ORUDIS ketoprofen 100mg suppositories blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketoprofen

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

ORUDIS
® SUPPOSITORIES
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ORUDIS SUPPOSITORIES?
Orudis Suppositories contains the active ingredient ketoprofen. Orudis
Suppositories is used to treat the symptoms of rheumatoid
arthritis and osteoarthritis.
For more information, see Section 1. Why am I using Orudis
Suppositories? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ORUDIS SUPPOSITORIES?
Do not use if you have ever had an allergic reaction to ketoprofen,
aspirin or any other anti-inflammatory drugs, or any of the
ingredients listed at the end of the CMI.
Do not use if you have a peptic ulcer; problems with your heart;
severe kidney or liver problems.
Do not use if you are in your third trimester of pregnancy.
The use of Orudis Suppositories during the first and second trimester
of pregnancy should be avoided, as the safety of Orudis
Suppositories in pregnant women has not been evaluated.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Orudis Suppositories? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Orudis Suppositories and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ORUDIS SUPPOSITORIES?
•
The usual dose for this medicine is one suppository (100mg) at night.
•
Follow the instructions provided and use Orudis Suppositories until
your doctor tells you to stop.
More instructions can be found in Section 4. How do I use Orudis
Suppositories? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ORUDIS SUPPOSITORIES?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Orudis Supp

Summary of Product characteristics

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Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – ORUDIS
® SR CAPSULES
AND ORUDIS
®
SUPPOSITORIES (KETOPROFEN)
1
NAME OF THE MEDICINE
Ketoprofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Orudis suppository contains ketoprofen 100 mg.
Each Orudis SR capsule contains ketoprofen 200 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Orudis: Suppositories: White or cream torpedo-shaped suppositories.
Orudis SR Capsules: modified release, hard gelatin capsule. Clear pink
base & white opaque
cap. Base and cap printed ‘ORUDIS SR 200’ and contains off-white
to cream spherical pellets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis, osteoarthritis.
4.2
DOSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for
the shortest possible duration should be used (see Section 4.4 Special
warnings and precautions
for use). Patients on long term treatment should be reviewed regularly
with regards to efficacy,
risk factors and ongoing need for treatment.
ORUDIS SUPPOSITORIES:
Normal suppository dosage is 1 suppository (100 mg) late at night
supplemented as required with Orudis capsules during daytime.
Orudis suppositories are especially appropriate for controlling
overnight symptoms (severity
of
night
and
morning
pain;
duration
and
severity
of
morning
stiffness).
Suppositories
administered late at night provide more consistent effective control
of overnight symptoms
than oral medication.
ORUDIS SR (SUSTAINED RELEASE) CAPSULES:
100 to 200 mg once daily depending on the
patient’s weight and on the severity of symptoms. Orudis SR should
be taken with food.
orudis-ccdsv11-piv20-02dec20
Page 2 of 17
USE IN THE ELDERLY:
It is generally advisable in the elderly to begin ketoprofen therapy
at the
lower end of the dosage range and to maintain such patients on the
lowest effective dosage.
4.3
CONTRAINDICATIONS
Active or a history of gastrointestinal inflammatory d