Fastum for pain relief

Package leaflet: Information for the user

FASTUM ANTIDOLORIFICO 10 mg/g GEL

Diclofenac
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.
• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement 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 FASTUM ANTIDOLORIFICO is and what it is used for

FASTUM ANTIDOLORIFICO contains diclofenac and belongs to the class 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 the joints, muscles, tendons and ligaments, of rheumatic or traumatic origin.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you should know before using FASTUM ANTIDOLORIFICO

Do not use FASTUM ANTIDOLORIFICO

• If you are allergic to the active substance, to any of the other ingredients of this medicine (listed in section 6), or to other NSAIDs, such as acetylsalicylic acid (aspirin).
• If in the past you have experienced asthma attacks, urticaria, or acute rhinitis (nasal mucosa inflammation) after taking acetylsalicylic acid or other NSAIDs.
• On or near open wounds or skin lesions, around the eyes, or on mucous membranes.
• During the third trimester of pregnancy and while breastfeeding (see "Pregnancy, breastfeeding and fertility").
• If you suspect you may be pregnant or if you are planning 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
Talk to your doctor or pharmacist before using FASTUM ANTIDOLORIFICO.
If you are elderly or have stomach disorders, concomitant 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 may lead to local sensitization (increased reactivity) or irritation. In such cases, treatment must be discontinued and you should consult your doctor to establish appropriate therapy.
The possibility of systemic adverse effects with topical diclofenac application cannot be ruled out if the preparation is used over large skin areas and for prolonged periods.
To avoid possible hypersensitivity or photosensitization reactions, do not expose yourself to direct sunlight, including solarium use, during treatment and for two weeks thereafter.
Immediately discontinue use of FASTUM ANTIDOLORIFICO if skin reactions such as rash, mucosal lesions, or any other signs of allergy occur after application.
FASTUM ANTIDOLORIFICO may be used with non-occlusive dressings but must not be used with occlusive dressings that do not allow air passage, as they increase absorption through the skin.
You should consult your doctor before using FASTUM ANTIDOLORIFICO:

• If you have or have previously had photosensitivity reactions after exposure to sunlight.
• If you suffer from chronic (i.e., long-term or permanent) obstructive bronchial diseases or nasal mucosa inflammation (nasal polyps) and experience asthma attacks, local skin or mucosal inflammation (Quincke's edema), or urticaria when treated with NSAIDs.

FASTUM ANTIDOLORIFICO must not come into contact with the eyes or mucous membranes and must not be ingested.
The medicine should be applied only on intact, healthy skin, and not on skin wounds or open lesions.
Do not use for prolonged treatments. If no significant improvement occurs after a short treatment period, consult your doctor.
Children and adolescents
There is insufficient data 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since systemic absorption of FASTUM ANTIDOLORIFICO following topical application is very low, interactions with other drugs administered systemically are highly unlikely.
However, especially during high-dose and prolonged treatments, the possibility of competition between absorbed FASTUM ANTIDOLORIFICO and other highly plasma protein-bound drugs (such as dicoumarol anticoagulants (warfarin), many NSAIDs, digoxin, and some antibiotics) should be considered.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of FASTUM ANTIDOLORIFICO, like any NSAID, is not recommended in women intending to become pregnant.
Like other NSAIDs, FASTUM ANTIDOLORIFICO must not be administered during the third trimester of pregnancy or during breastfeeding.
Administration of FASTUM ANTIDOLORIFICO should be discontinued in women with fertility problems or undergoing fertility investigations.
Systemic diclofenac concentrations are lower after topical administration compared to oral formulations. Based on experience with systemic NSAID therapy, the following is recommended:

• During the first and second trimesters of pregnancy, diclofenac should be used only if clearly needed and under strict medical supervision. If diclofenac is used by a woman trying to conceive, or during the first and second trimesters 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 may delay or prolong labor, prolong bleeding time, and may be toxic to the fetal heart, lungs, and kidneys.

Breastfeeding
After systemic administration, traces of diclofenac have been detected in breast milk. Although therapeutic doses of FASTUM ANTIDOLORIFICO are not expected to affect the nursing infant, 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 such cases, FASTUM ANTIDOLORIFICO must not be applied to the breasts of breastfeeding mothers, nor to other large skin areas or for prolonged periods (see "Warnings and precautions").
Driving and using machines
FASTUM ANTIDOLORIFICO does not impair the ability to drive vehicles or operate machinery.
FASTUM ANTIDOLORIFICO contains methyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
FASTUM ANTIDOLORIFICO contains lavender essential oil, which itself 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, equivalent to 55 g/100 g. It may cause a burning sensation on damaged skin.

3. How to use FASTUM ANTIDOLORIFICO

Take this medicine exactly as stated in this leaflet or as directed 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 area or surface, three or four times a day.
Do not exceed the recommended doses without medical advice and use FASTUM ANTIDOLORIFICO only for short-term treatment.
Consult your doctor if symptoms recur or if you notice any recent changes in their 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 daily to the affected area, massaging gently. The amount to apply depends on the size of the area to be treated. For example, 2–4 g of medicine (an amount varying in size between a cherry and a walnut) is sufficient to treat an area of 400–800 cm². After application, wash your hands thoroughly; otherwise, they will also be treated with the gel.

Adolescents aged 14 to 18 years
The dosage is the same as that recommended for adults.

If you use more FASTUM ANTIDOLORIFICO than you should
In case of accidental ingestion/overdose of FASTUM ANTIDOLORIFICO, contact your doctor immediately or go to the nearest hospital.
The low systemic absorption of topically administered diclofenac makes an overdose (ingestion of an excessive dose of the medicine) very unlikely.
However, adverse effects similar to those observed after an overdose of diclofenac tablets may occur if topical diclofenac is accidentally ingested.
In case of accidental ingestion leading to significant systemic effects, general therapeutic measures normally adopted for poisoning with non-steroidal anti-inflammatory drugs should be implemented. Gastric emptying and administration of activated charcoal should be considered, especially if performed shortly after ingestion.

If you have any questions 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 everyone experiences them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
FASTUM ANALGESIC is generally well tolerated.
Skin redness, itching, burning sensation or skin rashes (appearance of skin lesions) may occur.
The use of FASTUM ANALGESIC in combination with other medicinal products containing diclofenac may lead to light sensitivity (photosensitivity), skin rash with blistering, eczema (itchy inflammatory skin reaction), erythema, and skin reactions that may progress to severe conditions (Stevens-Johnson syndrome, Lyell's syndrome).
When FASTUM ANALGESIC is applied to relatively large skin areas for prolonged periods, systemic side effects cannot be completely ruled out.
Other systemic effects of anti-inflammatory medicines depend on the passage of the active ingredient through the skin, and therefore on the amount of gel applied, the surface area treated, the integrity of the skin, the duration of treatment, and the use of occlusive dressings (gastrointestinal and renal effects).
Possible side effects that may occur following the use of FASTUM ANALGESIC, listed in decreasing order of frequency, are:
Common side effects (may affect up to 1 in 10 people):

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

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.
• Pustular rash (skin lesions).
• Allergic reactions (including urticaria), angioneurotic edema (swelling of the skin and mucous membranes).
• Photosensitivity reactions.
• Side effects frequency not known (frequency cannot be estimated from available data):
• Burning sensation at the site of application.
• Dry skin.

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 PAIN RELIEF

Keep this medicine out of the 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 that month, provided the product remains unopened and is stored correctly.
After opening the tube, the product is valid for 6 months.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.
Do not store at temperatures above 30 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What FASTUM ANALGESIC contains
100 g of gel contain:
Active substance: diclofenac diethylammonium 1.16 g (equivalent to 1 g of sodium diclofenac).
Other components: carbomers, methyl 4-hydroxybenzoate, ethanol 96%, triethanolamine, lavender essential oil (containing benzyl alcohol, benzyl benzoate, coumarin, eugenol, linalool, d-Limonene, geraniol), purified water.

Description of the appearance of FASTUM ANALGESIC and contents of the pack
FASTUM ANALGESIC is a colourless, homogeneous gel for external use.
Pack sizes are 50 g and 100 g of gel in aluminium tubes. Not all pack sizes may be marketed.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite S.r.l., via Sette Santi, 3 - Florence.

Concessionaire for sale
Montefarmaco OTC S.p.A. – via IV Novembre, 92 – 20021 Bollate, Milan

Manufacturer
A. Menarini Manufacturing Logistics and Services S.r.l., manufacturing site via Sette Santi, 3 - Florence.