Voltalgan 3% 50 g skin foam

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

100 g of skin foam contains: Diclofenac 3 g For the complete list of excipients, see section 6.1

EXCIPIENTS

Sodium hydroxide, caprylocapric macrogolglycerides, hydrogenated soy lecithin, polysorbate 80, benzyl alcohol, potassium sorbate, disodium phosphate dodecahydrate, all-rac-α-tocopheryl 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).

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Patients verified with a history of asthma, angioedema, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds (see section 4.4). Third trimester of pregnancy (see section 4.6). Children and adolescents under the age of 14.

DOSAGE

Adults and adolescents aged 14 and over: Apply VOLTALGAN skin foam 1-3 times a day. For each application, spray a circular mass of foam 3-5 centimeters in diameter (equal to approximately 0.75-1.5 grams in weight) onto the palm of your hand, depending on the size of the area to be treated, massaging delicately until completely absorbed. In case of iontophoresis treatment, the product must be applied to the negative pole. VOLTALGAN skin foam can also be used in combination with ultrasound therapy. After application, ask the patient to wash their hands, otherwise they will also be treated with skin foam. Warning: the product must only be used for short treatment periods. If the product is needed for more than 7 days to relieve pain or if symptoms worsen, the doctor should reassess the situation (see section 4.4). Children 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 Voltalgan skin foam is contraindicated in children under 14 years of age. Elderly: The usual dosage for adults can be used. How to use: Shake before use. With the canister upside down, dispense the desired quantity by pressing the appropriate dispenser. For cutaneous use only.

CONSERVATION

Store below 30°C. Pressurized container: VOLTALGAN contains flammable propellant. Protect against sunlight and do not expose to temperatures above 50°C. Store away from any source of ignition.

WARNINGS

The possibility of systemic adverse events with the application of VOLTALGAN cannot be excluded if the preparation is used on large skin areas and for a prolonged period. VOLTALGAN must be applied only to intact, unaffected 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. It is necessary to discontinue treatment if skin rash develops after application of the product. VOLTALGAN can be used with non-occlusive bandages, but must not be used with an occlusive dressing that does not allow air to pass through. In elderly patients and/or with gastric problems, the concomitant use of systemic anti-inflammatory drugs is not recommended. Asthmatic patients, with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp), react, with asthmatic attacks, local inflammation of the skin, mucosa (Quincke's edema) or urticaria, to antirheumatic treatment carried out with NSAIDs, more often than other patients. The administration of VOLTALGAN must be suspended in women who have fertility problems or who are undergoing fertility investigations. The use of VOLTALGAN, especially if prolonged, can give rise to local sensitization phenomena, which require the interruption of treatment and the adoption of adequate therapeutic measures. To reduce any photosensitivity phenomena, patients should be advised not to expose themselves to direct sunlight or light from sunlamps during use. In case of allergic reactions or more serious adverse reactions, it is necessary to suspend treatment with VOLTALGAN and establish adequate therapy. The use of the medicine in combination with other medicines containing diclofenac can give rise to severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome). VOLTALGAN contains 7.5 mg of benzyl alcohol per dose (equivalent to 1.5 grams by weight). Benzyl alcohol may cause allergic reactions and mild local irritation. VOLTALGAN contains an aroma which in turn contains limonene. Limonene can cause allergic reactions.

INTERACTIONS

The systemic absorption of diclofenac following topical application is very low. In high-dose and prolonged treatments, keep in mind the possibility of competition between the absorbed diclofenac and other drugs with high binding to plasma proteins.

SIDE EFFECTS

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (<1/10,000); not known: cannot be estimated from available data. Table 1

Immune system disorders.

Very rare: Hypersensitivity (including urticaria), angioneurotic edema.

Infections and infestations.

Very rare: Rash with pustules.

Respiratory, thoracic and mediastinal disorders.

Very rare: Asthma.

Pathologies of the skin and subcutaneous tissue.

Common: Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus.

Rare: Bullous dermatitis.

Very rare: Photosensitivity reaction

Not known: Dry skin, burning sensation on application.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa.

OVERDOSE

Cases of overdose with VOLTALGAN have been reported, but no systemic adverse effects that may be caused by overdose with oral NSAIDs (e.g. vomiting, diarrhea, dizziness, tinnitus, gastrointestinal bleeding, convulsions) have been reported. However, side effects similar to those seen after an overdose of diclofenac tablets can be expected if topical diclofenac is inadvertently ingested (1 50 g pressurized foam container contains approximately 1.54 g of diclofenac sodium). In case of accidental ingestion, which gives rise to significant systemic side effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Further treatment modalities should take into account the recommendations of the poison control center, where available.

PREGNANCY AND BREASTFEEDING

Pregnancy The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Referring to experience with treatment with NSAIDs for systemic administration, the following is recommended: inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and 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 approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered 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 inhibitors of prostaglandin synthesis can 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 oligohydroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, and anti-aggregating effect which can 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. Breastfeeding Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of VOLTALGAN no effects on the infant are expected. Due to the lack of controlled studies in breastfeeding women, the product should be used during breastfeeding only if the expected benefit to the mother outweighs the risk to the baby. In this circumstance, VOLTALGAN must not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4). Fertility No data are available on the effects of diclofenac for topical use on fertility.

EFFECTS ON DRIVING ABILITY

VOLTALGAN has no or negligible influence on the ability to drive or use machinery.