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

Administration route:

Oral

Units in package:

30 x 200mg capsules, 7 x 200mg capsules, 100 x 200mg capsules, 28 x 200mg capsules

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 'ORUVAIL 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:

1993-01-07

Patient Information leaflet

ORUVAIL SR
®
O
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®
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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 ORUVAIL SR?
Oruvail SR contains the active ingredient ketoprofen. Oruvail SR is
used to treat the symptoms of rheumatoid arthritis and
osteoarthritis. Oruvail SR belongs to a family of medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines
work by relieving pain and inflammation.
For more information, see Section 1. Why am I using Oruvail SR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ORUVAIL 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 Oruvail SR during the first and second trimester of
pregnancy should be avoided, as the safety of Oruvail 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
Oruvail SR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Oruvail 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 ORUVAIL 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 Oruvail SR until your doctor
tells you to stop.
More instructions can be found in Section 4. How do I use Oruvail SR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ORUVAIL SR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit tha

Summary of Product characteristics

oruvail-ccdsv12-piv20-25may22
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION – ORUVAIL
®
SR
(KETOPROFEN)
1
NAME OF THE MEDICINE
Ketoprofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oruvail SR capsules contain ketoprofen 200mg.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Hard gelatin capsule, clear pink base & white opaque cap. Base & Cap
printed 'ORUVAIL
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.
100 to 200 mg once daily depending on the patient’s weight and on
the severity of symptoms.
Oruvail SR should be taken with food.
USE IN PREGNANCY:
see
SECTION 4.3 CONTRAINDICATIONS
and
SECTION
4.6 FERTILITY, PREGNANCY
AND LACTATION
.
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.
oruvail-ccdsv12-piv20-25may22
Page 2 of 16
4.3
CONTRAINDICATIONS
•
Active or history of gastrointestinal inflammatory disorder or
ulceration,
haemorrhage, chronic dyspepsia.
•
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs
therapy. Known hypersensitivity to ketoprofen, aspirin or other
NSAIDs.
•
Patients in whom aspirin or other NSAIDs induce symptoms of asthma,
rhinitis or
urticaria. Severe, rarely fatal anaphylactic reactions have been
reported in such
patients.
•
Third trimester of pregnancy (see
SECTION 4.6 FERTILITY, PREGNANCY AND LACTATION
).
•
Severe heart failure.
•
Severe renal insufficiency. Severe hepatic impairment.
•
Treatment of