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Medicated plasters useful for treating pain associated with muscle strains or bruises of the arms and legs.
Short-term local treatment (up to 7 days) of pain associated with muscle strains, sprains or bruises of the arms and legs due to blunt trauma in adolescents from 16 years of age and in adults.
Each medicated plaster contains 140 mg of diclofenac sodium. Each medicated plaster contains 2.90 mg of butylhydroxyanisole (E 320). For the full list of excipients, see section 6.1.
Backing layer: Non-woven polyester. Adhesive layer: polyacrylate dispersion, tributyl citrate, butylhydroxyanisole (E 320). Protective layer: single-sided siliconized paper.
Dosage Adults and adolescents aged 16 years and over Apply one medicated plaster once a day to the painful area. The maximum daily dose is 1 medicated plaster, even if more than one area is to be treated. Therefore, only one painful area can be treated at a time. Duration of use Voltadol Unidie should be used for the minimum time necessary to control symptoms. The patch should not be used for more than 7 days. A therapeutic benefit for longer durations of administration has not yet been demonstrated. Elderly patients The medicine should be used with caution in elderly patients as they are more susceptible to side effects (see also section 4.4). Patients with renal or hepatic impairment For the treatment of patients with renal or hepatic impairment, see section 4.4. Paediatric population There are insufficient data on the efficacy and safety of Voltadol Unidie in children and adolescents under 16 years of age (see section 4.3). The patient/parents of the adolescent are advised to consult a doctor if the medicinal product needs to be administered for more than 7 days to relieve pain or if symptoms worsen. Method of administration: Cutaneous use. The medicated plaster should only be applied to intact, healthy skin and should not be applied while bathing or showering. The medicated plaster should not be divided. If necessary, the medicated plaster can be kept in place using an elastic mesh bandage. The medicated plaster should not be used with an occlusive dressing.
The medicated plaster should not come into contact with or be applied to eyes or mucous membranes. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 4.2). Bronchospasm may occur in patients who suffer or have suffered in the past from bronchial asthma or allergies. If a rash develops after applying the medicated plaster, treatment should be discontinued immediately. After removing the medicated plaster, patients should be advised to avoid exposure to sunlight or sunlamps to reduce the risk of photosensitization. The possibility of systemic adverse events resulting from the application of diclofenac medicated plaster cannot be excluded if the product is used on large areas of skin for a prolonged period. Although systemic effects may be minimal, the medicated plaster should be used with caution in patients with impaired renal, cardiac, or hepatic function, or with a history of peptic ulcer, intestinal inflammation, or bleeding diathesis. Nonsteroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more susceptible to adverse effects. Do not administer simultaneously, topically or systemically, any other medicinal product containing diclofenac or other nonsteroidal anti-inflammatory drugs (NSAIDs). Butylhydroxyanisole (E 320) may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs [NSAIDs] - Patients who have previously experienced attacks of asthma, urticaria, or acute rhinitis after using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). - Patients with active peptic ulcers. - Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesions, burns, or wounds. - Third trimester of pregnancy. - Children and adolescents under 16 years of age.
Undesirable effects are reported according to the following frequency categories:
| Very common | ?1/10 |
| Common | From ? 1/100 to <1/10 |
| Uncommon | From ?1/1,000 to <1/100 |
| Rare | From ?1/10,000 to <1/1,000 |
| Very rare | <1/10,000 |
| Not known | Frequency cannot be estimated from the available data. be defined on the basis of available data. |
| Infections and manifestations | |
| Very rare | Pustular rash |
| Immune system disorders | |
| Very rare | Hypersensitivity (including urticaria), angioneurotic oedema, anaphylactoid reaction |
| Respiratory, thoracic and mediastinal disorders | |
| Very rare | Asthma |
| Skin and subcutaneous tissue disorders | |
| Common | Rash, eczema, erythema, dermatitis (including dermatitis allergic and contact dermatitis), pruritus |
| Rare | Bullous dermatitis (e.g. erythema bullous), dry skin |
| Very rare | Photosensitivity reactions |
| General disorders and administration site conditions | |
| Common | Injection site reactions administration |
The levels of diclofenac measured in systemic plasma according to the instructions for use of medicated patches indicated on the label are very low when compared with those detected after oral intake of diclofenac. The risk of developing systemic side effects (such as gastric, hepatic and renal disorders, systemic hypersensitivity reactions), therefore, appears low with the use of the patch. However, if diclofenac is used on large skin surfaces and for long periods of time, the appearance of systemic side effects is possible.
Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as 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.
No cases of overdose with diclofenac medicated plasters have been reported. In case of serious systemic adverse reactions following incorrect use of the drug or accidental overdose (e.g. in children), the appropriate precautionary measures employed for intoxication with nonsteroidal anti-inflammatory drugs must be applied.
Pregnancy The systemic concentration of diclofenac following topical administration is lower than that related to oral formulations. Based on experience with treatment with systemic NSAIDs, the following is recommended: inhibition of prostaglandin synthesis may lead to adverse effects during pregnancy and/or during embryonic/fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations, and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to a maximum of approximately 1.5%. The risk is believed to increase with dose and duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. Diclofenac should not be administered during the first and second trimesters of pregnancy unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters 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 may progress to renal failure with oligohydramnios; the mother and 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 labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding: Diclofenac, in small amounts, is secreted into breast milk. However, at therapeutic doses of diclofenac medicated plaster, no effects on the infant are expected. Given the lack of controlled clinical studies in breastfeeding women, the medicine should be used during breastfeeding only on the advice of a healthcare professional. In this case, Voltadol Unidie should not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period.
5 Medicated Plasters
This product has been on sale since 17/01/2023
In the last 30 days, the product's lowest price was 15,26 €
Negli ultimi mesi ho testato varie marche di cerotti medicati ma questa la boccio per la scarsa aderenza, dopo poche ore si è tolto dalla pelle e per la poca efficacia del principio attivo
Estimated delivery: 1-3 business days
Estimated delivery: 1-3 business days
Estimated delivery: 1-3 business days
Estimated delivery: 1-3 business days
