Indometacin 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

A A H Pharmaceuticals 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: 5025903001164

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:
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FMD info
NA (not a carton)

No
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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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indometacin capsules 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg Indometacin Ph. Eur.
Excipient with known effect: Also contains lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule
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.
To reduce the possibility of gastro-intestinal disturbance,
indometacin capsules
should always be taken with food, milk or 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 25 mg two or three times a day.
Chronic rheumatic disorders: 25 mg two or three times daily.(If
response is
inadequate, gradually increase by 25 mg. Adequate response is usually
achieved with
not more than 150 mg daily, rarely more than 200mg daily).
_Sudden flare up of chronic condition:_ Increase if necessary, by 25
mg daily until a
satisfactory response is obtained, or a dosage of 150-200 mg 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 50 mg two or three times
daily, according
to severity for 10-14 days. Normally 150mg da