Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
NILVADIPINE
Astellas Pharma Co. Ltd
8 Milligram
Prolonged Release Capsules
2005-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nivadil 8mg Prolonged release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Nilvadipine 8.0 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. (Prolonged release capsule) Hard gelatin capsules with an opaque brown cap (overprinted with "NV8" in white) and an opaque pink body containing yellow round pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nivadil is indicated for the treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The prolonged release capsule should be swallowed whole, with a little liquid, in the morning. It may be taken after breakfast. Adults The recommended dose is 1 Nivadil 8 mg prolonged release capsule per day in the morning as a starting dose. If after 2 - 4 weeks of therapy an adequate anti-hypertensive effect is not achieved, a daily dose of 16 mg nilvadipine (2 x 8 mg Nivadil prolonged release capsules, or 1 x 16 mg Nivadil prolonged release capsule, in the morning) may improve the blood pressure response. Renal impairment: No dosage adjustment is required in mild to moderate renal insufficiency. Nivadil should not however be used in patients with severe renal insufficiency. Hepatic impairment: In patients with cirrhosis of the liver, due to diminished first-pass effect, the bioavailability is increased by a factor of 2 to 3. The currently available data lead to the recommendation that a daily dose of 1 x 8 mg nilvadipine (equivalent to 1 Nivadil 8 mg prolonged release capsule) may only be exceeded under close monitoring in such patients. The Elderly Plasma levels in elderly patients may be higher than in younger patients and increa সম্পূর্ণ নথি পড়ুন