Fastum
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Fastum (Fastum Gel), 25 mg/g, gel
Ketoprofen
Fastum and Fastum Gel are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- What Fastum is and what it is used for.
- Important information before using Fastum.
- How to use Fastum.
- Possible side effects.
- How to store Fastum.
- Contents of the package and other information.
1. What Fastum is and what it is used for
Fastum is a non-steroidal anti-inflammatory and analgesic medicine intended for topical use.
Ketoprofen – the active substance in Fastum – when applied topically, penetrates through the skin into inflamed areas of joints, tendons, ligaments, and muscles. It does not accumulate in the body.
Due to its water-alcohol base, the gel also provides a superficial cooling and soothing effect.
The appropriate formulation ensures proper release of ketoprofen and minimal risk of systemic adverse effects. The medicine is well tolerated, even in individuals with sensitive skin.
Indications for use
- Local treatment of muscle and joint pain, e.g., caused by injuries (sports-related contusions, joint injuries with ligament sprains without dislocation, tendon and muscle damage due to excessive strain),
- Local treatment of lower back pain associated with 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 photosensitivity reactions to sunlight;
- if the patient has previously had hypersensitivity reactions such as asthma symptoms or allergic rhinitis after taking fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
- if the patient has had skin allergy after using ketoprofen, tiaprofenic acid, fenofibrate, or UV filters or perfumes;
- during exposure to sunlight (even when the sky is overcast) or UV radiation in sunbeds, during treatment and for 2 weeks after stopping the medicine;
- in the third trimester of pregnancy (see section "Pregnancy").
The gel should not be applied to damaged or diseased skin, such as in cases of eczema, acne, skin infections, or open wounds.
Children and adolescents
Due to the lack of controlled clinical studies on the efficacy and safety of ketoprofen in children, this medicine should not be used in children under 15 years of age.
Warnings and precautions
Exposure to sunlight (even when the sky is overcast) or UVA radiation on areas of skin treated with Fastum gel may cause serious skin reactions (photosensitivity). Therefore, it is essential to:
- protect the treated areas of skin by wearing clothing during treatment and for two weeks after discontinuing the medicine, in order to avoid the risk of photosensitivity;
- thoroughly wash hands after each application of Fastum gel.
Long-term use of topical medicines may in some patients cause allergic reactions or local irritation. If redness, rash, itching, or nausea occur, treatment should be stopped immediately and a doctor should be consulted. The medicine should not be applied to open wounds or abrasions, and if skin changes occur at the site of gel application, the medicine should be discontinued. Eyes and mucous membranes should be protected from contact with the medicine. Do not use under occlusive dressings. The medicine should not be taken orally or applied over large areas of the body. Local application of large amounts of the medicine may lead to systemic effects, including hypersensitivity reactions and asthma. Use with caution in patients with cardiac insufficiency or severe renal or hepatic impairment, as isolated cases of systemic adverse reactions have been reported. Hands should be washed after applying the gel, unless the hands themselves are the treated area. The use of protective gloves is recommended during prolonged treatment. Treatment should be discontinued immediately if any skin reactions occur after application of Fastum gel, as well as skin reactions after concomitant use of products containing octocrylene (octocrylene is one of the excipients used in various cosmetics and hygiene products such as shampoo, after-shave products, shower and bath gels, skin creams, lipsticks, anti-wrinkle creams, make-up removers, hair lacquers, to delay degradation by light).
Patients with asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of allergic reactions to aspirin and/or NSAIDs than the general population.
Fastum and other medicines
No interactions between Fastum and other medicines have been reported. However, caution should be exercised in patients concurrently receiving oral anticoagulants.
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of non-steroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause harmful effects on the fetal heart and lungs. NSAIDs may also delay labour.
Fastum should not be used during the last 3 months of pregnancy. During the first 6 months of pregnancy, Fastum should not be used unless the physician considers it absolutely necessary. If treatment is required during this period, the lowest possible dose for the shortest possible duration is recommended.
Oral forms (e.g. tablets) of ketoprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies when Fastum is applied to the skin.
Breast-feeding
Consult a doctor before using any medicine.
Ketoprofen passes into breast milk in small amounts. Administration of this medicine is not recommended during breast-feeding.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been reported.
Fastum contains orange fragrance and lavender fragrance
The medicine contains fragrance substances: citral, citronellol, coumarin, farnesol, geraniol, d-limonene, and linalool. These may cause allergic reactions.
Caution should be exercised when using this medicine in patients with a history of epilepsy, due to the presence of a terpene derivative (lavender fragrance) in the formulation.
3. How to use Fastum
Apply Fastum 1 to 2 times daily by spreading a thin layer of the gel (a gel strip 3 to 5 cm in length) onto the skin over the painful area and gently massage to enhance absorption.
If symptoms do not improve, worsen, or new symptoms occur after 7 days of using the medicine, consult a doctor.
Fastum must not be used in children under 15 years of age.
Use of a higher than recommended dose of Fastum
No cases of overdose or poisoning with Fastum have been reported.
In case of accidental ingestion of the gel, symptoms such as drowsiness, nausea, and vomiting may occur. Ingestion of large doses may lead to respiratory depression, coma, convulsions, gastrointestinal bleeding, increased or decreased arterial blood pressure, and acute kidney failure.
The physician should administer appropriate measures and initiate symptomatic treatment typically used in poisoning with nonsteroidal anti-inflammatory drugs. If less than 1 hour has passed since the overdose, gastric lavage should be performed and symptomatic treatment initiated.
4. Possible adverse reactions
Like all medicines, Fastum may cause adverse reactions, although not everybody experiences them.
Cases of local skin reactions have been observed, which may subsequently spread beyond the site of application. Rarely, severe reactions such as bullous or acneiform eruptions have occurred, which may spread or become generalized.
Other systemic adverse reactions (e.g. affecting the gastrointestinal system or kidneys) caused by non-steroidal anti-inflammatory drugs result from the penetration of the active substance through the skin and are therefore dependent on the amount of gel applied, the skin surface area treated, the degree of tissue absorption, duration of treatment, and possible use of an occlusive dressing (hypersensitivity, gastrointestinal disorders, and renal function disorders).
The following frequency categories are generally used to assess adverse reactions:
Very common: more than 1 in 10 patients treated;
Common: less than 1 in 10, but more than 1 in 100 patients treated;
Uncommon: less than 1 in 100, but more than 1 in 1,000 patients treated;
Rare: less than 1 in 1,000, but more than 1 in 10,000 patients treated;
Very rare: less than 1 in 10,000 patients treated;
Not known (frequency cannot be estimated from the available data).
| System Organ Class | Uncommon (≥1/1,000 to <1/100) | Rare (≥1/10,000 to <1/1,000) | Very rare (<1/10,000) |
| Immune system disorders | Anaphylactic reaction, hypersensitivity reactions | ||
| Gastrointestinal disorders | Peptic ulcer disease of stomach and (or) duodenum, gastrointestinal bleeding, diarrhoea | ||
| Skin and subcutaneous tissue disorders | Erythema, pruritus, rash, burning sensation | Photosensitivity, bullous eruption, urticaria | Contact dermatitis, angioedema |
| Renal and urinary disorders | Renal failure or worsening of renal function |
Elderly patients are particularly susceptible to adverse reactions following administration of non-steroidal anti-inflammatory drugs.
If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur, the physician or pharmacist should be informed immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables the collection of further information on the safety of the medicinal product.
5. How to store the medicine Fastum
No special storage instructions are required.
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. The expiry date refers to the last day of the stated month.
Period of use after first opening of the container: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What Fastum contains
- The active substance is: Ketoprofenum (ketoprofen). 25 mg of ketoprofen is contained in 1 g of gel.
- Other ingredients are: carbomer, ethanol 96%, trolamine, orange flavour (containing, among others, citral, citronellol, farnesol, geraniol, d-limonene and linalool), lavender flavour (containing, among others, coumarin, geraniol, d-limonene and linalool), purified water.
What Fastum looks like and contents of the pack
Tubes containing 50 g or 100 g of gel, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorisation number in Romania, country of export: 8884/2016/03
8884/2016/04
Parallel import authorisation number: 175/19
