What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.


Oruvail 2.5% Gel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oruvail® 2.5% Gel

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

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

2. Before you use Oruvail Gel

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 rashes)
  • 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.

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, anti-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.

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 stopping

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.

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

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

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.

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’ milk.

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

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 (dermatitis).
  • The usual dose is 15 grams a day (approximately 28 centimetres) of the gel onto the painful area.

Children

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 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.

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

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

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.

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

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.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. 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.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK
Tel: 0845 372 7101

Manufacturer

Sanofi Winthrop Industrie
196, rue du Maréchal Juin
45200 Amilly
France

This leaflet was last revised in 07/2019

© Sanofi, 1992 - 2019

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