DICLOREUM ANT LOC SCH 50G 3%

DICLOREUM LOCAL ANTI-INFLAMMATORY 3% SKIN FOAM, PRESSURE CONTAINER

active principles

100 g of skin foam contain: Active principle: Diclofenac 3 g Excipients with known effect: potassium sorbate 0.1 g, benzyl alcohol 0.5 g and mint/eucalyptus fragrance (geraniol, limonene and linalool) 1 g. For the complete list of excipients, see section 6.1.

Exceptions

Sodium hydroxide, caprylocaprat macroglycerols, phospholipon 80 H, polysorbate 80, benzyl alcohol, potassium sorbate, dibasic sodium phosphate dodecahydrate, tocopherol acetate, mint/eucalyptus fragrance, purified water. Each pressurized container (50 g) contains: 47.5 g of solution and 2.5 g of propellant (isobutane, n-butane, propane).

Therapeutic indications

Local treatment of painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Contraindications

§ Hypersensitivity to diclofenac, to any of the excipients, to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, as well as to isopropanol. § Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) and isopropanol. § Third trimester of pregnancy (see section 4.6 Fertility, pregnancy and breastfeeding). § Children and adolescents under the age of 14.

Posology

Adults over 18 years: To apply DICLOREUM LOCAL ANTI-INFLAMMATORY 1-3 times a day or according to medical prescription. For each application, depending on the size of the area to be treated, spray a circular mass of foam of 3-5 centimeters in diameter (equal to about 0.75-1.5 grams in weight) on the palm of the hand, massaging gently until completely absorption. In case of iontophoresis treatment, the product must be applied to the negative pole. DICLOREUM LOCAL ANTI-INFLAMMATORY can also be used in combination with ultrasound therapy. After application, wash your hands, otherwise they will also be treated with the skin foam. Warning: use only for short periods of treatment. Teenagers aged 14 to 18: To apply DICLOREUM LOCAL ANTI-INFLAMMATORY 1-3 times a day or according to medical prescription. For each application, depending on the size of the area to be treated, spray a circular mass of foam of 3-5 centimeters in diameter (equal to about 0.75-1.5 grams in weight) on the palm of the hand, massaging gently until completely absorption. In case of iontophoresis treatment, the product must be applied to the negative pole. DICLOREUM LOCAL ANTI-INFLAMMATORY can also be used in combination with ultrasound therapy. After application, wash your hands, otherwise they will also be treated with the skin foam. If you need this medicine for more than 7 days to relieve pain or if your symptoms get worse, see your doctor. Children and adolescents under 14 years: Insufficient data are available on efficacy and safety in children and adolescents under 14 years of age (see also section 4.3 Contraindications). Therefore, the use of DICLOREUM LOCAL ANTI-INFLAMMATORY is contraindicated in children under 14 years of age. Elderly people: The usual adult dosage can be used. How to use: Shake before using. Keeping the can upside down, dispense the desired quantity by pressing the appropriate dispenser.

Storage

Store at a temperature not exceeding 30°C. This medicine contains flammable propellant. Protect from sunlight and do not expose to temperatures exceeding 50°C.

Warnings

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 eyes or mucous membranes and should not be ingested. Concomitant use of systemic anti-inflammatory drugs is not recommended in elderly and/or gastric-suffering patients. DICLOREUM LOCAL ANTI-INFLAMMATORY should be used with caution in patients who have previously experienced a hypersensitivity reaction to NSAIDs or analgesics, e.g. asthma attacks, skin rashes or acute allergic rhinitis. Patients with asthma, chronic obstructive bronchial disease, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthmatic 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. Discontinue treatment if skin rash develops after application of the product. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an air-tight occlusive dressing. DICLOREUM LOCAL ANTI-INFLAMMATORY Contains potassium sorbate which can cause local skin reactions (for example contact dermatitis). This medicinal product contains 7.5 mg of benzyl alcohol per dose. Benzyl alcohol can cause allergic reactions. Benzyl alcohol can cause mild local irritation. This medicinal product contains a mint/eucalyptus fragrance which itself contains geraniol, limonene and linalool which may cause allergic reactions. To reduce any photosensitivity phenomena, it is advisable not to expose yourself excessively to the sun during use. Keep the medicine out of the sight and reach of children.

Interactions

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely. However, in high-dose and protracted treatments, keep in mind the possibility of competition between the absorbed diclofenac and other drugs highly bound to plasma proteins.

Effects

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: common (≥ 1/100, Immune system disorders Very rare Hypersensitivity (including urticaria), angioneurotic oedema. Infections and infestations Very rare Rash with pustules Respiratory, thoracic and mediastinal disorders Very rare Asthma Skin and subcutaneous tissue disorders Common Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus. Rare Bullous dermatitis. Very rare Photosensitivity reaction The use of the medicine in combination with other medicines containing diclofenac can give rise to phenomena of hypersensitivity to light, skin rash with blistering, eczema, erythema and severe evolution skin reactions (Stevens-Johnson syndrome, Lyell's syndrome). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

The low systemic absorption of topical diclofenac makes an overdose very unlikely. However, side effects similar to those observed after an overdose of diclofenac tablets can be expected if topical diclofenac is inadvertently ingested (a 50 g canister contains 1.5 g of diclofenac). In the event of accidental ingestion giving rise to significant systemic undesirable effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be implemented. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.

Pregnancy

The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to the experience with treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis can have negative effects on the pregnancy and/or on the embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to about 1.5%. The risk was thought 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-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered unless strictly necessary. 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 may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Feeding time

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of DICLOREUM LOCAL ANTI-INFLAMMATORY No effects on the infant are expected. Due to the lack of controlled studies in lactating women, the product should only be used during lactation under the advice of a healthcare professional. In this circumstance, DICLOREUM LOCAL ANTI-INFLAMMATORY should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).

Source: Farmadati