PLAQUENIL TABLET 200 mg (White)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HYDROXYCHLOROQUINE SULPHATE

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

Pending

Dosage:

200 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

HYDROXYCHLOROQUINE SULPHATE 200.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SANOFI AVENTIS, SA

Authorization status:

ACTIVE

Authorization date:

2003-02-28

Patient Information leaflet

PLAQUENIL 
® 
Hydroxychloroquine

Sulphate 
[sanofi logo] 
1 
NAME OF THE MEDICINAL PRODUCT 

 Plaquenil 
Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

 Hydroxychloroquine

Sulphate BP 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 
-  pregnancy (see section 4.6 Pregnancy and lactation)  

4.4  
SPECIAL WARNING AND SPECIAL

Summary of Product characteristics

SG/PLA/0923/CCDS V16 & 17
1
PLAQUENIL
®
Hydroxychloroquine
Sulphate
1
NAME OF THE MEDICINAL PRODUCT
Plaquenil Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxychloroquine
Sulphate BP 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 (see section 4.2)
SG/PLA/0923/CCDS V16 & 17
2
4.4
SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE
Retinopathy
-
All patients should have an ophthalmological examination before
tre