Indometacin 25mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Waymade Healthcare Plc

ATC code:

M01AB01

INN (International Name):

Indometacin

Dosage:

25mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indometacin Capsules BP 25 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg of indometacin
For excipients, see 6.1
3
PHARMACEUTICAL FORM
lndometacin capsules are presented as size 3, ivory opaque shells
printed with ‘IND
25’ and company logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin capsules are indicated for the pain and inflammation
associated with the
following conditions.
Active stages of rheumatoid arthritis.
Osteoarthritis.
Ankylosing spondylitis.
Degenerative joint disease of the hip.
Acute musculoskeletal disorders.
Low back pain.
Acute gout.
Inflammation, pain and oedema following orthopaedic procedures.
Pain and associated symptoms of primary dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. To be taken preferably with or after food,
milk or an
antacid.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
Chronic conditions
Adults: 25 mg two to four times daily increased if required, up to 200
mg
daily.
The recommended oral dose range is 50 – 200 mg daily in divided
doses.
Acute gouty arthritis
Adults: 150 – 200 mg daily in divided doses until all signs and
symptoms
subside.
Dysmenorrhoea
Up to 75 mg daily until the symptoms subside.
Paediatric dosage: Not established
Elderly: The elderly 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 indometacin or to any of the excipients.
•
NSAIDs are contraindicated in patients who have previously shown
hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or
urticaria) in
response to ibuprofen, aspirin or other non-steroidal
anti-inflammatory drugs