Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LERCANIDIPINE HYDROCHLORIDE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
LERCANIDIPINE HYDROCHLORIDE
28tablet Tablets
TORRENT PHARMACEUTICALS LTD.
TORIDIP TABLETS Lercanidipine Hydrochloride Tablets 10mg, 20mg 1 _Consumer Medication Information Leaflet (RiMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What Toridip is used for 2. How Toridip works 3. Before you use Toridip 4. How to use Toridip 5. While you are using it 6. Side effects 7. Storage and Disposal of Toridip 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TORIDIP IS USED FOR Toridip contains Lercanidipine. Toridip is used to treat high blood pressure also known as hypertension in adults over the age of 18 years. HOW TORIDIP WORKS Toridip belongs to a group of medicines called Calcium Channel Blockers. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle thus lowering total peripheral resistance. BEFORE YOU USE TORIDIP _When you must not use it _ If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Toridip tablets. If you have had allergic reactions to drugs closely related to Toridip tablets ( such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine). If you are suffering from certain heart diseases: • Untreated heart failure. • Obstruction to flow of blood from the heart. • Unstable angina (angina at rest or progressively increasing). • Within one month of heart attack. If you have severe liver or kidney problems. If you are taking drugs that are inhibitors of CYP3A4 isoenzyme: • Antifungal medicines (such as ketoconazole or itraconazole) • Macrolide antibiotics (such as erythromycin or troleandomycin) • Antivirals (such as ritonavir) If you are taking another drug called ciclosporin or cyclosporin (used after transplants to prevent organ rejection) With grapefruit or grapefruit juice. Do not use if you are pregnant or breast feeding. _Before you start use it _ Please tell your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses: You have Læs hele dokumentet
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory TORIDIP 10 MG TABLETS AND TORIDIP 20 MG TABLETS LERCANIDIPINE HYDROCHLORIDE TABLETS BRAND OR PRODUCT NAME TORIDIP 10 mg Tablets TORIDIP 20 mg Tablets NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) TORIDIP 10 mg Tablets Each film coated tablet contains: Lercanidipine Hydrochloride…….10mg equivalent to Lercanidipine……..9.4 mg Colours: Yellow oxide of Iron & Titanium dioxide TORIDIP 20 mg Tablets Each film coated tablet contains: Lercanidipine Hydrochloride…….20mg equivalent to Lercanidipine ………..18.8 mg Colours: Red oxide of Iron & Titanium dioxide PRODUCT DESCRIPTION TORIDIP 10 mg Tablets Yellow coloured round, shaped biconvex, film coated tablets with break-line on one side and plain on other side. TORIDIP 20 mg Tablets Pink coloured round, shaped biconvex, film coated tablets with break-line on one side and plain on other side. DOSAGE FORM Film coated tablet PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS Selective calcium channel blockers with mainly vascular effects ATC code: C08CA13 Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium into cardiac and smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle thus lowering total peripheral resistance. Despite its short pharmacokinetic plasma half-life, lercanidipine is endowed with a prolonged antihypertensive activity because of its high membrane partition coefficient, and is devoid of negative inotropic effects due to its high vascular selectivity. Since the vasodilatation induced by Lercanidipine is gradual in onset, acute hypotension with reflex tachycardia has rarely been observed in hypertensive patients. As for other asymmetric 1,4-dihydropyridines, the antihypertensive activity of lercanidipine is mainly due to its (S)-enantiomer. PHARMACOKINETICS Lercanidipine is completely absorbed from the gastroint Læs hele dokumentet