TILDIEM Modified-release tablets Ref.[6804] Active ingredients: Diltiazem

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Tildiem 60mg Modified-Release Tablets.

Pharmaceutical Form

Modified release tablet.

White, round, biconvex tablets engraved with’TILDIEM 60' or ‘DILT 60’ or ‘DTZ 60’ on one side.

Qualitative and quantitative composition

Each tablet contains 60mg of the active substance diltiazem hydrochloride.

Also contains 125.5mg of lactose monohydrate and 28mg of hydrogenated castor oil.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Diltiazem

Diltiazem is a calcium antagonist. It restricts the slow channel entry of calcium into the cell and so reduces the liberation of calcium from stores in the sarcoplasmic reticulum. This results in a reduction of the amount of available intracellular calcium reducing myocardial oxygen consumption.
List of Excipients

Lactose monohydrate
Macrogol 6000
Hydrogenated castor oil
Magnesium stearate

Pack sizes and marketing

PVC/foil blister packs of 90 and 100 tablets. Securitainers, polypropylene body with polyethylene cap containing 50, 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0640

Date of first authorisation: 8 March 1984
Date of latest renewal: 23 September 2005

Drugs

Drug Countries
TILDIEM France, Italy, Netherlands, Tunisia, United Kingdom
 
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