PATIENT INFORMATION LEAFLET

KETOPROFEN 2.5% w/w GEL Ketoprofen 25 mg/g

Read all of this leaflet carefully before you start using 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.

In this leaflet:

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

2.    Before you use Ketoprofen Gel

3.    How to use Ketoprofen Gel

4.    Possible side effects

5.    How to store Ketoprofen Gel

6.    Further information

1.    WHAT KETOPROFEN GEL IS AND WHAT IT IS USED FOR

Ketoprofen Gel is a homogeneous and colourless gel for application to the surface of the skin only. It contains ketoprofen which belongs to a non-steroidal group of anti-inflammatory drugs (NSAIDs), like aspirin, which help to reduce pain and inflammation. Ketoprofen Gel is used for pain relief in :

•    soft tissue injuries including sports injuries and sprains and strains

•    musculo-tendonitis

•    swelling

•    backache

•    rheumatic pain

2.    BEFORE YOU USE KETOPROFEN GEL Do not use Ketoprofen Gel

•    If you have a history of allergy to Ketoprofen or to any of the other ingredients of Ketoprofen Gel (see section 6),

tiaprofenic acid, fenofibrate, UV blockers or perfumes

•    If you have ever had asthma, urticaria (skin rash), or runny nose and sneezing after taking aspirin or other NSAIDs

•    On an area where you have any skin conditions, eczema, wounds or infections

•    In your eyes, mouth, nose, or on the anal or genital areas; if this happens, wash with plenty of clean water.

Stop using Ketoprofen Gel immediately if you experience any skin reactions including skin reactions after co-application of octocrylene-containing products (Octocrylene is one of the excipients included in severeal 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 to delay photodegradation).

Protect your skin from sunlight even on a bright but cloudy day. Do not use sun beds.

This applies during treatment and for two weeks after stopping.

Take special care with Ketoprofen Gel in the following situations

•    Exposure to sunlight (even hazy) or to UV light of areas treated with Ketoprofen Gel can cause serious skin reactions (Photosensitisation). Therefore it is necessary to:

•    protect treated areas by wearing clothing during treatment and for two weeks after stopping treatment, to avoid any risk of photosensitisation

•    wash hands thoroughly after each application of Ketoprofen Gel

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

Consult your doctor if you develop any skin reaction after using Ketoprofen Gel. If you have to go to a hospital, tell the medical staff that you are using this product.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially those for pain relief, such as aspirin or other NSAIDs.

Pregnancy and breast-feeding

Tell your doctor if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. Ketoprofen Gel must not be used if you are breast-feeding.

3.    HOW TO USE KETOPROFEN GEL

FOR EXTERNAL USE ONLY

Always use Ketoprofen Gel exactly as your doctor has told you. Your doctor will tell you how much to apply and how often, but you must check with your doctor if you are not sure.

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Do not exceed the stated dose.

For application to the surface of the skin only:

1.    Wash your hands thoroughly before use.

2.    Unscrew the cap, turn it upside down and use the spike of the cap to puncture the top of the tube.

3.    Apply the correct dose. Massage the gel gently into the painful or inflamed area to ensure absorption into the skin, and there may be a slight cooling effect as the gel is applied. Apply 2 to 4 g of Ketoprofen Gel (equivalent to a 5-10 cm strip) to the affected area two to four times a day. Do not apply more than 15 g of gel (equivalent to approximately 35 cm strip) in any one day.

The usual dose is

4.    Replace the cap tightly immediately after use.

5.    Wash your hands again, unless your hands are being treated with the gel.

6.    Once applied, do not cover the area with a dressing or plaster.

7.    If your symptoms remain at the end of 7 days, stop your treatment and consult your doctor or pharmacist.

Do not exceed the recommended maximum daily dose of 15 g (equivalent to a 35 cm strip) of Ketoprofen Gel in one day.

If you do, you may experience allergy (hypersensitivity) and asthma or other effects including kidney disease.

If you get the gel in your eyes, mouth, nose or on the anal or genital areas, wash with plenty of water.

If you use more Ketoprofen Gel than you should

If you apply more than 15 g of gel in any one day, you may experience an allergic reaction (hypersensitivity), asthma or other effects including kidney disease. If you accidentally use more gel than recommended or if you or your child accidentally swallow the gel, contact your doctor or nearest hospital casualty department immediately. Take any remaining gel with you and keep it in the original packaging to help identification.

If you forget to use Ketoprofen Gel

If you miss a treatment, apply the gel as soon as you remember, but do not use more than 4 times a day.

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

4.    POSSIBLE SIDE EFFECTS

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

Stop using Ketoprofen Gel immediately and contact your doctor if;

You have an allergic reaction after using the product. The signs may include: a rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing.

The following side effects have also been reported:

•    redness of the skin, itching, urticaria (skin rash) or sensitivity to sunlight (avoid exposure)

•    allergic skin reactions

•    severe skin reaction during exposure to sun light

•    cases of more severe skin reactions such as blistering or eczema of the eyes which may spread or become generalised, have occurred rarely.

If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE KETOPROFEN GEL

Keep Ketoprofen Gel away from naked flames.

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package and keep the tube in the outer carton.

Do not use this medicine after the expiry date stated on the tube/carton.

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 Ketoprofen Gel contains

•    The active substance is ketoprofen and the gel contains 25 mg in every 1 g.

•    The other ingredients are carbomer, triethanolamine, lavender essential oil, ethanol and purified water.

What Ketoprofen Gel looks like and contents of the pack

The gel is homogeneous and colourless and is available in tubes containing 50 g or 100 g. Not all packsizes may be marketed. Marketing Authorisation Holder/Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0069    This leaflet was last revised in September 2011    ^23LF