Quinoric 200mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Hydroxychloroquine sulfate

Disponível em:

Bristol Laboratories Ltd

Código ATC:

P01BA02

DCI (Denominação Comum Internacional):

Hydroxychloroquine sulfate

Dosagem:

200mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 10010300; GTIN: 5060013942228

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUINORIC
® 200MG 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 Quinoric
®
Tablets are and what they are used for
2. What you need to know before you take Quinoric
®
Tablets
3. How to take Quinoric
®
Tablets
4. Possible side effects
5. How to store Quinoric
®
Tablets
6 Contents of the pack and other information
1. WHAT QUINORIC
® TABLETS ARE AND WHAT THEY ARE USED FOR
Quinoric
®
Tablets contain a medicine called hydroxychloroquine
sulfate. Quinoric
®
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:
•
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 QUINORIC
® TABLETS
DO NOT TAKE THIS MEDICINE 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 this medicine (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 affects the retina, the inside of the
SAME SIZE ARTWORK
400 x 180 mm
Front
eye (maculopathy

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquine Sulfate 200 mg Film – Coated Tablets
Quinoric 200mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg Hydroxychloroquine Sulfate
B.P.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablet (tablet)
White, 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
Posology
_Adults (including the elderly) _
The minimum effective dose should be employed. This dose should not
exceed 6.5
mg/kg/day (calculated from ideal body weight and not actual body
weight) and will
be either 200 mg or 400 mg per day.
In patients able to receive 400mg daily:
Initially 400 mg daily in divided doses. The dose can be reduced to
200 mg when no
further improvement is evident. The maintenance dose should be
increased to 400 mg
daily if the response lessens.
_Paediatric population _
The minimum effective dose should be employed and should not exceed
6.5
mg/kg/day based on ideal body weight. The 200 mg tablet is therefore
not suitable for
use in children with an ideal body weight of less than 31kg.
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.
Method of administration
The tablets are for oral administration. Each dose should b