FASTUM 10 mg /G Żel

Treść ulotki

1. FASTUM ANTIDOLORIFICO 10 mg/g GEL
   1. What is FASTUM ANTIDOLORIFICO and what is it used for?
   2. What you need to know before using FASTUM ANTIDOLORIFICO
2. FASTUM ANTIDOLORIFICO contains lavender essential oil which in turn contains
3. FASTUM ANTIDOLORIFICO contains 550 mg of alcohol (ethanol) per gram of product which
   1. How to use FASTUM ANTIDOLORIFICO
   2. Possible side effects
   3. How to store FASTUM ANTIDOLORIFICO
   4. Contents of the pack and other information

FASTUM ANTIDOLORIFICO 10 mg/g GEL

Diclofenac

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

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 1. What FASTUM ANTIDOLORIFICO is and what it is used for
• 2. What you need to know before using FASTUM ANTIDOLORIFICO
• 3. How to use FASTUM ANTIDOLORIFICO
• 4. Possible side effects
• 5. How to store FASTUM ANTIDOLORIFICO
• 6. Contents of the pack and other information

1. What is FASTUM ANTIDOLORIFICO and what is it 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.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using FASTUM ANTIDOLORIFICO

Do not use FASTUM ANTIDOLORIFICO

• If you are allergic to the active ingredient, to any of the other ingredients of this medicine (listed in section 6) or to other NSAIDs, such as acetylsalicylic acid (aspirin).
• If you have previously experienced attacks of asthma, urticaria or acute nasal 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 problems, 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 products for topical (local) use, can give rise to local
phenomena of sensitization (increased reactivity) or irritation. In this case it is necessary
to interrupt the treatment and consult your doctor to establish suitable therapy.
The possibility of systemic adverse effects with the application of topical diclofenac cannot be
excluded if the preparation is used on large areas of skin and for a prolonged period.
To avoid any phenomena of hypersensitivity or photosensitization, do not expose yourself to
direct sunlight including solariums during treatment and for the following two weeks.
Immediately discontinue the use of FASTUM ANTIDOLORIFICO if skin (cutaneous) reactions such as
rash, mucosal lesions or any other sign of allergy occur after application of 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 consult your doctor before using FASTUM ANTIDOLORIFICO:

• If you have or have had photosensitization reactions in the past after exposure to sunlight.
• If you suffer from chronic obstructive bronchial diseases or inflammation of the nasal mucous membrane (nasal polyposis) and react with asthmatic attacks, local inflammation of the skin or mucous membrane (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 should only be applied to intact, healthy skin, 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”).

Other medicines and FASTUM ANTIDOLORIFICO
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Since the systemic absorption of FASTUM ANTIDOLORIFICO following topical
application is very low, interactions with other drugs administered systemically are very
unlikely.
However, especially in high-dose and prolonged treatments, be aware of the possibility
of competition between absorbed FASTUM ANTIDOLORIFICO and other drugs with high binding to
plasma proteins (blood), such as dicoumarol anticoagulants (warfarin), many NSAIDs, digoxin and some antibiotics.

Pregnancy, breastfeeding and fertility
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 using this medicine.
The use of FASTUM ANTIDOLORIFICO, like any NSAID, is not recommended in women who
intend to become pregnant.
Like other NSAIDs, FASTUM ANTIDOLORIFICO should not be administered in the third
trimester of pregnancy and during breastfeeding.
The administration of FASTUM ANTIDOLORIFICO should be discontinued in women who
have fertility problems or are undergoing fertility investigations.
The systemic concentration of diclofenac is lower after topical administration compared to
oral formulations. Referring to experience with NSAID treatment for
systemic administration, the following is recommended:

• During the first and second trimester of pregnancy, diclofenac should only be administered in case of actual need and under strict medical supervision. If diclofenac is used by a woman trying to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
• The use of diclofenac is contraindicated during the last trimester of pregnancy (see "Do not use FASTUM ANTIDOLORIFICO”). During the third trimester of pregnancy, NSAIDs can also delay or prolong labour and prolong bleeding time and their use can be toxic to the heart, lungs and kidneys of the fetus.

Breastfeeding
After systemic administration, traces of diclofenac have been detected in breast milk. Although
effects on infants are not expected with the therapeutic doses of FASTUM ANTIDOLORIFICO,
due to the lack of controlled studies in breastfeeding women, the product should be used
during breastfeeding only under the advice of a healthcare professional. In this circumstance
FASTUM ANTIDOLORIFICO should not be applied to the breasts of breastfeeding mothers, nor
elsewhere on large areas of skin or for a prolonged period of time (see “Warnings and
precautions”).

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

FASTUM ANTIDOLORIFICO contains methyl parahydroxybenzoatewhich may cause allergic reactions (including delayed reactions).

FASTUM ANTIDOLORIFICO contains lavender essential oil which in turn contains

allergens: benzyl alcohol, benzyl benzoate, coumarin, eugenol, linalool, d-Limonene, geraniol
which may cause allergic reactions.

FASTUM ANTIDOLORIFICO contains 550 mg of alcohol (ethanol) per gram of product which

is equivalent to 55 g/100 g. It may cause a burning sensation on damaged skin.

3. How to use FASTUM ANTIDOLORIFICO

Take this medicine following exactly as indicated in this leaflet or as
instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply 2-4 g of gel, depending on the extent of the painful areas or surfaces, three or four
times a day.
Do not exceed the indicated doses without your doctor's advice and use FASTUM ANTIDOLORIFICO
only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change
in its characteristics.
If this product is needed for more than 7 days to relieve pain, or if symptoms worsen,
consult a doctor.

Adults over 18 years of age
Apply FASTUM ANTIDOLORIFICO 3 or 4 times a day to the area to be treated, gently massaging.
The amount to be applied depends on the size of the affected area. For
example, 2-4 g of medicine (an amount varying in size between a cherry and a walnut) are
sufficient to treat an area of 400-800 cm . After application, wash your hands, otherwise
they too will be treated with the gel.

Adolescents aged 14 to 18 years
The dosage is similar to that indicated for adults.

If you use more FASTUM ANTIDOLORIFICO than you should
In case of ingestion/accidental intake of an excessive dose of FASTUM
ANTIDOLORIFICO, immediately inform your doctor or go to the nearest hospital.
The low systemic absorption of diclofenac administered topically means that an
overdose (intake of an excessive dose of the drug) is very unlikely.
However, undesirable effects similar to those observed after a diclofenac overdose
tablets can be expected in the event that topical diclofenac is inadvertently ingested.
In the event of accidental ingestion leading to significant systemic effects, measures
therapeutic general normally adopted to treat poisoning with
non-steroidal anti-inflammatory drugs must be taken. Gastric emptying and the use of activated charcoal should be considered, in particular
within a short time of ingestion.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by using the lowest effective dose for the shortest duration possible to control the symptoms.
FASTUM ANTIDOLORIFICO is generally well tolerated.
Redness of the skin, itching, burning or skin rashes (appearance of skin lesions) may occur.
The use of FASTUM ANTIDOLORIFICO, in combination with other medicines containing
diclofenac, may lead to phenomena of light sensitivity (photosensitivity), skin rash with blister formation, eczema (itchy inflammatory skin reaction),
erythema and skin reactions with even severe evolution (Stevens-Johnson syndrome, Lyell's syndrome).
If FASTUM ANTIDOLORIFICO is applied to relatively large areas of skin 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 area involved, the degree of
skin integrity, the duration of treatment and the use of occlusive bandages (digestive and
renal effects).
Possible side effects that may occur following the use of FASTUM
ANTIDOLORIFICO are, in decreasing order of frequency:

Common side effects (may affect up to 1 in 10 people):

• Rash, eczema, erythema, dermatitis (including contact dermatitis), itching.

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

• Bullous dermatitis.

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

• Asthma.
• Rash with pustules (skin lesions).
• Allergy (including urticaria), angioedema (swelling of the skin and mucous membranes).
• Photosensitivity reactions.
• Side effects with unknown frequency (frequency cannot be estimated from available data):
• Burning sensation at the application site
• Dry skin

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 ANTIDOLORIFICO

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 in intact packaging, correctly
stored.
After opening the tube, the validity is 6 months.
It is important to always have the information about the medicine available, therefore keep both the
Do not store at a temperature above 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FASTUM ANTIDOLORIFICO contains
100 g of gel contain:

Active ingredient: diclofenac diethylammonium 1.16 g (equivalent to 1 g of diclofenac sodium).

Other components:carbomers, methyl parahydroxybenzoate, 96% ethanol, triethanolamine, lavender essential oil (containing benzyl alcohol, benzyl benzoate, coumarin, eugenol, linalool, d-Limonene, geraniol), purified water,.

Description of the appearance of FASTUM ANTIDOLORIFICO and contents of the pack
FASTUM ANTIDOLORIFICO is presented in the form of a colorless and homogeneous gel for external use.
The pack contains 50 g and 100 g of gel in an aluminum tube. Not all pack sizes may be marketed.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence. Distributor for salesMontefarmaco 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.