Hydroxychloroquine 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydroxychloroquine sulfate

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Hydroxychloroquine Sulfate
Film-coated Tablets 200mg x 30, 60 (UK)
296x210 (Reel Fed)
50990014
Leaflet for Blisters
1921
T. Hull
27.03.2020
approved for print/date
PROOF ROUND
Technical
Approval
DATE SENT:
DATE RECEIVED:
Item number:
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ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
NON PRINTING COLOURS
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[e-mail]
G. Worth
31/03/2020
03/04/2020
G. Worth
296x210
9pt
Accord Barnstaple
n/a
n/a
HYDROXYCHLOROQUINE 200 MG FILM-COATED TABLETS PACK PIL - UNITED
KINGDOM
Black
Profile
BBBA7901
5
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
German GTIN 14
(incorporating PZN):
page 4
page 1
50990014
BBBA7901
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROXYCHLOROQUINE SULFATE 200MG
FILM-COATED TABLETS
• You notice yellowing of your skin or your
eyes or your urine becomes darker in colour.
This could be a liver problem, such as
jaundice or hepatitis
• Fits
• Lack of movement, stiffness, shaking or
abnormal movements in the mouth and
tongue.
TELL YOUR DOCTOR OR PHARMACIST IF ANY OF THE
FOLLOWING SIDE EFFECTS GET SERIOUS OR LASTS
LONGER THAN A FEW DAYS:
Very common (affects more than 1 in 10
people)
• Stomach pain
• Feeling sick.
Common (affects 1 to 10 people in a 100
people)
• Skin rashes, itching
• Being sick, diarrhoea
• Loss of appetite (anorexia)
• Headache
• Changes in mood with uncontrollable
laughing or crying.
Uncommon (affects 1 to 10 people in a 1,000)
• Changes in the colour of your skin or the
inside of your nose or mouth
• Hair loss or loss of hair colour
• Feeling nervous
• Ringing in the ear (tinnitus)
• Balance

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