NIFELAT Film-coated tablet Ref.[28292] Active ingredients: Nifedipine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Nifelat 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, round, scored, film-coated tablets with Remedica’s logo on one side.

The tablet can be divided into equal doses using a pill cutter.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg nifedipine.

Excipient(s) with known effect: This product contains 60,9 mg lactose.

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

Core:

Povidone
Cellulose, microcrystalline
Magnesium stearate
Sodium starch glycolate (Type A)
Lactose monohydrate
Maize starch
Silica, colloidal anhydrous

Coating:

Hypromellose
Macrogol 400
Titanium dioxide E171
Talc
Quinoline yellow aluminium lake E104

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 30, 100 and 1000 film-coated tablets.
PP/PE containers with PE closure. Pack sizes of 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

19905

Date of first authorization: 29 December 2005
Date of latest renewal: 10 July 2013

Drugs

Drug Countries
NIFELAT Cyprus, Hong Kong, Malta, Singapore

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