Indocid Suppositories Strip Pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

indometacin, Quantity: 100 mg

Beschikbaar vanaf:

Aspen Pharmacare Australia Pty Ltd

farmaceutische vorm:

Suppository, moulded

Samenstelling:

Excipient Ingredients: macrogol 3350; purified water; glycerol; edetic acid; butylated hydroxyanisole; butylated hydroxytoluene; macrogol 8000

Toedieningsweg:

Rectal

Eenheden in pakket:

20 Suppositories

klasse:

Medicine Registered

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

INDOCID is indicated in active stage of: Rheumatoid arthritis, Osteoarthritis, Degenerative joint disease of the hip, Ankylosing spondylitis, Gout. It is also indicated for: Acute musculoskeletal disorders, such as bursitis, tendonitis, synovitis, tenosynovitis, tenosynovitis, capsulitis of the shoulder, sprains and strains; Low back pain (commonly referred to as lumbago); Inflammation, pain and oedema following orthopaedic surgical procedures and nonsurgical procedures associated with reduction and immobilisation of fractures or dislocations; Pain and associated symptoms of primary dysmenorrhoea.

Product samenvatting:

Visual Identification: White opaque with yellowish caste; Container Type: Strip Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

1991-07-22

Bijsluiter

INDOCID – Consumer Medicine Information
Page 1 of 4
INDOCID CAPSULE/ SUPPOSITORY
_indometacin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INDOCID. It does
not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking INDOCID
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT INDOCID IS USED
FOR
INDOCID contains indometacin as
the active ingredient. It belongs to a
group of medicines called Non-
Steroidal Anti-Inflammatory Drugs
(or NSAID).
INDOCID is used to relieve pain and
reduce inflammation (swelling,
redness and soreness) that may
occur in the following conditions:
•
different types of arthritis
including rheumatoid arthritis,
osteoarthritis, gouty arthritis and
ankylosing spondylitis
•
muscle and bone injuries such as
sprains, strains, low back pain
(lumbago) and tendonitis, such
as tennis elbow
•
swelling and pain after setting
broken or dislocated bones
•
menstrual cramps (period pain).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INDOCID
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor’s prescription.
There is no evidence that it is
addictive.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE INDOCID IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
indometacin
•
any of the ingredients listed at
the end of this leaflet
•
aspirin or any other NSAID
medicines.
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
NSAID medicines.
Symptoms of an allergic reaction to
these medicines may include
asthma, shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any

Productkenmerken

Indocid-PI-Jun-21
1
AUSTRALIAN PRODUCT INFORMATION INDOCID (INDOMETACIN) CAPSULES AND SUPPOSITORIES
1
NAME OF THE MEDICINE
Indometacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effects: Indocid capsules contain sugars as
lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
INDOCID 25 mg, white powder in an opaque ivory capsule. Marked with
"25"on the
capsule in black.
INDOCID suppositories, 100 mg, white opaque with yellowish cast.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
INDOCID is indicated in active stages of:
- Rheumatoid arthritis
- Osteoarthritis
- Degenerative joint disease of the hip
- Ankylosing spondylitis
- Gout.
It is also indicated for:
- Acute musculoskeletal disorders, such as bursitis, tendonitis,
synovitis, tenosynovitis,
capsulitis of the shoulder, sprains and strains.
- Low back pain (commonly referred to as lumbago).
-
Inflammation,
pain
and
oedema
following
orthopaedic
surgical
procedures
and
nonsurgical procedures associated with reduction and immobilisation of
fractures or
dislocations.
- Pain and associated symptoms of primary dysmenorrhoea.
4.2
D
OSE AND METHOD OF ADMINISTRATION
INDOCID is available for oral administration as a 25 mg capsule and as
a rectal
suppository containing 100 mg of indometacin.
The recommended dosage of INDOCID is 50 mg to 200 mg daily in divided
doses and
should be individually adjusted to the patient's response and
tolerance. Use the lowest
effective dose for the shortest duration consistent with individual
patient treatment
goals.
Indocid-PI-Jun-21
2
Patients on long term treatment should be reviewed regularly with
regards to efficacy,
risk factors and ongoing need for treatment.
Unlike some other potent antirheumatic agents, an initial high
"loading" dose of
INDOCID is not necessary. In chronic rheumatic disorders, initiating
therapy with low
doses, increasing gradually when necessary, and continuing for an
adequate period (up
to one month is recommended) will produce