RAMIPRIL/AMLODIPINE GLENMARK Hard capsule Ref.[108219] Active ingredients: Ramipril and Amlodipine

Source: Web Search  Revision Year: 2023 

Product name and form

Ramipril/Amlodipine Glenmark, 5 mg/5 mg, hard capsules.

Ramipril/Amlodipine Glenmark, 5 mg/10 mg, hard capsules.

Ramipril/Amlodipine Glenmark, 10 mg/5 mg, hard capsules.

Ramipril/Amlodipine Glenmark, 10 mg/10 mg, hard capsules.

Pharmaceutical Form

Hard capsule.

Ramipril/Amlodipine Glenmark, 5 mg/5 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque pink colour, body: opaque white colour. Content of capsules: white or almost white powder.

Ramipril/Amlodipine Glenmark, 5 mg/10 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque red – brown colour, body: opaque white colour. Content of capsules: white or almost white powder.

Ramipril/Amlodipine Glenmark, 10 mg/5 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque dark pink colour, body: opaque white colour. Content of capsules: white or almost white powder.

Ramipril/Amlodipine Glenmark, 10 mg/10 mg, hard capsules: hard gelatin capsules with a length of 19 mm, cap: opaque brown colour, body: opaque white colour. Content of capsules: white or almost white powder.

Qualitative and quantitative composition

Ramipril/Amlodipine Glenmark, 5 mg/5 mg, hard capsules: each capsule contains 5 mg ramipril and amlodipine besilate equivalent to 5 mg amlodipine.

Ramipril/Amlodipine Glenmark, 5 mg/10 mg, hard capsules: each capsule contains 5 mg ramipril and amlodipine besilate equivalent to 10 mg amlodipine.

Ramipril/Amlodipine Glenmark, 10 mg/5 mg, hard capsules: each capsule contains 10 mg ramipril and amlodipine besilate equivalent to5 mg amlodipine.

Ramipril/Amlodipine Glenmark, 10 mg/10 mg, hard capsules: each capsule contains 10 mg ramipril and amlodipine besilate equivalent to 10 mg amlodipine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ramipril and Amlodipine

Ramiprilat, the active metabolite of the prodrug ramipril, 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. Amlodipine dilates peripheral arterioles and thus, reduces the total peripheral resistance (afterload) against which the heart works. Since the heart rate remains stable, this unloading of the heart reduces myocardial energy consumption and oxygen requirements. The mechanism of action of amlodipine also probably involves dilatation of the main coronary arteries and coronary arterioles, both in normal and ischaemic regions.

List of Excipients

Capsule content:

Cellulose, microcrystalline
Calcium hydrogen phosphate, anhydrous
Maize starch, pregelatinised
Sodium starch glycolate (type A)
Sodium stearyl fumarate

Capsule shell (5 mg/5 mg; 10 mg/5 mg; 5mg/10mg):

Iron oxide red (E172)
Titanium dioxide (E171)
Gelatin

Capsule shell (10 mg /10 mg):

Iron oxide yellow (E172)
Iron oxide black (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Gelatin

Pack sizes and marketing

PA/Aluminium/PVC/Aluminium blisters.

Pack sizes: 28, 30, 32, 56, 60, 90, 91, 96, 98, 100 capsules, hard.

Not all pack sizes may be marketed.

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