DURAPHAT

Duraphat 50mg/ml Dental Suspension is to be applied by the dentist. Before applying Duraphat, excess plaque should be removed and the teeth dried. Duraphat is applied as a thin layer to the most susceptible areas of dentition using a brush, probe or swab.

95mg Fluoride) For caries prophylaxis: the application is usually repeated every 6 months but more frequent applications (every 3 months) may be made. For hypersensitivity: 2 or 3 applications should be made within a few days. The patient should not brush the teeth or chew food for 4 hours after treatment.

Method of administration:

For dental use.

Gastrointestinal disorders:

Very rare (<1/10,000): Stomatitis, gingivitis ulcerative, retching, oedema mouth and nausea may occur in sensitive (allergic) individuals - if necessary, the dental suspension layer can easily be removed from the mouth by brushing and rinsing.

Skin and subcutaneous tissue disorders:

Very rare (<1/10,000): Irritation in sensitive individuals, angioedema Immune System Disorders Not known (cannot be estimated from the available data): Hypersensitivity.

Respiratory, thoracic and mediastinal disorders:

Very rare/Isolated report (<1/10,000): Asthma 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.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard.

Application of Duraphat 50mg/ml Dental Suspension to the whole dentition should not be carried out on an empty stomach. On the day when Duraphat has been applied, no high dose Fluoride preparations, such as Fluoride gels, should be used.

The administration of Fluoride supplements should be suspended for several days after applying Duraphat. Prolonged daily ingestion of excessive fluoride may result in varying degrees of fluorosis.

Tubes:

The container of this medicinal product contains latex rubber. May cause severe allergic reactions. This medicine contains flavouring agent raspberry essence with allergens- Geraniol, Citronellol, Citral, Benzyl benzoate, Linalool, and Benzyl alcohol.

These allergens may cause allergic reactions.

Hypersensitivity to colophony and/or any other constituents. Ulcerative gingivitis. Stomatitis. Bronchial asthma.