tissue infections:

The usual dose of Clarithromycin Krka film-coated tablets for adults and adolescents over 12 years of age is 250 mg twice daily for 6–14 days, e.g., one tablet of Clarithromycin Krka 250 mg in the morning and another in the early evening. Your doctor may increase the dose in more severe infections to Clarithromycin Krka 500 mg tablets, twice daily.

Clarithromycin Krka tablets should be taken with at least half a glass of water.

For the treatment of Helicobacter pylori infections associated with duodenal ulcers:

There are several effective combination therapies available for the treatment of Helicobacter pylori in which Clarithromycin Krka tablets are taken together with one or two other medicines.

These combinations include:

1. one tablet of Clarithromycin Krka 500 mg twice daily, together with 1000 mg of amoxicillin twice daily, and 30 mg of lansoprazole twice daily.
2. one tablet of Clarithromycin Krka 500 mg twice daily, together with 30 mg of lansoprazole twice daily, plus 400 mg of metronidazole twice daily.
3. one tablet of Clarithromycin Krka 500 mg twice daily, together with 1000 mg of amoxicillin twice daily, or 400 mg of metronidazole twice daily, plus omeprazole 40 mg once daily.
4. one tablet of Clarithromycin Krka 500 mg twice daily, together with 1000 mg of amoxicillin twice daily, plus omeprazole 20 mg once daily.
5. one tablet of Clarithromycin Krka 500 mg three times daily, together with omeprazole 40 mg once daily.

Depending on the dosage regimen, other medicines may be more suitable. Your doctor will advise you on the most appropriate medicine for your treatment.

The combination therapy you receive may differ slightly from those listed above. Your doctor will decide which combination therapy is most suitable for you. If you are unsure about which tablets you should take or for how long, please consult your doctor.

Patients with kidney problems:

If you have severe kidney problems, your doctor may need to reduce your dose by half, i.e., once daily, and limit treatment to a maximum of 14 days.

Use in children and adolescents

Do not give these tablets to children under 12 years of age. Your doctor will prescribe another medicine appropriate for these children.

If you take more Clarithromycin Krka than you should

If you have accidentally taken more tablets in one day than your doctor has prescribed, or if a child accidentally swallows several tablets, contact your doctor or nearest emergency department immediately.

Overdose may cause stomach pain and vomiting.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Clarithromycin Krka

If you forget to take a dose of clarithromycin, take it as soon as you remember. Do not take more tablets in one day than your doctor has prescribed. Do not take a double dose to make up for a missed dose.

If you stop taking Clarithromycin Krka

Do not stop taking your medicine just because you feel better. If you stop taking clarithromycin too early, not all the bacteria causing the infection may have been eliminated, and the infection could return.

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

4. Possible adverse effects

Like all medicines, clarithromycin can cause adverse effects, although not everyone experiences them.

If any of the following occur during treatment, stop taking these tablets immediately and contact your doctor:

• Severe or prolonged diarrhoea, which may contain blood or mucus. Diarrhoea may occur up to two months after treatment with clarithromycin, in which case you should continue to consult your doctor.
• Skin rash, difficulty breathing, fainting, or swelling of the face and throat. These are signs of an allergic reaction.
• Yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, abdominal tenderness, or loss of appetite. These may be signs that the liver is not functioning properly.
• Serious skin reactions such as blistering of the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis). A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis); the frequency of this adverse effect is considered unknown (cannot be estimated from available data). Rare skin allergic reactions causing serious illness with mouth, lip, and skin ulcers, leading to severe illness with skin rash, fever, and inflammation of internal organs (DRESS).
• Muscle pain or weakness, known as rhabdomyolysis (a condition causing breakdown of muscle tissue that may result in kidney damage).

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

• Difficulty sleeping (insomnia);
• Changes in taste sensation;
• Headache;
• Stomach problems such as nausea, vomiting, stomach pain, indigestion, or diarrhoea;
• Abnormal blood test results for liver function;
• Skin rash, excessive sweating, redness.

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

• Fungal infections of the skin or vagina (candidiasis);
• Changes in white blood cell count (which may make infections more likely);
• Changes in blood platelet levels (increased risk of bruising, bleeding, or blood clots);
• Allergic reactions;
• Loss of appetite;
• Anxiety, nervousness, screaming;
• Fainting, dizziness, drowsiness, tremor, involuntary movements of the tongue, face, lips, or limbs;
• Sensation of spinning (vertigo), ringing in the ears, hearing loss;
• Strong and rapid heartbeat (palpitations), changes in heart rhythm, or cardiac arrest;
• Breathing problems (asthma), nosebleeds;
• Blood clot in the lungs;
• Stomach problems such as bloating, constipation, gas (flatulence), burping, heartburn, or anal pain;
• Inflammation of the stomach or oesophagus wall (the tube connecting the mouth to the stomach);
• Mouth pain, dry mouth, tongue inflammation;
• Liver problems such as hepatitis or cholestasis, which may cause yellowing of the skin (jaundice), pale stools, or dark urine;
• Increased liver enzymes;
• Itching, hives, skin inflammation;
• Stiffness, aches, or spasms in muscles;
• Kidney problems such as elevated levels of protein normally excreted by the kidneys or elevated levels of renal enzymes;
• Fever, chills, weakness, fatigue, chest pain, or general feeling of being unwell;
• Abnormal blood test results.

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

• Colon infection;
• Skin infection;
• Psychotic disorder, confusion, changes in sense of reality, depression, loss of orientation (disorientation), hallucinations (seeing things), abnormal dreams (nightmares), manic episodes;
• Seizures;
• Change or loss of taste and/or smell;
• Paraesthesia (tingling and burning sensations in the skin, numbness, prickling);
• Deafness;
• Bleeding;
• Type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia);
• Inflammation of the pancreas;
• Discoloration of the tongue, discoloration of teeth;
• Liver failure, jaundice (yellowing of the skin);
• Rare allergic skin reactions, such as DRESS syndrome (causing serious illness with skin rash, fever, and inflammation of internal organs);
• Acne;
• Muscle disease (myopathy);
• Kidney inflammation (which may cause swelling of the ankles or high blood pressure) or kidney failure.

Contact your doctor immediately if you experience any of these conditions or any unexpected or unusual symptoms.

Reporting of adverse effects

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

5. Storage of Clarithromycin 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. Instead, dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clarithromycin Krka

• The active substance is clarithromycin. Each film-coated tablet contains 500 mg of clarithromycin.
• The other components are microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate, talc and stearic acid in the tablet core, and titanium dioxide (E171), hypromellose, hydroxypropylcellulose, iron oxide yellow (E172) and propylene glycol in the coating. See section 2 "Clarithromycin Krka contains sodium".

Appearance of the product and contents of the pack

Oval, biconvex, slightly yellowish-brown film-coated tablets, 19.5 to 19.8 mm long and 10 mm wide.

Clarithromycin Krka 500 mg is available in blister packs containing 7, 10, 14, 16, 20 or 21 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

or

TAD Pharma GmbH,
Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany

You can request further information about this medicinal product from 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 last revision of this leaflet: April 2024

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