Indocid 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Organon Pharma (UK) 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

PACKAGE LEAFLET: INFORMATION FOR THE USER
INDOCID CAPSULES 25MG AND 50MG
INDOMETACIN
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.
IN THIS LEAFLET:
1.
What Indocid Capsules are and what they are used for
2.
Before you take Indocid Capsules
3.
How to take Indocid Capsules
4.
Possible side effects
5.
How to store Indocid Capsules
6.
Contents of the pack and other Information
1.
WHAT INDOCID CAPSULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in your medicine is indometacin. This belongs to
a group of medicines known as
‘non-steroidal anti-inflammatory agents’ or NSAIDs. These work by
reducing the body’s ability to produce
inflammation, which may cause pain and discomfort.
Your doctor has prescribed Indocid for you because you are suffering
from one of the following:
•
Rheumatoid arthritis.
•
Osteoarthritis.
•
Ankylosing spondylitis.
•
Pain, inflammation, and swelling following orthopaedic surgery.
•
Musculoskeletal disorders.
•
Period pain.
•
Low back pain.
•
Disease of the hip joint.
In addition, Indocid Capsules may be prescribed for acute gouty
arthritis.
2.
BEFORE YOU TAKE INDOCID CAPSULES
DO NOT TAKE INDOCID CAPSULES
•
If you are allergic to indometacin or any of the other ingredients of
this medicine (listed in section 6)
•
If you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have
had two episodes of peptic ulcers, stomach bleeding or perforation.
•
If you have polyps in your nose, associated with itching, nettle rash,
wheezing, or swell

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indocid Capsules 50 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indocid Capsules 50 mg contain 50 mg of indometacin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Indocid Capsules 50 mg are ivory, opaque capsules marked ‘MSD 50’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 gouty arthritis.
Also
indicated
in
inflammation,
pain
and
oedema
following
orthopaedic
procedures; and the treatment of pain and associated symptoms of
primary
dysmenorrhoea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of indometacin should be carefully adjusted to suit the
needs of the
individual patient.
Posology
Dosage in dysmenorrhoea: Up to 75 mg a day, starting with onset of
cramps or
bleeding, and continuing for as long as the symptoms usually last.
Dosage in acute gouty arthritis: 150 mg to 200 mg daily in divided
doses until all
symptoms and signs subside.
In order to reduce the possibility of gastro-intestinal disturbances,
indometacin
Capsules should always be taken with food or an antacid.
_Elderly _
Indometacin should be used with particular care in older patients who
are more prone
to adverse reactions.
_Paediatric population _
The safety and efficacy of indometacin in children has not yet been
established.
_Chronic conditions _
In chronic conditions, starting therapy with a low dosage, increasing
this gradually as
necessary, and continuing a trial of therapy for an adequate period
(in some cases, up
to one month) will give the best results with a minimum of unwanted
reactions. The
recommended oral dosage range is 50 mg to 200 mg daily in divided
doses.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1
-
History of peptic u