VASEXTEN Modified release capsules Ref.[6384] Active ingredients: Barnidipine

Source: European Medicines Agency (EU)  Revision Year: 2013  Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Product name and form

Vasexten 10, 10 mg modified release capsules.

Pharmaceutical Form

Modified release capsules, hard.

Vasexten 10 modified release capsules are yellow and marked: 155 10

Qualitative and quantitative composition

Vasexten contains barnidipine hydrochloride.

Vasexten 10 modified release capsules, hard, contain 10 mg barnidipine hydrochloride, equivalent to 9.3 mg barnidipine per capsule.

Excipients with known effect: sucrose 95 mg.

For the full list of excipients, see section 6.1

Active Ingredient Description
Barnidipine

Barnidipine is a lipophilic 1,4-dihydropyridine calcium antagonist showing high affinity for the calcium channels of the smooth muscle cells in the vascular wall.

List of Excipients

The excipients of Vasexten capsules are:

Capsule content: carboxymethylethylcellulose, polysorbate 80, sucrose, ethylcellulose, talc.

Capsule shell: titanium dioxide (E171), yellow iron oxide (E172) and gelatine.

Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), ammonia.

Pack sizes and marketing

Vasexten modified release capsules are packed in boxes containing 10, 14, 20, 28, 30, 50, 56, 98 or 100 capsules in aluminium-aluminium (with PVC and polyamide coating) blisters. A blister contains 7, 10 or 14 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Drugs

Drug Countries
VASEXTEN Netherlands

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