Hydroxychloroquine 200mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Hydroxychloroquine sulfate

Dostopno od:

Ipca Laboratories UK Ltd

Koda artikla:

P01BA02

INN (mednarodno ime):

Hydroxychloroquine sulfate

Odmerek:

200mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 10010300; GTIN: 18901079116236

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROXYCHLOROQUINE SULFATE 200MG FILM-COATED TABLETS
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness 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.
-
The full name of this medicine is Hydroxychloroquine Sulfate 200mg
Film-coated Tablets but
within the leaflet it will be referred to as Hydroxychloroquine
Sulfate Tablets.
WHAT IS IN THIS LEAFLET
1.
What Hydroxychloroquine Sulfate Tablets are and what they are used for
2.
What you need to know before you take Hydroxychloroquine Sulfate
Tablets
3.
How to take Hydroxychloroquine Sulfate Tablets
4.
Possible side effects
5.
How to store Hydroxychloroquine Sulfate Tablets
6.
Contents of the pack and other information
1.
WHAT HYDROXYCHLOROQUINE SULFATE TABLETS ARE AND WHAT THEY ARE USED FOR
Hydroxychloroquine Sulfate Tablets contain a medicine called
hydroxy-chloroquine sulfate.
Hydroxychloroquine Sulfate Tablets work 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:
_Adults _

For the treatment of a chronic condition with inflammation of joints,
muscles, tendons or
ligaments (rheumatoid arthritis)

Against certain diseases that manifest themselves by, among other
things, skin problems and /
or joint complaints (Discoid and systemic lupus erythematosus)

Skin problems which are sensitive to sunlight.
_Children _

For the treatment of childhood rheumatism in combination with other
treatments (Juvenile
idiopathic arthritis)

Against certain diseases that manifest themselves by, a

Lastnosti izdelka

SmPC fragment
1.
NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquine Sulfate 200mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxychloroquine Sulfate 200mg Film-coated Tablet: Each film- coated
tablet contains
Hydroxychloroquine Sulfate 200mg
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
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 administration.
4.3
CONTRAINDICATIONS
-
known hypersensitivity to 4-aminoquinolin