Plaquenil 200mg Film-coated Tablets/Hydroxychloroquine sulfate 200mg film-coated Tablets
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
Hydroxychloroquine Sulfate
Available from:
Zentiva
ATC code:
P01BA02
INN (International Name):
Hydroxychloroquine Sulfate
Dosage:
200mg
Pharmaceutical form:
Film-coated tablets
Administration route:
Oral use
Units in package:
blister pack containing 56 or 60 tablets; bottle containing 56 or 100 tablets
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
sanofi-aventis SA
Therapeutic indications:
Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight in adults; Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus in children
Authorization status:
Authorised
Authorization date:
2015-03-05
Patient Information leaflet
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Summary of Product characteristics
PlaquenilHydroxychloroquine sulfate 200mg FC Tabs
Summary of Product Characteristics Updated 12Mar2015 | Zentiva
1. Name of the medicinal product
Plaquenil 200mg Filmcoated Tablets/Hydroxychloroquine sulfate 200mg filmcoated Tablets
2. Qualitative and quantitative composition
Hydroxychloroquine Sulfate BP 200mg
3. Pharmaceutical form
Film coated tablet
White, round, filmcoated tablets marked 'HCQ' on one side and '200' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
_Adults_
Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or
aggravated by sunlight.
_Paediatric population_
Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus
erythematosus.
4.2 Posology and method of administration
Adults (including the elderly)
The minimum effective dose should be employed. This dose should not exceed 6.5mg/kg/day (calculated from ideal
body weight and not actual body weight) and will be either 200mg or 400mg per day.
In patients able to receive 400mg daily:
Initially 400mg daily in divided doses. The dose can be reduced to 200mg when no further improvement is evident. The
maintenance dose should be increased to 400mg daily if the response lessens.
Paediatric population
The minimum effective dose should be employed and should not exceed 6.5mg/kg/day based on ideal body weight. The
200mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg.
Each dose should be taken with a meal or glass of milk.
Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor
side effects may occur relatively early. For rheumatic disease treatment should be discontinued
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