FENAMON SR Modified release tablet Ref.[28313] Active ingredients: Nifedipine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Fenamon SR 20 mg modified release tablets.

Pharmaceutical Form

Modified release tablet.

Yellow, round, convex modified release tablet.

Qualitative and quantitative composition

Each modified release tablet contains 20 mg of nifedipine.

Excipients with known effect: lactose, sunset yellow.

Each modified release tablet contains 19.00 mg lactose monohydrate and 0.79 mg sunset yellow.

For the full list of excipients, see section 6.1.

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

Lactose monohydrate
Starch maize
Polysorbate 80
Cellulose microcrystalline
Colloidal silica gel
Magnesium stearate

The film coating consists of:

Hypromellose
Polyethylene glycol 400
Titanium dioxide (E171)
Quinoline yellow (E104)
Iron oxide yellow (E172)
Sunset yellow (E110)

Pack sizes and marketing

White polyvinylchloride film – aluminium foil blisters of ten tablets. Packs, with a patient information leaflet, containing 20, 30 or 50 tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

19938

22/12/2005

Drugs

Drug Countries
FENAMON Cyprus, Hong Kong, Malta

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