Indometacin 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Crescent Pharma 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; GTIN: 5017123071133

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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SUPPLIER:
1.
2.
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5.
6.
1.
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FMD info
NA (not a carton)

No

Yes
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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

1
1.
NAME OF THE MEDICINAL PRODUCT
Indometacin Capsules BP 50mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains indometacin 50mg.
Excipient of known effect: Lactose 287 mg per capsule.
_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
INDOMETACIN CAPSULES ARE PRESENTED AS SIZE 1, IVORY OPAQUE SHELLS
PRINTED WITH ‘IND 50’
AND COMPANY LOGO
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
•
Lumbago
•
Acute gout
•
Inflammation, pain and oedema following orthopaedic procedures
•
Treatment of pain and associated symptoms of primary dysmenorrhoea.
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 dose range is 50 – 200 mg daily in divided
doses.
Acute rheumatoid arthritis
Initially 25 mg two or three times a day.
Chronic rheumatic disorders
25 mg two or three times daily, increase gradually by 25 mg if
required. Adequate
response is usually achieved with 150 mg daily, rarely more than
2
200 mg daily.
Acute gout
150 – 200 mg daily in divided doses until all signs and symptoms
subside.
Acute musculoskeletal disorders
Initially 50mg two or three times daily, according to severity for
10-14 days. Normally
150mg daily, rarely 200mg daily.
Lumbago
50mg two or three times daily, according to severity. Duration of
treatment is not
normally more than five days, but may be continued for up to 10 days.
Dysmenorrhoea
Up to 75 mg dai