Indocid 100mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indometacin

Available from:

Aspen Pharma Trading Ltd

ATC code:

M01AB01

INN (International Name):

Indometacin

Dosage:

100mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 6091403210527

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION
FOR THE USER
Indocid® Suppositories
100 mg
Indometacin
Read all of this leaflet carefully before
you start using 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 Suppositories are and
what they are used for
2. Before you use Indocid Suppositories
3. How to use Indocid Suppositories
4. Possible side effects
5. How to store Indocid Suppositories
6. Contents of the pack and other
information
1. What Indocid Suppositories are and
what they are used for
Indocid Suppositories contain the active
ingredient indometacin.
This belongs to a group of medicines
known as ‘non-steroidal anti-inflammatory
agents’ or NSAlDs. 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 (disease mainly of
the joints)
• Osteoarthritis (disease of the joints)
• Ankylosing spondylitis (a form of
arthritis which mainly affects the back)
• Pain, inflammation, and swelling
following orthopaedic surgery.
• Musculoskeletal disorders (muscles and
bone disorders).
• Period pain.
• Low back pain.
• Disease of the hip joint.
• Acute gouty arthritis (a form of arthritis
in which crystals build up in the joints).
2. Before you use Indocid suppositories
Do not use Indocid Suppositories
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
yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indocid Suppositories 100 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indocid Suppositories contains 100 mg of indometacin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Indocid is available in polyethylene glycol suppositories.
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.
Indometacin Suppositories may be used where night pain and morning
stiffness are
prominent. One suppository at bedtime will frequently give relief from
pain and
stiffness for 13 to 16 hours after administration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of indometacin should be carefully adjusted to suit the
needs of the
individual patient.
Posology
_Adult_
One suppository to be inserted once or twice a day. One should be used
at bedtime. If
another is necessary, it should be used in the morning.
_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 indomethacin in children has not yet been
established.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1
History of peptic ulcer or active peptic ulcer
Recurrent history of gastro-intestinal lesions
Patients who have nasal polyps associated with angioneurotic oedema,
who show
sensitivity to indometacin or any of the ingredients in this product,
or who have
experienced acute asthmatic attacks, urticaria or rhinitis as a result
of therapy with
aspirin or other non-steroidal anti-inflammatory drugs
Patients with a h