Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Morningside Healthcare Ltd, 115 Narborough Road, Leicester, LE3 0PA, UK
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to substances that are chemically closely correlated to them, to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs.
Eventual involuntary swallowing of a dose of solution used for the rinses or gargling causes no damage to patient since it is equivalent to one fifth/sixth of the dose recommended for systemic administration. The use of topical preparations, particularly if prolonged, can lead to development of sensitization phenomena. If this occurs, treatment with Diclodent/diclofenac mouthwash should be suspended and suitable treatment instituted if necessary.
Diclodent/diclofenac mouthwash contains Sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Diclodent/diclofenac mouthwash also contains Sodium benzoate, which is mildly irritant to the skin, eyes and mucous membranes and Ponceau 4R, which may cause allergic reactions.
No negative interactions have been reported with other drugs commonly used in the patient treatment.
Diclodent/diclofenac mouthwash should not be used in pregnancy or lactation unless considered essential by the physician. There are no adequate and well-controlled studies to support its use.
Diclofenac mouthwash has no or negligible influence on the ability to drive and use machines.
Although no undesirable effects that could definitely be attributed to Diclofenac mouthwash were observed during the clinical trials performed with the product, it is possible, particularly in prolonged treatment, that signs of irritation of the oral mucosa, generally, mild, and cough appear. The use of topical preparations, particularly if prolonged, can give rise to sensitization phenomena. If this occurs, treatment with Diclofenac mouthwash should be suspended and suitable treatment instituted if appropriate.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
Not applicable.
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