QUININE SULFATE Film-coated tablet Ref.[8821] Active ingredients: Quinine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Strides Pharma UK Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS

Product name and form

Quinine Sulfate 200mg Tablets.

Pharmaceutical Form

Film-coated tablet.

A white, biconvex film-coated tablet, plain on both sides.

Qualitative and quantitative composition

Each tablet contains quinine sulfate 200mg.

Excipient(s) with known effect:

Lactose

Sodium less than 1 mmol sodium (23 mg) per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Quinine

Quinine is a cinchona alkaloid and a 4-methanolquinoline antimalarial agent which is a rapidly acting blood schizontocide with activity against Plasmodium falciparum, P vivax, P ovale and P malariae. It is active against the gametocytes of P malariae and P vivax, but not against mature gametocytes of P falciparum.

List of Excipients

Lactose
Microcrystalline cellulose
Maize starch
Colloidal anhydrous silica
Purified talc
Magnesium stearate
Sodium starch glycollate

Coating Components/Tablet:

Methylhydroxypropylcellulose
Opadry white Y-1-7000 (containing methylhydroxypropylcellulose, titanium dioxide, polyethylene glycol 400)
Carnauba wax

Pack sizes and marketing

PVC (250ยตm)/aluminium (25ยตm) foil blisters.

Pack sizes: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500.

Not all pack sizes may be marketed.

Marketing authorization holder

Strides Pharma UK Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS

Marketing authorization dates and numbers

PL 13606/0200

25/10/2016

Drugs

Drug Countries
QUININE SULPHATE United Kingdom

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