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 Powergel contains a medicine called ketoprofen. Powergel belongs to a group of medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs). These reduce inflammation and relieve pain. Powergel is used to relieve the pain of soft tissue injuries, and acute strains and sprains. Powergel should only be used by adults and children over 12 years of age.
e Powergel Do not use Powergel: If you are allergic to ketoprofen or to any of the other ingredients of this medicine (listed in Section 6) If you are allergic to UV blockers (sun creams) or perfumes If you are allergic to aspirin, other NSAIDs (eg ibuprofen) or any medicines for pain relief or inflammation including tiaprofenic acid If you are allergic to fenofibrate (a medicine used to lower blood cholesterol) If you have had wheezing (asthma), runny nose (rhinitis) or an itchy rash (hives) after taking aspirin or other NSAIDs (eg ibuprofen) If you intend to use it on skin conditions such as eczema or acne, an open or infected wound, abscess, ulcer or tumour If the area to be treated is near the eyes If you are in the last 3 months of pregnancy. (see Pregnancy, breast-feeding and fertility section) If the area is near mucous membranes (eg lips, vagina).
Stop using Powergel immediately if you experience any skin reaction including reactions after co-application with octocrylene containing products (octocrylene is an ingredient used in several 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 in order to delay product breakdown due to sunlight).
Protect your skin from sunlight even on a bright but cloudy day. Do not use sunbeds. This applies during treatment and for two weeks after stopping. Warnings and precautions Talk to your doctor before using Powergel: If you have heart, liver or kidney problems. The use of large amounts of Powergel may give rise to side effects such as hypersensitivity and asthma. Exposure to the sun (even hazy) or to UV from a sunbed or solarium of areas treated with Powergel can induce potentially serious skin reactions (photosensitisation). Therefore it is necessary to: o protect treated areas by wearing clothing during treatment and for two weeks following its discontinuation to avoid any risk of photosensitisation. o wash your hands thoroughly after each application of Powergel. Treatment should be discontinued immediately upon development of any skin reaction such as rash after application of Powergel. 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. Children and adolescents The safety and efficacy of Powergel in children has not been established. Other medicines and Powergel Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, e.g. oral anticoagulants (blood thinning medicines). Powergel with food, drink and alcohol No known effects Pregnancy, breast-feeding and fertility 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 taking this medicine. Do not use Powergel if you are in the last 3 months of pregnancy. You should not use Powergel 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 Powergel can cause adverse effects in your unborn baby. It is not known if the same risk applies to Powergel when it is used on the skin.
Driving and using machines It has not been established if Powergel could affect your ability to drive and use machinery. Powergel contains Neroli fragrance and Lavandin fragrance This medicine contains fragrances with citral, citronellols, coumarin, farnesol, geraniol, d-limonene and linalool that may cause allergic reactions.
Powergel contains ethanol This medicine contains 307 mg alcohol (ethanol) in each g of gel. Ethanol may cause a burning sensation on damaged skin.
Powergel Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The recommended dose is a length of gel 5-10 cm (2-4 inches) long (3-6 pushes of the pump dispenser) applied to the skin of the affected area two or three times daily. How to apply Powergel It is important to use Powergel as directed: tube: unscrew the cap and pierce the aluminium seal with the point in the top of the cap.
pump dispenser: when using the pump dispenser for the first time, press the top of the dispenser several times or push the bottom until the gel is released). Keep the dispenser in a horizontal position during use (see the pictures below).
How and where to use Powergel Powergel is for external use only Gently massage the gel on the area you need to treat Wash your hands immediately after use Do not apply Powergel to sore, broken or infected skin Do not use Powergel near the eyes, mouth, nostrils, anal and genital regions Stop using Powergel if you get a rash, itchy or sensitive skin after use Do not use with an air-tight or water-tight dressing (i.e. do not bandage, wrap, or cover the area with a plastic dressing) Do not use too much of this medicine. Protection from the sun and sunbeds Do not expose the skin that has been treated with Powergel to direct sunlight or sunbeds during treatment or for the following 2 weeks. Use in children and adolescents Do not use in children under 12 years of age. How long should you use Powergel for? Do not use Powergel for more than 10 days in a row. If your symptoms persist after 10 days, tell your doctor. If you use more Powergel than you should When Powergel is externally applied (on the skin), very little reaches the blood. For this reason overdose effects are most unlikely. If you forget to use Powergel
If you forget a dose, use it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Powergel can cause side effects, although not everybody gets them. Stop using Powergel and tell your doctor if you notice any of the following side-effects: Uncommon side effects (may affect up to 1 in 100 people) are: Localised allergic skin reactions such as redness, swelling, itching and blisters: in some severe cases, these might also spread beyond the area of application Sensation of burning skin Rare side effects (may affect up to 1 in 1,000 people) are: Severe skin reactions (similar to severe sunburn) during exposure to sunlight Increased sensitivity of your skin to sunlight. Skin vesicles (skin blisters) Itchy skin reactions (skin rash) Cases of more severe forms of eczema which may spread or become generalized have occurred rarely. Very rare side effects (may affect less than 1 in 1,000 people) are: Kidney insufficiency (New or worsening of a pre-existing kidney disorders). Not 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 an air-tight or water-tight dressing, are the following: Allergic reactions, which may lead to difficulty breathing and/or may be very severe (anaphylaxis). If this occurs, seek medical aid immediately. A kind of skin infection (known as impetigo) Higher than normal levels of eosinophils (a particular kind of blood cell) Hypersensitivity (a type of allergic reaction) Swelling of the eyelids or of the lips Inflammation of blood vessels (known as vasculitis) Stomach ulcer, which may be bleeding, and diarrhoea Higher than normal body temperature Complication of wounds Elderly people are generally more likely to suffer from side effects of Non Steroidal Anti-Inflammatory Drugs (the drug class to which Powergel belongs). 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. Website: 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.
Powergel Keep out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use Powergel after the expiry date which is stated on the carton and tube/dispenser. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
What Powergel contains The active substance is ketoprofen. The other ingredients are: purified water, ethanol, triethanolamine, carbomer, neroli fragrance (containing citral, citronellols, farnesol, geraniol, d-limonene and linalool), lavandin fragrance (containing coumarin, geraniol, dlimonene and linalool). What Powergel looks like and contents of the pack Powergel is a gel of mucilaginous consistency, colourless or slightly yellowish, almost transparent, with an aromatic odour. Powergel is available in the following pack sizes – 50 g and 100 g tube, 50 g and 100 g pump dispenser. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: A Menarini Industrie Farmaceutiche Riunite S.r.l. Via Sette Santi, 3 50131 Florence Italy Manufacturer A.Menarini Manufacturing, Logistics and Service, S.R.L. via Sette Santi 3 50131 Florence Italy This leaflet was last revised in 01/2024.
Powergel 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 Powergel 2.5% gel is ketoprofen.
Medicines with the same active substance, strength and form include: Tiloket (Ketoprofen) 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 Powergel 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.
For local relief of pain and inflammation associated with soft tissue injuries and acute strains and sprains.
Powergel is indicated in adults.
Posology
Powergel should be applied topically to the affected area two or three times daily. Maximum duration of use should not exceed 10 days.
Paediatric population
Not recommended in children under 12 years of age. The safety and efficacy of ketoprofen gel in children have not been established.
Method of administration
For cutaneous use.
Powergel should be applied with gentle massage only.
Tube or dispenser: Apply 5 to 10cm of gel (100-200mg ketoprofen) with each application; for the pump dispenser push the pump 3-6 times.
• Known hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• History of any photosensitivity reaction.
• Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis or urticaria to fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs.
• History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate or UV blocker or perfumes.
• Sun exposure, even in case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation (see section 4.4).
• Ketoprofen gel should not be applied to open or infected wounds or lesions of the skin, such as occurs, for example, with eczema or acne, or near the eyes.
• Third trimester of pregnancy (see section 4.6).
• The gel should be used with caution in patients with reduced heart, liver or renal function: isolated cases of systemic adverse reactions affecting renal function have been reported.
• The topical use of large amounts of product may give rise to systemic effects such as hypersensitivity and asthma.
• The treatment should be interrupted if rash appears.
• The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increases over time.
• Hands should be washed thoroughly after each application of the product.
• 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 avoid exposure of treated skin to direct sunlight including solarium (sunbeds), and to protect treated areas by wearing clothing during treatment with the product and for two weeks following its discontinuation to avoid the risk of photosensitisation.
• Do not use with occlusive dressings.
• The gel must not come into contact with mucous membranes and with the eyes.
• 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 use of topical products, especially if it is prolonged, may give rise to phenomena of sensitisation or local irritation.
• The excipients citral, citronellols, coumarin, farnesol, geraniol, d-limonene and linalool may cause allergic reactions.
• Ethanol may cause a burning sensation on damaged skin.
Interactions are unlikely as serum concentrations following topical administration are low. It is, however, advisable to monitor patients under treatment with coumarinic substances.
Pregnancy
During the first and second trimester:
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/fetus. 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 and duration of treatment as short as possible.
During the third trimester of pregnancy:
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the fetus. 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)
Breast-feeding
No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.
Not 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 15 days 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).
Since marketing, the following adverse reactions have been reported. They have been listed according to classes of organ and system and classified according to their frequency as follows: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); not known (the frequency cannot be established based on the available data).
System Organ Class
Uncommon
Rare
Very rare
Not known
Infections and infestations
Secondary impetigo
Blood and lymphatic system disorders
Eosinophilia
Immune system disorders
Anaphylactic reactions, including anaphylactic shock, angioedema, hypersensitivity reactions
Eye disorders
Eyelid oedema
Vascular disorders
Vasculitis
Gastrointestinal disorders
Peptic ulcer, gastrointestinal bleeding, diarrhoea, lip oedema
Skin and subcutaneous tissue disorders
Localised skin reactions such as erythema, eczema, pruritus and burning sensation
Dermatitis (allergic, bullous, contact, exfoliative, vesicular), urticaria, blister, photosensitivity reaction, photosensitivity allergic reaction, skin exfoliation, skin oedema
Renal and urinary disorders
New cases or worsening of existing cases of renal insufficience.
General disorders and administration site conditions
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 the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 symptomatic and supportive in accordance with overdosage of oral anti-inflammatories.
Ask anything about Powergel 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.