PLAQUENIL 200 Milligram Film Coated Tablet
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:
LTT Pharma Limited
INN (Jina la Kimataifa):
HYDROXYCHLOROQUINE SULFATE
Kipimo:
200 Milligram
Dawa fomu:
Film Coated Tablet
Dawa ya aina:
Product subject to prescription which may be renewed (B)
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2013-03-11
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Plaquenil 200 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg Hydroxychloroquine sulphate
Excipient: Lactose monohydrate.
For a full list of excipients see 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from Greece_:
White, biconvex tablets with flat sides, marked HCQ on one side and 200 on the reverse.
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
IRISH MEDICINES BOARD
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