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Tiloket Gel 2.5%

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PATIENT INFORMATION LEAFLET

Tiloket 2.5% Gel

(Ketoprofen)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

■    If you have further questions, please ask your doctor or your 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.

■    This medicine is for external (topical) use only.

What is in this leaflet:

J What Tiloket Gel is and what it is used for    Possible side effects

£ What you need to know before you take Tiloket Gel Q How to store Tiloket Gel £ How to take Tiloket Gel    Q Contents of the pack and other

information


H What Tiloket Gel is and what it is used for

The name of this medicine is Tiloket 2.5% Gel (referred to as Tiloket Gel throughout this leaflet). It contains ketoprofen, which belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking some chemicals in your body that normally cause inflammation and reduces pain.

Tiloket Gel is used to treat the swelling, pain, heat, redness and stiffness in your joints and muscles in the following:

■    soft tissue injury, including rheumatic pain

■    sports injuries

■    sprains, strains, joint pain

■    ligaments, muscle and tendon injuries as well as swelling and backache

[2 What you need to know before you take Tiloket Gel

Do not use Tiloket Gel

■    If you are allergic (hypersensitive) to ketoprofen or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information")

■    If you suffer from allergic reactions such as asthma, swelling of the face or throat, "runny nose" (rhinitis) or wheals on the skin (urticaria) after using aspirin, fenofibrate or tiaprofenic acid or other Non-Steroidal Anti-Inflammatory Drugs (NSAID), such as ibuprofen or indometacin

■    If you have a history of skin allergy to ketoprofen, fenofibrate, tiaprofenic acid, UV blockers or perfume

■    If you suffer from skin problems including eczema, acne, infected skin lesions, wounds, broken skin and sores

■    If you are in the third trimester of pregnancy

Do not use on the eyes, nostrils, mouth, back

passage or genital areas. Also, do not use with

air/water-tight wound dressings.

Warnings and precautions

Talk to your doctor before using Tiloket Gel:

■    If you have problems with your heart, liver or kidney

■    If you have asthma and also long term (chronic) runny nose, inflammation of the sinuses and/or nasal polyps

A 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.

Recommended length of treatment should not be exceeded due to the increased risk of developing inflammation of the skin and photosensitivity reactions.

Stop using Tiloket Gel immediately if you experience any skin reaction 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).

If any of the above apply to you or if you are unsure, you should seek advice from your doctor or pharmacist.

Other medicines and Tiloket Gel:

Tell your doctor or pharmacist if you are taking or 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)

Pregnancy and breastfeeding

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

Talk to your doctor before using Tiloket Gel if you are less than or up to 6 months pregnant.

Do not use Tiloket Gel if you are in the last 3 months of pregnancy.

Breastfeeding

Do not use Tiloket Gel if you are breastfeeding as small amount of this medicine may pass into the breast milk.

Driving and using machines

There are no known effects associated with the use of this gel.

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