Fastum Gel 25 mg/g – ketoprofen gel for muscle and joint pain, sprains and strains

Fastum Gel contains ketoprofen, a non-steroidal anti-inflammatory drug (NSAID), as a gel for application to the skin. One gram of gel contains 25 mg of ketoprofen.

According to the leaflet, Fastum Gel is applied locally for pain and inflammation of the bones, joints and muscles of rheumatic and traumatic origin, as well as for soft tissue injuries and acute sprains and dislocations. In Serbia, Fastum Gel is a prescription-only medicine.

What is Fastum Gel used for and how should it be applied correctly?

Key facts about the medicine

What is Fastum Gel used for?

• pain and inflammation of the bones, joints and muscles of rheumatic origin;
• pain and inflammation after injuries (traumatic origin);
• soft tissue injuries;
• acute sprains and dislocations.

How is it applied and dosed?

• Apply 5–10 cm of gel (100–200 mg ketoprofen) to the skin over the affected area 1 to 3 times daily.
• Apply a thin layer and massage gently for better absorption.
• For external use only. Wash your hands thoroughly and for longer after each application.
• Treatment is short – no longer than 7 days. Do not use the gel for longer than prescribed, as the risk of photosensitivity and dermatitis increases.
• Do not apply to damaged or infected skin, or near the eyes, mouth, nostrils, anal and genital areas.
• Do not use airtight or waterproof dressings and do not cover treated skin with occlusive plastic clothing.
• Do not use the gel together with any other product on the same area.
• Opening the tube: unscrew the cap and pierce the aluminium seal with the point on the outside of the cap.
• If symptoms return or get worse, consult a doctor.

Special patient groups

• Children: safety and efficacy have not been established.
• Elderly: NSAID side effects are more common.
• Heart, liver or kidney disease: consult your doctor before use.
• Asthma with chronic rhinitis, sinusitis or nasal polyps: higher risk of allergic reaction to aspirin and other NSAIDs.

Contraindications – when the medicine must not be used

Do not use Fastum Gel:

• if you are allergic to ketoprofen or any of the excipients;
• if you are allergic to UV filters (sunscreens) or perfumes;
• if you are allergic to fenofibrate (a cholesterol-lowering medicine);
• if you have had wheezing (asthma), runny nose or itching after aspirin, other NSAIDs (e.g. ibuprofen) or other pain and anti-inflammatory medicines (including tiaprofenic acid);
• on diseased skin – eczema, acne, infected or open wounds, abscesses, ulcers or tumours;
• near the eyes;
• in the third trimester of pregnancy.

Warnings and precautions

• Serious skin reactions may occur on skin where the gel was applied after exposure to sunlight (even when cloudy), UV light or sunbeds – protect these areas with clothing during treatment and for 2 weeks after stopping.
• Stop use immediately if skin reactions occur, including reactions after use of products containing octocrylene (an ingredient of some shampoos, aftershaves, shower gels, skin creams, lipsticks, anti-ageing creams, make-up removers and hair sprays).
• Using large amounts of gel may cause side effects such as hypersensitivity and asthma.
• Do not use near mucous membranes (e.g. lips, vagina) or longer than the recommended duration.
• The gel contains fragrances (bitter orange flower, lavender) with citral, citronellol, coumarin, farnesol, geraniol, d-limonene and linalool, which may cause allergic reactions; it also contains ethanol.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take, especially oral anticoagulants (blood thinners). Do not use the gel together with other products on the same area, and avoid cosmetics containing octocrylene on treated skin.

Pregnancy and breast-feeding

• First and second trimester: use is not recommended – tell your doctor before use.
• Third trimester: Fastum Gel must not be used.
• Breast-feeding: do not breast-feed while using the medicine, as a small amount may pass into breast milk.

Driving and using machines

Fastum Gel has no influence on the ability to drive and use machines.

Possible side effects

Stop using the medicine and see a doctor if you notice any of the following side effects:

• Uncommon (up to 1 in 100 people): local allergic skin reactions (redness, swelling, itching, burning) which in more severe cases may spread beyond the area of application; burning sensation of the skin.
• Rare (up to 1 in 1,000 people): serious burn-like skin reactions on sun exposure, increased sensitivity to sunlight, blisters, itchy rash, more severe forms of eczema that may spread.
• Very rare (up to 1 in 10,000 people): impaired kidney function or worsening of existing kidney failure.
• Frequency not known (depending on amount, area, skin thickness, duration and occlusive dressings): severe allergic reactions with difficulty breathing (anaphylactic shock), swelling of the face and tongue with difficulty breathing and swallowing (angioedema), skin infection (impetigo), increased eosinophils, swelling of the lips or eyelids, inflammation of blood vessels (vasculitis), stomach ulcer possibly with bleeding, diarrhoea, raised body temperature, wound complications.

Overdose, missed dose and stopping treatment

• Too much on the skin: unlikely to cause problems.
• Accidental swallowing: contact a doctor immediately or go to the nearest hospital and take the pack with you.
• Missed application: apply the gel as soon as you remember; if it is nearly time for the next application, skip the missed one. Do not apply a double dose.

Related information

For additional care and support with muscle and joint complaints, see also the Bones, joints and muscles category – products in this category do not replace the medicine you have been prescribed, and other creams and gels should not be applied to the same area at the same time as Fastum Gel.

Composition, pack and manufacturer

• Active substance: ketoprofen – 25 mg per 1 g gel.
• Excipients: carbomer; ethanol; bitter orange flower fragrance (contains citral, citronellol, farnesol, geraniol, d-limonene and linalool); lavender fragrance (contains coumarin, geraniol, d-limonene and linalool); trolamine; purified water.
• Appearance: mucilaginous gel, colourless or almost clear, with an aromatic smell.
• Pack: soft aluminium tube with 50 g gel, in a carton with the leaflet.
• Marketing authorisation holder: Berlin-Chemie A. Menarini Distribution d.o.o., Đorđa Stanojevića 14, Belgrade – Novi Beograd. Manufacturer: A. Menarini Manufacturing Logistics and Services S.r.l., Via Sette Santi 3, Florence, Italy.

Storage

• No special storage conditions; after first opening keep in the original package.
• Shelf life is 5 years, and 6 months after first opening.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Why must I avoid the sun after using Fastum Gel?

Ketoprofen can cause photosensitisation – serious burn-like skin reactions when treated skin is exposed to sunlight or sunbeds. The skin should therefore be protected with clothing during treatment and for 2 weeks afterwards, even on cloudy days.

How long can I use Fastum Gel?

According to the leaflet, treatment should be short – no longer than 7 days. If symptoms do not improve, come back or get worse, see a doctor.

Can I put a bandage over the gel?

Airtight or waterproof dressings should not be used, and treated skin should not be covered with occlusive plastic clothing.

Can I use Fastum Gel during pregnancy?

In the first and second trimester use is not recommended and should be discussed with a doctor; in the third trimester Fastum Gel must not be used. Do not breast-feed while using the medicine.

Sources

• ALIMS – Summary of Product Characteristics, Fastum® Gel 25 mg/g gel (SmPC, Serbian)
• ALIMS – Package leaflet, Fastum® Gel 25 mg/g gel (PIL, Serbian)

Sources checked on: 25 October 2026.