FASTUM 25 mg /G Gel

Зміст інструкції

1. FASTUM 25 mg/g GEL
   1. What is FASTUM 25 mg/g GEL and what is it used for
   2. What you need to know 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

FASTUM 25 mg/g GEL

ketoprofen

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FASTUM is and what it is used for
• 2. What you need to know 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 is FASTUM 25 mg/g GEL and what is it used for

FASTUM contains ketoprofen and belongs to the category of non-steroidal anti-inflammatory and rheumatic drugs (against rheumatism).
FASTUM is used for the local treatment of painful conditions of the osteo-articular and muscular system of
rheumatic or traumatic origin: contusions, sprains, muscle strains, torticollis, lumbago.
See a doctor if you do not feel better or if you feel worse after 4-5 days.

2. What you need to know before using FASTUM

Do not use FASTUM

• If you are allergic to the active ingredient or to other related substances, such as fenofibrate, tiaprofenic acid, acetylsalicylic acid or other NSAIDs (Non-Steroidal Anti-inflammatory Drugs), or to any of the other components of this medicine (listed in section 6).
• If you have previously experienced photosensitization reactions (skin reactions during exposure to sunlight).
• If you have previously experienced allergies to ketoprofen, tiaprofenic acid, fenofibrate, UV sun filters or perfumes.
• Near open wounds or skin lesions, in the area around the eyes, on skin areas with alterations such as dermatoses, acne or eczema.
• If you are in the last three months of pregnancy (see "Pregnancy and breastfeeding").

Do not expose the treated areas to sunlight or UV lamps of the solarium for
the entire duration of treatment and for two weeks after its
interruption.
Warnings and precautions
See a doctor or pharmacist before using FASTUM.
The use, especially if prolonged, of topical (local) products, can give rise to local phenomena of
sensitization (increased reactivity) or irritation.
Immediately discontinue the use of FASTUM if skin reactions (of the skin) occur
including those that develop following the concomitant use of products containing octocrylene
(octocrylene is an excipient present in various cosmetic and personal hygiene products such as shampoos,
aftershaves, shower gels and baths, skin creams, lipsticks, anti-aging creams, make-up removers, hair sprays,
used to prevent their degradation caused by light).
The use of large amounts of topical products can give rise to systemic effects (which can
affect the whole organism) such as hypersensitivity (exaggerated sensitivity, of an allergic type, to one or more
substances) and asthma.

Exposure to sunlight (even when the sky is cloudy) or to UVA lamps of the areas treated
with FASTUM can induce skin reactions potentially serious (photosensitization).
Therefore it is necessary to:

• protect the treated parts from the sun with appropriate clothing for the entire duration of treatment and in the two weeks following its interruption in order to avoid any risk ofphotosensitization
• wash your hands thoroughly and for a long time after each application of FASTUM

Treatment should be discontinued immediately if any skin reaction occurs
following the application of FASTUM. The treatment should not be administered for longer than the time
prescribed: the risk of developing contact dermatitis and photosensitivity reactions increases over time.
Patients with asthma associated with chronic (i.e. long-lasting or
permanent) rhinitis (inflammation of the nasal mucous membranes), chronic sinusitis and/or nasal polyps have an increased risk of allergy to aspirin and/or
NSAIDs compared to the rest of the population.
Avoid contact with mucous membranes or eyes.
Do not use occlusive bandages (strip of gauze or other material, as they increase absorption
through the skin).
FASTUM does not cause habituation.
Use ketoprofen gel with caution in patients with reduced cardiac, hepatic (liver) or renal function:
isolated cases of systemic adverse reactions (kidney pathologies) have been reported.

Children
There is no data to support the safety and efficacy of ketoprofen gel in children and therefore its use must
be avoided.

Other medicines and FASTUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions of FASTUM with other drugs have been found. However, it is advisable to carry out blood tests in patients undergoing treatment with coumarins (oral anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

• Do not use FASTUM in the last 3 months of pregnancy (see "Do not use FASTUM”). You should not use FASTUM in the first 6 months of pregnancy, unless strictly necessary and under the advice of a doctor. If treatment is necessary during this period, the minimum dose should be used for the shortest possible time. Oral formulations (e.g. tablets) of ketoprofen can cause adverse effects on the fetus. It is not known whether FASTUM entails the same risk when used on the skin.

Breastfeeding
After systemic administration, traces of ketoprofen have been detected in breast milk. The use of
Ketoprofen is not recommended in breastfeeding women.
During the first and second trimester of pregnancy and during breastfeeding, FASTUM should be used only
after consulting your doctor and evaluating with him the risk/benefit ratio in your case. Consult
your doctor if you suspect or are planning a pregnancy.

Driving and operating machinery
FASTUM does not alter the ability to drive vehicles and operate machinery.

FASTUM contains neroli fragrance, lavandino fragrance and ethanol
FASTUM contains neroli fragrance in turn containing the allergens citral, citronellol,
farnesol, geraniol, d-Limonene and linalool; and lavandino fragrance in turn containing the
allergens citral, citronellol, coumarin, eugenol, geraniol, d-Limonene and linalool.These allergens
can cause allergic reactions.
This medicine contains 307 mg of ethanolin each gram of gel. Ethanol can cause a burning sensation on damaged skin.

3. How to use FASTUM

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
How much
Warning: do not exceed the indicated doses without the advice of your doctor.
Apply the gel in a thin layer to the affected skin area.
Do not use occlusive bandages on the area where the medicine has been applied.
In case of allergic or other skin reactions, stop treatment and consult
your doctor.
When and for how long
One or two times a day.
Warning: use only for short periods of treatment.
How
Apply the gel and massage gently to promote absorption. Wash your hands thoroughly
after each use.
Tube with screw cap: to open the tube, unscrew the cap and pierce the aluminum diaphragm with the tip of the
cap turned upside down.
Tube with dispenser: to prime the tube, press the applicator cap several times or push
the bottom of the tube forward until the gel appears; it is recommended to use it in a horizontal position.

Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its
characteristics.

If you use more FASTUM than you should
In case of ingestion/taking an excessive dose of FASTUM, immediately notify your doctor or
go to the nearest hospital.
Given the low levels of FASTUM in the blood when applied percutaneously (through the skin), phenomena of overdose, i.e. caused by taking an excessive dose of the drug, can be ruled out.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As with other medicines for topical use, side effects involving the skin may occur. Cases of skin allergic reactions and severe skin reactions during exposure to sunlight (photosensitization) have been reported. Rare cases of more serious adverse reactions, such as bullous or blistering eczema (presence of blisters filled with fluid), have also been reported, which may extend beyond the application area or become widespread.
The frequency and severity of these effects are significantly reduced by avoiding exposure to the sun, including solariums, during treatment and for the two weeks following.
Other systemic effects of anti-inflammatory drugs depend on the passage of the active ingredient through the skin and therefore on the amount of gel applied, the surface area involved, the degree of skin integrity, the duration of treatment and the use of occlusive bandages (digestive and renal effects).
Possible side effects are:

Uncommon side effects (may affect up to 1 in 100 people):

• localized skin reactions such as erythema, itching, eczema, burning sensation.

Rare side effects (may affect up to 1 in 1,000 people):

• skin reactions, even severe, during exposure to sunlight (photosensitization reactions), blistering eruptions, urticaria, rare cases of more serious skin reactions such as bullous or blistering eczema (presence of blisters filled with fluid) which may extend beyond the application area or become widespread.

Very rare side effects (may affect up to 1 in 10,000 people):

• contact dermatitis (skin inflammation), peptic ulcer, gastrointestinal bleeding, diarrhea, renal failure (new cases or worsening of pre-existing conditions). Isolated cases of systemic effects (which can affect the whole body) such as kidney disorders have also been reported.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• anaphylactic reactions (severe allergic reactions with rapid onset, including anaphylactic shock), angioedema (swelling of the skin and mucous membranes), hypersensitivity reactions, bullous dermatitis (a particular type of irritation involving the formation of blisters and vesicles on the skin).

Immediately stop treatment and see a doctor if you experience any skin reaction following application of FASTUM.
Elderly patients are particularly susceptible to the adverse events of non-steroidal anti-inflammatory drugs.
These side effects are generally transient. However, when they occur, it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store FASTUM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to
the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
It is important to always have the information about the medicine available, therefore keep both the box
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FASTUM contains
100 g of gel contains:

Active ingredient: ketoprofen 2.5 g.

Other components:carbomer, ethanol, neroli fragrance (containing citral, citronellol, farnesol,
geraniol, d-Limonene and linalool), lavender fragrance (containing citral, citronellol, coumarin,
eugenol, geraniol, d-Limonene and linalool), triethanolamine, purified water.

Description of the appearance of FASTUM and contents of the pack
FASTUM is for external use and is presented in the form of a mucilaginous consistency gel, colorless or
slightly yellowish, almost transparent, with an aromatic odor.
Aluminum tube with screw cap: tube containing 50 g of FASTUM 25 mg/g GEL.
Tube with dispenser: tube containing 50 g of FASTUM 25 mg/g GEL.
Aluminum tube with screw cap: tube containing 100 g of FASTUM 25 mg/g GEL.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence. Sales representativeMontefarmaco OTC S.p.A. – via IV Novembre, 92 – 20021 Bollate Milan

Manufacturer

• A. Menarini Manufacturing Logistics and Services s.r.l., production site via Sette Santi, 3 - Florence.