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CARVEDILOL Film-coated tablets (2018)

Active ingredients: Carvedilol

Product Name and Form

Carvedilol 12.5 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet.

Film-coated tablets white to off-white, oval, engraved with “F58” on one side and scored on the other side. The tablet can be divided into equal doses.

Qualitative and Quantitative Composition

Each tablet contains 12.5 mg of carvedilol.

Excipient(s) with known effect: Each tablet contains 114.5 mg of lactose monohydrate and 2.5 mg of sucrose.

For a full list of excipients, see section 6.1.

Chemical substance
Description
Carvedilol

Carvedilol is a vasodilatory non-selective beta-blocker, which reduces the peripheral vascular resistance by selective alpha1-receptor blockade and suppresses the renin-angiotensin system through non-selective beta-blockade. Plasma renin activity is reduced and fluid retention is rare.

List of excipients

Tablet core:

Lactose monohydrate
Silica colloidal anhydrous
Crospovidone (Type A)
Crospovidone (Type B)
Povidone 30
Sucrose
Magnesium stearate

Tablet coating:

Macrogol 400
Polysorbate 80
Titanium dioxide (E171)
Hypromellose

Pack sizes and Marketing

PVC/PE/PVDC – Aluminum:

Package sizes: 5, 7, 10, 14, 15, 20, 28, 30, 40, 50, 56, 60, 90, 98, 100, 120, 150, 200, 250, 300, 400, 500 and 1000 film-coated tablets.

Bottle of high density polyethylene (HDPE) with a white cap, opaque polypropylene.

Package sizes: 30, 50, 60, 100, 250, 500 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 04/10/2012

Date of last renewal: 03/02/2018

Marketing authorization number:

PL 16363/0353