Sulindac 100mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Sulindac

Tersedia dari:

Viatris UK Healthcare Ltd

Kode ATC:

M01AB02

INN (Nama Internasional):

Sulindac

Dosis:

100mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 10010100; GTIN: 5016695710068

Selebaran informasi

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Barcode Info
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24 Jan 2019
I/I
14:50
Sulindac 100mg 56
Label Leaflet
1597213
318333
1597213
PL 04569/0187
N/A
LL0453AK
158
N/A
357012
3
United Kingdom
N/A
5016695710068
N/A
4
Varnish
Free
Myriad Pro
52 x 101 mm
7pt
5.5pt
Keyline
Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Dimensions
Main Font
Body Text Size
Min Text Size used
Page Count
No. of colours
Description
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
v3/July 2017
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
3D Render ID
24 Jan 2019
II/II
14:50
Sulindac 100mg 56
Label Leaflet
1597213
318333
1597213
PL 04569/0187
N/A
LL0453AK
158
N/A
357012
3
United Kingdom
N/A
5016695710068
N/A
4
Varnish
Free
Myriad Pro
52 x 101 mm
7pt
5.5pt
Keyline
Braille
Sulind-
ac
#100 mg
Tablets
Sulind-
ac
#100 mg
Tablets
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(1)
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layout:
Standard font size is 2.0mm for online printed batch data.
Keep this section as part of the artwork in keyline colour.
Keep this flap blank and varnish free for online printing.
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*PC: 00000000000000
*SN: 00000000000000
Lot: 0000000000
EXP: MM/YYYY
Variable Data Information box for online
printing - United Kingdom
* Will be printed only after serialisation go live
Keep this section as part of the Artwork in Keyline colour

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sulindac 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of sulindac
Excipients with known effect:
Each tablet contains 18 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
8mm flat bevel-edged orange yellow tablet marked “SD” breakline
“100” on one side
and “
α
” on the reverse.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Sulindac
is
a
non-steroidal
anti-inflammatory
drug
with
analgesic
and
antipyretic activity and is indicated in rheumatoid arthritis,
osteoarthritis, acute
gouty arthritis, ankylosing spondylitis and musculoskeletal and
periarticular
disorders such as tendinitis, tenosynovitis, and bursitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
For oral administration.
Sulindac should always be taken with fluids either with food or
immediately after
food and is normally taken twice a day. The usual adult dosage is 400
mg a day and
doses above this level are not recommended. Lower doses may be found
sufficient.
Seven days treatment is usually sufficient for acute gouty arthritis.
For peri-articular
disorders treatment should be no longer than 7 to 10 days.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
_ _
_Paediatric population _
Not recommended.
_ _
_Older people _
Older people are at increased risk of the serious consequences of
adverse reactions. If
an NSAID is considered necessary, the lowest effective dose should be
used and for
the shortest possible duration. The patient should be monitored
regularly for GI
bleeding during NSAID therapy.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1. NSAIDS are contraindicated in patients who have previously shown
hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or
urticaria) in response
to ibuprofen, aspirin