HCQS HYDROXYCHLOROQUINE TABLET BP 200 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

HYDROXYCHLOROQUINE SULPHATE

Διαθέσιμο από:

ZYFAS PHARMA PTE LTD

Φαρμακολογική κατηγορία (ATC):

P01BA02

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

HYDROXYCHLOROQUINE SULPHATE 200 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

IPCA LABORATORIES LIMITED

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2022-10-28

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT:
HCQS
HYDROXYCHLOROQUINE TABLET BP 200 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Hydroxychloroquine Sulfate Ph. Eur ….200mg
3. PHARMACEUTICAL FORM
Film-coated tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
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.
Children:
The minimum effective doses 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 31 kg.
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 not 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-aminoquinoline compounds
- pre-existing maculopathy of the eye
- Below 6 years of age (200 mg tablets not adapted for weight < 35 kg)
or for ideal body weight
< 31 Kg.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Retinopathy
-
All
patients
should
have
an
ophthalmological
examination
before
treatment
w