2.5% gel
ketoprofen
What Orudis is and what it is used for
Orudis contains the active substance ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory / anti-rheumatic drugs ( NSAIDs ). It is a topical drug used on the skin to relieve pain and reduce inflammation locally where the damage is.
Orudis is used for mild to moderate pain in connection with muscle and/or joint injuries, such as sports injuries.
What you need to know before using Orudis
Do not use Orudis
- If you are allergic to ketoprofen or any of the other ingredients of Orudis (see section 6).
- If you have ever had a hypersensitivity reaction (eg symptoms of asthma , hay fever, hives ) while taking fenofibrate, acetylsalicylic acid or other NSAIDs .
- If you have eczema (scaly, itchy skin rash), acne , infection or open sores in the treatment area.
- If you are in any of the last three months of a pregnancy.
- If you have ever had an abnormal skin reaction to sunlight.
- If you have known allergies to ketoprofen , thiaprofenic acid, fenofibrate, UV blockers or perfumes.
- Stop using Orudis immediately if you get a skin reaction including reactions after concomitant use of products containing octocrylene (octocrylene is one of the ingredients in several cosmetics and hygiene articles and protects them from light degradation. It is found in shampoos , after-shaves, showers And bath gels, skin creams, lipsticks, anti-wrinkle creams, make-up removers and hair sprays).
- Do not expose the treated area to sunlight or UV light from the solarium during the treatment and for 2 weeks after the end of the treatment.
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.
Warnings and cautions
Talk to your doctor or pharmacist before using Orudis if any of the following apply to you.
- If you have asthma
- If you have heart, liver or kidney problems, talk to your doctor before using Orudis.
- Do not cover the treated area with bandages or other dressings.
- Gel one should not be used on sensitive skin such as mouth, other mucous membranes, genitals, rectum or eyes.
Exposure to the sun (including sun ice) or UV light in areas that have come into contact with Orudis can cause skin reactions that can be serious (light hypersensitivity). It is, therefore, necessary to:
- protect treated areas by wearing clothing during treatment and for two weeks after the end of treatment to reduce the risk of photosensitivity,
- wash your hands thoroughly after using Orudis.
If you develop a skin reaction, stop treatment immediately and contact your doctor or healthcare professional, see section 4 Possible side effects.
Do not use Orudis for more than 7 days. The risk of certain side effects increases over time.
If you are not sure if any of the above applies to you, talk to your doctor before using Orudis.
Children
Orudis is not recommended for use in children.
Other medicines and Orudis
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
Pregnancy
- Avoid using Orudis during the first 6 months of pregnancy. Always consult a doctor before using Orudis.
- Do not use gel one during the last three months of pregnancy as the fetus may be affected.
Lactation
It is not known whether ketoprofen is excreted in human milk. You should avoid breastfeeding when using Orudis 2.5% gel.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No known risks to the ability to drive and use machines.
How to use Orudis
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Use of this medicine
- Orudis is applied only to the skin ( cutaneous use).
- Massage gel into the skin for a few minutes. Remember to screw the lid on the gel tube again.
Dosage
Adults
- Apply a thin layer of gel on the painful or inflamed area 2-3 times daily for up to 7 days as directed.
- Do not use more gel than necessary and no more than 15 g per day to cover the damaged area. 7.5 g corresponds to approximately 14 cm of gel .
Children
Orudis is not recommended for use in children.
If you use more Orudis than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. If you have used too much medicine, it is not likely to cause any problems. If you or anyone else accidentally swallows Orudis, tell a doctor immediately or go to a hospital as soon as possible.
Take the pack with you so that your doctor knows what you have taken.
If you forget to use Orudis
If you forget a treatment, treat it as soon as you remember. If it is close to the next treatment opportunity, skip the missed treatment. Do not take a double dose to make up for forgotten treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Orudis and contact a doctor immediately if you:
- gets symptoms of angioedema (unknown frequency) such as:
- swelling of the face, tongue or throat
- difficulty swallowing or breathing
- hives
- experiencing symptoms of severe skin problems (frequency unknown), for example:
- blistering, flaking or bleeding on any part of your skin with or without a rash (including your lips, eyes, mouth, nose, genitals, hands or feet)
- You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.
Other side effects include:
Uncommon (may affect up to 1 in 100 people)
- Local skin reactions such as redness , eczema , itching and burning sensation
Rare (may affect up to 1 in 1,000 people)
- Severe skin reactions when exposed to sunlight and allergic skin reactions such as hives have been reported. Cases of more severe reactions such as eczema with blisters or blisters that can spread or become common have occurred in rare cases.
Very rare (may affect up to 1 in 10,000 people)
- Deterioration of previous renal impairment.
Unknown frequency (can not be determined from the available data)
Anaphylactic shock, allergic reactions.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
How to store Orudis
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 tube. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
The medicine 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.
Contents of the pack and other information
Content declaration
The active substance is ketoprofen. 1 gram of gel contains 25 mg of ketoprofen.
The other ingredients are ethanol, carbomer, triethanolamine, lavender oil, and purified water.
What the medicine looks like and contents of the pack
Orudis is a colorless transparent gel with a scent of lavender. It is available in tubes of 30 g or 60 g. One pack contains 1 tube of 30 g or 60 g or 2 tubes of 60 g.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of sales license:
Sanofi AB, Box 30052, 104 25 Stockholm
This medicine is authorized in the European Economic Area under the names:
Sweden: Orudis 2.5% gel
Italy: Orudis 2.5% gel