Fastum

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Fastum (Fastum Gel)
25 mg/g, gel
Ketoprofenum
Fastum and Fastum Gel are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

Fastum is a medicine belonging to the group of non-steroidal anti-inflammatory and analgesic drugs 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. The gel, due to its water-alcohol base, also provides a superficial cooling and soothing effect. The appropriate formulation ensures proper release of ketoprofen and a low risk of systemic adverse effects. The medicine is well tolerated, even in individuals with sensitive skin.

Indications

• 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
Do not use Fastum if you have a history of hypersensitivity to ketoprofen or any of the other
components of Fastum, tiaprofenic acid, acetylsalicylic acid or other nonsteroidal anti-inflammatory
drugs (NSAIDs), fenofibrate, UV filters, or perfumes.
Ketoprofen must not be used in patients who experience "aspirin-induced asthma" attacks,
rash, or rhinitis after taking acetylsalicylic acid or its derivatives.
The product is contraindicated in individuals with a history of aspirin-induced asthma or other
hypersensitivity reactions.
Fastum should not be applied to open wounds or on individuals with rashes, eczema, or oozing
skin lesions of unknown origin.
Discontinue use immediately if skin reactions occur, including skin reactions following
concomitant use of products containing octocrylene (octocrylene is one of the excipients used in
various cosmetics and hygiene products such as shampoos, after-shave lotions, shower and bath
gels, skin creams, lip balms, anti-wrinkle creams, make-up removers, hair lacquers, to delay
decomposition under light exposure).
Avoid exposing treated skin areas to sunlight (even when the sky is overcast) or UV radiation in
solariums during treatment and for 2 weeks after discontinuation of the product.
The use of ketoprofen is not recommended in children under 15 years of age due to lack of
controlled clinical data on efficacy and safety. Do not use in women from the sixth month of
pregnancy.

Warnings and precautions
Exposure to sunlight (even when the sky is overcast) or UVA radiation on skin areas treated with
Fastum may cause severe skin reactions (photosensitivity). Therefore, it is essential to:

• protect treated skin areas by wearing clothing during treatment and for two weeks after discontinuation of Fastum to avoid the risk of photosensitivity reactions,
• thoroughly wash hands after each application of Fastum.

Long-term use of topical medications may, in some patients, cause allergic reactions or local irritation. If redness, rash, itching, or nausea occur, discontinue use immediately and consult a physician. Do not apply the product to open wounds or abrasions. If skin changes occur at the site of gel application, discontinue the product. Avoid contact with eyes and mucous membranes. Do not use under occlusive dressings. Do not take orally or apply over large body surface areas. Local application of large amounts of the product may lead to systemic effects, including hypersensitivity reactions and asthma. Use Fastum with caution in patients with circulatory insufficiency or severe renal or hepatic impairment, as isolated cases of systemic adverse reactions have been reported. Exercise caution when using the product in patients with a history of epilepsy due to the presence of a terpene derivative (lavender fragrance) among excipients. After applying the gel, wash hands unless the hands are the treated area. During prolonged use, protective gloves are recommended. Discontinue treatment immediately if any skin reactions develop following application of Fastum. This product contains alcohol; do not use near fire. Patients with asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of allergic reactions to aspirin and/or NSAIDs compared to the general population.

Fastum with other medicines
No interactions between Fastum and other medicinal products have been reported. However, caution
should be exercised in patients concurrently receiving oral anticoagulants.

Pregnancy
Before using any medicinal product, consult a physician.
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may
have harmful effects on the fetal heart and lungs. NSAIDs may delay the onset of labor. The use of
this medicinal product should be avoided during the first and second trimesters of pregnancy. Do
not use in women from the third trimester of pregnancy.

Breast-feeding
Before using any medicinal product, consult a physician.
Ketoprofen passes into breast milk in small amounts. Administration of the product to breast-feeding
women is not recommended.

Driving and operating machinery
No effects of the medicinal product on the ability to drive or operate machinery have been reported.

Fastum contains orange fragrance and lavender fragrance.
This product contains fragrances composed of: citral, citronellol, coumarin, farnesol, geraniol, d-limonene, and linalool, which may cause allergic reactions.

3. How to use Fastum

Fastum should be applied 1 to 2 times daily. Apply a thin layer of gel (a gel strip 3 to 5 cm in length) to the skin over the painful area and gently massage to aid absorption. If symptoms do not improve, worsen, or new symptoms occur after 7 days of using the medicine, consult a doctor.

Fastum should not be used in children under 15 years of age.

Use of a higher than recommended dose of Fastum

Cases of overdose or poisoning with Fastum have not been reported.

In case of accidental ingestion of the gel, symptoms such as drowsiness, nausea, and vomiting may occur. Ingestion of large amounts may lead to respiratory depression, coma, convulsions, gastrointestinal bleeding, increased or decreased arterial blood pressure, and acute kidney failure. The physician will apply appropriate measures and initiate symptomatic treatment usually used in cases of poisoning with non-steroidal 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 can cause adverse reactions, although they do not occur in everyone.
The following frequency categories are generally used to assess adverse reactions:
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 from available data).

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. gastrointestinal or renal) 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 treated skin surface area, the degree of tissue absorption, duration of therapy, and possible use of an occlusive dressing (hypersensitivity, gastrointestinal disorders, and renal function disturbances).

Since the product was placed on the market, the following adverse reactions have been observed, listed below by organ system and frequency as: very common (≥10%), common (between 1% and 10%), uncommon (between 0.1% and 1%), rare (between 0.01% and 0.1%), or very rare (<0.01%), including single cases.

Immune system disorders
Very rare: Anaphylactic reaction, hypersensitivity reactions

Gastrointestinal disorders
Very rare: Peptic ulceration of the stomach and/or duodenum, gastrointestinal bleeding, diarrhoea

Skin and subcutaneous tissue disorders
Uncommon: Erythema, pruritus, rash, burning sensation
Rare: Photosensitivity, bullous eruption, urticaria
Very rare: Contact dermatitis, angioedema

Renal and urinary disorders
Very rare: Renal failure or worsening of renal function disorders

Elderly patients are particularly susceptible to adverse reactions following administration of non-steroidal anti-inflammatory drugs.

If any adverse reaction worsens or if any adverse reaction not listed in this leaflet occurs, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, Tel.: +48 22 4921 301, Fax: +48 22 4921 309, Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder or parallel importer.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fastum

No special storage requirements apply.
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 specified month. Shelf-life after first opening 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Fastum contains

• The active substance is: Ketoprofenum (ketoprofen).
• Other ingredients of the medicine are: carbomer, ethanol 96%, triethanolamine, orange flavour (containing citral, citronellol, farnesol, geraniol, d-limonene and linalool), lavender flavour (containing coumarin, geraniol, d-limonene and linalool), purified water.

What Fastum looks like and contents of the pack
Tubes containing 20 g, 30 g, 50 g or 100 g of gel.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Via Sette Santi 3
50131 Florence
Italy
Manufacturer
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Sette Santi 3
50131 Florence
Italy
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation numbers in Romania, country of export:
8884/2016/01
8884/2016/02
8884/2016/04
8884/2016/03
Parallel import authorisation number: 320/22