Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLARITHROMYCIN
HEALOL PHARMACEUTICALS SDN. BHD.
CLARITHROMYCIN
1x10'stablet Tablets
Aurobindo Pharma Limited
KLAR 250 & KLAR 500 _Consumer Medication Information Leaflet (RiMUP)_ Clarithromycin Tablets 250 mg & Clarithromycin Tablets 500 mg 1 WHAT IS IN THIS LEAFLET 1. What KLAR tablets is used for 2. How KLAR tablets works 3. Before you use KLAR tablets 4. How to use KLAR tablets 5. While you are using it 6. Side effects 7. Storage and Disposal of KLAR tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS KLAR TABLETS USED FOR KLAR tablets are indicated for the treatment of the following bacterial infections. • Treatment of infections caused by pathogens sensitive to Clarithromycin. • Infection of nose-pharynx tract (tonsillitis, pharyngitis) and of paranasal sinuses. Infections of lower respiratory tract: bronchitis (inflammation of airways in the lungs), bacterial pneumonia and atypical pneumonia. •Skin infections: impetigo, erysipelas (bacterial infection in the upper layer of the skin), folliculitis (inflammation of hair follicles), furunculosis (infection of hair follicles) and septic wounds. • Eradication of _H.pylori_ in patients with duodenal ulcers in the presence of acid suppression effected by omeprazole. HOW KLAR TABLETS WORKS KLAR belongs to a group of medicine called macrolide antibiotics. Antibiotics stop the growth of bacteria which cause infections. BEFORE YOU USE KLAR TABLETS -When you must not use it • If you are allergic to clarithromycin, other macrolide antibiotics or any of the other ingredients of this medicine. • If you have a history of certain abnormal heart rhythms (ventricular arrhythmia, including torsades de pointes) or changes in the heart activity as measured in the electro- cardiogram called “QT prolongation” • If you suffer from severe liver failure and kidney problems at the same time. • If you have low levels of potassium in the blood (a condition known as hypokalaemia). • If you are taking any of the following medicines: - other macrolides (eg erythromycin, azithromycin) - ergotamine, dihy Lesen Sie das vollständige Dokument
However, data establishing the efficacy of this antibiotic in the subsequent prevention of rheumatic fever are not available. In pharyngitis related to beta-haemolytic streptococcal infection the treatment duration should be at least 10 days. _H. pylori_: Use of any antimicrobial therapy, such as clarithromycin, to treat _H. pylori infection _may select for drug-resistant organisms. Long-term use may, as with other antibiotics, result in colonization with increased numbers of non- susceptible bacteria and fungi. If super infections occur, appropriate therapy should be instituted. Attention should also be paid to the possibility of cross resistance and cross-allergy between clarithromycin and other macrolides, clindamycin and lincomycin. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The use of the following drugs is strictly contraindicated due to the potential for severe drug interaction effects: _Cisapride, pimozide, astemizole and terfenadine:_ Elevated cisapride levels have been reported in patients receiving clarithromycin and cisapride concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades depointes. Similar effects have been observed in patients taking clarithromycin and pimozide concomitantly. Macrolides have been reported to alter the metabolism of terfenadine resulting in increased levels of terfenadine which has occasionally been associated with cardiac arrhythmias, such as QT prolongation, ventricular tachycardia, ventricular fibrillation and torsades de pointes. _Ergotamine/dihydroergotamine:_ Co-administration of clarithromycin with ergotamine or dihydroergotamine has been associa Lesen Sie das vollständige Dokument