Package leaflet: Information for the user
Orudis 2.5% gel
ketoprofen
Read all of this leaflet carefully before you start using 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 of these effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1.
What Orudis 2.5% gel is and what it is used for
2.
What you need to know before you use Orudis 2.5% gel
3.
How to use Orudis 2.5% gel
4.
Possible side effects
5.
How to store Orudis 2.5% gel
6.
Contents of the pack and other information
1.
What Orudis 2.5% gel is and what it is used for
Orudis 2.5% gel belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs). This is a cutaneous medicine that is applied on the skin to relieve pain and reduce
inflammation locally at the sight of the injury.
Orudis 2.5% gel is used for the relief of mild to moderate pain associated with muscle and/or joint
injuries, e.g. sport injuries.
2.
What you need to know before you use Orudis 2.5% gel
Do not use Orudis 2.5% gel
If you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in
Section 6)
If you have ever had an allergic reaction (such as symptoms of asthma, hay fever, hives) when
you have taken fenofibrate, acetylsalicylic acid or other Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs)
If you have eczema (a scaly, itching rash), acne, infections or open wounds on the treatment
area
If you are in the last three months of pregnancy
If you have ever had an abnormal skin reaction to sunlight
If history of allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers or perfumes is
known
Stop using Orudis 2.5% gel immediately if you experience any skin reaction including
cutaneous reactions after co-application of octocrylene containing products (Octocrylene is one
of the ingredients of several cosmetic and hygiene products such as shampoo, after-shave,
shower- and bath-gels, skin creams, lipsticks, anti-ageing creams, make-up removers, hair
sprays in order to delay photodegradation)
Do not expose treated areas to sunlight or UV light from solarium during the treatment and the
2 weeks following its discontinuation
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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 Orudis 2.5% gel.
Warnings and precautions
Talk to your doctor or pharmacist before using Orudis 2.5% gel if any of the following applies to you.
-
If you are asthmatic
If you have heart, liver or kidney problems, consult your doctor before taking Orudis.
Do not cover the treated area with bandages or other dressings.
It must not be put on sensitive skin such as the mouth, other mucous membranes, genitals, back
passage or eyes.
The exposure to the sun (even hazy) or to UVA of areas in touch with Orudis 2.5% gel can induce
potentially serious cutaneous reactions (photosensitisation). Therefore it is necessary to:
protect treated areas by wearing clothing during the treatment and for two weeks after its
discontinuation to avoid any risk of photosensitisation.
wash your hands thoroughly after each application of Orudis 2.5% gel.
Treatment should be discontinued immediately upon development of any skin reaction after
application of Orudis 2.5% gel.
Do not use Orudis 2.5% gel for more than 7 days. The risk of certain side effects increases with time.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using
Orudis 2.5% gel.
Children
Orudis 2.5% gel is not recommended for use in children.
Other medicines and Orudis 2.5% gel
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Pregnancy
 Avoid the use of Orudis 2.5% gel during the first six months of pregnancy. Ask your doctor
for advice before taking Orudis 2.5% gel.
 Do not use the gel during the last three months of pregnancy, as the foetus may be affected.
Breast-feeding
It is not known if ketoprofen, the active substance of Orudis 2.5% gel, passes into mothers’ milk. You
should avoid using Orudis 2.5% gel if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Orudis 2.5% gel is not known to effect your ability to drive a car.
3.
How to use Orudis 2.5% gel
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
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Using this medicine

Orudis 2.5% gel is applied on the skin only (cutaneous use).

Massage the gel into the skin for a few minutes. Remember to close the tube.
How much to use
Adults

Apply a thin layer of gel to the painful area two to three times a day for up to 7 days, as
directed.

Do not use more gel than needed, and no more than 15 g a day, to cover the injured area. 7.5 g
corresponds to approximately 14 cm.
Children
Orudis 2.5% gel is not recommended for use in children.
If you use more Orudis 2.5% gel than you should
If you use more gel on the skin than you should it is unlikely to cause a problem. If you or someone
else accidentally swallows Orudis 2.5% gel, tell a doctor or go to a hospital emergency department as
soon as possible. Take the medicine with you so that the doctor knows what you have taken.
If you forget to use Orudis 2.5% 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop using Orudis 2.5% gel and see your doctor immediately if you experience symptoms
of angioedema, such as:

swollen face, tongue or throat

difficulty swallowing or breathing

nettle rash
Other side effects include:
Uncommon (affects 1 to 10 users in 1,000)

Local skin reactions such as redness, eczema, itching and burning sensations.
Rare (affects 1 to 10 users in 10,000)

Severe skin reactions during exposure to sun light, and allergic skin reactions such as hives,
have been reported. Cases of more severe reactions such as eczema with blistering of the skin or
pustules (bullous or phlyctenular eczema) which may spread or become generalised have
occured rarely.
Very rare (affects less than 1 user in 10,000)

Worsening of previous kidney impairment.
Unknown (cannot be estimated from available data)

Anaphylactic shock, swelling (angioedema) of the face, tongue or throat, allergic reactions.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
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5.
How to store Orudis 2.5% gel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the tube. The expiry
date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Orudis 2.5% gel contains
The active substance is ketoprofen. Each gram of gel contains 25 mg ketoprofen.
The other ingredients are ethanol, carbomer, triethanolamine, lavender oil, and purified water.
What Orudis 2.5% gel looks like and contents of the pack
Orudis 2.5% gel is a colourless transparent gel with a scent of lavender. It is supplied in tubes of 30 g
or 60 g. One box contains 1 tube of 30 g or 60 g, or 2 tubes of 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following
names:
Sweden: Orudis 2.5% gel
Italy: Orudis 2.5% gel
This leaflet was last approved in 2013-01-10
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