Tiloket (Ketoprofen) 2.5% Gel

• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tiloket Gel is and what it is used for
2. What you need to know before you use Tiloket Gel
3. How to use Tiloket Gel
4. Possible side effects
5. How to store Tiloket Gel
6. Contents of the pack and other information

• If you are allergic to Ketoprofen, other NSAIDs or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from allergic reactions such as difficulty breathing, swelling of the face, throat or tongue, "runny nose" (rhinitis) or wheals on the skin (urticaria) after using aspirin, tiaprofenic acid or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen or indometacin, or fenofibrate (a medicine used to lower blood cholesterol)
• If you have a history of increased sensitivity of the skin to sunlight (photosensitivity)
• If you have a history of skin allergy to ketoprofen, fenofibrate, tiaprofenic acid, UV blockers (sun creams) or perfume
• If you suffer from skin problems including eczema, acne, infected skin lesions, wounds, broken skin and sores
• If you are in the last 3 months of pregnancy

Do not use Tiloket Gel on the eyes, nostrils, mouth, back passage or genital area or with air/water−tight wound dressings

(Graphic: Explanation symbol)

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.

Talk to your doctor before using Tiloket Gel:

• If you have problems with your heart, liver or kidneys
• If you have asthma and also long term (chronic) runny nose (rhinitis), inflammation of the sinuses (sinusitis) and/or nasal polyps

Recommended length of treatment should not be exceeded as prolonged use or use of large amounts of Tiloket Gel may increase the risk of developing inflammation of the skin and photosensitivity reactions

Stop using Tiloket Gel immediately if you experience any skin reaction such as a rash including skin reactions after using it with products containing octocrylene (ingredient 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 hairsprays).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

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

Methotrexate, used for some types of cancer or psoriasis (chronic skin disease which causes scaly pink patches)

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

• Do not use Tiloket Gel if you are in the last 3 months of pregnancy. You should not use Tiloket Gel during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should be used.
• Oral forms (e.g. tablets) of ketoprofen can cause adverse effects in your unborn baby. It is not known if the same risk applies to Tiloket Gel when it is used on the skin.

Breast-feeding

Do not use Tiloket Gel if you are breast-feeding as a small amount may pass into the breast milk.

• Wash your hands thoroughly before and after use unless the hands are being treated.
• Unscrew the plastic cap and using the spike inside the cap, pierce the top of the tube.
• Apply to the skin of the affected area as directed.
• Replace plastic cap immediately after use.

• 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.

Tiloket Gel is not recommended.

If you accidentally apply more gel than you should and/or you develop a rash or other skin irritation, contact your doctor or pharmacist as soon as possible for advice.

Apply it as soon as you remember, unless it is nearly time for your next application. If you miss an application, do not apply double the amount of gel to make up for a forgotten application.

It is important that you keep using Tiloket Gel for as long as your doctor has told you to.

If the gel is accidentally swallowed, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or tube with you.

Stop using Tiloket Gel and seek medical advice immediately if you develop:

• Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
• Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia)
• Localised skin reactions such as redness, swelling, itching and blisters
• Burning sensation including on application site

Uncommon: may affect up to 1 in 100 people

The following side effects are usually mild and disappear after stopping treatment with Tiloket Gel:

• Severe itching (pruritus)
• Skin rashes (erythema) and inflammation of the skin (eczema)

Rare: may affect up to 1 in 1,000 people

• Skin rash or inflammation (dermatitis)
• Abnormal sensitivity of the skin to sunlight (photosensitivity)
• Skin rashes with the formation of wheals (urticaria)

Very rare: may affect less than 1 in 10,000 people

• Worsening of existing kidney problems or kidney failure

Not known: frequency cannot be estimated from the available data

• Contagious skin infection that causes sores and blisters (impetigo)
• Swelling of the eyelids and/or lips
• Inflammation of blood vessels (vasculitis)
• Stomach ulcer
• Bleeding from the stomach, gums or bottom
• Diarrhoea
• Fever (pyrexia)
• Complication of wounds

Elderly people are particularly susceptible to the side effects of Non Steroidal Anti-Inflammatory Drugs (NSAIDs).

If you get any side effects, talk to your doctor or pharmacist. 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.

Tiloket Gel contains 2.5% w/w of Ketoprofen.

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

Tiloket Gel is a homogeneous transparent gel with an odour of alcohol and lavender.

A 50g and 100g tube with a plastic screw cap.

Not all packs sizes may be marketed.

Product Licence Number: PL 11311/0127