Hydroxychloroquine Sulfate 200mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Ipca Produtos Farmaceuticos Unipessoal LDA Rua Jose Nogueira Vaz no 8B 2625-099 Povoa de Santa Iria , Portugal

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

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-05-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR USER
HYDROXYCHLOROQUINE SULFATE 200 MG FILM-COATED TABLETS
Hydroxychloroquine sulfate
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 Hydroxychloroquine sulfate is and what it is used for
2.
What you need to know before you take Hydroxychloroquine sulfate
3.
How to take Hydroxychloroquine sulfate
4.
Possible side effects
5.
How to store Hydroxychloroquine sulfate
6.
Contents of the pack and other information
1.
WHAT HYDROXYCHLOROQUINE SULFATE IS AND WHAT IT IS USED FOR
Hydroxychloroquine sulfate contains an active substance called
hydroxychloroquine sulfate.
Hydroxychloroquine sulfate 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 (in children)
•
Discoid and systemic lupus erythematosus (a disease of the skin or the
internal organs)
•
Skin problems which are sensitive to sunlight
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROXYCHLOROQUINE SULFATE
DO NOT TAKE HYDROXYCHLOROQUINE SULFATE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to
o
Hydroxychloroquine
o
Other similar medicines such as quinolones and quinine
o
Any of the other ingredients of Hydroxychloroquine sulfate (listed in
Section 6).
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 aff

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquine Sulfate 200mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film- coated tablet contains 200mg of Hydroxychloroquine Sulfate
Excipient with known effect:
For the full list of excipients, see section 6.1.
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
Page 2 of 12
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 ad