TRITACE Tablet Ref.[27725] Active ingredients: Ramipril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Ltd., 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Or trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Tritace 1.25 mg Tablets

or

Ramipril 1.25mg Tablets

Pharmaceutical Form

Tablets 1.25mg.

White to almost white oblong tablet with dimensions of 8 × 4 mm with score-line.

Upper stamp: 1.25 & logo ( )

Lower stamp: HMN & 1.25

The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Tablets.

Each tablet contains ramipril 1.25 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ramipril

Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.

List of Excipients

Hypromellose
Pregelatinised maize starch
Microcrystalline cellulose
Sodium stearyl fumarate

Pack sizes and marketing

Packs of 14, 15, 20, 28, 30, 50, 90, 98, 100 tablets in PVC/Alu blisters.

500 tablets in brown type III (Ph. Eur.) glass bottle with HDPE screw cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Ltd., 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Or trading as

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0356

Date of first authorisation: 30th September 2003
Date of latest renewal: 31st March 2012

Drugs

Drug Countries
TRITACE Austria, Australia, Hong Kong, Croatia, Ireland, Israel, Mexico, Nigeria, Poland, Romania, Singapore, United Kingdom, South Africa

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