Ketoprofenum Fastum

Leaflet attached to the packaging: information for the user

Note! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ketoprofenum Fastum (Fastum Gel)

25 mg/g, gel

Ketoprofenum
Ketoprofenum Fastum and Fastum Gel are different trade names for the same drug.

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Ketoprofenum Fastum and what is it used for

Ketoprofenum Fastum is a non-steroidal anti-inflammatory drug for topical use.
Ketoprofen - the active substance of Ketoprofenum Fastum - when 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 appropriate base ensures proper release of ketoprofen and minimal risk of systemic side effects. The drug 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 low back pain in the course of discopathy.

2. Important information before using Ketoprofenum Fastum

When not to use Ketoprofenum Fastum

Do not use the drug if there is a history of hypersensitivity to ketoprofen or any of the other ingredients of Ketoprofenum Fastum; to tiaprofenic acid, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, fenofibrate, UV filters or perfumes.
Ketoprofen should not be used in patients who have experienced "aspirin asthma" attacks, rash or rhinitis after using acetylsalicylic acid and its derivatives.
The drug is contraindicated in people with a history of aspirin asthma or who have experienced other hypersensitivity reactions.
Ketoprofenum Fastum should not be used on open wounds and in people with eczema or oozing skin lesions of unknown origin.
Stop using the drug immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (octocrylene is one of the auxiliary substances used in various cosmetics and hygiene products, such as shampoos, after-shave 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).
Do not expose the treated skin surface to sunlight (even on cloudy days) or UV rays in a solarium, during treatment and 2 weeks after stopping the use of the drug.
Ketoprofen is not recommended for children under 15 years of age due to the lack of controlled clinical trials regarding the efficacy and safety of use.
It is not recommended for use in women from the sixth month of pregnancy.

Warnings and precautions

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

• to protect the treated skin areas by wearing clothing during treatment and for two weeks after stopping the use of the drug, in order to avoid the risk of photosensitivity
• to wash your hands thoroughly after each application of Ketoprofenum Fastum.

Prolonged use of topical drugs may cause allergic reactions or local irritations in some patients. If redness, rash, itching, or nausea occur, you should stop using the drug immediately and contact your doctor.
The drug should not be used on open wounds or cuts, and if skin changes occur at the site of application, the drug should be discontinued.
Eyes and mucous membranes should be protected from contact with the drug, and it should not be used under occlusive dressings.
The drug should not be used orally or on a large surface of the body. Local administration of large amounts of the drug may cause systemic effects, including hypersensitivity reactions and asthma.
The drug should be used with caution in patients with circulatory failure, severe kidney or liver dysfunction, as there have been reports of systemic side effects.
Patients with a history of epilepsy should be cautious when using the drug due to the presence of a terpene derivative (lavender aroma) in the drug's composition.
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 if any skin reactions occur after using Ketoprofenum Fastum.
The drug contains alcohol, do not use near fire.
Patients with asthma and chronic rhinitis, chronic sinusitis, and (or) nasal polyps are at higher risk of developing an allergic reaction to aspirin and (or) non-steroidal anti-inflammatory drugs.

Ketoprofenum Fastum and other drugs

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

Pregnancy

Before using any drug, you should 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. The use of the drug should be avoided during the first and second trimester of pregnancy.
Do not use in women from the third trimester of pregnancy.

Breastfeeding

Before using any drug, you should consult a doctor.
Ketoprofen passes into breast milk in small amounts. The use of the drug is not recommended for breastfeeding women.

Driving and operating machines

The effect of the drug on the ability to drive vehicles and operate machinery has not been reported.

Ketoprofenum Fastum contains orange aroma and lavender aroma

This drug contains aromas, which include, among others, citral, citronellol, coumarin, farnesol, geraniol, d-limonene, and linalool, which may cause allergic reactions.

3. How to use Ketoprofenum Fastum

Ketoprofenum 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 drug the symptoms do not disappear, worsen, or new symptoms appear, you should consult a doctor.
Ketoprofenum Fastum should not be used in children under 15 years of age.

Using a higher dose of Ketoprofenum Fastum than recommended

No cases of overdose or poisoning with Ketoprofenum Fastum have been reported.
In the event 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 kidney failure. The doctor will take appropriate measures and initiate symptomatic treatment usually used in the treatment of non-steroidal anti-inflammatory drug poisoning. If it has been less than 1 hour since the overdose, gastric lavage should be performed and symptomatic treatment should be used.

4. Possible side effects

Like all drugs, Ketoprofenum Fastum can cause side effects, although they may not occur in every patient.

The following frequencies of occurrence 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, unknown (cannot be estimated based on available data).
There have been reports of local skin reactions that may spread beyond the site of application. Rarely, severe reactions such as bullous or papular rashes have occurred, which may spread or become generalized.
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 are therefore dependent on the amount of gel used, the treated skin surface, 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 drug was introduced to the market, 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 single cases.

Immune system disorders

Very rare:
Anaphylactic reaction, hypersensitivity reactions

Gastrointestinal disorders

Very rare:
Peptic ulcer disease, gastrointestinal bleeding, diarrhea

Skin and subcutaneous tissue disorders

Uncommon:
Redness, itching, rash, burning
Rare:
Photosensitivity, bullous rash, urticaria
Very rare:
Contact dermatitis, angioedema

Renal and urinary disorders

Very rare:
Kidney failure or worsening of kidney function disorders
Elderly patients are particularly at risk of developing 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Ketoprofenum Fastum

There are no special recommendations for storage.
Shelf life after first opening: 6 months.

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

Do not use this drug after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Ketoprofenum Fastum contains

• The active substance of the drug is ketoprofen (Ketoprofenum). 1 g of gel contains 25 mg of ketoprofen.
• The other ingredients of the drug are: carbomer, ethanol 96%, tromethamine, orange aroma (contains, among others, citral, citronellol, farnesol, geraniol, d-limonene, and linalool), lavender aroma (contains, among others, coumarin, geraniol, d-limonene, and linalool), purified water.

What Ketoprofenum Fastum looks like and what the package contains

An aluminum tube with a PE/PP cap containing 50 g or 100 g of gel, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export:
8884/2016/03
8884/2016/04

Parallel import authorization number: 240/18 Date of leaflet approval: 25.05.2023

[Information about the trademark]