RILCAPTON Tablet Ref.[28310] Active ingredients: Captopril

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Rilcapton 25 mg tablets.

Rilcapton 50 mg tablets.

Pharmaceutical Form

Tablet.

Rilcapton 25 mg tablet is white, round flat, scored tablet.

Rilcapton 50 mg tablet is yellow round flat scored tablet.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Rilcapton 25 mg tablets: Each tablet contains 25 mg captopril.

Rilcapton 50 mg tablets: Each tablet contains 50 mg captopril.

Excipient with known effect: lactose monohydrate.

Each Rilcapton 25 mg tablet contains 74.0 mg lactose monohydrate, equivalent to 70.303 mg lactose.

Each Rilcapton 50 mg tablet contains 75.0 mg lactose monohydrate, equivalent to 71.253 mg lactose.

For the full list of excipients see section 6.1.

Active Ingredient 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

Rilcapton 25 mg: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, powdered cellulose, magnesium stearate.

Rilcapton 50 mg: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, quinolline yellow (E104), colloidal silicon dioxide, magnesium stearate.

Pack sizes and marketing

Rilcapton 25 mg:

PVC/PVDC-Al blisters. Packs of 20, 30 and 100 tablets.
PP/PE security bottles of 100, 500 and 1000 tablets.

Rilcapton 50mg:

PVC/PVDC-Al blisters. Packs of 20, 30, 100, 500 & 1000 tablets.
PP/PE security bottles of 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Rilcapton 25 mg: 11053
Rilcapton 50 mg: 20020

Rilcapton 25 mg: 3/11/1987
Rilcapton 50 mg: 28/12/2005

Drugs

Drug Countries
RILCAPTON Cyprus, Hong Kong, Malta

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