País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
NILVADIPINE
Astellas Pharma Co. Ltd
NILVADIPINE
16 Milligram
Prolonged Release Capsules
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
140007 140007 Nivadil Cap Ireland LFT 148 x 272 mm LFT_181 VTB 4366 Eq. to: N/A 23.05.2013 Black rp* IN THIS LEAFLET: 1. What Nivadil is and what it is used for 2. Before you take Nivadil 3. How to take Nivadil 4. Possible side effects 5. How to store Nivadil 6. Further information 1. WHAT NIVADIL IS AND WHAT IT IS USED FOR Nivadil contains nilvadipine as the active ingredient which is a calcium channel blocker and belongs to a group of medicines known as anti-hypertensives. Nilvadipine works by causing widening of the blood vessels (vasodilatation) which decreases the effort needed by your heart to push the blood around the body and in turn reduces your blood pressure. Nivadil is indicated for the treatment of high blood pressure (essential hypertension). 2. BEFORE YOU TAKE NIVADIL DO NOT TAKE NIVADIL IF YOU: • are allergic to nilvadipine or any other ingredient of this medicine please refer to section 6 of this leaflet • are within 4 weeks of heart attack • have unstable angina pectoris • have kidney problems • have a serious heart problem where your heart fails to pump effectively (cardiovascular shock) • have a restriction in your heart output (aortic stenosis) • are receiving a medicine known as dantrolene (medicine used to for malignant hyperthermia) • you are or might be pregnant or you are breast- feeding. Nivadil is not recommended for use in children. TAKE SPECIAL CARE WITH NIVADIL SPEAK TO YOUR DOCTOR BEFORE TAKING NIVADIL IF YOU HAVE: • liver problems • heart problems • first degree AV block • mild bradycardia Your doctor will monitor your blood pressure regularly during treatment with Nivadil. TAKING OTHER MEDICINES If you are taking other medicines make sure your doctor is aware of th Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nivadil 16mg Prolonged release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Nilvadipine 16.0 mg For the full list of excipents, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. (Prolonged release capsule) Hard gelatin capsules with an opaque brown cap (overprinted with "NV16" in white) and an opaque brown/red 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 a Leer el documento completo