Indometacin 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Sandoz Ltd

ATC code:

M01AB01

INN (International Name):

Indometacin

Dosage:

50mg

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

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Indometacin Hard Capsules 25,
50mg x 28’s (UK)
296x210 (Reel Fed)
50967738
Leaflet for Blisters
4453
T. Hull
01/05/19
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DATE SENT:
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ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
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FMD info
NA (not a carton)

No

Yes

Details
INDOMETACINE 25MG & 50MG 28 TABS PIL - UK
Black
Profile
BBBA4736
RH
09-05-19
11-11-19
RH
296x210
10pt
Accord Barnstaple
NA
NA
05
Version 2
01.11.2017
page 4
page 1
50967738 BBBA4736
page 4
page 1
INDOMETACIN 25MG
AND 50MG CAPSULES
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 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 capsules belong to a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). These medicines ar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indometacin Capsules BP 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indometacin BP 50mg
3
PHARMACEUTICAL FORM
Capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin is a non-steroidal anti-inflammatory agent indicated for
the active
stages
of
:-Rheumatoid
Arthritis,
Osteoarthritis,
Ankylosing
Spondylitis,
Acute Musculoskeletal Disorders, Degenerative Joint Disease of the
Hip, Low
Back Pain and Acute Gout. It is also indicated for Pain, Inflammation
and
Oedema following Orthopaedic procedures and pain associated symptoms
of
primary Dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
ADULTS:
The recommended oral dosage range is 50- 200mg daily in divided doses.
Dysmennorrhoea: Up to 75mg daily, staring with onset of symptoms and
continuing for as long as they usually last.
Acute Gouty Arthritis: 150 - 200mg daily in divided doses until all
signs and
symptoms subside.
CHILDREN:
Safety and dosage has not been established, but Indometacin has been
shown
to be effective in Juvenile Rheumatoid Arthritis with a dosage range
of 1.5-
3mg/kg/day and a maximum daily dosage of 200mg.
ELDERLY:
Indometacin should be used with great care in elderly patients who are
more
prone to side effects.
RENAL IMPAIRMENT/HEPATIC DISEASE:
The use of Non-Steroidal anti-inflammatory Agents may result in
deterioration
of renal function. Renal function should be monitored (see
warnings/precautions)
4.3
CONTRAINDICATIONS
Hypersensitivity to Indometacin or to any of the exipients 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 or other non-steroidal
anti-inflammatory drugs.
Nasal polyps associated with angioneurotic oedema.
Severe hepatic, renal and cardiac failure