ANTI-PAIN FASTUM * 1% 50G

ANTI-PAIN FASTUM * 1% 50G

Therapeutic indications

Fastum Painkiller is indicated for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Dosage and method of use

Depending on the extent of the painful areas or surfaces, 2-4 g of Fastum Painkiller will be applied 3-4 times a day and rubbed lightly. Use Fastum Painkiller only for short periods of treatment.Adults over 18 years:Apply Fastum Painkiller 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of Fastum Painkiller (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel.Teenagers aged 14 to 18:Apply Fastum Painkiller 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of Fastum Painkiller (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.Children under the age of 14:Insufficient data are available on efficacy and safety in children below 14 years (see section 4.3). Therefore, the use of Fastum Painkiller is contraindicated in children below 14 years of age.Elderly people:The usual adult dosage can be used.

Contraindications

Hypersensitivity to diclofenac or to any of the excipients listed in section 6.1. Hypersensitivity to other non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid. Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Third trimester of pregnancy and lactation (see section 4.6). Pediatric population: Use in children below 14 years of age is contraindicated.

Side effects

Fastum Pain Relief is generally well tolerated. Itching, redness, burning of the skin or rashes may occur. The use of Fastum Painkiller, in association with other medications containing diclofenac, can give rise to sensitization phenomena to light (photosensitivity), skin rash with blistering, eczema, erythema and skin reactions with even severe evolution (Stevens syndrome- Johnson, Lyell's syndrome). If Fastum Painkiller is applied to relatively large 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, most frequent first, using the following convention: common (≥ 1/100,

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Special warnings

Do not use for prolonged treatments. The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see the summary of product characteristics of the systemic forms of diclofenac). Topical diclofenac should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested. Discontinue treatment if skin rash develops after application of the product. The concomitant use of systemic anti-inflammatory drugs is not recommended in elderly and / or gastric patients. Patients with asthma, chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs more often than other patients. The use, especially if prolonged, of other products for topical use, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy. To avoid any hypersensitivity or photosensitization phenomena, avoid exposure to direct sunlight including the solarium during the treatment and in the following two weeks. The administration of Fastum Painkiller should be discontinued in women who have fertility problems or who are undergoing fertility investigations. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass. Fastum Painkiller containsmethyl parahydroxybenzoate (E218)which can cause allergic reactions (including delayed). Fastum Painkiller contains lavender essential oil which in turn contains allergens:benzyl alcohol, benzyl benzoate, coumarin, eugenol, linalool, dLimonene, geraniolwhich can cause allergic reactions. Fastum Painkiller contains 550 mg of alcohol (ethanol)in each gram of product which is equivalent to 55 g / 100 g. It can cause burning sensations on damaged skin.

Pregnancy and breastfeeding

Pregnancy:Like other NSAIDs, Fastum Painkiller should not be administered 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 can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. Referring to the experience with treatment with NSAIDs for systemic administration, the following is recommended: - during the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman attempting 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; - during the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. The use of Fastum Painkiller, as well as any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant.Feeding time:Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Fastum Painkiller no effects on the infant are expected. Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, Fastum Pain Relief should not be applied to the breasts of nursing mothers, or elsewhere on large areas of the skin or for an extended period of time (see section 4.4).

Expiration and retention

Do not store above 30 ° C

Interactions with other drugs

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely. In high-dose and protracted treatments, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding power should be borne in mind.

Overdose

Topical overdose: the low systemic absorption of topical diclofenac makes an overdose very unlikely; however, in this case, it is recommended to wash the affected skin area with water. A specific antidote is not available. Undesirable effects similar to those seen 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 taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.

Active principles

100 g of gel contain: Active ingredient: DICLOFENAC DIETILAMMONIIO 1.16 g (equal to 1 g of Diclofenac sodium). Excipients with known effects: ethanol, rnetyl parahydroxybenzoate (E218) and allergens such as benzyl alcohol, benzyl benzoate, coumarin, eugenol, linalool, d-Limonene, geraniol (contained in the essential oil of lavender). For the full list of excipients, see section 6.1

Excipients

Carbomers, methyl parahydroxybenzoate (E218), ethanol 96%, triethanolamine, lavender essential oil (containing benzyl alcohol, benzyl benzoate, coumarin, eugenol, linalool, d-Limonene, geraniol), purified water.