Hydroxychloroquine sulfate Accord 200 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Hydroxychloroquine sulfate

Boleh didapati daripada:

Accord Healthcare Ireland Ltd.

Kod ATC:

P01BA02

INN (Nama Antarabangsa):

Hydroxychloroquine sulfate

Dos:

200 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Kawasan terapeutik:

hydroxychloroquine

Status kebenaran:

Not marketed

Tarikh kebenaran:

2020-04-24

Risalah maklumat

NL/H/4784/001/II/009‐ version 01 ‐ 11/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROXYCHLOROQUINE SULFATE ACCORD 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 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 Hydroxychloroquine sulfate Accord is and what it is used for
2.
What you need to know before you take Hydroxychloroquine sulfate
Accord
3.
How to take Hydroxychloroquine sulfate Accord
4.
Possible side effects
5.
How to store Hydroxychloroquine sulfate Accord
6.
Contents of the pack and other information
1.
WHAT HYDROXYCHLOROQUINE SULFATE ACCORD IS AND WHAT IT IS USED FOR
Hydroxychloroquine sulfate Accord contains the active substance
hydroxychloroquine sulfate.
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).

for the treatment of skin problems which are sensitive to sunlight
(photodermatoses).

for the treatment of acute attacks of malaria and to prevent malaria.
_Children (≥ 6 years and ≥ 31 kg) _

For the treatment of childhood rheumatism in combination with other
treatments (Juvenile
idiopathic arthritis)

Against certain diseases that manifest themselves by, among other
things, skin problems and /
or joint complaints (Discoid and systemic lupus erythematosus)

For the treatment of acu

Ciri produk

Health Products Regulatory Authority
24 November 2023
CRN00DL72
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquine sulfate Accord 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Hydroxychloroquine sulfate 200 mg
Excipient(s) with known effect
Each tablet contains 35.50 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, peanut shaped, biconvex, film-coated tablets
debossed with "H11" on one side and plain on the other side
with approximate dimension of 12.80 ± 0.05 mm × 6.10 ± 0.05 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Hydroxychloroquine sulfate Accord tablets are recommended for the
treatment of rheumatoid arthritis, discoid and systemic
lupus erythematosus, and photodermatoses.
This product is also indicated in adults for prevention and treatment
of uncomplicated malaria caused by _Plasmodium vivax_, _P. _
_ovale_, _P. malariae _and chloroquine sensitive _P. falciparum_.
Paediatric population (≥ 6 years and ≥ 31 kg)
Treatment of juvenile idiopathic arthritis (in combination with other
therapies), discoid and systemic lupus erythematosus.
Also indicated for prevention and treatment of uncomplicated malaria,
caused by _Plasmodium vivax_, _P. malariae_, _P. ovale _and
chloroquine-sensitive _P. falciparum_.
Chloroquine-resistant _P. falciparum_, and increasingly
chloroquine-resistant _P. vivax_, are found in many areas which limits
the
usefulness of hydroxychloroquine in these areas. Official guidelines
andlocal information on the occurrence of resistance to
anti-malaria agents must be observed (e.g. WHOand public health
directives).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hydroxychloroquine works cumulatively and needs a few weeks in order
to attain its therapeutic effect for rheumatoid diseases,
whereas minor side effects may occur relatively early.
For rheumatic diseases, treatment should be discontinued i