Fastum

Leaflet attached to the packaging: information for the user

Fastum, 25 mg/g, gel

Ketoprofen

Read the leaflet carefully before using the medicine because it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 packaging and other information.

1. What is Fastum and what is it used for

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

Indications for use

• Local treatment of muscle and joint pains, e.g. caused by injuries (injuries resulting from sports, joint injuries with ligament sprains without dislocation, tendon and muscle damage resulting from excessive exertion),
• Local treatment of lower back pain in the course of discopathy.

2. Important information before using Fastum

When not to use Fastum

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced hypersensitivity reactions to sunlight;
• if the patient has experienced hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis after using fenofibrate, tiaprofenic acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has experienced skin allergy after using ketoprofen, tiaprofenic acid, fenofibrate or UV filters or perfumes;
• in case of exposure to sunlight (even when the sky is cloudy), as well as UV rays in a solarium, during treatment and 2 weeks after stopping the use of the medicine;
• if the patient is in the last 3 months of pregnancy.

The gel should not be applied to damaged or diseased skin, e.g. in the case of eczema, acne, skin infections, or open wounds.

Children and adolescents

The safety and efficacy of Fastum in children and adolescents have not been established, and therefore, the medicine should not be used in this group of patients.
It is not recommended to use ketoprofen in children under 15 years of age, due to the lack of controlled clinical trials regarding the efficacy and safety of ketoprofen in children.

Warnings and precautions

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

• to protect the treated areas of skin by wearing clothing during treatment and for 2 weeks after stopping the use of the medicine, in order to avoid the risk of hypersensitivity to sunlight
• to wash hands thoroughly after each application of Fastum. Prolonged use of topical medicines may cause allergic reactions or local irritations in some patients. If redness, rash, itching, or nausea occur, the use of the medicine should be stopped immediately and a doctor should be consulted.

Avoid contact of the gel with mucous membranes and eyes. The gel should not be used under occlusive dressings.
The medicine should not be taken orally or applied to a large area of the body. Administration of large amounts of topical medicines may cause systemic effects, including hypersensitivity reactions and asthma.
The medicine should be used with caution in patients with heart, liver, or kidney function disorders: single cases of adverse reactions affecting the kidneys have been reported.
After applying the gel, hands should be washed, unless they are the area being treated. During prolonged use, it is recommended to wear protective gloves.
Treatment should be stopped immediately in case of any skin reactions, including skin reactions after concurrent use of products containing octocrylene (octocrylene is one of the excipients 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 decomposition under the influence of light).
In patients with asthma associated with chronic rhinitis and chronic sinusitis and (or) nasal polyps, the risk of an allergic reaction to acetylsalicylic acid and (or) NSAIDs is higher than in the rest of the population.

Fastum and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. No interactions with other medicines have been described for Fastum. Interactions are unlikely because the serum concentrations after topical application are low. However, caution should be exercised in patients taking oral anticoagulant medicines at the same time.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
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.
Do not use Fastum if you are in the last 3 months of pregnancy. During the first 6 months of pregnancy, do not take Fastum unless your doctor considers it absolutely necessary. If treatment is necessary during this period, the smallest possible dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of ketoprofen may cause side effects in the unborn child. It is not known whether the same risk occurs when using Fastum on the skin.

Breastfeeding

Consult a doctor before using any medicine.
There is no data on the penetration of ketoprofen into breast milk. It is not recommended to use the medicine in women during breastfeeding.

Driving and using machines

Unknown effect.

Fastum contains orange flavor and lavender flavor

The medicine contains fragrances with citral, citronellol, coumarin, farnesol, geraniol, d-limonene, and linalool. They may cause allergic reactions.
In patients with a history of epilepsy, caution should be exercised when using the medicine due to the content of a terpene derivative (lavender flavor) in the product.

Fastum contains ethanol

This medicine contains 307 mg of alcohol (ethanol) per gram. Ethanol may cause burning of damaged skin.

3. How to use Fastum

Fastum is used 1 to 2 times a day, a thin layer of gel (a strip of gel 3 cm to 5 cm long) should be applied to the skin in the painful area and gently massaged to facilitate absorption. If after 7 days of using the medicine the symptoms do not disappear, worsen, or new symptoms appear, a doctor should be consulted.
Fastum should not be used 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. Overdose is unlikely due to topical application.
In case of accidental ingestion of the gel, systemic side effects may occur, depending on the amount of medicine swallowed. In such a case, symptomatic and supportive treatment used in the event of overdose of oral non-steroidal anti-inflammatory drugs should be administered. If the overdose occurred no more than 1 hour earlier, gastric lavage should be performed and symptomatic treatment should be used.

4. Possible side effects

Like all medicines, Fastum can cause side effects, although not everybody gets them.
Local skin reactions that can spread beyond the application site have been observed.
Rarely, severe reactions such as bullous or pustular rash have occurred, which can spread beyond the application site or be generalized.
Other systemic side effects caused by non-steroidal anti-inflammatory drugs: resulting from the penetration of the active substance through the skin, are therefore dependent on the amount of gel applied to the treated skin surface, the degree of skin damage, the duration of treatment, and the possible use of an occlusive dressing (hypersensitivity, gastrointestinal disorders, and kidney function disorders).
Possible side effects are listed below and ranked according to their frequency of occurrence.
If the patient notices any of the following side effects, they should stop using Fastum and consult a doctor.
Uncommon: occurring in less than 1 in 100 people

• local skin reactions such as redness, itching, rash, burning sensation

Rare: occurring in less than 1 in 1000 people

• skin reactions: hypersensitivity to light (including hypersensitivity to sunlight), urticaria, bullous or pustular rash (rash with blisters or sores), which can spread beyond the application site or be generalized.

Very rare: occurring in less than 1 in 10,000 people

• gastric ulcer and (or) duodenal ulcer, gastrointestinal bleeding, diarrhea
• contact dermatitis (skin inflammation after contact with the active substance)
• new cases or worsening of existing kidney function disorders

Frequency not known: cannot be estimated from the available data

• anaphylactic reactions including anaphylactic shock (anaphylactic shock), angioedema (allergic swelling, occurring in different parts of the body, most often on the face and neck), hypersensitivity reactions (allergic rhinitis, asthma attack)

Elderly patients are particularly at risk of side effects after using non-steroidal anti-inflammatory drugs.
If any of the side effects worsen or any side effects not listed in this leaflet occur, a doctor or pharmacist should be informed.
Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fastum

There are no special precautions for storage.

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

Do not use this medicine after the expiry date stated on the packaging after: EXP (abbreviation used to describe the expiry date). The expiry date stated is the last day of the specified month.
Shelf life after first opening the packaging: 6 months.
The "Lot" abbreviation on the packaging means the batch number.
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 packaging and other information

What Fastum contains

• The active substance of Fastum is: Ketoprofen(ketoprofen).
• Other ingredients of the medicine are: carbomer, ethanol, triethanolamine, orange flavor (contains citral, citronellol, farnesol, geraniol, d-limonene, and linalool), lavender flavor (contains coumarin, geraniol, d-limonene, and linalool), purified water.

What Fastum looks like and contents of the packaging

Tube containing 20 g, 30 g, 50 g, or 100 g of gel.
Dispenser containing 100 g of gel.

Marketing authorization holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. 3 Via Sette Santi, 50 131 Florence, Italy

Manufacturer

• A. Menarini Manufacturing Logistics and Services s.r.l. 3 Via Sette Santi, 50 131 Florence, Italy

For more detailed information on this medicine, please contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
phone (22) 566 21 00; fax (22) 566 21 01

Date of leaflet approval:
08/2024