Oruvail SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ketoprofen 100mg

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Ketoprofen 100 mg

Dosage:

100 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Ketoprofen 100mg Excipient: Colloidal silicon dioxide Erythrosine Ethylcellulose Gelatin Non pariel beads, maize starch + sucrose Opacode white S-1-7020 Patent blue V Purified talc Shellac Sodium laurilsulfate Titanium dioxide

Units in package:

Blister pack, PVC/PVdC/AL, 10, 50, 100 capsules (not marketed),

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/AL, 10, 50, 100 capsules -   - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Securitianer - 50 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Securitianer - 100 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1982-04-02

Patient Information leaflet

Oruvail® SR
1
ORUVAIL SR
®
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 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 that you are using

Summary of Product characteristics

oruvail-sr-ccdsv14-dsv17-13nov23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Oruvail SR 200 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen (200mg).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified release capsule.
_ _
Oruvail SR 200 mg capsules are presented pink/white capsules printed
ORUVAIL SR 200.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oruvail is recommended in the management of rheumatoid arthritis,
osteoarthritis, ankylosing
spondylitis, acute articular and periarticular disorders (bursitis,
capsulitis, synovitis, tendonitis),
fibrositis, cervical spondylitis, low back pain, (strain, lumbago,
sciatica), gout and
dysmenorrhoea. Oruvail reduces joint pain and inflammation and
facilitates increase in mobility
and functional independence. It is also indicated in the treatment of
post-operative pain.
As with other non-steroidal anti-inflammatory agents, ketoprofen does
not cure the underlying
disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
4.2.1
DOSE
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
oruvail-sr-ccdsv14-dsv17-13nov23
Page 2
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.
4.2.2
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.
Elderly patients are more
prone to adverse effects. Caution must be taken with dosage in this
group and also in patients with
renal impairment.
4.3
CONTRAINDICATIONS
Active or history of gastrointestinal inflammatory disorder