Plaquenil 200mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROXYCHLOROQUINE SULFATE

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

P01BA02

INN (International Name):

HYDROXYCHLOROQUINE SULFATE 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROXYCHLOROQUINE SULFATE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIPROTOZOALS

Authorization status:

Authorised

Authorization date:

2006-06-12

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLAQUENIL 200MG FILM-COATED TABLETS
hydroxychloroquine sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them even if
their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Plaquenil is and what it is used for
2.
What you need to know before you take Plaquenil
3.
How to take Plaquenil
4.
Possible side effects
5.
How to store Plaquenil
6.
Further information
1.
WHAT PLAQUENIL IS AND WHAT IT IS USED FOR
Plaquenil contains a medicine called hydroxy-chloroquine sulphate.
Plaquenil works by reducing inflammation in people with autoimmune
diseases (this is where the
body’s immune system attacks itself by mistake).
It can be used for:
• Rheumatoid arthritis (inflammation of the joints)
• Juvenile idiopathic arthritis (inflammation of the joints)
• Discoid and systemic lupus erythematosus (a disease of the skin or
internal organs)
• Skin problems which are sensitive to sunlight
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLAQUENIL
DO NOT TAKE PLAQUENIL AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to:
-
hydroxychloroquine
-
other similar medicines such as quinolones and quinine
-
any of the other ingredients of Plaquenil (listed in Section 6 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 in children under 6 years of age or below
35kg.
Do

Summary of Product characteristics

Page 1 of 14
1
NAME OF MEDICINAL PRODUCT
Plaquenil 200mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg Hydroxychloroquine sulphate.
Excipient
with known effect
Lactose monohydrate
35.25 mg per tablet
For the 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
Adults
Plaquenil tablets are recommended for the 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
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.
Page 2 of 14
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.
4.3
CONTRAINDICATIONS
−
known hypersensitivity to 4-aminoquinoline compounds
−
pre-existing maculopathy of the eye
−
below 6 years of age (200mg tablets no