Sulindac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulindac

Available from:

A A H Pharmaceuticals Ltd

ATC code:

M01AB02

INN (International Name):

Sulindac

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5025903003335

Patient Information leaflet

PAGE 1 OF 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SULINDAC 100 MG AND 200 MG TABLETS
(sulindac)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Sulindac is and what it is used for
2.
What you need to know before you take Sulindac
3.
How to take Sulindac
4.
Possible side effects
5.
How to store Sulindac
6.
Contents of the pack and other information
1.
WHAT SULINDAC IS AND WHAT IT IS USED FOR
Sulindac belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). It is a
painkiller and antipyretic (reduces fever). Sulindac works by reducing
inflammation and relieving pain,
swelling and stiffness in the joints and muscles. There are a number
of painful conditions that can affect your
joints and muscles, which can be helped by taking Sulindac. These
conditions include:
-
Rheumatoid arthritis
-
Osteoarthritis
-
Ankylosing spondylitis (arthritis in the spine)
-
Gout
-
Musculo-skeletal disorders such as sprains, strains and other
injuries.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULINDAC
DO NOT TAKE SULINDAC IF YOU
-
are allergic to sulindac or any of the other ingredients of this
medicine (listed in section 6)
-
have taken an NSAID in the past (e.g. ibuprofen, aspirin) and suffered
an allergic reaction or had
problems such as bleeding or ulcers
-
have a stomach or gut ulcer, bleeding in your stomach or know that you
have suffered with ulcers,
stomach bleeding or perforation in the past
-
have severe heart failure
-
have severe liver or kidney problems
-
are already tak

Summary of Product characteristics

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