SIMCARD Film-coated tablet Ref.[50448] Active ingredients: Simvastatin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: iPharma (Pty) Ltd., 124 Elevation Avenue, Randjesfontein, MIDRAND, 1683, SOUTH AFRICA

Product name and form

SIMCARD 10, 10 mg, film-coated tablets.

SIMCARD 20, 20 mg, film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Simcard 10: A pale pink coloured, oval, convex, coated tablets with “SIM 10” embossed on side and break line on the other side. Size: Approximately 9,8 mm x 5 mm.

Simcard 20: An orange coloured, oval, convex, coated tablets with “SIM 20” embossed on one side and break line on the other side. Size: Approximately 11,7 mm x 6 mm.

Qualitative and quantitative composition

Each SIMCARD 10 film-coated tablet contains: 10 mg simvastatin.

Each SIMCARD 20 film-coated tablet contains: 20 mg simvastatin.

Contains sugar (SIMCARD 10 contains 95,2 mg lactose monohydrate per tablet. SIMCARD 20 contains 190 mg lactose monohydrate per tablet).

For full list of excipients, see section 6.1.

Active Ingredient Description
Simvastatin

Simvastatin has a potent activity in inhibiting HMG-CoA reductase (3-hydroxy–3-ethylglutaryl-CoA-reductase). Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.

List of Excipients

Tablet core:

Ascorbic acid
Butylhydroxyanisole
Citric acid monohydrate
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose pH 101
Pregelatinized starch

Tablet coating:

Ferric oxide, red (E172)
Ferric oxide, yellow (E172)
Hypromellose 5 cps
Hypromellose 15 cps
Talc
Titanium dioxide (E171)

Pack sizes and marketing

White opaque polyethylene (HPDE) containers and closures (tamper evident) containing 28/30 tablets or white opaque PVC/aluminium blister packs containing 28/30 tablets per carton.

Marketing authorization holder

iPharma (Pty) Ltd., 124 Elevation Avenue, Randjesfontein, MIDRAND, 1683, SOUTH AFRICA

Marketing authorization dates and numbers

SIMCARD 10: 36/7.5/0215
SIMCARD 20: 36/7.5/0216

Date of registration: July 2005

Drugs

Drug Countries
SIMCARD Hong Kong, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.