VOLTADOL 10CER MEDIC 140MG

VOLTADOL 140 MG MEDICATED PATCH

active ingredients

One medicated plaster contains: active substance: diclofenac sodium 140 mg.For the full list of excipients, see section 6.1.

Excellent

Butyl methacrylate copolymer basic;acrylate-vinyl acetate copolymer;polyethylene glycol 12 stearate;sorbitan oleate;non-woven fabric;siliconized paper.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active substance, to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in paragraph 6.1. Patients with anamnesi of asthma, angioedema, hives or acute rhinitis after intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). Damaged Cute, regardless of the type of injury: exudatory dermatitis, eczema, infected lesion, burns or wounds. Third quarter of pregnancy (see paragraph 4.6). Patients with active peptic ulcer. Children and adolescents under the age of 16.

Population

For cutaneous use only. Population: VOLTADOL it should be applied only to intact, healthy skin and should not be applied while bathing or showering. VOLTADOL should be used for the shortest time possible. Adults and teenagers from 16 years on: Apply a patch 2 times a day, in the morning and in the evening, on the skin of the area to be treated, for a period not exceeding 7 days. Do not exceed the recommended dose. If there is no improvement or if a worsening of symptoms is reported after 7 days of treatment, reevaluate the situation (see paragraph 4.4). Special popularity. . Children and teenagers under 16: VOLTADOL is contraindicated in children and adolescents under the age of 16 (see paragraph 4.3). Elders and patients with liver or kidney failure: VOLTADOL must be used with caution (see paragraph 4.4). Method of administration: 1 - Cut the envelope along the dotted line and take the plaster. For the application of the plaster: 2 - Remove one of the two protective sheets. 3 - Apply on the part to treat and remove the remaining protective sheet. 4 - Exercise a slight pressure with the palm of the hand until the full adherence to the skin. The plaster must be used whole. To remove the plaster: 5 - Wet the plaster with water and lift a flap then gently pulling. 6 - To eliminate any residues of the product wash the affected area with water by performing with fingers circular movements.

Conservation

Do not store at temperature above 30°C.

Warnings

In case of use of VOLTADOL for a prolonged period of time, it is not possible to exclude the possibility of systemic adverse events. VOLTADOL should be applied only on the skin intact and healthy, and should not be applied on the skin loose or on open wounds. The patches should not get in touch with the mucous membranes or eyes and should not be ingested. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Treatment should be stopped immediately if a rash develops after application of the medicated patch. 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 treatment performed with NSAIDs more often than other patients. The administration of VOLTADOL must be suspended in women who have fertility problems or who are subject to fertility surveys. The use, especially if prolonged, of products for topical use can give rise to awareness-raising phenomena. In this case it is necessary to stop treatment and establish suitable therapy. Although systemic absorption is minimal, the use of VOLTADOL is not recommended in women who intend to start a pregnancy. Do not administer another medicine with diclofenac or other NANS at the same time. The use of VOLTADOL in association with other drugs containing diclofenac can give rise to severely evolving skin reactions ( Stevens-Johnson syndrome, Lyell syndrome). Considered the way of administration, the risk of systemic effects onset is lower, however the medicated patch should be used with caution in patients with kidney, heart or hepatic impairment, history of peptic ulcer or intestinal inflammatory disease or hemorrhagic diathesis. NSAIDs must be used with particular attention in older patients who are more prepared for unwanted effects. 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. Patients should be warned not to expose themselves to direct sunlight or sunlight for about a day after removal of the medicated patch so as to reduce the risk of photosensitivity.

Interactions

Systemic absorption of diclofenac following the use of medicated patches is low. It is not however to exclude the possibility of competition between absorbed diclofenac and other high-linked drugs with plasma proteins. The topical or systemic use of other drugs containing diclofenac or other NANS is not recommended.

Effects

Adverse reactions are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, Infections and infestations. Very rare: Rash with pustula. Immune system disorders. Very rare: Hypersensitivity (including hives), angiourotic edema, anaphylactoid reaction. Respiratory, chest and mediastinic pathologies. Very rare: Asthma. Pathologies of skin and subcutaneous tissue. Common: Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching; Raro: Bold dermatitis (p.es. bollous erythema), burning sensation in place of application, dry skin; Very rare: Reaction of photosensitivity. Systemic pathologies and conditions for administration. City: Reactions in the administration. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Overdose cases were reported with VOLTADOL, but no systemic adverse effects have been reported that can be caused by overdose with oral NSAIDs (e.g. vomiting, diarrhea, dizziness, tinnitus, gastrointestinal hemorrhage, seizures). However side effects similar to those observed after overdosing diclofenac tablets, may be expected in case topical diclofenac was inadvertently ingested (1 pack of 10 patches contains 1400 mg of sodium diclofenac). If systemic side effects occur due to incorrect use or accidental overdose (p.es. in children) with the product we recommend general therapeutic measures to be taken in case of intoxication with non-steroidal anti-inflammatory drugs. 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: 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 oligo-idroamnios. 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. Food: Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of VOLTADOL there are no effects on the infant. Due to the lack of controlled studies in women nursing with breast milk, the administration of VOLTADOL during breastfeeding should be taken into account only if the expected benefit for the mother exceeds the risk for the child. In this case, Voltadol must not be applied to the breasts of nursing mothers, or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati