RAMIPRIL Capsule, hard Ref.[7067] Active ingredients: Ramipril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2024  Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Product name and form

Ramipril 5 mg capsules.

Pharmaceutical Form

Capsules, hard.

Red/White size ‘4’ hard gelatin capsules imprinted with ‘D’ on red cap and ‘42’ on white body with black edible ink filled with white to almost white powder.

Qualitative and quantitative composition

Each hard capsule contains ramipril 5 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ramipril

Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.

List of Excipients

Capsule Fill:

Hydrophobic colloidal anhydrous silica
Pregelatinized starch (maize)
Capsule Shell:
Gelatin
Sodium lauryl sulfate
Ponceau 4R (E124)
Patent blue V (E131)
Titanium dioxide (E171)

Printing Ink:

Shellac
Propylene glycol
Black iron oxide (E172)
Potassium hydroxide

Pack sizes and marketing

Ramipril capsules are available in Clear PVC/ PE/ PVdC- Aluminium blister pack and white opaque HDPE bottle pack.

Pack size:

Blister pack: 7, 10, 14, 20, 21, 28, 30, 42, 50, 56, 60, 90, 98 & 100 capsules.

Bottle pack: 30, 100, 500 & 1000 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0357

23/11/2011

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