ORUDIS SR ketoprofen 200mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketoprofen, Quantity: 185.8 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: Shellac; purified talc; colloidal anhydrous silica; Gelatin; sodium lauryl sulfate; titanium dioxide; erythrosine; ethylcellulose; indigo carmine aluminium lake; butan-1-ol; industrial methylated spirit; purified water; sulfuric acid; ammonia; maize starch; sucrose

Administration route:

Oral

Units in package:

100 x 200mg capsules, 28 x 200mg capsules, 30 x 200mg capsules, 4 x 200mg capsules

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rheumatoid arthritis, osteoarthritis

Product summary:

Visual Identification: hard gelatin capsule,clear pink base & white opaque cap. Base & cap printed 'ORUDIS SR 200' and contains off-white to cream spherical pellets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-21

Patient Information leaflet

ORUDIS SR
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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 SR?
Orudis SR contains the active ingredient ketoprofen. Orudis SR is used
to treat the symptoms of rheumatoid arthritis and
osteoarthritis.
For more information, see Section 1. Why am I using Orudis SR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ORUDIS SR?
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 SR during the first and second trimester of
pregnancy should be avoided, as the safety of Orudis SR 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 SR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Orudis SR 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 SR?
•
The usual dose for this medicine is 100mg to 200mg taken once a day,
with food and plenty of fluids.
•
Follow the instructions provided and use Orudis SR until your doctor
tells you to stop.
More instructions can be found in Section 4. How do I use Orudis SR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ORUDIS SR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Orudis SR.
•
Call your doctor straight away if you become pregnant while you are
taking this medicine
•
Call your doctor straight away if you get an inf

Summary of Product characteristics

orudis-ccdsv11-piv20-02dec20
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