FASTUM PAIN RELIEF*1% 50G

FASTUM ANTIDOLORIFICO 10 mg/g GEL
Diclofenac

What it is and what it is used for
FASTUM ANTIDOLORIFICO contains diclofenac and belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) for topical (local) use.

FASTUM ANTIDOLORIFICO is used for the local treatment of painful and inflammatory conditions, of rheumatic or traumatic origin, of the joints, muscles, tendons and ligaments.

Contact your doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before taking the medicine
Do not use FASTUM ANTIDOLORIFICO
- If you are allergic to the active ingredient, to any of the other ingredients of this medicine (listed in paragraph 6) or to other NSAIDs, such as acetylsalicylic acid (aspirin).
- If you have previously experienced asthma attacks, urticaria or acute rhinitis (inflammation of the nasal mucous membranes) after taking acetylsalicylic acid or other NSAIDs. - Near skin wounds or open lesions, in the area around the eyes, and on mucous membranes.
- During the third trimester of pregnancy and breastfeeding (see Pregnancy, breastfeeding and fertility).
- If you suspect you are pregnant or wish to plan a pregnancy (see Pregnancy, breastfeeding and fertility).
- If you have fertility problems or are undergoing fertility investigations (see Pregnancy, breastfeeding and fertility).

The use of FASTUM ANTIDOLORIFICO is contraindicated in children under 14 years of age (see "Children and adolescents").

Warnings and precautions
Consult your doctor or pharmacist before using FASTUM ANTIDOLORIFICO.

If you are elderly or have stomach conditions, the simultaneous use of FASTUM ANTIDOLORIFICO and systemic anti-inflammatory drugs (i.e. drugs taken orally, intramuscularly or intravenously) is not recommended.

The use, especially if prolonged, of topical (local) products, can give rise to local sensitization (increased reactivity) or irritation phenomena. In this case, it is necessary to interrupt the treatment and consult your doctor to establish an appropriate therapy.

The possibility of systemic undesirable effects with the application of topical diclofenac cannot be excluded if the preparation is used on extensive skin areas and for a prolonged period.

To avoid any hypersensitivity or photosensitization phenomena, do not expose yourself to direct sunlight including solarium during treatment and in the two subsequent weeks.

Immediately stop using FASTUM ANTIDOLORIFICO if skin reactions (skin) such as skin rash, mucosal lesions or any other sign of allergy appear after applying the product.

FASTUM ANTIDOLORIFICO can be used with non-occlusive bandages but should not be used with occlusive bandages that do not allow air to pass through, as they increase absorption through the skin.

You should contact your doctor before using FASTUM ANTIDOLORIFICO:
- If you have or have had photosensitization reactions after exposure to sunlight in the past.
- If you suffer from chronic (i.e. long-lasting or permanent) obstructive bronchial diseases or inflammation of the nasal mucous membrane (nasal polyposis) and react with asthmatic attacks, local skin or mucosal inflammation (Quincke's edema) or urticaria to treatment with NSAIDs.

FASTUM ANTIDOLORIFICO must not come into contact with the eyes or mucous membranes and must not be ingested.

The medicine must be applied only to intact, healthy skin, and not to skin wounds or open lesions.

Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor.

Children and adolescents
Insufficient data are available on efficacy and safety in children under 14 years of age.
Therefore, the use of FASTUM ANTIDOLORIFICO is contraindicated in children under 14 years of age (see "Do not use FASTUM ANTIDOLORIFICO").

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

Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

FASTUM ANTIDOLORIFICO is generally well tolerated.

Skin redness, itching, burning or skin rashes (onset of skin lesions) may occur.
The use of FASTUM ANTIDORIFICO, in association with other diclofenac-containing drugs, may lead to light sensitization (photosensitivity), skin rash with blister formation, eczema (itchy inflammatory skin reaction), erythema and skin reactions that may also be severe (Stevens-Johnson syndrome, Lyell's syndrome).
If FASTUM ANTIDORIFICO is applied to relatively large skin areas and for a prolonged period, the possibility of systemic side effects cannot be completely excluded.
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 involved, the degree of skin integrity, the duration of treatment and the use of occlusive dressings (digestive and renal effects).
Possible side effects that may occur following the use of FASTUM ANTIDORIFICO are, in decreasing order of frequency:

Common side effects (may affect up to 1 in 10 patients):
- Rash, eczema, erythema, dermatitis (including contact), itching.

Rare side effects (may affect up to 1 in 1,000 patients):
- Bullous dermatitis.

Very rare side effects (may affect up to 1 in 10,000 patients):
- Asthma.
- Rash with pustules (skin lesions).
- Allergy (including urticaria), angioneurotic edema (swelling of the skin and mucous membranes).
- Photosensitivity reactions.

Side effects not known (frequency cannot be estimated from available data):
- Burning sensation at the application site
- Dry skin

Adherence to the instructions in the package leaflet reduces the risk of side effects.

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