EUCARDIC Tablet Ref.[51666] Active ingredients: Carvedilol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Product name and form

Eucardic 12.5 mg Tablets.

Pharmaceutical Form

Tablet.

Round, light brown tablets, scored on both sides, marked BM on one side and H3 on the other.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 12.5 mg carvedilol.

Excipients with known effect: Each tablet contains 59.1 mg lactose monohydrate and 12.5 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient 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

Lactose monohydrate
Sucrose
Povidone (E1201)
Crospovidone (E1202)
Colloidal anhydrous silica (E551)
Magnesium stearate (E572)
Yellow iron oxide (E172)
Red iron oxide (E172)

Pack sizes and marketing

Oriented Polyamide/Aluminium/PVC blister.

Blisters are packed in cartons containing 14, 28, 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Marketing authorization dates and numbers

PA2239/001/002

Date of first authorisation: 19th January 1995
Date of last renewal: 3rd April 2008

Drugs

Drug Countries
EUCARDIC Ireland

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