Indometacin 25mg capsules

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Indometacin

Disponibbli minn:

Kent Pharma (UK) Ltd

Kodiċi ATC:

M01AB01

INN (Isem Internazzjonali):

Indometacin

Dożaġġ:

25mg

Għamla farmaċewtika:

Oral capsule

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 10010100

Fuljett ta 'informazzjoni

PATIENT INFORMATION LEAFLET
INDOMETACIN 25MG CAPSULES
INFLAMID 25MG CAPSULES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE AS IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or your 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.
IN THIS LEAFLET
1. What Indometacin Capsules are and what they are used for
2. What you need to know before you take Indometacin Capsules
3. How to take Indometacin Capsules
4. Possible side effects
5. How to store Indometacin Capsules
6. Contents of the pack and other information
1. WHAT INDOMETACIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Indometacin belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
Indometacin works by reducing inflammation and relieving pain,
swelling and stiffness in the joints and
muscles. Indometacin is used to relieve some symptoms caused by:
•
gout (pain and inflammation of the joints)
•
rheumatoid arthritis
•
osteoarthritis
•
acute musculoskeletal disorders (e.g. sprains, strains and other
injuries, such as backache and
neck ache)
•
lower back pain
•
ankylosing spondylitis (arthritis of the spine)
•
degenerative hip disease
•
pain following bone and joint surgery
•
period pain
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN CAPSULES
DO NOT TAKE INDOMETACIN CAPSULES IF YOU:
•
are allergic (hypersensitive) to indometacin or any other ingredients
in these capsules. An allergic
reaction may include a rash, itching, difficulty breathing or swelling
of the face, lips, throat or
tongue
•
suffer from severe heart failure, a disease of the heart that causes
shortness of breath and swelling
of the feet or legs due to fluid build up
•

Karatteristiċi tal-prodott

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