Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LERCANIDIPINE HYDROCHLORIDE
ABBOTT LABORATORIES (M) SDN. BHD.
LERCANIDIPINE HYDROCHLORIDE
28Tablet Tablets
RECORDATI CHIMICA E FARMACEUTICA S.P.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ ZANIDIP FILM-COATED TABLETS Lercanidipine hydrochloride (10mg, 20mg) Page no. WHAT IS IN THIS LEAFLET 1. What Zanidip is used for 2. How Zanidip works 3. Before you use Zanidip 4. How to use Zanidip 5. While you are using it 6. Side effects 7. Storage and disposal of Zanidip 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT ZANIDIP IS USED FOR Zanidip is used to treat high blood pressure also known as hypertension in adults over the age of 18 years (it is not recommended for children under 18 years old) HOW ZANIDIP WORKS Zanidip belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). BEFORE YOU USE ZANIDIP _- When you must not use it_ • If you are allergic to lercanidipine hydrochloride or any of the ingredients listed at the end of this leaflet • You have had allergic reactions to drugs closely related to Zanidip tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) • If you are suffering from certain heart diseases: o Untreated heart failure o Obstruction to flow of blood from the heart o Unstable angina (angina at rest or progressively increasing) o Within one month of heart attack • You have severe liver or kidney problems • You are taking drugs that are inhibitors of CYP3A4 isoenzyme: o Antifungal medicines (such as ketoconazole or itraconazole) o Macrolide antibiotics (such as erythromycin or troleandomycin) o Antivirals (such as ritonavir) • 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 breastfeeding (see Pregnancy and Breastfeeding section for more information). _- Before you start to use it_ Take special care with Zanidip and tell your doctor if: • You have certain other heart conditions which have not been treated by insertion of a pacemaker or have pre- existing angina • Прочетете целия документ
1. TRADE NAME OF THE MEDICINAL PRODUCT ZANIDIP 10 mg film-coated tablets 2. ACTIVE INGREDIENT COMPOSITION Lercanidipine 9.4 mg (equivalent to 10mg lercanidipine hydrochloride). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, circular, biconvex tablets, scored on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZANIDIP is indicated in adults for the treatment of mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is 10mg orally once a day at least 15 minutes before meals; the dose may be increased to 20mg depending on the individual patient’s response. Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent. Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of ZANIDIP to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril). Since the dose-response curve is steep with a plateau at doses between 20-30mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase. _USE IN ELDERLY:_ although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly. _USE IN CHILDREN:_ Not recommended since there is no clinical experience in patients under the age of 18years _USE IN RENAL/HEPATIC DYSFUNCTION:_ special care should be exercised when treatment is commenced in patients with mild to moderate renal or hepatic dysfunction. Caution is necessary when increasing the daily dose to 20mg. The antihypertensive effect may be enhanced in patients with hepatic impairment and consequently an adjustment of the dosage should be considered. ZANIDIP is not recommended for use in patients with severe hepatic or renal impairment (GFR<30ml Прочетете целия документ