TRUVALIN Film-coated tablet Ref.[51197] Active ingredients: Quetiapine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: AstraZeneca Pharmaceuticals (Pty) Limited, Building 2 Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg, 2191, South Africa

Product name and form

TRUVALIN 25; TRUVALIN 100; TRUVALIN 200; TRUVALIN 300 Film-coated Tablet.

Pharmaceutical Form

Film-coated Tablet.

TRUVALIN 25: Peach, round, bi-convex, film-coated tablet intagliated with Q 25.

TRUVALIN 100: Yellow, round, bi-convex, film-coated tablet intagliated with Q 100.

TRUVALIN 200: White, round, bi-convex, film-coated tablet intagliated with Q 200.

TRUVALIN 300: White, capsule-shaped, film-coated tablet intagliated with Q on one side and 300 on the other.

Qualitative and quantitative composition

TRUVALIN 25: Each tablet contains quetiapine fumarate equivalent to 25 mg of quetiapine free base.

TRUVALIN 100: Each tablet contains quetiapine fumarate equivalent to 100 mg of quetiapine free base.

TRUVALIN 200: Each tablet contains quetiapine fumarate equivalent to 200 mg of quetiapine free base.

TRUVALIN 300: Each tablet contains quetiapine fumarate equivalent to 300 mg of quetiapine free base.

Contains sugar: lactose monohydrate 19 mg (25 mg tablet); 20,70 mg (100 mg tablet); 41,40 mg (200 mg tablet); 62,10 mg (300 mg tablet).

For full list of excipients, see section 6.1.

Active Ingredient Description
Quetiapine

Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors.

List of Excipients

Tablet core:

Calcium hydrogen phosphate
Microcrystalline cellulose
Sodium starch glycolate
Lactose monohydrate
Magnesium stearate
Povidone

Coating:

Methylhydroxypropylcellulose
Macrogol
Titanium dioxide
Ferric oxide, yellow (25 mg, 100 mg tablets)
Ferric oxide, red (25 mg tablets)

Pack sizes and marketing

TRUVALIN tablets are packed into white opaque PVC aluminum foil blisters with each blister strip containing 6 or 10 tablets, packed into unit cartons.

TRUVALIN 25: Packs of 6 or 100 tablets.

TRUVALIN 100: Packs of 60, 90 or 100 tablets.

TRUVALIN 200: Packs of 60, 90 or 100 tablets.

TRUVALIN 300: Packs of 60, 90 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca Pharmaceuticals (Pty) Limited, Building 2 Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg, 2191, South Africa

Marketing authorization dates and numbers

TRUVALIN 25: 43/2.6.2/0159

TRUVALIN 100: 43/2.6.2/0160

TRUVALIN 200: 43/2.6.2/0161

TRUVALIN 300: 43/2.6.2/0162

25 November 2011

Drugs

Drug Countries
TRUVALIN South Africa

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