AMLORINE Tablet Ref.[28103] Active ingredients: Amlodipine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Amlorine 5, 5 mg tablets.

Amlorine 10, 10 mg tablets.

Pharmaceutical Form

Tablet.

Amlorine 5, 5mg tablets: White, round, normal convex tablets.

Amlorine 10, 10 mg tablets: White, round, normal convex tablets, scored on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Amlorine 5, 5 mg tablets: Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine.

Amlorine 10, 10 mg tablets: Each tablet contains amlodipine besilate equivalent to 10 mg amlodipine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amlodipine

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

List of Excipients

Microcrystalline cellulose
Calcium phosphate dibasic anhydrous
Sodium starch glycolate
Magnesium stearate

Pack sizes and marketing

PVC-PE-PVDC/Aluminium blisters.

Pack-sizes of 10, 20, 30, 50, and 100 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

Amlorine 5, 5 mg tablets: 20258
Amlorine 10, 10 mg tablets: 20259

Amlorine 5, 5 mg tablets:

Date of first authorisation: 29 August 2007
Date of latest renewal: 16 January 2013

Amlorine 10, 10 mg tablets:

Date of first authorisation: 29 August 2007
Date of latest renewal: 20 May 2013

Drugs

Drug Countries
AMLORINE Cyprus, Hong Kong, Malta

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