AMLOBE Tablet Ref.[27866] Active ingredients: Amlodipine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany Tel: +49 4721 606 0, Fax: +49 4721 606 333, Email: info@tad.de Distributor: Ki.Pa pharrmacal Ltd, 9, Polygyrou Street PO Box 40608 Larnaca, ...

Product name and form

AmloBe 5 mg tablets.

AmloBe 10 mg tablets.

Pharmaceutical Form

Tablet.

5 mg tablets: white, round, slightly biconvex, bevel-edged, scored on one side, diameter 8 mm. The tablet can be divided into equal halves.

10 mg tablets: white, round, slightly biconvex, bevel-edged, diameter 10.5 mm.

Qualitative and quantitative composition

AmloBe 5 mg tablets: Each tablet contains 6.94 mg amlodipine besylate equivalent to 5 mg of amlodipine.

AmloBe 10 mg tablets: Each tablet contains 13.88 mg amlodipine besylate equivalent to 10 mg of amlodipine.

For a 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

Microcristalline cellulose (E460)
Pregelatinised maize starch
Sodium starch glycolate (type A)
Colloidal anhydrous silica (E551)
Magnesium stearate (E470b)

Pack sizes and marketing

OPA-Al-PVC/Al blister: 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany
Tel: +49 4721 606 0, Fax: +49 4721 606 333, Email: info@tad.de

Distributor:

Ki.Pa pharrmacal Ltd, 9, Polygyrou Street PO Box 40608 Larnaca, Cyprus
Tel: +35724651882, Fax: +35724627038

Marketing authorization dates and numbers

AmloBe 5 mg tablets: 21192
AmloBe 10 mg tablets: 21193

Date of first authorisation: 05.03.2012 / 20/09/2018

Drugs

Drug Countries
AMLOBE Cyprus

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