Monday, September 12, 2016

Oruvail Gel 2.5% (30g)





Oruvail 2.5% Gel



ketoprofen







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Read all of this leaflet carefully because it contains important information for you.



This medicine is available without prescription. However, you still need to use Oruvail Gel carefully to get the best results from it.



  • Keep this leaflet. You may need to read it again.

  • Ask your pharmacist if you need more information or advice.

  • You must contact a doctor if your symptoms worsen or do not improve after using this medicine for 7 days.

  • 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





What Oruvail Gel is and what it is used for






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.





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





Before you use Oruvail Gel






Do not use this medicine and tell your doctor if:



  • You are allergic (hypersensitive) to:

    • ketoprofen

    • 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)

    • 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 rashes)

  • You have sore, broken or infected skin

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.







Take special care with Oruvail Gel



Check with your doctor or pharmacist before using your medicine if:



  • You have severe kidney problems

  • You are planning to use a solarium or will be exposed to direct sunlight or ultraviolet rays for up to two weeks after you have used the medicine

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







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 works.



In particular, tell your doctor if you are taking any of the following:



  • Methotrexate – used for some types of cancer or psoriasis




Pregnancy and breast-feeding



Do not use this medicine if you are pregnant, might become pregnant, or think you may be pregnant.



You should not breast-feed if you are using Oruvail Gel. This is because small amounts may pass into mothers’ milk.



Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.






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


How much to use



Adults (including the elderly) and children 12 years of age and older



  • Apply a thin layer of gel to the painful area three times a day for up to 7 days as directed.

Children under 12 years of age



Oruvail Gel is not recommended for use in children under 12 years of age.





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 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.






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





Possible side effects



Like all medicines, Oruvail Gel can cause side effects, although not everybody gets them.




Stop taking and see your doctor or go to a hospital straight away if:



  • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

  • You get a skin rash, blisters, red lumps or eczema

  • You have a skin reaction to light or sunlamps (photosensitivity)




Other side effects



  • Itching skin



Tell your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.





How to store Oruvail Gel



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.





Further information




What Oruvail 2.5% Gel contains



  • The gel contains 2.5% w/w of the active substance, ketoprofen

  • The other ingredients are carbopol, triethanolamine, lavender oil, ethanol and purified water




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 tubes of 30, 50, 60, 100 or 150g. Not all pack sizes may be marketed.





Marketing Authorisation Holder and Manufacturer



Marketing Authorisation Holder




Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com



Manufacturer




Sanofi Winthrop Industrie

196, rue du Maréchal Juin

45200 Amilly

France





This leaflet was last revised in December 2007



© sanofi-aventis, 2007



210678 - WLK71L





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