FASTUM ANTIDOLOGICAL 1% 100G

FASTUM 10 Mg/G GEL

active ingredients

100 g gel contains: Active ingredient: DICLOFENAC DIETILAMMONIO 1,16 g (equal to 1 g of Sodium Diclofenac). Excipients with known effects: ethanol, rnetile parahydroxybenzoate (E218) and allergens such as benzil alcohol, benzil benzoato, cumarin, eugenol, linalol, d-Limonene, geranium (contained in the essential oil of lavender). For the full list of excipients, see paragraph 6.1

Excellent

Carbomers, methyl parahydroxybenzoate (E218), ethanol 96%, triethanolamine, essential oil of lavender (containing benzil alcohol, benzil benzoato, cumarin, eugenol, linalol, d-Limonene, geraaniol), purified water.

Therapeutic indications

Fastum Antidolorifico is indicated for the local treatment of painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to diclofenac or any of the excipients listed in paragraph 6.1. Hypersensitivity to other non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid. Patients in which asthma, urticaria or acute strokes occurred after taking acetylicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). Third quarter of pregnancy and nursing (see paragraph 4.6). Pediatric population: Use in children under the age of 14 is contraindicated.

Population

Depending on the extension of the areas or the sore surfaces, 3-4 times a day 2-4 g of Fastum Antidolorifico will apply and it will fry slightly. Use Fastum Sweetener only for short periods of treatment. Adults over 18 years: Apply Fastum Sweetener 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example, 2-4 g of Fastum Antidolorifico (quantitative of variable dimensions between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After the application, wash your hands, otherwise they will also be treated with the gel. Teenagers from 14 to 18 years: Apply Fastum Sweetener 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example, 2-4 g of Fastum Antidolorifico (quantitative of variable dimensions between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After the application, wash your hands, otherwise they will also be treated with the gel. If this product is necessary for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: Insufficient information on effectiveness and safety in children under the age of 14 is available (see paragraph 4.3). Therefore, the use of Fastum Painkiller is contraindicated in children under 14 years of age. Seniors: The usual dosage for adults can be used.

Conservation

Do not store at temperature above 30°C

Warnings

Do not use for protracted treatments. The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on extended skin areas and for a prolonged period (see the summary of the product characteristics of systemic forms of diclofenac). The topical diclofenac should be applied only on the intact, unsick skin, and not on skin wounds or open injuries. It should not be let into contact with mucous membranes or eyes and should not be ingested. Stop the treatment if you develop skin rash after application of the product. In elderly and/or gastric patients we do not recommend the concomitant use of systemic anti-flogistic drugs. Asthmatic patients, with chronic obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasmal polipo) react with asthmatic attacks, local inflammation of the skin or mucosa (Quincke edema) or urticaria to the anti-rheumatic treatment performed with NSAIDs more often than other patients. The use, especially if prolonged, of other products for topical use, can give rise to awareness-raising phenomena. In this case it is necessary to stop the treatment and establish suitable therapy. To avoid any hypersensitivity or photosensitization phenomena avoid exposure to direct sunlight including the solarium during treatment and in the next two weeks. The administration of Fastum Painkiller should be suspended in women who have fertility problems or who are subject to fertility surveys. The topical diclofenac can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass. Fastum Sweetener contains methyl parahydroxybenzoate (E218) which can cause allergic reactions (also delayed). Fastum Antidolorifico contains essential lavender oil in turn containing allergens: benzil alcohol, benzil benzoato, cumarin, eugenol, linalol, dLimonene, geraniol which can cause allergic reactions. Fastum Antidolorifico contains 550 mg of alcohol (ethanol) in each product gram which is equivalent to 55 g/100 g. It can cause burning sensations on damaged skin.

Interactions

Since systemic absorption of diclofenac as a result of a topical application is very low, such interactions are very unlikely. In high dose treatments and protracted over time, the possibility of competition between absorbed dichlofenac and other high-powered drugs that bind with plasma proteins is held.

Effects

Fastum Painkiller is generally well tolerated. Itching, redness, skin burning or skin rash may occur. The use of Fastum Antidolorifico, in association with other drugs containing diclofenac, can give rise to phenomena of light sensitization (photosensitivity), rash with formation of vesicles, eczema, erythema and skin reactions with also severe evolution ( Stevens-Johnson syndrome, Lyell syndrome). If Fastum Anti-sweet is applied to relatively extensive skin areas and for a prolonged period, the possibility of systemic side effects cannot be completely excluded. Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, Immune system disorders Very rare Hypersensitivity (including hives), angiourotic edema. Infections and infestations Very rare Rash with pustles Respiratory, chest and mediastinic pathologies Very rare Asthma Pathologies of skin and subcutaneous tissue Town Rash, eczema, erythema, dermatitis (including contact dermatitis), itching. Rare Bold dermatitis. Very rare Reaction of photosensitivity. Burning sensation in the application Notable Cute dry Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

Overdose from topical use: The low systemic absorption of topical diclofenac makes an overdose very unlikely;however, in such an event, it is recommended to wash the affected skin area with water.A specific antidote is not available.Undesirable effects similar to those observed after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 mg of diclofenac sodium).In the event of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken.Gastric decontamination and the use of activated charcoal should be considered, especially within a short time after ingestion.

Pregnancy:

Like other NSAIDs, Fastum Painkiller should not be given in the third trimester of pregnancy and during breastfeeding. The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardivoascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. Referring to the experience with treatment with NSAIDs for systemic administration, we recommend the following: - during the first and second trimester of pregnancy diclofenac should not be administered unless in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must be kept as low as possible and the duration of treatment as short as possible; - during the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligoidroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. The use of Fastum Antidolorifico, as of any drug inhibitor of the synthesis of prostaglandins and cycloxygenase is not recommended in women who intend to start a pregnancy.

Nursing:

Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at the therapeutic doses of Fastum Antidolorifico there are no lactating effects. Due to the lack of controlled studies in nursing women, the product must 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 nursing mothers, or elsewhere on extended areas of the skin or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati