Plaquenil Tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

HYDROXYCHLOROQUINE SULPHATE

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

HYDROXYCHLOROQUINE SULPHATE

Units in package:

60Tablet Tablets

Manufactured by:

SANOFI-AVENTIS, S.A

Patient Information leaflet

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PLAQUENIL
®
TABLET
_ _
Hydroxychloroquine Sulphate (200mg)
_ _
WHAT IS IN THIS LEAFLET
1.
What Plaquenil is used for
2.
How Plaquenil works
3.
Before you use Plaquenil
4.
How to use Plaquenil
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Plaquenil
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT PLAQUENIL IS USED FOR
Plaquenil can be used for:
• Rheumatoid arthritis (inflammation
of the joints)
• Juvenile chronic arthritis (in children)
• Discoid and systemic lupus
erythematosus (a disease of the skin or
the internal organs)
• Skin problems which are due to/
aggravated by sunlight.
HOW PLAQUENIL WORKS
Plaquenil contains a medicine called
hydroxychloroquine sulphate.
It works by reducing inflammation in
people with autoimmune diseases (this
is where the body’s immune system
attacks itself by mistake).
BEFORE YOU USE PLAQUENIL
-
_When you must not use it _
Do not take Plaquenil if:
• You are allergic (hypersensitive) any
of the other ingredients of 4-
aminoquinoline compounds (listed in
section 8 below)
- Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue.
• You have an eye problem which
affects the retina, the inside of the eye
(maculopathy) or you get a change in
eye colour or any other eye problem
• Plaquenil should not be used during
pregnancy unless your doctor considers
the benefits outweigh the risks.
• Plaquenil should not be used during
breast-feeding unless your doctor
considers the benefits outweigh the
risks.
Do not use this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist
before taking Plaquenil.
-
_BEFORE YOU START TO USE IT _
Take special care and check with your
doctor if:
-You have liver or kidney problems
-You have serious stomach or gut
problems
- You are taking a drug called
Tamoxifen, used to treat breast cancer
-You have any proble

Summary of Product characteristics

MY/PLA/06201121/CCDSV 14 & 15
3
1
PLAQUENIL 200MG FILM-COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Plaquenil 200mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg Hydroxychloroquine sulphate.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex tablets with flat sides, marked 'HCQ' on one side and
'200' on the reverse.
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
The 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.
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 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.
4.3 CONTRAINDICATIONS
- known hypersensitivity to 4-aminoquinoline compounds
- pre-existing maculopathy of the eye
- below 6 years of age (200mg tablets not adapted for weight <31 kg
(see section 4.2)
4.4 SPECIAL WARNINGS