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CAPOTEN Tablets (2017)

Active ingredients: Captopril

Product Name and Form

Capoten 25 mg Tablets.

Pharmaceutical form

Tablet.

White, slightly mottled, square, biconvex tablet, with “25” embossed on one side and cross scored on the other side.

The score line is to facilitate breaking for ease of swallowing and to divide into equal doses of 12.5mg (half tablet) or 6.25mg (quarter tablet).

Qualitative and Quantitative Composition

Each tablet contains 25 mg captopril.

Excipient(s) with known effect: Lactose monohydrate

For the full list of excipients, see section 6.1.

Chemical substance
Description
Captopril

Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme (ACE inhibitors). Inhibition of ACE results in decreased plasma angiotensin-II, which leads to decreased vasopressor activity and to reduced aldosterone secretion. In patients with hypertension, captopril causes a reduction in supine and erect blood pressure, without inducing any compensatory increase in heart rate, nor water and sodium retention.

List of excipients

Lactose monohydrate
Maize starch
Microcrystalline cellulose
Stearic acid

Pack sizes and Marketing

The tablets are packaged in PVC/aluminium blisters or PVC/PVdC/aluminium blisters in packs of 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

E.R. Squibb & Sons Limited, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH

Date of first authorisation: 27th March 1981

Date of latest renewal: 26th November 1996

Marketing authorization number:

PL 00034/0193