“Directions
Short-term local treatment (maximum 7 days) of pain associated with muscle strains, dislocations or bruises of the arms and legs due to blunt trauma in adolescents from 16 years of age and in adults.
Method of administration and dosage
Dosage Adults and adolescents aged 16 years and over Apply one medicated patch once daily to the painful area. The maximum daily dose is 1 medicated patch, 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 period necessary to control symptoms. The patch should not be used for more than 7 days. The therapeutic effect of longer use has not yet been demonstrated. Elderly patients The medicinal product should be used with caution in elderly patients, as they are more prone to adverse reactions (see also section 4.4). Patients with renal or hepatic insufficiency. For information on the treatment of patients with renal or hepatic impairment, see section 4.4. Paediatric population There is insufficient data on the efficacy and safety of Voltadol Unidi 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 medicine needs to be used for more than 7 days to relieve pain or if symptoms worsen. Method of administration: Cutaneous application. The medicated patch should only be applied to intact, healthy skin and should not be applied during bathing or showering. The medicated patch must not be divided. If necessary, the medicated patch can be secured with an elastic mesh dressing. The medicated patch must not be used together with an occlusive dressing.
Warnings
The medicated patch should not be applied to the eyes or mucous membranes. Undesirable effects can be minimised by using the lowest effective dose for the shortest possible duration (see section 4.2). Bronchospasm may occur in patients with or with a history of asthma or allergy. If a skin rash occurs after application of the medicated patch, treatment should be stopped immediately. After removal of the medicated patch, patients should be advised to avoid exposure to sunlight or solariums to reduce the risk of photosensitisation. The possibility of systemic side effects as a result of the diclofenac patch cannot be excluded if the preparation is used on large skin surfaces over a long period of time. Although systemic effects may be minimal, the medicated patch should be used with caution in patients with impaired renal, cardiac or hepatic function or with a history of gastric ulcer, inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more susceptible to side effects. Do not use any other medicinal products containing diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs) topically or systemically. Butylated hydroxyanisole (E 320) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Contraindications
– Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. – Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs [NSAIDs] – Patients who have experienced attacks of asthma, urticaria or acute rhinitis in the past after using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). – Patients with active peptic ulcer disease. – Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesions, burns or wounds. – Third trimester of pregnancy. – Children and adolescents up to 16 years of age.
Composition
Active ingredients
Each medicated patch contains 140 mg of diclofenac sodium. Each medicated patch contains 2.90 mg of butylhydroxyanisole (E 320). For the full list of excipients, see section 6.1.
Excipients
Backing material: non-woven polyester. Adhesive layer: polyacrylate dispersion, tributyl citrate, butylhydroxyanisole (E 320). Protective layer: single-sided silicone paper.”
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