Indometacin 25mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Indometacin

Διαθέσιμο από:

DE Pharmaceuticals

Φαρμακολογική κατηγορία (ATC):

M01AB01

INN (Διεθνής Όνομα):

Indometacin

Δοσολογία:

25mg

Φαρμακοτεχνική μορφή:

Oral capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 10010100

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
INDOMETACIN 25 MG &
50 MG CAPSULES
1. WHAT INDOMETACIN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
INDOMETACIN
3. HOW TO TAKE INDOMETACIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE INDOMETACIN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Indometacin capsules belongs to a group of medicines called
non-steroidal
anti-Inflammatory
drugs
(NSAIDs).
These
medicines are pain killers which reduce swelling.
Indometacin capsules are for:

inflammatory disease of the joints such as rheumatoid
arthritis, osteoarthritis and degenerative hip disease

pain and stiffness in the backbone (ankylosing spondylitis)

sprain and strains (acute muscle and bone disorders)

low back pain

pain and swelling following muscle or bone surgery

period pain

gout
If you are not sure why you have been prescribed this medicine
then please ask your doctor.
DO NOT TAKE INDOMETACIN CAPSULES IF YOU:

are in the LAST THREE MONTHS OF PREGNANCY

are ALLERGIC (HYPERSENSITIVE) TO INDOMETACIN or any of the
ingredients of Indometacin capsules (see Section 6)

are ALLERGIC (HYPERSENSITIVE) TO ASPIRIN, IBUPROFEN OR
OTHER NSAIDS or you have developed signs of asthma
(wheezing), runny nose, swelling of the face, lips, tongue or
throat or a skin rash with pale or red irregular raised patches
with severe itching, when taking these medicines

are taking other NSAIDS (e.g. naproxen) including COX II
INHIBITORS (e.g. celecoxib)

suffer with ANGIONEUROTIC OEDEMA (swelling of the face,
lips, tongue or throat)

have or have had a history of two or more episodes of
PEPTIC ULCERS (ulcer in your stomach or duodenum) OR
BLEEDING IN YOUR STOMACH or INTESTINES in the past.
Symptoms may include vomiting particles that look like
coffee-grounds, black tarry stools and blood in your faeces
(stools/motions)

have severe LIVER, KIDNEY or HEART problems

have NASAL OBSTRUCTION (nasal polyps).
WARNING AND PRECAUTIONS
If you are elderly or you have previously had stomach ulc

Αρχείο Π.Χ.Π.

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