Fastum 25 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fastum 25 mg/g gel
ketoprofen
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Fastum is and what it is used for
- What you need to know before using Fastum
- How to use Fastum
- Possible side effects
- How to store Fastum
- Contents of the pack and other information
1. What Fastum is and what it is used for
Fastum contains ketoprofen, which is a medicine belonging to the group of non-steroidal anti-inflammatory drugs.
Fastum is indicated for the treatment of painful, inflammatory or traumatic conditions affecting the joints, tendons, ligaments and muscles (arthritis, periarthritis, arthrosynovitis, tendinitis, tenosynovitis, bursitis, contusions, sprains, dislocations, meniscal injuries of the knee, torticollis, lumbago).
2. What you need to know before using Fastum
Do not use Fastum
- If you have a history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers, fragrances, or to any of the other components of this medicine (listed in section 6).
- If you have previously experienced allergic reactions to acetylsalicylic acid or to any other medicine in the group of non-steroidal anti-inflammatory drugs (symptoms include difficulty breathing, nasal mucosa swelling, or hives).
- On skin areas showing pathological changes such as eczema or acne; on infected skin or open wounds.
- If you are in the last 3 months of pregnancy.
- Stop using Fastum immediately if you experience any skin reaction, including skin reactions after simultaneous use of products containing octocrylene (octocrylene is an excipient found in various cosmetic and hygiene products such as shampoo, aftershave lotion, bath and shower gel, skin creams, lipsticks, anti-aging creams, makeup removers, hair sprays, and is used to delay photodegradation).
- Do not expose treated areas to sunlight—even on cloudy days—or to ultraviolet lamps (solariums, sunlamps) during treatment and for 2 weeks after stopping treatment.
Warnings and precautions
Consult your doctor or pharmacist before using Fastum
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If you have heart, liver, or kidney disorders, as isolated cases of systemic adverse reactions affecting the kidneys have been reported.
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After applying the gel, do not wear tight clothing or use occlusive dressings.
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Discontinue treatment immediately if any skin reaction occurs after application of Fastum.
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The gel must not come into contact with mucous membranes, eyes, periorbital area, or genital area.
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Exposure to sunlight (even on cloudy days) or to ultraviolet (UVA) lamps on areas treated with Fastum may cause potentially severe skin reactions (photosensitization). Therefore, it is necessary to:
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cover treated areas with clothing to protect them during treatment and for two weeks after stopping treatment to avoid any risk of photosensitization.
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wash your hands thoroughly after each application of Fastum.
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Prolonged use or application of large amounts of the product may cause systemic effects such as hypersensitivity and asthma.
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Treatment must be discontinued if a rash develops.
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Do not exceed the recommended duration of treatment, as the risk of developing contact dermatitis and photosensitivity reactions increases over time.
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Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of allergy to acetylsalicylic acid and/or other NSAIDs compared to the general population.
Children and adolescents
The safety and efficacy of ketoprofen in children have not been established.
Other medicines and Fastum
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Inform your doctor if you are taking oral anticoagulants (medicines to prevent blood clots).
Interaction with other medicines is unlikely due to the topical application of Fastum.
Do not apply other topical skin preparations to the same skin area where you are using this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use ketoprofen during the last 3 months of pregnancy. Ketoprofen should not be used during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.
Oral formulations (e.g., tablets) may cause adverse effects on the fetus. It is unknown whether the same risk applies to topical ketoprofen.
There are no data available on the excretion of ketoprofen in human breast milk; therefore, use during breastfeeding is not recommended.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Fastum contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, alcohol (ethanol), and lavender essence.
This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
This medicine contains 400 mg of alcohol (ethanol) per gram of gel. It may cause a burning sensation on damaged skin.
This medicine contains lavender essence with benzyl alcohol, amyl cinnamaldehyde, citral, eugenol, hydroxycitronellal, coumarin, geraniol, farnesol, linalool, benzyl benzoate, citronellol, and d-limonene, which may cause allergic reactions.
3. How to use Fastum
Cutaneous use.
Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Fastum is used topically. Apply the gel once or several times a day (3-5 cm or more, depending on the size of the affected area), with a gentle massage to promote absorption.
The total daily dose should not exceed 15 g per day, equivalent to 28 cm of skin.
Close the Fastum tube after each use. Wash your hands after each application.
Your doctor will advise you on the duration of your treatment with Fastum.
The duration of continuous treatment with topical ketoprofen should be limited to a maximum of 7 days.
If you feel that the effect of Fastum is too strong or too weak, inform your doctor or pharmacist.
If you use more Fastum than you should
Because the medicine is administered topically, overdose is very unlikely.
In case of accidental ingestion of Fastum, contact your doctor or the nearest hospital emergency department immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Fastum
If you forget to apply a dose, apply the usual dose as soon as possible, but do not apply a double dose to make up for the missed one.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone experiences them.
The most frequently occurring adverse effects are localized skin reactions, which may extend beyond the site of application and are rarely severe and/or generalized.
Adverse effects may occur with the following frequency:
Uncommon (may affect up to 1 in 100 patients):
- Localized skin reactions such as redness (erythema), itching (pruritus), or skin inflammation (eczema), burning sensation.
Rare (may affect up to 1 in 1,000 patients):
- Skin reaction when exposing the application site to sunlight (photosensitivity). Appearance of pale or reddish itchy wheals on the skin (urticaria). Rarely, more severe reactions have occurred, such as blister-like lesions resembling burns (bullous or flictenular eczema), which may extend beyond the application area or become generalized.
Very rare (may affect up to 1 in 10,000 patients):
- Damage to the stomach lining or beginning of the intestine (ulcer), gastrointestinal bleeding, diarrhea.
- Skin allergic reaction (contact dermatitis).
- Impaired kidney function or worsening of pre-existing kidney impairment (renal failure).
Frequency not known (cannot be estimated from available data):
- Generalized urticaria accompanied by swelling of feet, hands, throat, lips, and airways (angioedema), severe allergic reaction (anaphylactic reaction including anaphylactic shock, hypersensitivity reactions), and bullous dermatitis.
Elderly patients are more susceptible to adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs), the group to which ketoprofen—the active substance in Fastum—belongs.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fastum
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fastum
- The active substance is ketoprofen. Each gram of gel contains 25 mg of ketoprofen.
- The other components are methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), carbomer, 96% ethanol, tromethamine, lavender essence (containing: benzyl alcohol, amyl cinnamaldehyde, citral, eugenol, hydroxycitronellal, coumarin, geraniol, farnesol, linalool, benzyl benzoate, citronellol, and d-limonene), and purified water.
Appearance of the product and contents of the pack
Fastum is a transparent gel. Each package contains 60 grams of gel.
Marketing Authorization Holder and Manufacturer
Laboratorios Menarini, S.A.
Alfons XII, 587
08918 Badalona (Barcelona)
Spain
Further information about this medicine can be requested from the local representative of the Marketing Authorization Holder
Guidotti Farma, S.L.
Alfons XII, 587
08918 Badalona (Barcelona)
Spain
**Date of the most recent revision of this leaflet: April 2026.
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)