Indometacin 25mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Accord-UK 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; GTIN: 5012617010186

Patient Information leaflet

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Indometacin, Capsules, 25 &
50mg, 28s - UK
296x210 (Reel Fed)
51015325
Leaflet for Blisters
3972
RH
31-08-22
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[e-mail]
INDOMETACINE 25MG & 50MG 28 TABS PIL - UK
Black
Profile
BBBB5609
M.Ellott
07/09/2022
08/09/2022
M.Ellott
296x210
10pt
Accord Barnstaple
n/a
n/a
2
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
page 4
page 1
51015325
BBBB5609
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 drug

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indometacin Capsules BP 25mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25mg Indometacin Ph.Eur.
3
PHARMACEUTICAL FORM
Ivory hard gelatin capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin has non-steroidal analgesic and anti-inflammatory
properties.
It is indicated for the following conditions:
•
active stages of rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis,
degenerative joint disease of the hip, acute musculoskeletal
disorders, gout
and lumbago
•
inflammation, pain and oedema following orthopaedic procedures
•
treatment of pain and associated symptoms of primary dysmenorrhoea
Since indometacin is not a simple analgesic, its use should be limited
to the
above conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The dosage should be carefully adjusted according to the needs of the
individual
patient, starting with a low dose.
To reduce the possibility of gastro-intestinal disturbances,
indometacin capsules
should always be taken with food, milk or immediately after meals, or
with an antacid
and in chronic conditions start the therapy with a low dosage,
increasing as required.
Adults: The recommended oral dosage range is 50-200mg daily.
Acute rheumatoid arthritis: Initially 25mg two or three times a day.
Chronic rheumatic disorders: 25mg two or three times daily. (If
response is
inadequate, gradually increase by 25mg. Adequate response is usually
achieved with
not more than 150mg daily, rarely more than 200mg daily).
Sudden flare up of chronic condition: Increase if necessary, by 25mg
daily until a
satisfactory response is obtained, or a dosage of 150-200mg daily is
reached. (If this
causes any adverse effects, it should be reduced to a tolerable level
for two or three
days, then carefully increased, as tolerated).
Acute musculoskeletal disorders: Initially 50mg two or three times
daily, according
to severity for 10-14 days. Normally 150mg daily, rarely 200mg daily.
Lumb