Hydroxychloroquinesulfaat DOC 200 mg, filmomhulde tabletten

البلد: هولندا

اللغة: الهولندية

المصدر: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

العنصر النشط:

HYDROXYCHLOROQUINESULFAAT 200 mg/stuk SAMENSTELLING overeenkomend met ; HYDROXYCHLOROQUINE 154,8 mg/stuk

متاح من:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC رمز:

P01BA02

INN (الاسم الدولي):

HYDROXYCHLOROQUINESULFAAT 200 mg/stuk SAMENSTELLING overeenkomend met ; HYDROXYCHLOROQUINE 154,8 mg/stuk

الشكل الصيدلاني:

Filmomhulde tablet

تركيب:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEDROOGD ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

طريقة التعاطي:

Oraal gebruik

المجال العلاجي:

Hydroxychloroquine

تاريخ الترخيص:

1900-01-01

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROXYCHLOROQUINESULFAAT DOC 200 MG, FILMOMHULDE TABLETTEN
_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 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.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
_ _
contains hydroxychloroquine sulphate that works by reducing
inflammation in people with
autoimmune diseases (this is where the body’s immune system attacks
itself by mistake).
This medicine is also used to prevent and treat acute attacks of
malaria, an infectious disease caused by the
presence of parasites in red blood cells, with symptoms such as high
fever, shaking, chills, and extreme
sweating.
_ is used in adults for: _
−
treatment of chronic inflammation of joints, muscles, tendons or
muscle attachment inflammation
(rheumatoid arthritis)
−
treatment of acute malaria attacks and malaria prevention
−
treatment of skin problems and/or joint complaints caused by systemic
and discoid lupus erythematosus
−
treatment of skin rashes following exposure to the sun
(photodermatoses).
_ is used in children for:_
−
treatment of juvenile arthritis in combination with other treatments
−
treatment of skin problems and/or joint complaints caused by systemic
and discoid lupus erythematosus.

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquinesulfaat DOC 200 mg filmomhulde tabletten.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
A film-coated tablet contains 200 mg of hydroxychloroquine sulphate,
which corresponds to 154.8 mg of
hydroxychloroquine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White, round, biconvex, film-coated tablets (with a dimension of 9.5
mm) embossed with “200’ on one side
and plain on other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
-
Rheumatoid arthritis
-
Systemic lupus erythematosus
-
Discoid lupus erythematosus
-
Photodermatosis
-
Treatment of acute attacks and prophylaxis of malaria caused by
_Plasmodium vivax, P. falciparum, P. _
_ovale_
and
_P. malariae. _
Children
-
Juvenile idiopathic arthritis (in association with other treatments)
-
Systemic lupus erythematosus
-
Discoid lupus erythematosus
-
Treatment of acute attacks and prophylaxis of malaria caused by
_Plasmodium vivax, P. falciparum, P. _
_ovale_
and
_P. malariae_
.
Chloroquine-resistant
_P. falciparum_
, and increasingly chloroquine-resistant
_P. vivax_
, occur in many regions,
which limits the usability of hydroxychloroquine in these regions.
Official guidelines and local information about the occurrence of
anti-malarial drug resistance need to be taken
into account. Examples of this include WHO and public safety
guidelines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
General
Hydroxychloroquine works cumulatively and needs a few weeks in order
to attain its therapeutic effect for
rheumatoid diseases.
Posology
_Rheumatoid arthritis _
Adults
Children
Starting dose: 400 mg a day.
The treatment needs to be continued for 6-8 weeks
before assessing the effect. During this period,
Hydroxychloroquine
sulphate
DOC
can
be
combined with prostaglandin synthetase inhibitors
(such as acetylsalicylic acid or indomethacin).
Combination therapy with gold or phenylbutazone
is discouraged.
The daily dose can be decreased aft