Indometacin 25mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Phoenix Healthcare Distribution Ltd

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

Patient Information leaflet

SAME SIZE ARTWORK
430 x 140 mm
Front
•
Lower back pain
•
Pain, inflammation and swelling following muscle or bone surgery
•
Period pain
•
Disease of the hip joint
In addition, Indometacin capsules may be prescribed for acute gouty
arthritis.
2. What you need to know before you take
Indometacin Capsules
Do not take Indometacin capsules if you:
•
are allergic to indometacin or any of the other ingredients of this
medicine (listed in section 6), for example, if you have experienced
breathing difficulties, skin rashes which look like nettle rash, or a
runny
nose or if you are hypersensitive to aspirin or another non steroidal
anti-inflammatory medicine.
•
If you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have had two episodes of peptic ulcers,
stomach bleeding or perforation.
•
If you have polyps in your nose, associated with itching, nettle rash,
wheezing, or swelling of the face, lips, tongue and/or throat or
difficulties
in swallowing or breathing.
•
If you are in the third trimester of pregnancy or while you are
breastfeeding (see pregnancy, breast feeding and fertility)
Warnings and Precautions
Talk to your doctor or pharmacist before taking Indometacin Capsules
if
y o u :
•
are epileptic
•
have Parkinson’s disease
•
have a psychiatric problem
•
have heart disease, high blood pressure or have a tendency for fluid
retention
•
are being treated for infection or you have a fever
•
know you suffer from asthma, digestive tract, liver or kidney disease,
diabetes or heart failure
•
have a problem with your blood clotting.
140 mm
430 mm
Package leaflet: Information for the user
INDOMETACIN 25 MG CAPSULES
Indometacin
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 ma

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