Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Actavis Group PTC ehf
J01FA09
CLARITHROMYCIN
500 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Macrolides
Authorised
2011-01-07
Clarithromycin 250mg and 500mg Film-coated Tablets PIL - Ireland item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAJ2123 2 09.08.16 DR 22.08.16 S.Anson IL/Medochemie 155x300 7 pt 09.08.16 22.08.16 Package leaflet: Information for the user CLARITHROMYCIN ACTAVIS 250 MG AND 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 further questions, ask your doctor or your 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 ACTAVIS IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN ACTAVIS 3 HOW TO TAKE CLARITHROMYCIN ACTAVIS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE CLARITHROMYCIN ACTAVIS 6 CONTENTS OF THE PACK AND FURTHER INFORMATION 1 WHAT CLARITHROMYCIN ACTAVIS IS AND WHAT IT IS USED FOR Clarithromycin is an antibiotic belonging to a group called the macrolides. Antibiotics stop the growth of bacteria which cause infections. Clarithromycin Actavis is used to treat infections such as: • Chest infections such as bronchitis and pneumonia • Throat and sinus infections • Skin and tissue infections • Mycobacterial infections • _Helicobacter pylori _infection associated with duodenal ulcer. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE C Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin Actavis 500mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains Clarithromycin 500mg Excipients with known effect: Contains 0.22mg glucose per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Yellow, oval-shaped film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Consideration should be given to official guidance on the appropriate use of antibacterial agents. Clarithromycin is indicated in adults and children 12 years and older. Clarithromycin Actavis is indicated in the treatment of infections due to susceptible organisms. Such infections include: 1. Lower respiratory tract infections (e.g. bronchitis, pneumonia). 2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis). 3. Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas). 4. Disseminated or localised mycobacterial infections due to_ Mycobacterium avium_ or_ Mycobacterium_ _intracellulare_. Localised infections due to_ Mycobacterium chelonae_,_ Mycobacterium fortuitum_, or _Mycobacterium kansasii_. 5. Clarithromycin in the presence of acid suppression is indicated for the eradication of_ H. pylori_, resulting in decreased recurrence of duodenal ulcer. _FURTHER INFORMATION_ _H. pylori_ is strongly associated with peptic ulcer disease. Ninety to 100% of patients with duodenal ulcers are infected with this agent. Eradication of_ H. pylori_ has been shown to markedly reduce the rate of duodenal ulcer recurrence, thereby reducing the need for maintenance anti-secretory therapy. In a well-controlled double-blind study,_ H. pylori_ infected patients with duodenal ulcer received clarithromycin 500 mg TID for 14 days with omeprazole 40 mg daily for 28 days. Clarithromycin has been used in other treatment regimens for the eradication of_ H. pylori_. These regimens include: clarithromycin plus tinidazole and omeprazole; and clarithromycin Les hele dokumentet