NIDEF Prolonged release tablet Ref.[7009] Active ingredients: Nifedipine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK

Product name and form

Nidef 30 mg Prolonged Release Tablets.

Nifedipine Morningside 30 mg Prolonged Release Tablets.

Pharmaceutical Form

Pink coloured, film coated circular biconvex prolonged release tablets, having orifice on one side and plain on the other side.

Qualitative and quantitative composition

Each prolonged release tablet contains 30 mg nifedipine.

Each tablet contains a 10% overage of nifedipine to deliver the label claim.

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:

Polyethylene oxide
Hydroxy propyl methyl cellulose (E463)
Sodium chloride
Polyethylene oxide
Ferric oxide (E172)
Magnesium stearate (E572)

Seal coating:

Hypromellose (E464)
Cellulose acetate coating

Cellulose Acetate:

Polyethylene glycol (E1521)
Dichloromethane
Methanol

Film coating:

Hydroxypropyl cellulose (E463)
Hypromellose (E464)
Titanium dioxide (E171)
Talc (E553b)
Iron oxide red (E172)

Pack sizes and marketing

PVC/PE/PVDC, Aluminium Blister. Blister packs of 10, 14, 15, 28, 30, 56, 60, 90 and 112 Prolonged Release Tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Morningside Healthcare Ltd, Unit C, Harcourt Way, Leicester, LE19 1WP, UK

Marketing authorization dates and numbers

PL 20117/0228

29/07/2013

Drugs

Drug Countries
NIDEF United Kingdom

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