Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ketoprofen may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of this medicine is Tiloket Gel. It contains ketoprofen, which belongs to the group of medicines known as Non−Steroidal Anti−Inflammatory Drugs (NSAIDs). It works by reducing inflammation and relieving pain. Tiloket Gel is used to treat the swelling, pain, heat, redness and stiffness in your joints and muscles in the following:
e Tiloket Gel Do not use Tiloket Gel:
•
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). Other medicines and Tiloket Gel: 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) Pregnancy and breast-feeding 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
Tiloket Gel Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. • • • • •
Tiloket Gel is for external use only. It must not be applied to eyes, mouth, nostrils, genitals, back passage or broken skin Protect treated areas by wearing clothing during the treatment and for two weeks after you have stopped to avoid any risk of sensitivity of the skin to sunlight (photosensitivity) Avoid direct sunlight, UV rays and sun beds Do not cover the gel with a dressing
How to apply
Tiloket Gel is not recommended. If you apply more Tiloket Gel than you should 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. If you forget to apply Tiloket Gel 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. If you stop using Tiloket Gel It is important that you keep using Tiloket Gel for as long as your doctor has told you to. If you swallow Tiloket Gel 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious Side Effects Stop using Tiloket Gel and seek medical advice immediately if you develop:
Reporting of side effects 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Tiloket Gel
What Tiloket Gel contains: Tiloket Gel contains 2.5% w/w of Ketoprofen. The other ingredients are: carbomer, triethanolamine, lavender essential oil, ethanol and purified water. What Tiloket Gel looks like and contents of the pack: Tiloket Gel is a homogeneous transparent gel with an odour of alcohol and lavender. Tiloket Gel is available in: A 50g and 100g tube with a plastic screw cap. Not all packs sizes may be marketed. Product Licence Number: PL 11311/0127 Marketing Authorisation Holder & Manufacturer: Marketing Authorisation Holder Tillomed Laboratories Ltd. 220 Butterfield Great Marlings Luton, LU2 8DL United Kingdom Manufacturer Tillomed Laboratories Ltd. 220 Butterfield Great Marlings Luton, LU2 8DL United Kingdom Laboratórios Basi – Indústria Farmacêutica, S.A. Parque Industrial Manuel Lourenço Ferreira Lote 15 3450-232 Mortágua Portugal This leaflet was last revised in March 2025 Till−Ver.13
Tiloket (Ketoprofen) 2.5% Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tiloket (Ketoprofen) 2.5% Gel is ketoprofen.
Medicines with the same active substance, strength and form include: Powergel 2.5% gel, Ketoprofen 2.5% w/w Gel. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Tiloket (Ketoprofen) 2.5% Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ketoprofen is a non–steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions.
Symptomatic relief of acute painful musculoskeletal conditions caused by trauma, such as soft tissue injuries, including sports injuries, sprains, strains, contusions and musculo-tendonitis swelling, backache and rheumatic pain.
Pain of non-serious arthritis
Posology
Adults
To be applied two to four times daily to the skin in the painful or inflamed region for up to 7 days. Apply gently but massage well to ensure gel penetration. The usual recommendation dose is 15g per day (7.5grams correspond to approximately 14cm of gel)
Elderly
There are no specific dosage recommendations for the elderly
Paediatric population
Children under 15 years: Not recommended, as safety in children has not been established.
Method of administration
Local route.
Tiloket Gel must not be used in patients with:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to fenofibrate, tiaprofenic acid, acetylsalicylic acid or to other Non-Steroidal Anti-Inflammatory drugs (NSAID).
• History of photosensitivity reaction
• History of skin allergy reactions to ketoprofen, tiaprofenic acid, fenofibrate or UV blockers or perfumes
• Sun exposure, even in case of hazy sun, including UV light from solarium, during treatment and for 2 weeks after its discontinuation (see section 4.4).
• Exudative dermatoses, on pathological skin changes such as eczema or acne; or in infected skin lesions, open wounds, broken skin and sores.
• Tiloket gel should not be applied to mucous membranes, anal or genital areas, eyes or used with occlusive dressings.
• Third trimester of pregnancy.
For topical use only.
• Although systemic effects are minimal, the gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions consisting of renal affections have been reported.
• The topical use of large amounts of product may give rise to systemic effects such as hypersensitivity and asthma.
• Hands should be washed thoroughly after each application of the gel.
• Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene-containing products.
• It is recommended to protect treated areas by wearing clothing during all the application of the gel and two weeks following its discontinuation to avoid the risk of photosensitisation.
• Do not apply Tiloket Gel beneath occlusive dressings.
• The gel must not come in contact with mucous membrane or the eyes.
• Keep the gel away from naked flames. Do not incinerate.
• Should a skin rash occur after gel application, treatment must be stopped.
• The recommended length of treatment should not be exceeded (see section 4.2) due to the risk of developing contact dermatitis and photosensitivity reactions which increases over time.
• Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population.
• The safety and efficacy of ketoprofen gel in children have not been established.
• Areas of skin treated with Tiloket Gel should not be exposed to direct sunlight, or solarium ultraviolet light, either during treatment or for two weeks following treatment discontinuation, in order to avoid, phototoxicity reactions and photoallergy.
• The use of topical products, especially if it is prolonged, may give rise to phenomena of sensitisation or local irritation.
• Keep out of the sight and reach of children.
Interactions are unlikely, as serum concentrations following topical application are low.
It is, however, advisable to monitor patients under treatment with coumarinic substances
Serious interactions have been recorded after the use of high dose methotrexate with non-steroidal anti-inflammatory agents, including ketoprofen, when administered by the systemic route.
Pregnancy
There are no clinical data from the use of topical forms of ketoprofen during pregnancy. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic ketoprofen exposure reached after topical administration can be harmful to an embryo/foetus. During the first and second trimester of pregnancy, Tiloket gel should not be used unless clearly necessary. If used, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed. Therefore, Tiloket gel is contraindicated during the last trimester of pregnancy (see section 4.3).
Breast-feeding
Trace amounts of ketoprofen are excreted in breast milk; therefore, Tiloket gel should not be used during breast feeding.
None known.
The most common adverse reactions are photosensitive reactions (phototoxic and photosensitivity allergic reactions), the majority of which occurs after an incorrect use of the product (exposure of the skin to sunlight or solarium before 15days from the last application, see sections 4.3 and 4.4). There have been reports of localised skin reactions due to photosensitivity, including erythema, pruritus and burning sensations, which might spread beyond the area of application. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
Other systemic effects of anti-inflammatory drugs: hypersensitivity, gastrointestinal and renal disorders (these depend on the transdermic spreading of the active ingredient, hence on the amount of gel applied, on the surface involved, on the degree of intactness of the skin, on the duration of the treatment and on the use of occlusive bandages).
The below mentioned adverse reactions have been collected in the post-marketing experience.
System Organ Class
Uncommon
(≥1/1000 to <1/100)
Rare
(≥1/10 000 to <1/1000)
Very rare
(<1/10 000)
Not known
(cannot be estimated from the available data).
Infections and infestations
Secondary impetigo
Blood and lymphatic system disorders
Eosinophilia
Immune System disorder
Anaphylactic reaction, angioedema, hypersensitivity
Eye disorders
Eyelid oedema
Vascular disorders
Vasculitis
Gastrointestinal disorders
Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema
Skin and subcutaneous tissue disorders
Rash (erythematous, generalised, maculo-papular, papular, pruritic, pustular, vesicular), eczema, pruritus, burning sensations application site burn.
Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, allergic reaction, skin exfoliation, skin oedema.
Renal and urinary disorders
Acute renal failure, insufficiency aggravated
General disorder and administration site condition
Pyrexia
Injury, poisoning and procedural complications
Wound complication
Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Overdose is unlikely to be caused by topical administration. If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be supportive and symptomatic in accordance with over dosage of oral anti-inflammatories.
Ask anything about Tiloket (Ketoprofen) 2.5% Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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