Plaquenil 200mg Film-coated Tablets/Hydroxychloroquine sulfate 200mg film-coated Tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: myHealthbox

active_ingredient:

Hydroxychloroquine Sulfate

MAH:

Zentiva

ATC_code:

P01BA02

INN:

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_indication:

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

PIL

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SPC

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�