INDECIN CAPSULE 25MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

INDOMETHACIN

Available from:

DYNAPHARM (M) SDN BHD

INN (International Name):

INDOMETHACIN

Units in package:

1000 Capsules; 500 Capsules

Manufactured by:

DYNAPHARM (M) SDN BHD

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
INDECIN CAPSULE 25MG
Indomethacin (25mg)
1
What is in this leaflet
1.
What Indecin Capsule 25mg is used
for
2.
How Indecin Capsule 25mg works
3.
Before you use Indecin Capsule
25mg
4.
How to use Indecin Capsule 25mg
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Indecin
Capsule 25mg
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What Indecin Capsule 25mg is used
for
Pain and inflammation in rheumatic
disease
How Indecin Capsule 25mg works
Indomethacin is an anti-inflammatory,
antipyretic substance with analgesic
properties. It is effective in relieving pain
and swelling in cases of gout and of
rheumatoid and allied forms of arthritis
and painful symptoms in other disorders
of bone and joint, such as osteoarthritis
and ankylosing spondylitis. It may also
reduce fever and relieve symptoms in
feverish inflammatory conditions such as
glandular fever (viral fever).
Before you use Indecin Capsule 25mg
-
When you must not use it
Do not use Indecin Capsule 25mg if:
-
Hypersensitive to Indomethacin
-
It should not be given to individuals
with stomach ulcer or with a recurrent
history of stomach or intestinal
ulceration.
-
Indomethacin is not recommended for
children under 14 years.
Pregnancy and lactation
Do not take Indecin Capsule 25mg if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Indecin Capsule 25mg if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
Before you start use it
Tell your doctor / pharmacist if
-
You have acute asthmatic attacks
-
Hives
-
Hypersensitive to, or had an allergic
reaction to Aspirin or other NSAIDs.
-
You have impaired kidney function.
-
Bleeding disorders
-
Seizure
-
Parkinsonism or psychiatric disorders.
-
High blood pressure
-
Heart diseases or stroke
-
If you have or had ulceration, bleeding
and perforation of the stomach and
intestinal
-
Taking other medicines
Tell your doctor if you are tak

Summary of Product characteristics

INDECIN CAPSULE 25MG
MAL19910015AZ
DESCRIPTION:
CAPSULE
Capsule Colour
:
White/Blue
Capsule Size
:
# 4
Granules Colour
:
White
EACH CAPSULE CONTAINS:
Indomethacin ....................................... 25 mg
PHARMACODYNAMICS:
Indomethacin is an anti-inflammatory, antipyretic substance with
analgesic properties. It is effective in relieving pain
and swelling in cases of gout and of rheumatoid and allied forms of
arthritis and painful symptoms in other disorders
of bone and joint, such as osteoarthritis and ankylosing spondylitis.
It may also reduce fever and relieve symptoms in
febrile inflammatory conditions such as glandular fever.
PHARMACOKINETICS:
Indomethacin is rapidly absorbed when taken by mouth and is excreted
largely by the kidneys. Its action begins within
2 hours of ingestion.
INDICATIONS:
It
is
indicated
in
active
stages
of
rheumatoid
arthritis;
moderate
to
severe
juvenile
rheumatoid
arthritis;
osteoarthritis; degenerative joint disease of the hip, ankylosing
spondylitis; gout. It is also indicated for acute
musculoskeletal disorders, e.g. bursitis, tendinitis, synovitis,
tenosynovitis, capsulitis of the shoulder, sprains and
strains; lumbago; inflammatory conditions following orthopedic
procedures; pain and associated symptoms of primary
dysmenorrhea.
RECOMMENDED DOSAGE:
The recommended dosage is 50 to 200 mg daily in divided doses and
should be adjusted to the individual patient’s
response and tolerability to the drug.
In treatment of acute gouty arthritis, 150 mg to 200 mg in divided
doses is given until all symptoms and signs subside.
In primary dysmenorrhoea, 75 mg daily as a single or divided doses,
starting at the onset of cramps or bleeding and
continuing for as long as symptoms usually last.
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest possible
duration should be used.
CONTRAINDICATIONS:
It is contraindicated in patients hypersensitive to Indomethacin,
patients in whom acute asthmatic attacks, urticaria,
or rhinitis are preci