VOLTAROL ONE A DAY MUSCLE PAIN RELIEF

Posology Adults and adolescents from 16 years of age One medicated plaster should be applied to the painful area once daily. The maximum daily dose is 1 medicated plaster a day, even if there is more than one injured area to be treated.

Therefore, only one painful area can be treated at a time. Duration of use Voltarol ONE A DAY Muscle Pain Relief 140 mg Medicated Plaster is to be used for the shortest duration necessary to control symptoms. The duration of use should not exceed 7 days.

The therapeutic benefit of longer use has not been established. 4). Patients with renal or hepatic impairment In treatment of patients with renal or hepatic impairment see section

g. erythema bullosum), dry skin Very rare Photosensitivity reaction General disorders and administration site conditions Common Application site reactions Systemic plasma diclofenac levels measured during labelled use of the medicated plasters are very low compared to those obtained after oral intake of diclofenac.

The risk of developing systemically induced undesirable effects (like gastric, hepatic and renal disorders, systemic hypersensitivity reactions) during use of the plaster therefore appears to be low. However, in particular when the medicated plaster is used on a large area of skin and over a prolonged period of time, systemic undesirable effects may occur.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. 3). If this medicinal product is required for more than 7 days for pain relief or if the symptoms worsen, the patient/parents of the adolescent is/are advised to consult a doctor. Method of administration Cutaneous use. The medicated plaster must be applied only to intact non-diseased skin and should not be worn when bathing or showering.

The medicated plaster should not be divided. If necessary, the medicated plaster can be held in place using a net bandage. The medicated plaster must not be used together with an occlusive dressing. 1; - hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs [NSAIDs]; - patients who have previously experienced an asthma attack, urticaria or acute rhinitis when taking acetylsalicylic acid or any other non-steroidal anti- inflammatory drugs (NSAIDs); - patients with active peptic ulcer; - on damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound; - third trimester of pregnancy; - children and adolescents aged less than 16 years.

4 Special warnings and precautions for use The medicated plaster must not come into contact with or be applied to the eyes or mucous membranes. 2). Bronchospasm can occur in patients who suffer or have previously suffered from bronchial asthma or allergies.

Treatment must be stopped immediately if a skin rash develops after applying the medicated plaster. Patients should be warned against exposure to sunlight or solarium radiation after removal of the medicated plaster in order to reduce the risk of photosensitisation.

The possibility of systemic adverse events from application of diclofenac medicated plaster cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. Although the systemic effects are expected to be minimal, the medicated plasters should be used with caution in patients with impaired renal, cardiac or hepatic function, or a history of peptic ulcer, inflammatory bowel disease or haemorrhagic diathesis.

Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients as they are more likely to experience undesirable effects. No other medicinal products containing diclofenac or any other non-steroidal anti- inflammatory drugs (NSAIDs) should be used concomitantly, neither topically nor systemically.

g. contact dermatitis), or irritation to the eyes and mucous membranes.

1; - hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs [NSAIDs]; - patients who have previously experienced an asthma attack, urticaria or acute rhinitis when taking acetylsalicylic acid or any other non-steroidal anti- inflammatory drugs (NSAIDs); - patients with active peptic ulcer; - on damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound; - third trimester of pregnancy; - children and adolescents aged less than 16 years.