Hydroxychloroquine 200mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Hydroxychloroquine sulfate

Dostępny od:

Bristol Laboratories Ltd

Kod ATC:

P01BA02

INN (International Nazwa):

Hydroxychloroquine sulfate

Dawkowanie:

200mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 10010300; GTIN: 5060013942228

Charakterystyka produktu

SmPC fragment
1.
NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquine Sulfate 200mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxychloroquine Sulfate 200mg Film-coated Tablet: Each film- coated
tablet contains
Hydroxychloroquine Sulfate 200mg
3.
PHARMACEUTICAL FORM
Film - coated tablet.
White, approximately 9.5mm circular, biconvex, film-coated tablets
debossed with 200 on one side
and plain 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 if there is no improvement by 6 months. In
light-sensitive diseases,
treatment should only be given during periods of maximum exposure to
light.
The tablets are for oral administration.
4.3
CONTRAINDICATIONS
-
known hypersensitivity to 4-aminoquinolin