Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Clarithromycin
Teva Pharma B.V.
J01FA; J01FA09
Clarithromycin
250 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Macrolides; clarithromycin
Marketed
2012-05-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITHROMYCIN TEVA 250 MG FILM-COATED TABLETS CLARITHROMYCIN TEVA 500 MG FILM-COATED TABLETS clarithromycin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Clarithromycin Teva is and what it is used for 2. What you need to know before you take Clarithromycin Teva 3. How to take Clarithromycin Teva 4. Possible side effects 5. How to store Clarithromycin Teva 6. Contents of the pack and other information 1. WHAT CLARITHROMYCIN TEVA IS AND WHAT IT IS USED FOR Clarithromycin Teva belongs to a group of drugs called macrolide antibiotics. Clarithromycin Teva is used in the treatment of the following infections: - bronchitis and pneumonia - throat and sinus infections: sinusitis and pharyngitis - skin and soft tissue infections _- _ _Helicobacter pylori_ infection associated with duodenal ulcer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TEVA DO NOT TAKE CLARITHROMYCIN TEVA - if you are allergic to clarithromycin, to other macrolide antibiotics (e.g. erythromycin, azithromycin) or to any of the other ingredients of this medicine (listed in section 6). - if you are taking any of the following medicines: - astemizole or terfenadine (for hay fever or allergies), cisapride or domperidone (for stomach disorders) or pimozide (to treat certain psychiatric diseases) as taking these medicines with Clarithromycine Teva can cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines. - other medicines which are known Les hele dokumentet
Health Products Regulatory Authority 01 February 2023 CRN00CLGP Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin Teva 250 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg clarithromycin. Excipients with known effect Each film-coated tablet contains 0.30 mg tartrazine aluminium lake (E102) and 0.008 mg allura red aluminium lake (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, film-coated oval shaped tablet, debossed with "93" on one side and "7157" on the other. Length: 17 mm Width: 8 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin Teva is indicated in adults and adolescents 12 years and older for the treatment of the following infections caused by susceptible organisms: - Bacterial pharyngitis - Acute bacterial sinusitis (adequately diagnosed) - Acute exacerbation of chronic bronchitis - Community-acquired pneumonia - Skin and soft tissue infections (mild to moderate severity) In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer-healing agent for the eradication of _H. pylori_ in patients with _H. pylori_-associated ulcers. See section 4.2. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the physician. 250 mg and 500 mg tablets are available. POSOLOGY Adults and adolescents (12 years and older) The recommended dose is 250 mg twice daily. In severe infections, the dose may be increased to 500 mg twice daily. Paediatric population Clarithromycin tablets are not suitable for children under 12 years of age weighing less than 30 kg. Other pharmaceutical forms are more adapted for these patients. Elderly people As for adults. Health Products Regulatory Authority 01 February 2023 CRN00CLGP Page 2 o Les hele dokumentet