Oruvail 200mg Prolonged-Release Capsules, Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketoprofen

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

M01AE; M01AE03

INN (International Name):

Ketoprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Prolonged-release capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives; ketoprofen

Authorization status:

Marketed

Authorization date:

1984-08-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ORUVAIL™ 200MG PROLONGED RELEASE CAPSULES, HARD
Ketoprofen
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. (See section 4).
IN THIS LEAFLET:
1.
What Oruvail Capsules are and what they are used for
2.
What you need to know before you take Oruvail Capsules
3.
How to take Oruvail Capsules
4.
Possible side effects
5.
How to store Oruvail Capsules
6.
Contents of the pack and other information
1. WHAT ORUVAIL CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT ORUVAIL CAPSULES ARE AND HOW THEY WORK
The name of your medicine is Oruvail 200mg Prolonged Release Capsules,
Hard (called Oruvail
Capsules in this leaflet). Oruvail Capsules contain a medicine called
ketoprofen. This belongs to a
group of medicines called ‘Non-Steroidal Anti-Inflammatory Drugs’
(NSAID’s). It works by blocking
chemicals in your body that normally cause inflammation.
WHAT ORUVAIL CAPSULES ARE USED FOR
Oruvail Capsules are used to treat the swelling, pain, heat, redness
and stiffness in your joints and
muscles in the following:
•
Rheumatoid arthritis (inflammation of your joints)
•
Osteoarthritis (where the cushioning (cartilage) between your bone
joints is damaged)
•
Pain due to problems with your spine
•
Lower back pain
•
Sprains and strains
•
Painful periods
•
Pain and inflammation after an operation
•
Other painful inflammatory joint, tendon, nerve or muscle problems
•
Gout (painful, red, swollen joints)
2. WHAT YOU NEED TO KNOW BEFORE YOU TA

Summary of Product characteristics

Health Products Regulatory Authority
14 August 2023
CRN00D6ZQ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oruvail 200mg Prolonged-Release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg of Ketoprofen.
Excipients: Sucrose 52.62mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-Release capsules, Hard.
Having a transparent pink body with opaque white cap with the product
name ‘Oruvail 200’ imprinted on both sections and
containing off-white to cream coloured spherical pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oruvail is recommended in the management of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis, gout, non-infectious
arthropathy, acute articular and periarticular disorders (bursitis,
capsulitis, synovitis, tendonitis), sciatica, painful musculoskeletal
conditions and management of the pain of dysmenorrhoea.
Oruvail reduces joint pain and inflammation, and facilitates increase
in mobility and functional independence. As with other
non-steroidal anti-inflammatory agents, it does not cure the
underlying disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be taken orally.
Adults Only:
The usual total daily dose is 100 to 200 mg as a single dose to be
taken with food.
The maximum daily dose is 200 mg. The balance of risks and benefits
should be carefully considered before commencing
treatment with 200 mg daily, and higher doses are not recommended (see
also section 4.4).
Elderly:
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events. It is advisable to
reduce the initial dosage and maintain such patients on the minimal
effective dose.
Patients with impaired renal function:
It is advisable to reduce the initial dose and maintain such patients
on the minimal effective dose. Individual assessment may
be considered only after good individual tolerance has been
ascertained.
Patients with impaired hepatic function:
These patients sho