VOLTALGAN CUT 50G 3%

VOLTALGAN 3%

active ingredients

100 g of skin foam contain: Diclofenac 3 g For the full list of excipients, see paragraph 6.1

Excellent

Sodium hydroxide, Macrogolglycerides, Hydrogenated soy Lecithin, Polysorbate 80, Benzyl Alcohol, Sorbate Potassium, Sodium phosphate dibasic dodecaidrate, All-rac-α-tocopheral acetate, Mint/eucalyptus Perfume, Purified Water. Each container under pressure (50 g) contains: 47,5 g solution and 2.5 g propellant (isobutane; n-butane; propane).

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Patients tested with asthma, angioedema, hives or acute rhinitis after intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAID). Damaged Cute, regardless of the type of injury: exudatory dermatitis, eczema, infected lesion, burns or wounds (see paragraph 4.4). Third quarter of pregnancy (see paragraph 4.6). Children and adolescents under the age of 14.

Population

Adults and teenagers from 14 years old: Apply VOLTALGAN skin foam 1-3 times a day. For each application spray on the palm of the hand, depending on the size of the area to be treated, a circular foam mass of 3-5 cm in diameter (equal to about 0.75-1.5 grams in weight) gently massaging until completely absorbed. In case of treatment for ionophoresis the product must be applied to the negative pole. VOLTALGAN skin foam can also be used in combination with treatment ultrasuoni.Dopo the application, invite the patient to wash his hands, otherwise they will also be treated with the skin foam. Caution: the product should only be used for short periods of treatment. If the product is necessary for more than 7 days to relieve pain or if symptoms worsen, the doctor will have to reevaluate the situation (see paragraph 4.4). Children under 14 years: Insufficient data are available on effectiveness and safety in children and adolescents under 14 years (see also section 4.3 Contraindications). Therefore the use of Voltalgan skin foam is contraindicated in children under 14 years of age. Seniors: The usual dosage for adults can be used. Mode of use : Shake before use. Upside down, deliver the desired quantity by pressing the appropriate erogatore.Solo for skin use.

Conservation

Store at a temperature below 30°C. Pressure recipient: VOLTALGAN contains flammable propellant. Protect against sun rays and do not expose at a temperature greater than 50°C. Keep away from any source of combustion.

Warnings

The possibility of systemic adverse events with the application of VOLTALGAN cannot be excluded if the preparation is used on extended skin areas and for a prolonged period. VOLTALGAN must be applied only on intact skin, not sliced, 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. It is necessary to stop treatment if you develop skin rash after application of the product. VOLTALGAN can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass. 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 ( nasal polipo), react, with asthmatic attacks, local inflammation of the skin, mucosa (Quincke edema) or hives, to the anti-reumatic treatment carried out with NSAIDs, more often than other patients. The administration of VOLTALGAN must be suspended in women who have fertility problems or are subject to fertility surveys. The use of VOLTALGAN, especially if prolonged, may give rise to local phenomena of sensitization, which impose the interruption of treatment and the adoption of adequate therapeutic measures. In order to reduce any awareness-raising phenomena, patients must be warned not to expose themselves to direct sunlight or sunlight during use. In case of allergic reactions or adverse reactions of greater importance, it is necessary to suspend treatment with VOLTALGAN and to establish adequate therapy. The use of the medicine in association with other drugs containing diclofenac can result in severe evolving 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 can cause allergic reactions and mild local irritation. VOLTALGAN contains an aroma in turn containing lemon. Lemon may cause allergic reactions.

Interactions

Systemic absorption of diclofenac following a topical application is very low. In high dose treatments and protracted over time, the possibility of competition between absorbed dichlofenac and other high-linked drugs with plasma proteins is held.

Effects

Adverse reactions are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Overdose cases have been reported with VOLTALGAN, but there have been no systemic adverse effects that can be caused by overdose with oral NSAIDs (e.g. vomiting, diarrhea, dizziness, tinnitus, gastrointestinal hemorrhage, seizures). However undesirable effects similar to those observed after overdose of diclofenac tablets, may be expected in case the topical diclofenac was inadvertently ingested (1 container under pressure from 50 g foam contains about 1.54 g sodium diclofenac). In case of accidental ingestion, which results in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. Additional treatment methods must take into account the recommendations of the anti-veleni center, where available.

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, we recommend the following: the 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 cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, diclofenac should not be administered if not 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. Nursing: Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, the therapeutic doses of VOLTALGAN are not expected to affect the infant. Due to the lack of controlled studies in women nursing breasts, the product should be used during breastfeeding only if the expected benefit for the mother exceeds the risk for the child. In this case, VOLTALGAN should not be applied to the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4). Fertility: Data on diclofenac effects for topical use on fertility are not available.

Source: Farmadati