PLAQUENIL Film Coated Tablet 200 Milligram
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
09-06-2024
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Viambatanisho vya kazi:
HYDROXYCHLOROQUINE SULFATE
Inapatikana kutoka:
IMED Healthcare Ltd.
Kipimo:
200 Milligram
Dawa fomu:
Film Coated Tablet
Idhini ya tarehe:
2011-09-30
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Plaquenil 200mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg hydroxychloroquine sulphate.
Excipient: lactose monohydrate
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
_Product imported from the UK:_
White, round, film-coated tablets with HCQ on one side and 200 on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Plaquenil tablets are recommended for the treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and
systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Plaquenil tablets are for oral administration. 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 if there is no improvement by 6 months. In light-sensitive
diseases treatment should only be given during periods of maximum exposure to light.
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. The 400mg tablet should not be used in
adults with an ideal body weight of less than 62kg.
Children:
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 35kg
4.3 CONTRAINDICATIONS
known hypersensitivity to 4-aminoquinoline co
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