OFCRAM Prolonged release capsules, hard Ref.[7998] Active ingredients: Dipyridamole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Focus Pharmaceuticals Ltd, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, United Kingdom

Product name and form

Ofcram PR 200mg Prolonged Release Capsules, Hard.

Pharmaceutical Form

Prolonged release capsules, hard.

Appearance: Hard gelatin capsules consisting of a red cap and an orange body. Dimension 7,66 mm x 23,1 mm.

The capsule contains yellow coloured slow release pellets.

Qualitative and quantitative composition

Each modified release capsule contains dipyridamole 200 mg.

Excipient(s) with known effect:

Sucrose: 4.56mg (2%w/w)
Sodium benzoate: 0.02mg (Up-to 1%w/v)
Sodium: 0.0032mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dipyridamole

Dipyridamole is an antithrombotic agent with antiplatelet activity. Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which are factors associated with the initiation of thrombus formation.

List of Excipients

Tartaric acid pellets [Tartaric acid, Sucrose and Povidone]
Hypromellose
Talc
Acacia, spray-dried
Triacetin
Povidone
Simeticone Emulsion (30% W/V) [Simethicone, Cetostearyl alcohol and Ethoxylate Sodium benzoate]
Methacrylic acid – ethyl acrylate copolymer
Hypromellose phthalate P55
Capsule shells
Gelatin
Titanium dioxide (E171)
Red and yellow iron oxides (E172)

Pack sizes and marketing

HDPE bottle with polypropylene child resistant closure, containing a desiccant in a pillow pouch.

Packs contain 60 capsules.

Marketing authorization holder

Focus Pharmaceuticals Ltd, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20046/ 0270

18/10/2013

Drugs

Drug Countries
OFCRAM United Kingdom

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