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Active substance(s): KETOPROFEN

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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 Gel is and what it is used for
2. Before you use Oruvail Gel
3. How to use Oruvail Gel
4. Possible side effects
5. How to store Oruvail Gel
6. Further information

1. What Oruvail Gel is and
what it is used for

Stop using Oruvail Gel immediately if you experience
any skin reaction including skin reactions after
co-application of octocrylene-containing products
(Octocrylene is one of the excipients of several
cosmetic and hygiene products such as shampoo,
after-shave, shower- and bath-gels, skin creams,
lipsticks, anit-ageing creams, make-up removers and
hair sprays in order to delay photodegradation).
Do not use this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before using Oruvail Gel.

If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using Oruvail

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because Oruvail
Gel can affect the way some other medicines work.
Also some medicines can affect the way Oruvail Gel
In particular, tell your doctor if you are taking any
of the following:
• Methotrexate - used for some types of cancer or
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
you are less than or up to 6 months pregnant, might
become pregnant, or think you may be pregnant.

555618_NPA ORUVAIL GEL 2,5% 100G GB-G.indd 1

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V2 - 16/06/2014

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Treatment should be discontinued immediately upon
development of any skin reaction after application of
Oruvail Gel.


What Oruvail Gel is and how it works
The name of your medicine is Oruvail 2.5% Gel (called
Oruvail Gel in this leaflet). Oruvail Gel contains a
medicine called ketoprofen. This belongs to a group
of medicines called ‘Non-Steroidal Anti-Inflammatory
Drugs’ (NSAID’s). It works by blocking some chemicals
in your body that normally cause inflammation and
reduces pain.

Do not use this medicine and tell your
doctor if:
You are allergic (hypersensitive) to:
– ketoprofen, tiaprofenic acid, fenofibrate, UV
blockers or perfumes
– aspirin
– any other Non-Steroidal Anti-Inflammatory Drug
(NSAID) such as ibuprofen or indometacin
– any of the other ingredients of Oruvail Gel (listed
in Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
You have or have ever had asthma or other allergies
You have or ever had eczema (scaly and itching
You have sore, broken or infected skin
You are in the last 3 months of pregnancy (see
‘Pregnancy and breast-feeding’ below)
You are applying the gel on sensitive skin such as;
interior of the nose, anal or genital areas and eyes
or under an airtight dressing.

Take special care with Oruvail Gel
Check with your doctor or pharmacist before using
your medicine if:
▲ You have heart, liver or kidney problems
▲ Following exposure to sunlight (even hazy) or
to UV light, areas treated with Oruvail Gel can
cause serious skin reactions (photosensitisation).
Therefore it is necessary to:
– protect treated areas by wearing clothing during
the treatment and for two weeks after stopping
treatment to avoid any risk of photosensitisation.
– wash hands thoroughly after each application of
Oruvail Gel.


2. Before you use Oruvail Gel

For Sanofi-Aventis use only



Protect your skin from sunlight even
on a bright but cloudy day. Do not
use sunbeds. This applies during
treatment and for 2 weeks after

Technical Data

Oruvail® 2.5% Gel

What Oruvail Gel is used for
It is used to treat the swelling, pain, heat, redness and
stiffness in your joints and muscles in the following:
• Arthritis (inflammation of the joints)
• Pain from injuries such as sports injuries, sprains
and strains



16/06/14 17:26

V1 - 10/06/2014: New regulatory text
V2 - 16/06/2014: Minor amendments


Do not use this medicine if you are in the last 3 months
of pregnancy.
You should not breast-feed if you are using Oruvail Gel.
This is because small amounts may pass into mothers’
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.

casualty department straight away. Take the medicine
pack with you. This is so the doctor knows what you
have taken.
If you forget to use Oruvail Gel
If you forget a dose, use it as soon as you remember.
However, if it is nearly time for the next dose, skip the
missed dose. Do not use a double dose to make up for
a forgotten dose.

5. How to store Oruvail Gel

3. How to use Oruvail Gel
Always use Oruvail Gel exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.


Using this medicine
• This medicine is applied on the skin
• It must not be put on sensitive skin such as the
mouth, genitals, back passage or eyes
• Do not cover the gel with a dressing
• Do not mix this gel with anything else
• Avoid direct sunlight, ultraviolet rays and sunbeds
• Protect the treated region with clothing when
outdoors, even in the absence of direct sun
• Careful and prolonged hand washing should be
carried out after each use of the gel
How much to use
Adults and the elderly
• Apply to the painful area two to four times a day
for up to 7 days as directed. Do not use for longer
than directed as this can increase your chances of
getting side effects such as skin reactions to light
(photosensitivity) or inflammation of the skin
• The usual dose is 15 grams a day (approximately
28 centimetres) of the gel onto the painful area.
Oruvail Gel is not recommended for use in children.
How to use this medicine
• Wash your hands before you apply the medicine
• Remove the cap from the tube
• Squeeze out the required amount onto your palm
• Rub gently into the painful area
• Wash your hands again
• Replace the cap on the tube
• Do not cover the area. Allow it to dry
If you use more Oruvail Gel than you should
If you use more gel than you should it is unlikely to
cause a problem. If you or someone else accidentally
swallows Oruvail Gel, tell a doctor or go to a hospital

555618_NPA ORUVAIL GEL 2,5% 100G GB-G.indd 2

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.
By reporting side effects you can help provide more
information on the safety of this medicine.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Oruvail Gel can cause side effects,
although not everybody gets them.
Stop taking your medicine and see your doctor or go
to a hospital straight away if:
• You have an allergic reaction following application
of the product. The signs may include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue (frequency not known)
The following rare side effects (affecting less than 1 in
1000 patients) have been reported:
• severe skin reactions during exposure to sunlight
such as blistering or eczema of the eyes which may
spread or become generalized.
Not known: Frequency cannot be estimated from the
available data

Keep this medicine in a safe place where children
cannot see or reach it
Do not use Oruvail Gel after the expiry date which is
stated on the carton and the tube after EXP. The expiry
date refers to the last day of that month.
Store below 25°C. Keep the gel away from naked
flames. Do not incinerate.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6. Further information
What Oruvail 2.5% Gel contains
• The gel contains 2.5% w/w of the active substance,
• The other ingredients are carbopol, triethanolamine, lavender oil, ethanol and purified water

• a serious allergic reaction such as skin rash,
swelling of the face, wheezing or difficulty
breathing(anaphylactic shock)

What Oruvail Gel looks like and contents of the pack
Oruvail 2.5% Gel is a colourless transparent gel with a
scent of lavender. It is supplied in tubes of 30, 50, 60,
100 or 150g. Not all pack sizes may be marketed.

Tell your doctor or pharmacist if you have any of the
following side effects. Also tell them if you notice
any side effects not listed in this leaflet.

Marketing Authorisation Holder and Manufacturer

Uncommon side effects (affecting less than 1 in 100
patients) have been reported:
• Local skin reactions such as redness, eczema, itching
or burning sensation.
Rare side effects (affecting less than 1 in 1000) have
been reported:
• Skin reaction to light or sunlamps (photosensitivity)
• Skin rashes, blisters, red lumps or eczema
Very rare side effects (affecting less than 1 in 10,000
patients) have been reported:
• Worsening of existing kidney problems

Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS,
Tel: 0845 372 7101
Sanofi Winthrop Industrie, 196, rue du Maréchal Juin,
45200 Amilly, France
This leaflet was last revised in 06/2014
© Sanofi, 1992 - 2014

16/06/14 17:26

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.