国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Clarithromycin
Sun Pharmaceutical Industries Europe B.V.
J01FA; J01FA09
Clarithromycin
500 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Macrolides; clarithromycin
Marketed
2006-10-20
V047 PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITHROMYCIN 500 MG FILM-COATED TABLETS 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 Film-Coated Tablets are and what they are used for 2. What you need to know before you take Clarithromycin Film-Coated Tablets 3. How to take Clarithromycin Film-Coated Tablets 4. Possible side effects 5. How to store Clarithromycin Film-Coated Tablets 6. Contents of the pack and other information _ _ 1. WHAT CLARITHROMYCIN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Clarithromycin Film-Coated Tablets contains the active ingredient clarithromycin, which is an macrolide antibiotic which stop the growth of bacteria which cause infections. Clarithromycin Film-Coated Tablets is indicated for use in adults and adolescents over 12 years of age for the treatment of infections caused by micro-organisms sensitive to clarithromycin. These infections include: • Upper respiratory tract infections (e.g. pharyngitis, sinusitis) • Lower respiratory tract infections (e.g. bronchitis, pneumonia) • Acute otitis media • Skin and soft tissue infections (e.g. impetigo, folliculitis, cellulitis, abscesses) • Disseminated or localised mycobacterial infections In HIV-infected patients (CD4 cell count ≤100/mm3), Clarithromycin is indicated for the prevention of disseminated infections caused by the Mycobacterium avium (MAC) complex. In patients with duodenal ulceration and diagnostically confirmed Helicobacter pylori infection, clarithromycin treatm 完全なドキュメントを読む
Health Products Regulatory Authority 28 October 2022 CRN00CVZ4 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clarithromycin 500 mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet Light yellow coloured, oval shaped biconvex film coated tablets, with “C” and “2” embossed on either side of a breakline on one side and notched on both sides. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Consideration should be given to official guidance on the appropriate use of antibacterial agents. Clarithromycin is indicated for use in adults and adolescents older than 12 years for the treatment of infections caused by micro-organisms sensitive to clarithromycin. These infections include: Lower respiratory tract infections for example bronchitis, and pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing). Upper respiratory tract infections for example sinusitis and pharyngitis. Acute otitis media Skin and soft tissue infections (e.g. impetigo, folliculitis, cellulitis, abscesses) (see section 4.4 and 5.1 regarding Sensitivity Testing) Disseminated or localised _Mycobacterium avium _or _Mycobacterium intracellulare_ infections; localised _Mycobacterium chelonae_, _Mycobacterium fortuitum _or _Mycobacterium kansasii_ infections. In HIV-infected patients (CD4 cell count ≤100 / mm 3 ), clarithromycin is indicated for the prevention of disseminated infections caused by the _Mycobacterium avium_ (MAC) complex. In patients with duodenal ulceration and diagnostically confirmed _Helicobacter pylori _infection, clarithromycin treatment is recommended simultaneously with preparations that suppress gastric acid secretion and other antibiotics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage Patients with respiratory tract, skin and soft tissue and acute otitis media infectio 完全なドキュメントを読む