NIVADIL Prolonged release capsule, hard Ref.[9636] Active ingredients: Nilvadipine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Astellas Pharma Co. Ltd, 5 Waterside, Citywest Business Campus, Naas Road, Dublin 24, Ireland

Product name and form

Nivadil 16mg Prolonged release capsules.

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.

Qualitative and quantitative composition

Each capsule contains Nilvadipine 16.0 mg.

For the full list of excipents, see section 6.1.

Active Ingredient Description
Nilvadipine

Nilvadipine at very low concentrations inhibits the influx of calcium into the cell of the smooth vascular musculature and thereby cause vasodilatation. The myogenic vascular-wall tonus is reduced and the peripheral vascular resistance diminished. This in turn results in an antihypertensive effect.

List of Excipients

Contents of capsule:

Maize starch
Microcrystalline cellulose
Povidone
Croscarmellose sodium

Capsule shell:

Iron oxides (E172)
Titanium dioxide (E171)
Gelatin

Printing ink:

Shellac
Titanium dioxide (E171)
Propylene glycol

Pack sizes and marketing

Nature: Blister made of PVC/PVDC Film on aluminium foil (250 mm coated with 40 g/m PVDC; 20 mm Al).

Package sizes: Original packages containing: 28 prolonged release capsules

Marketing authorization holder

Astellas Pharma Co. Ltd, 5 Waterside, Citywest Business Campus, Naas Road, Dublin 24, Ireland

Marketing authorization dates and numbers

PA 1241/13/2

Date of first authorisation: 22nd July 1996
Date of last renewal: 22nd July 2006

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