Hydroxychloroquine 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydroxychloroquine sulfate

Available from:

Zentiva Pharma UK Ltd

ATC code:

P01BA02

INN (International Name):

Hydroxychloroquine sulfate

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5000283657705

Patient Information leaflet

Format :
150 x 315 mm
Plant barcode :
455
Colours :
1
- REFLEX BLUE
Fonts :
Ocean Sans Pro SAN (9pt)
Weight : 50 grms (+/- 5%)
Diametros : 600 (ext) / 70-76 (int)
Spot : 3 x 8 mm
Packaging line :
IMA C-09/2
Technical Data
Code :
688499 / G-679531
Update :
V6- 07/07/2017
VISTA folder : 3043909
Current item code: 688428
Product/Item type :
PRO HCLOROQUINE 200MG
Country : GB
Artwork by :
M.Pacho
Plant :
Riells
GMID code : 587955
For sanofi use only
SANOFI
RIELLS PACKAGING TEAM
Reason for change:
R.Text
PAG 1
Avance bobina
PAG 2
150 x 315 mm
688499 - G679531
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROXYCHLOROQUINE
SULFATE 200MG
FILM-COATED TABLETS
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 Hydroxychloroquine sulfate is and what it is
used for
2. Before you take Hydroxychloroquine sulfate
3. How to take Hydroxychloroquine sulfate
4. Possible side effects
5. How to store Hydroxychloroquine sulfate
6. Further information
1. WHAT HYDROXYCHLOROQUINE SULFATE
IS AND WHAT IT IS USED FOR
Hydroxychloroquine
sulfate
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 HYDROXYCHLOROQUINE SULFATE
DO NOT TAKE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
x
You are allergic (hypersensitive) to:
- hydroxychloroquine
- o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydroxychloroquine Sulfate 200mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of hydroxychloroquine sulfate
Excipient(s) with known effect
Each tablet contains 35.5 mg of lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white, plain, 9mm, round, biconvex, film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Hydroxychloroquine Sulfate Tablets are recommended for the 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 administ