DILATREND Tablet Ref.[51031] Active ingredients: Carvedilol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2016  Publisher: Pharmaco Distribution (Pty) Ltd., 3 Sandown Valley Crescent, South Tower, 1st Floor, Sandton, 2196, South Africa Ethical assistance Line: +27 (0)11 784 0077

Product name and form

DILATREND 6,25 mg tablet.

DILATREND 12,5 mg tablet.

DILATREND tablet.

Pharmaceutical Form

DILATREND 6,25 mg: Yellow, round tablet with a bilateral score line and coded BM on one side and F1 on the other side.

DILATREND 12,5 mg: Light brown, round tablet with a bilateral score line and coded BM on one side and H3 on the other side.

DILATREND Tablet: Off-white to yellowish pale-beige, round biconvex tablet, with a bilateral score line and coded BM on one side and D5 on the other side.

Qualitative and quantitative composition

Each DILATREND 6,25 mg tablet contains 6,25 mg carvedilol.

Inactive ingredients: Lactose, sucrose, povidone, crospovidone, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (E172).

Each DILATREND 12,5 mg tablet contains 12,5 mg carvedilol.

Inactive ingredients: Lactose, sucrose, povidone, crospovidone, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172).

Each DILATREND tablet contains 25 mg carvedilol.

Inactive ingredients: Sucrose, lactose, povidone, colloidal anhydrous silica, crospovidone, magnesium stearate. Contains lactose and sucrose.

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

Pack sizes and marketing

DILATREND 6,25 mg tablets: available in blisters containing 10, 30 or 100 tablets.

DILATREND 12,5 mg tablets: available in blisters containing 30 or 100 tablets.

DILATREND (25 mg) Tablet: available in blisters containing 30 or 100 tablets.

Marketing authorization holder

Pharmaco Distribution (Pty) Ltd., 3 Sandown Valley Crescent, South Tower, 1st Floor, Sandton, 2196, South Africa
Ethical assistance Line: +27 (0)11 784 0077

Marketing authorization dates and numbers

DILATREND 6,25 mg: 31/7.1.3/0198

DILATREND 12,5 mg: 31/7.1.3/0199

DILATREND tablet: X/7.1.3/246

Drugs

Drug Countries
DILATREND Austria, Australia, Germany, Ecuador, Hong Kong, Italy, Mexico, Poland, Singapore, Turkey, South Africa

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