Flurbiprofen 50mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Flurbiprofen

Verfügbar ab:

Viatris UK Healthcare Ltd

ATC-Code:

M01AE09

INN (Internationale Bezeichnung):

Flurbiprofen

Dosierung:

50mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 10010100; GTIN: 5016695005133

Gebrauchsinformation

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v3/July 2017
05 OCT 2018
23:44
Leaflet (Insert)
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PR1612197
400535431; 400535429 ; 400535430
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1612197
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67048
Switzerland
Mylan Laboratories Ltd
(Nashik - IN)
LIT BQS ( X ) PRODUCTS
- 150 x 520 mm (Larger
Size - 300 x 520 mm )
tbc
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Helvetica Neue LT W1G
300 x 520 mm
7 pt
C u t t i n g
Die
7 pt
Colours
Non-Print
Colours
Date:
Time:
Dimensions
Main Font
Body Text Size
Min Text Size used
Page Count
No. of colours
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
3D Render ID
Description
Component Type
TrackWise PR No.
MA No.
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Supplier Code
Sign-offs
Equivalent Pantone+
Color Bridge Coated
colours
v3/July 2017
Flurbiprofen, 50 mg, 100 mg, 100 tabs
Leaflet (Insert)
51
1635100
400522968; 400522967
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United Kingdom
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ALLC0081-ZT
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28 NOV 2018
19:40
What is in this leaflet
1. What Flurbiprofen Coated Tablets are and
what they are used for
2. What you need to know before you take
Flurbiprofen Coated Tablets
3. How to take Flurbiprofen Coated Tablets
4. Possible side effects
5. How to store Flurbiprofen Coated Tablets
6. Contents of the pack and other information
1. What
Flurbiprofen
Coated
Tablets
are
and what they are used for
Flurbiprofen
Coated
Tablets
belong
to
a
group of medicines called non-steroidal anti-
inflammatory
drugs
(NSAIDs).
They
can
be
used to relieve pain and inflammation (redness,
heat and swelling) in conditions such as:
•

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Froben Tablets 50 mg
Flurbiprofen 50 mg coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Froben Tablets 50mg contain 50 mg flurbiprofen EP.
Flurbiprofen 50 mg coated tablets contain 50 mg flurbiprofen EP.
3
PHARMACEUTICAL FORM
The tablets are 7.6 mm in diameter, sugar-coated and white in colour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of rheumatoid disease, osteoarthritis, ankylosing
spondylitis,
musculoskeletal disorders and trauma such as periarthritis, frozen
shoulder,
bursitis, tendinitis, tenosynovitis, low back pain, sprains and
strains.
Flurbiprofen is also indicated for its analgesic effect in the relief
of mild to
moderate pain in conditions such as dental pain, post-operative pain,
dysmenorrhoea and migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see Section 4.4).
_Adults_:
150 to 200 mg daily in two, three or four divided doses. In patients
with severe
symptoms or disease of recent origin, or during acute exacerbations,
the total daily
dosage may be increased to 300 mg in divided doses.
For dysmenorrhoea, a dosage of 100 mg may be administered at the start
of
symptoms followed by 50 or 100 mg given at four- to six-hour
intervals. The
maximum total daily dosage should not exceed 300 mg.
_ _
_Paediatric population_:
Not recommended for use in children under 12 years.
_Older people_:
The elderly are at increased risk of the serious consequences of
adverse reactions.
Although flurbiprofen is generally well tolerated in the elderly, some
patients,
especially those with impaired renal function, may eliminate NSAIDs
more slowly
than normal. In these cases, flurbiprofen should be used with caution
and dosage
should be assessed individually.
If an NSAID is considered necessary, the lowest effective dose should