Plaquenil 200mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Hydroxychloroquine sulfate

Mevcut itibaren:

Sanofi

ATC kodu:

P01BA02

INN (International Adı):

Hydroxychloroquine sulfate

Doz:

200mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 10010300; GTIN: 5000283603887

Bilgilendirme broşürü

1
4
31612306
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PLAQUENIL 200MG
FILM-COATED TABLETS
hydroxychloroquine sulphate
Is this leaflet hard to see or
read?
Phone [phone] for help
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
•
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 any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Plaquenil is and what it is used for
2. Before you take Plaquenil
3. How to take Plaquenil
4. Possible side effects
5. How to store Plaquenil
6. Further information 1. WHAT PLAQUENIL IS AND WHAT IT
IS USED FOR
Plaquenil contains a medicine called
hydroxychloroquine sulphate.
Plaquenil 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. BEFORE YOU TAKE PLAQUENIL
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
Plaquenil (listed in Section 6 below)
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 eye
(maculopathy) or you get a change in
eye colour or any other eye problem
 You are pregnant, might become
pregnant or think you may be pregnant
(see ‘Pregnancy and breast-feeding’
below)
Do not

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Plaquenil 200mg Film-coated Tablets / Hydroxychloroquine sulfate 200mg
Film-
coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxychloroquine Sulfate 200 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet
White, round, film-coated tablets marked ‘HCQ’ on one side and
‘200’ 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 400 mg 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 31
kg.
Method of administration
The tablets are for oral administration.
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.
4.3
CONTRAINDICATIONS