Fastum

PATIENT INFORMATION LEAFLET: USER INFORMATION

WARNING: Keep the leaflet, the information on the immediate packaging is in a foreign language.

Fastum (KETUM)

25 mg/g (2.5%), gel

Ketoprofen
Fastum KETUMare different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Fastum and what is it used for
• 2. Important information before using Fastum
• 3. How to use Fastum
• 4. Possible side effects
• 5. How to store Fastum
• 6. Contents of the pack and other information

1. What is Fastum and what is it used for

Fastum is a non-steroidal anti-inflammatory drug for topical use. The active substance of Fastum, ketoprofen, is absorbed through the skin into inflamed areas of joints, tendons, ligaments, and muscles when applied locally. It does not accumulate in the body. The gel also has a surface cooling and soothing effect due to its water-alcohol base. The base ensures proper release of ketoprofen and minimal risk of systemic side effects. The medicine is well-tolerated even in cases of sensitive skin.

Indications for use

• Local treatment of muscle and joint pain, e.g., caused by injuries (sports injuries, joint sprains without dislocation, tendon and muscle damage due to excessive strain).
• Local treatment of low back pain in discopathy.

2. Important information before using Fastum

When not to use Fastum

Do not use the medicine if you have a history of hypersensitivity to ketoprofen or any other component of Fastum, tiaprofenic acid, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs, fenofibrate, UV filters, or perfumes.
Ketoprofen should not be used in patients who experience "aspirin-induced asthma" attacks, rash, or rhinitis after using acetylsalicylic acid and its derivatives.
The medicine is contraindicated in patients with a history of aspirin-induced asthma or other hypersensitivity reactions.
Fastum should not be used on open wounds or in people with eczema, blisters, or oozing skin changes of unknown origin.
Stop using the medicine immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (octocrylene is a helper substance used in various cosmetics and hygiene products such as shampoo, aftershave products, shower gels and bath products, skin creams, lip balms, anti-wrinkle creams, makeup removers, hair lacquers, to delay breakdown under the influence of light).
Avoid exposure to sunlight on the treated skin area (even on cloudy days) and UV rays in a solarium during treatment and for 2 weeks after stopping the use of the medicine.
Ketoprofen is not recommended for children under 15 years of age due to the lack of controlled clinical trials on its efficacy and safety.
Do not use in women from the sixth month of pregnancy.

Warnings and precautions

Exposure to sunlight (even on cloudy days) or UVA rays on skin areas where Fastum has been applied may cause severe skin reactions (photosensitivity). Therefore, it is necessary:

• to protect the treated skin areas by wearing clothing during treatment and for 2 weeks after stopping the use of the medicine to avoid the risk of photosensitivity,
• to wash your hands thoroughly after each application of Fastum. Prolonged use of topical medicines may cause allergic reactions or local irritation in some patients. If redness, rash, itching, or nausea occur, stop using the medicine and consult a doctor. Do not apply the medicine to open wounds or cuts, and if skin changes occur at the site of application, discontinue the medicine. Protect your eyes and mucous membranes from contact with the medicine, and do not use under occlusive dressings. Do not use the medicine orally or on large areas of the body. Local application of large amounts of the medicine may cause systemic effects, including hypersensitivity reactions and asthma. Use the medicine with caution in patients with circulatory failure, severe kidney or liver dysfunction, as isolated cases of systemic side effects have been reported. In patients with a history of epilepsy, caution should be exercised when using the medicine due to the presence of a helper substance in the product - a terpene derivative (lavender aroma). After applying the gel, wash your hands unless they are the area being treated. During prolonged use, it is recommended to wear protective gloves. Treatment should be stopped immediately if any skin reactions occur after using Fastum. The medicine contains alcohol; do not use near fire. In patients with asthma and chronic rhinitis, chronic sinusitis, and (or) nasal polyps, the risk of an allergic reaction to aspirin and (or) non-steroidal anti-inflammatory drugs is higher than in the rest of the population.

Fastum and other medicines

No interactions between Fastum and other medicines have been reported. However, caution should be exercised in patients taking oral anticoagulant medicines at the same time.

Pregnancy

Before using any medicine, consult a doctor.
Using non-steroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may have a harmful effect on the fetus's heart and lungs. Non-steroidal anti-inflammatory drugs may cause delayed labor. Avoid using the medicine during the first and second trimesters of pregnancy. Do not use in women from the third trimester of pregnancy.

Breast-feeding

Before using any medicine, consult a doctor.
Ketoprofen passes into breast milk in small amounts. It is not recommended to give the medicine to breastfeeding women.

Driving and using machines

The effect of the medicinal product on the ability to drive and use machines has not been described.
Fastum contains orange aroma and lavender aroma.
This medicine contains aromas with the following composition: citral, citronellol, coumarin, farnesol, geraniol, d-limonene, and linalol, which may cause allergic reactions.

3. How to use Fastum

Fastum is used 1 to 2 times a day; apply a thin layer of gel (a strip of gel 3 cm to 5 cm long) to the skin in the painful area and gently massage to facilitate absorption. If symptoms do not disappear after 7 days of using the medicine, worsen, or new symptoms appear, consult a doctor.
Do not use Fastum in children under 15 years of age.

Using a higher dose of Fastum than recommended

No cases of overdose or poisoning with Fastum have been reported.
In case of accidental ingestion of the gel, the following may occur: drowsiness, nausea, vomiting. Ingestion of large doses may cause respiratory depression, coma, convulsions, gastrointestinal bleeding, increased or decreased blood pressure, acute renal failure. The doctor will take appropriate measures and initiate symptomatic treatment usually used in the treatment of non-steroidal anti-inflammatory drug poisoning. If the overdose occurred less than 1 hour ago, gastric lavage should be performed and symptomatic treatment should be applied.

4. Possible side effects

Like all medicines, Fastum can cause side effects, although not everybody gets them.
The following frequencies are usually the basis for assessing side effects:
Very common: more than 1 in 10 treated patients;
Common: less than 1 in 10 but more than 1 in 100 treated patients;
Uncommon: less than 1 in 100 but more than 1 in 1,000 treated patients;
Rare: less than 1 in 1,000 but more than 1 in 10,000 treated patients;
Very rare: less than 1 in 10,000 treated patients, not known (cannot be estimated from the available data).
Local skin reactions that can spread beyond the application site have been observed. Rarely, severe reactions such as blistering or pustular rashes, which can spread or become generalized, have occurred.
Other systemic side effects (e.g., related to the gastrointestinal tract or kidneys) caused by non-steroidal anti-inflammatory drugs result from the absorption of the active substance through the skin and depend on the amount of gel used, the treated skin area, the degree of absorption into the tissue, the duration of therapy, and the possible use of an occlusive dressing (hypersensitivity, gastrointestinal disorders, and kidney function disorders).
Since the marketing authorization of the medicine, the following side effects have been observed, which are listed below, grouped by organ system and frequency of occurrence as: very common (greater than or equal to 10%), common (between 1% and 10%), uncommon (between 0.1% and 1%), rare (between 0.01% and 0.1%), or very rare (less than 0.01%) including isolated cases.
Immune system disorders
Very rare:
Anaphylactic reaction, hypersensitivity reactions
Gastrointestinal disorders
Very rare:
Stomach and duodenal ulcer disease,
gastrointestinal bleeding, diarrhea
Skin and subcutaneous tissue disorders
Uncommon:
Redness, itching, rash, burning
Rare:
Photosensitivity, blistering rash,
urticaria
Very rare:
Contact dermatitis, angioedema
Renal and urinary disorders
Very rare:
Renal failure or worsening of renal function disorders
Elderly patients are particularly at risk of side effects after taking non-steroidal anti-inflammatory drugs.
If any of the side effects worsen or any side effects not listed in this leaflet occur, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fastum

Store in a temperature below 25°C.

The medicine should be stored in a place out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fastum contains

• The active substance of Fastum is: Ketoprofen(ketoprofen). 1 g of gel contains 25 mg of ketoprofen (100 g of gel contains 2.5 g of ketoprofen). The other ingredients of the medicine are: carbomer, ethanol, orange aroma (contains citral, citronellol, farnesol, geraniol, d-limonene, and linalol), lavender aroma (contains coumarin, geraniol, d-limonene, and linalol), triethanolamine, purified water.

What Fastum looks like and contents of the pack

A tube containing 50 g or 60 g of gel.
A dispenser containing 120 g of gel.

For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

MENARINI FRANCE, 1/7, rue du Jura, 94633 Rungis Cedex, France

Manufacturer:

• A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L., Via Sette Santi, 3, 50131, Florence, Italy Laboratoires MENARINI S.A., Alfonso XII, 587, 08912 BADALONA (BARCELONA), Spain

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Authorization number in France, the country of export:333 549-7
34009 333 549 7 8
333 550-5
34009 333 550 50
344 447-6
34009 344 447 6 0
Parallel import authorization number:495/12
Date of leaflet approval: 23.02.2022