Indometacin 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

The Boots Company Plc

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
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
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 50mg Capsules and Inflamid 50mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg indometacin
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Indometacin capsules are size 1 hard gelatin capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indometacin has non-steroidal analgesic and anti-inflammatory
properties.
Indometacin is indicated for the treatment of:
o
active stages of rheumatoid arthritis
o
ankylosing spondylitis
o
osteoarthritis
o
acute musculoskeletal disorders
o
acute gout
o
lumbago
o
degenerative joint disease of the hip
o
inflammation, pain, and oedema following orthopaedic procedures
o
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 dose should be carefully adjusted to suit the needs of the
individual patient,
starting with a low dose._ _
Indometacin should be taken with food, milk or immediately after
meals, or with an
antacid to lessen gastric disturbances. In chronic conditions start
the therapy with a
low dose, increasing as required.
USE IN ADULTS
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 da