VOLTADOL * 5CER MEDIC 140MG
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
For cutaneous use only.Dosage: VOLTADOL should only be applied to intact and healthy skin and should not be applied when bathing or showering. VOLTADOL should be used for the shortest possible time.Adults and adolescents aged 16 and over: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 no improvement is found or worsening of symptoms is reported after 7 days of treatment, reassess the situation (see section 4.4).Special populations. Children and adolescents under the age of 16: VOLTADOL is contraindicated in children and adolescents less than 16 years of age (see section 4.3). Elderly and patients with hepatic or renal insufficiency: VOLTADOL should be used with caution (see section 4.4).Method of administration: 1 - Cut the pouch along the dotted line and remove the patch.For applying the patch: 2 - Remove one of the two protective sheets. 3 - Apply on the part to be treated and remove the remaining protective sheet. 4 - Apply light pressure with the palm of your hand until it adheres completely to the skin. The patch must be used whole.For removing the patch: 5 - Wet the patch with water and then lift a flap by pulling gently. 6 - To eliminate any product residues, wash the affected area with water, making circular movements with your fingers.
Hypersensitivity to the active substance, to acetylsalicylic acid or to other non-steroidal anti-inflammatory preparations (NSAIDs) or to any of the excipients listed in section 6.1. Patients 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. Third trimester of pregnancy (see section 4.6). Patients with active peptic ulcer. Children and adolescents under the age of 16.
Adverse reactions are listed by frequency, most frequent first, using the following convention: common (≥ 1/100, Infections and infestations. Very rare: Rash with pustules.Disorders of the immune system. Very rare: Hypersensitivity (including urticaria), angioneurotic edema, anaphylactoid reaction.Respiratory, thoracic and mediastinal disorders. Very rare: Asthma.Skin and subcutaneous tissue disorders. Common: Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), pruritus; Rare: Bullous dermatitis (eg bullous erythema), burning sensation on application, dry skin; Very rare: Photosensitivity reaction.General disorders and administration site conditions.Common: Administration site reactions. 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
If VOLTADOL is used for an extended period of time, the possibility of systemic adverse events cannot be excluded. VOLTADOL should only be applied to intact and healthy skin, and should not be applied to broken skin or open wounds. The patches should not come into contact with the eyes or mucous membranes and should not be swallowed. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Treatment should be stopped immediately if a skin rash develops after applying the medicated plaster. 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 treatment with NSAIDs more often than others patients. The administration of VOLTADOL should be discontinued in women who have fertility problems or who are undergoing fertility investigations. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and establish a suitable therapy. Although systemic absorption is minimal, the use of VOLTADOL is not recommended in women planning to become pregnant. Do not administer topically or systemically another diclofenac medicinal product or other NSAIDs at the same time. The use of VOLTADOL in combination with other medications containing diclofenac can lead to skin reactions with severe evolution (Stevens-Johnson syndrome, Lyell's syndrome). Considering the route of administration, the risk of onset of systemic effects is lower, however the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulcer or inflammatory bowel disease or haemorrhagic diathesis. NSAIDs should be used with particular care in elderly patients who are more prone to side effects. 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. Patients should be advised not to expose themselves to direct sunlight or sunlamps for approximately one day after removal of the medicated plaster to reduce the risk of photosensitivity.
Pregnancy and breastfeeding
Pregnancy: The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may 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. In addition, an increased incidence of various malformations, including cardiovascular, has 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 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 oligo-hydroamnios. The mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet 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.Feeding time: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, no effects on the suckling child are expected at therapeutic doses of VOLTADOL. Due to the lack of controlled studies in breastfeeding women, administration of VOLTADOL during breastfeeding should only be considered if the expected benefit to the mother outweighs the risk to the baby. In this circumstance, Voltadol should not be applied to the breasts of nursing mothers, nor for an extended period of time (see section 4.4).
Expiry and retention
Do not store above 30 ° C.
Interactions with other drugs
Systemic absorption of diclofenac following the use of medicated plasters is low. However, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding cannot be excluded. Concomitant topical or systemic use of other medications containing diclofenac or other NSAIDs is not recommended.
Cases of overdose with VOLTADOL have been reported, but no systemic adverse effects that may be caused by overdose with oral NSAIDs (e.g. vomiting, diarrhea, dizziness, tinnitus, gastrointestinal haemorrhage, convulsions) have been reported. However, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 pack of 10 patches contains 1400 mg diclofenac sodium). If systemic side effects occur due to incorrect use or accidental overdose (eg in children) with the product, general therapeutic supportive measures are recommended to be taken in case of intoxication with non-steroidal anti-inflammatory drugs. Additional treatment modalities should take into account the recommendations of the poison control center, where available.
A medicated plaster contains: active ingredient: diclofenac sodium 140 mg. For the full list of excipients, see section 6.1.
Butyl-methacrylate-copolymer-basic; acrylate-vinyl-acetate copolymer; polyethylene glycol 12 stearate; sorbitan oleate; non-woven fabric; silicone paper.