Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ketoprofen 2.5% w/w Gel
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
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 K non-steroidal group of anti-inflammatory drugs (NSAIDs), like aspirin, which help to reduce pain and inflammation. n Ketoprofen Gel is used for pain relief in: K
- soft tissue injuries including sports injuries and sprains and strains
- musculo-tendonitis
- swelling
- backache
- conditions affecting the joints and/or connective tissues e.g. arthritis (inflammation of the joints). 2.
What you need to know before you take it
e Ketoprofen Gel Do D not use Ketoprofen Gel
- If you have a history of allergy or hypersensitivity to Ketoprofen or to any of the other ingredients of Ketoprofen Gel (see section 6), tiaprofenic acid, fenofibrate, UV blockers or perfumes. Symptoms of this would include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
- 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 or acne, open wounds or infections
- In your eyes, mouth, nose, or on the anal or genital areas; if this happens, wash with plenty of clean water
- If you are in the last 3 months of pregnancy
- If you have a history of photosensitivity reactions/reactions to light
- On an area with an occlusive dressing. Stop using Ketoprofen Gel immediately if you experience any skin reactions including skin reactions after co-application of octocrylene-containing S products (octocrylene is one of the excipients included in several cosmetic and hygiene products such as shampoo, after-shave, shower-and p bath-gels, skin creams, lipsticks, anti-ageing creams, make-up removers and hair sprays to delay photodegradation). b 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. Warnings and precautions W Talk T to your doctor before using Ketoprofen Gel:
- If you have heart, liver or kidney problems.
- The use of large amounts of Ketoprofen Gel may give rise to side effects such as hypersensitivity and asthma.
- 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.
- Avoid direct sunlight and solarium (sunbeds) during and for 2 weeks after treatment.
- Do not exceed the recommended length of treatment.
- If you have asthma as well as a persistent runny nose, sinusitis or nasal polyps, you may have a higher risk of being allergic to aspirin or similar medicines than other people.
- If you have an infection – please see heading "Infections" below. C 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 u using this product. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Ketoprofen Gel. I Infections K Ketoprofen Gel may hide signs of infections such as fever and pain. It is therefore possible that Ketoprofen Gel may delay appropriate treatment of i infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin i infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay. T 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 t those for pain relief, such as aspirin or other NSAIDs or Methotrexate used for the treatment of some types of cancer or psoriasis. 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 or pharmacist for advice before t taking this medicine. Do not use Ketoprofen Gel if you are in the last 3 months of pregnancy. You should not use Ketoprofen Gel during the first 6 months of pregnancy u unless clearly necessary and advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should b used. be O forms (e.g. tablets) of Ketoprofen Gel can cause adverse effects in your unborn baby. It is not known if the same risk applies to Ketoprofen Gel Oral w when used on the skin. 'RQRWXVHWKLVPHGLFLQHLIRXDUHEUHDVWIHHGLQJ7KLVLVEHFDXVHVPDOODPRXQWVPDSDVVLQWRPRWKHUV·PLON
How to take it
Ketoprofen Gel 3. FOR EXTERNAL USE ONLY A 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 yyour doctor if you are not sure. D not exceed the stated dose. Do 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 T Adults, the elderly and children over 15 years:
Apply 5 – 10 cm of the gel to the affected area 2 – 4 times a day for up to 7 days.
Children under 15 years:
Not recommended.
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. T lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without The delay if symptoms (such as fever and pain) persist or worsen (see Section 2). d I you use more Ketoprofen Gel than you should If 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 kkidney 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. n I you forget to use Ketoprofen Gel If If you miss a treatment, apply the gel as soon as you remember, but do not use more than 4 times a day. If yyou have anyy further q questions on the use of this p product,, ask yyour doctor or p pharmacist.
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4. 4 Possible side effects Like all medicines, Ketoprofen Gel can cause side effects, although not everybody gets them. L Stop using Ketoprofen Gel immediately and see your doctor or go to the hospital straight away if: S
- 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).
- severe skin reactions during exposure to sunlight such as blistering or eczema of the eyes which may spread or become generalized (frequency rare)
- a serious allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing (anaphylactic shock) (frequency not known)
- You have flu-like symptoms at the same time, such as fever, chills or aching muscles (frequency not known). Tell T 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. l Uncommon side effects (may affect up to 1 in 100 people) are: U
- Local skin reactions such as redness, eczema, itching or burning sensation Rare side effects (may affect up to 1 in 1,000 people) are:
- Skin reaction to light or sunlamps (photosensitivity)
- Skin rashes, blisters, red lumps or eczema Very rare side effects (may affect up to 1 in 10,000 people) are: V
- Worsening of existing kidney problems, interruption of normal functioning of the kidneys Not N known (frequency cannot be estimated from the available data) Other effects, which depend on the amount of gel applied, the extent of the area that is treated, skin thickness, length of treatment, and the use of O an a air-tight or water-tight dressing, are the following:
- Higher than normal levels of eosinophils (a particular kind of blood cell)
- Inflammation of blood vessels (known as vasculitis)
- Stomach ulcer, which may be bleeding, and diarrhoea
- Higher than normal body temperature
- Complication of wounds in patients with increased vulnerability to infection Elderly people are generally more likely to suffer from side effects of Non-Steroidal Anti-Inflammatory Drugs (the drug class to which Ketoprofen Gel G belongs). 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
Possible 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 r Apple App Store. A By B reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Ketoprofen Gel Keep Ketoprofen Gel away from naked flames. K Keep out of the sight and reach of children. K 'RQRWVWRUHDERYHÝ&6WRUHLQWKHRULJLQDOSDFNDJHDQGNHHSWKHWXEHLQWKHRXWHUFDUWRQ'RQRWXVHWKLVPHGLFLQHDIWHUWKHH[SLUGDWHVWDWHG on o 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. l 6.
Contents of the pack and other information
What Ketoprofen Gel contains W
- 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 W The T 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. M PL 04917/0069 This leaflet was last revised in 01/2023 T
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Frequently asked questions about Ketoprofen 2.5% w/w Gel
How do I take Ketoprofen 2.5% w/w Gel?
Ketoprofen 2.5% w/w Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ketoprofen 2.5% w/w Gel?
The active substance in Ketoprofen 2.5% w/w Gel is ketoprofen.
Are there equivalent medicines to Ketoprofen 2.5% w/w Gel?
Medicines with the same active substance, strength and form include: Powergel 2.5% gel, Tiloket (Ketoprofen) 2.5% Gel. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ketoprofen 2.5% w/w Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ketoprofen 2.5% w/w Gel without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ketoprofen
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Symptomatic relief of pain in such conditions as soft tissue injuries, including sport injuries, sprains, strains, musculo-tendonitis, swelling, backache and rheumatic pain.
4.2. Posology and method of administration
For cutaneous use.
Penetration of the gel by gentle and prolonged massage on the painful or inflamed surface for up to seven days.
Two to four daily applications of approximately 2 to 4 g gel, representing approximately 5 to 10 cm. The usual maximum dose is 15 g per day.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
Children (under 15 years): Not recommended, as safety in children has not been established.
4.3. Contraindications
• Known allergy to Ketoprofen, to substances of similar activity to aspirin.
• History of hypersensitivity to any of the excipients listed in section 6.1.
• History of any photosensitivity reactions.
• Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs (including when taken by mouth).
• History of skin allergy to ketoprofen, tiaprofenic acid, fenobrate or UV blocker or perfumes.
• Sun exposure, even in the case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation (see Section 4.4. Special warnings and precautions for use).
• Third trimester of pregnancy (see section 4.6).
• Patholgical skin changes such as dermatosis, eczema or acne, infected skin lesions, or open wounds.
• Not to be applied neither to mucous membranes, anal or genital areas, nor on the eyes.
• Not to be used with occlusive dressings.
• Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene-containing products.
4.4. Special warnings and precautions for use
For topical use only.
Hands should be washed thoroughly before use and immediately after each application of product (unless they are the area being treated).
It is recommended to protect treated areas by wearing clothing during all the application of the product and two weeks following its discontinuation to avoid the risk of photosensitisation.
Topical application of large amounts may result in systemic effects including hypersensitivity and asthma (renal disease has also been reported).
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.
Serious skin reactions, such as Stevens-Johnson Syndrome (SJS), have been reported in association with the use of NSAIDs, including ketoprofen gel. Patients should be informed about the signs and symptoms of serious skin manifestations. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Masking of symptoms of underlying infections
Ketoprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When ketoprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
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.
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.
Should a skin rash occur after gel application, treatment must be stopped.
Areas of skin treated with Ketoprofen 2.5 % 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.
Keep the gel away from naked flames. Do not incinerate.
The label will state:
Do not exceed the stated dose.
For external use only.
Keep out of the sight and reach of children.
If symptoms persist consult your doctor or pharmacist.
Do not use if you are allergic to ketoprofen or any of the ingredients, aspirin or any other pain killers.
Do not expose treated areas to sunlight (even hazy) including UV from solarium during the treatment and the 2 weeks after its discontinuation.
Consult your doctor before use if:
You are taking aspirin or any other pain-relieving medication.
You are pregnant or breast feeding.
4.5. Interaction with other medicinal products and other forms of interaction
Interactions are unlikely, as serum concentrations following topical application are low. However concurrent aspirin or other NSAIDs may result in increased incidence of adverse reaction. 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.
4.6. Pregnancy and lactation
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, ketoprofen should not be used unless clearly necessary. If used, the dose should be kept as low as possible.
During the third trimester of pregnancy, all 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, ketoprofen is contraindicated during the last trimester of pregnancy (see section 4.3).
Lactation
Trace amounts of ketoprofen are excreted in breast milk following oral administration, therefore the gel should not be used during breast feeding.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); 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:
Not known: Secondary impetigo
Blood and lymphatic system disorders
Not known: Eosinophilia
Immune system disorders
Not known: anaphylactic shock, angioedema, hypersensitivity reactions
Eye disorders
Not known: Eyelid oedema
Vascular disorders
Not known: Vasculitis
Gastrointestinal disorders
Not known: Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema
Skin and subcutaneous tissue disorders
Uncommon: Local skin reactions such as rash, erythema, eczema, pruritus and burning sensation, application site burn.
Rare: Photosensitisation, urticaria, bullous/contact/exfoliative/vesicular dermatitis, phlyctenular eczema, blister, photosensitivity reaction, allergic reaction, skin exfoliation, skin oedema.
Not known: Stevens-Johnson syndrome.
Renal and urinary disorders
Very rare: Cases of aggravation of previous renal insufficiency, acute renal failure
General disorders and administration site conditions
Not known: Pyrexia
Injury, poisoning and procedural complications
Not known: Wound complication
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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage 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.
💬 Ask about this leaflet
Ask anything about Ketoprofen 2.5% w/w 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.