国: マルタ
言語: 英語
ソース: Medicines Authority
CLARITHROMYCIN
Thrive Pharma LTD 12 Nikolay Haytov Str., fl.5, office 19, Sofia, 1113 , Bulgaria
J01FA09
CLARITHROMYCIN 250 mg
FILM-COATED TABLET
CLARITHROMYCIN 250 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2017-03-15
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITHROMYCIN 250MG FILM-COATED TABLETS CLARITHROMYCIN 500MGFILM-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 TABLET SIS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS 3.HOW TO TAKE CLARITHROMYCIN TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLARITHROMYCIN TABLETS 6.CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CLARITHROMYCIN TABLETS IS AND WHAT IT IS USED FOR This medicine contains clarithromycin. Clarithromycin belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. Clarithromycin tablets are used in adults and children 12 years and older to treat infections such as: - Bacterial pharyngitis - Mild to moderate community acquired pneumonia - Acute bacterial sinusitis (adequately diagnosed) - Acute exacerbation of chronic bronchitis - Skin infections and soft tissue infections of mild to moderate severity Clarithromycin tablets are also used to treat Helicobacter pylori associated ulcers in adults ( in appropriate combination with antibacterial therapeutic regimens and appropriate ulcer healing agent) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS DO NOT TAKE CLARITHROMYCIN TABLETS IF YOU • are ALLERGIC to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in sectio 完全なドキュメントを読む
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin 250mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clarithromycin Tablets contain 250 mg of clarithromycin. Excipient(s) with known effect: Each film coated tablet contains 7.2mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral film-coated tablet White, oblong, biconvex film-coated tablets of approximately 15mm length, and 6mm width with ‘K’ and ‘250’ debossed on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin film-coated tablets are indicated for the treatment of the following bacterial infections in adults and children 12 years and older, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1). • Bacterial pharyngitis • Mild to moderate community acquired pneumonia • Acute bacterial sinusitis (adequately diagnosed) • Acute exacerbation of chronic bronchitis • Skin infections and soft tissue infections of mild to moderate severity Clarithromycin film-coated tablets are also indicated for the eradication of Helicobacter pylori in adult patients with Helicobacter pylori associated ulcers, in appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing agent (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 Page 2 of 18 The dosage of clarithromycin film-coated tablets depends on the clinical condition of the patient and has to be defined in any case by the physician. _Children older than 12 years and adults: _ • Standard dosage: The usual dose is 250 mg twice daily. • High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, 完全なドキュメントを読む