Oruvail 100 modified-release capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketoprofen

Available from:

Sanofi

ATC code:

M01AE03

INN (International Name):

Ketoprofen

Dosage:

100mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5000283652489

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ORUVAIL® 100MG OR 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
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Oruvail Capsules are and what they
are used for
2. Before you take Oruvail Capsules
3. How to take Oruvail Capsules
4. Possible side effects
5. How to store Oruvail Capsules
6. Further 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 100mg
or 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
(such as ankylosing spondilitis)
• 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. BEFORE YOU TAKE ORUVAIL CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL
YOUR DOCTOR IF:
 You are alle

Summary of Product characteristics

OBJECT 1
ORUVAIL 100MG CAPSULES
Summary of Product Characteristics Updated 07-Aug-2017 | SANOFI
1. Name of the medicinal product
Oruvail 100 mg Prolonged-Release Capsules, Hard
2. Qualitative and quantitative composition
Ketoprofen 100 mg
3. Pharmaceutical form
Controlled release capsules
4. Clinical particulars
4.1 Therapeutic indications
Oruvail is recommended in the management of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis,
acute articular and peri-articular disorders, (bursitis, capsulitis,
synovitis, tendinitis), cervical spondylitis,
low back pain (strain, lumbago, sciatica, fibrositis), painful
musculo-skeletal conditions, acute gout,
dysmenorrhoea and control of pain and inflammation following
orthopaedic surgery.
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
_Adults:_ 100 – 200 mg once daily, depending on patient weight and
on severity of symptoms.
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:_ The elderly are at increased risk of the serious
consequences of adverse reactions. If an NSAID
is considered necessary, the lowest effective dose should be used and
for the shortest possible duration.
The patient should be monitored regularly for GI bleeding during NSAID
therapy.
Paediatric dosage not established.
Oruvail capsules are for oral administration. To be taken preferably
with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
4.3 Contraindications
Ketoprofen is contraindicated in patients who have a history of
hypersensitivity reactions such as
bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria o