ADALAT Tablet Ref.[51097] Active ingredients: Nifedipine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627 Free Phone 0800 233 988 www.bayer.co.nz

Product name and form

ADALAT 10 (nifedipine) modified release tablets.

ADALAT 20 (nifedipine) modified release tablets.

Pharmaceutical Form

Tablet: Round to convex, grey-pink coated.

Qualitative and quantitative composition

Each ADALAT 10 modified release tablet contains 10 mg nifedipine.

Each ADALAT 20 modified release tablet contains 20 mg nifedipine.

Active Ingredient Description
Nifedipine

Nifedipine is a calcium antagonist of the 1,4-dihydropyridine type. Calcium antagonists reduce the transmembranal influx of calcium ions through the slow calcium channel into the cell. As a specific and potent calcium antagonist, nifedipine acts particularly on the cells of the myocardium and the smooth muscle cells of the coronary arteries and the peripheral resistance vessels. The main action of nifedipine is to relax arterial smooth muscle, both in the coronary and peripheral circulation. Nifedipine Tablets are formulated to achieve controlled delivery of nifedipine in a release profile sufficient to enable once-daily administration to be effective in clinical use.

List of Excipients

ADALAT contains the excipients:

Hypromellose
Lactose monohydrate
Macrogol 4000
Magnesium stearate
Maize starch
Microcrystalline cellulose
Polysorbate 80
Iron oxide red (E172/C.I.77491)
Titanium dioxide (E171/C.I.77891)

Pack sizes and marketing

PP/Alu blister strips of 10 tablets in boxes containing 60 tablets.

Marketing authorization holder

Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627
Free Phone 0800 233 988
www.bayer.co.nz

Marketing authorization dates and numbers

Date of first approval: 20 December 1984

Drugs

Drug Countries
ADALAT Austria, Brazil, Canada, Estonia, Spain, Hong Kong, Ireland, Italy, Japan, Mexico, Nigeria, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, South Africa

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