PLAQUENIL Film coated tablet Ref.[50772] Active ingredients: Hydroxychloroquine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, PO Box 62027, Sylvia Park Auckland 1644, Freecall: 0800 283 684, Email: medinfo.australia@sanofi.com

Product name and form

PLAQUENIL 200mg Tablet, film coated.

Pharmaceutical Form

Film coated tablet.

White to off-white peanut shaped tablets, marked “Plaquenil” in black ink on one face of the tablet.

Qualitative and quantitative composition

Hydroxychloroquine sulfate 200mg equivalent to 155mg hydroxychloroquine.

For full list of excipients, see section 6.1 List of excipients.

Active Ingredient Description
Hydroxychloroquine

Hydroxychloroquine is a antimalarial agent with have several pharmacological actions which may be involved in their therapeutic effect in the treatment of rheumatic disease, but its role is not known.

List of Excipients

Tablet core:

Calcium hydrogen phosphate dihydrate
Maize starch
Purified water
Magnesium stearate

Film coating:

Hypromellose
Macrogol 400
Titanium dioxide
Polysorbate 80
Carnauba wax
iron oxide black (Tekprint SB-9014SD)
propylene glycol
isopropyl alcohol
ethanol
dimeticone
butan-1-ol
Purified water

Pack sizes and marketing

Plaquenil is supplied as 100 tablets in a plastic HDPE bottle with a child resistant closure.

Marketing authorization holder

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, PO Box 62027, Sylvia Park Auckland 1644, Freecall: 0800 283 684, Email: medinfo.australia@sanofi.com

Marketing authorization dates and numbers

31 December 1969

Drugs

Drug Countries
PLAQUENIL Australia, Canada, Cyprus, Germany, Estonia, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Romania, Singapore, Tunisia, Turkey, United States

© 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.