TELGEN Tablet Ref.[115277] Active ingredients: Telmisartan

Source: Health Products Regulatory Authority (ZA)  Publisher: RANBAXY (SA) (PTY) LTD, a Sun Pharma company, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion

Product name and form

TELGEN 40 (Tablets).

TELGEN 80 (Tablets).

Pharmaceutical Form

TELGEN 40: Off white to light yellow coloured, oblong tablets, debossed with ‘T12’ on one side and plain on other side.

TELGEN 80: Off white to light yellow coloured, oblong tablets, debossed with ‘T13’ on one side and plain on other side.

Qualitative and quantitative composition

TELGEN 40:

Each tablet contains telmisartan 40 mg.

Contains sugar: sorbitol 174,64 mg per tablet.

Contain sodium hydroxide 3,36 mg per tablet.

TELGEN 80:

Each tablet contains telmisartan 80 mg.

Contains sugar: sorbitol 349,28 mg per tablet.

Contains sodium hydroxide 6,72 mg per tablet.

For full list of excipients, see section 6.1

Active Ingredient

Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting.

List of Excipients

TELGEN also contains the following excipients:

Magnesium stearate
Meglumine
Povidone
Sodium hydroxide
Sorbitol

Pack sizes and marketing

Carton contains 30 tablets packed in desiccant embedded silver cold form blisters or silver cold form blisters of 10 tablets each.

Marketing authorization holder

RANBAXY (SA) (PTY) LTD, a Sun Pharma company, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion

Marketing authorization dates and numbers

TELGEN 40: 45/7.1.3/0610
TELGEN 80: 45/7.1.3/0611

Date of registration: 10 October 2013
Date of last approval: 20 March 2024

Drugs

Drug Countries
TELGEN South Africa

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