FASTUM 25 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
   1. You should carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Fastum and what is it used for
   1. Indications for use
4. Important information before using Fastum
   1. When not to use Fastum
   2. Children and adolescents
   3. Warnings and precautions
   4. Fastum and other medicines
   5. Pregnancy
   6. Breastfeeding
   7. Driving and using machines
   8. Fastum contains orange flavor and lavender flavor
5. How to use Fastum
   1. Using a higher dose of Fastum than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Fastum
   1. The medicine should be stored out of sight and reach of children.
8. Contents of the packaging and other information
   1. What Fastum contains
   2. What Fastum looks like and what the packaging contains
   3. Marketing authorization holder in Romania, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Date of leaflet approval: 24.04.2024

Leaflet attached to the packaging: 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 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 specifically for you. 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 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 and analgesic drugs
for topical use.
Ketoprofen - the active substance of Fastum - administered 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
cases of sensitive skin.

Indications for use

• Local treatment of muscle and joint pain, e.g. caused by injuries (injuries caused by playing sports, joint injuries with ligament sprains without dislocation, tendon and muscle damage caused by excessive strain),
• Local treatment of low 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 had hypersensitivity reactions to sunlight;
• if the patient has had 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 had skin allergies 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;
• during the third trimester of pregnancy (see "Pregnancy").

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

Children and adolescents

Due to the lack of controlled clinical trials on the efficacy and safety of
using 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 cloudy) or UVA rays on
skin areas where Fastum has been applied may cause severe skin reactions
(hypersensitivity to sunlight). 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 medicine, in order to avoid the risk of hypersensitivity to sunlight
• 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, you should stop using the medicine and contact your doctor. The medicine should not be used on open wounds or cuts, and if skin changes occur at the site of application, the medicine should be discontinued. You should protect your eyes and mucous membranes from contact with the medicine, do not use under occlusive dressings. The medicine should not be used orally or on a large surface of the body. Local administration of large amounts of the medicine may cause systemic effects, including hypersensitivity reactions and asthma. The medicine should be used with caution in patients with circulatory failure, severe kidney or liver dysfunction, as individual cases of systemic side effects have been reported. After applying the gel, you should wash your hands, unless it is your hands that are being treated. During prolonged use, it is recommended to wear protective gloves. Treatment should be stopped immediately in case of any skin reactions after using Fastum, as well as 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 shampoo, 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). In patients with asthma and chronic rhinitis, chronic sinusitis and (or) nasal polyps, the risk of an allergic reaction to aspirin and (or) NSAIDs 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

If the patient is pregnant or breastfeeding, suspects that she may be pregnant or plans to have
a child, she should consult her doctor or pharmacist 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 delivery.
Fastum should not be used if the patient is in the last 3 months of pregnancy. During the first 6 months of pregnancy, Fastum should not be taken unless the doctor considers its use 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

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

Driving and using machines

The effect of the medicine on the ability to drive and use machines has not been described.

Fastum contains orange flavor and lavender flavor

The medicine contains flavoring substances 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 presence of a terpene derivative (lavender flavor) in the product.

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 occur, you should consult a doctor.
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.
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 no more than 1 hour ago, gastric lavage should be performed and symptomatic treatment should be administered.

4. Possible side effects

Like all medicines, Fastum can cause side effects, although not everybody gets them.
Local skin reactions have been observed, which can then spread beyond the site of application of the medicine. Rarely, severe reactions such as blistering or pustular rash have occurred, which can spread or become generalized.
Other systemic side effects (e.g. related to the digestive system or kidneys) caused by non-steroidal anti-inflammatory drugs result from the absorption of the active substance of the medicine 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 treatment, and the possible use of an occlusive dressing (hypersensitivity, gastrointestinal disorders, and kidney function disorders).
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 (frequency cannot be estimated from available data).

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 Monitoring of Adverse Reactions to Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181 C, 02-222 Warsaw, tel.: + 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 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. The expiry date refers to the last day of the month.
Shelf life after first opening the packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fastum contains

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

What Fastum looks like and what the packaging contains

A tube containing 50 g or 100 g of gel in a cardboard box.
For more detailed information, please 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:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Authorization number in Romania, the country of export:8884/2016/03
8884/2016/04
Parallel import authorization number:175/19

Date of leaflet approval: 24.04.2024

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