Informations for option: Endekay Fluorinse 2%W/V Mouthrinse, show other option

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1. Endekay Fluorinse 2%W/V Mouthrinse
2. Endekay Fluorinse 2%W/V Mouthrinse

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Endekay Fluorinse 2%w/v Mouthrinse

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient Sodium fluoride BP

Quantity per dose 2.0 w/v

3. PHARMACEUTICAL FORM

Mouthwash solution clear deep red, mobile aqueous liquid with an odour of

blackcurrant.

4. Clinical Particulars

4.1. Therapeutic Indications

For children of 8 years of age and upwards as an aid in the prevention of dental caries.

4.2. Posology and Method of Administration

For daily use: Dilute 1 in 40 (5 drops in 10ml) with water in the container provided;

equivalent to 2.3 mg fluoride ion after dilution.

For weekly use:    Dilute 1 in 10 (20 drops in 10ml) with water in the container provided;

equivalent to 9.0mg fluoride ion after dilution.

Rinse teeth thoroughly for one minute and spit out.

4.3 Contraindications

Hypersensitivity to sodium fluoride or any of the other ingredients.

CLINICAL PARTICULARS

4.1 Therapeutic indications

For children of 8 years of age and upwards as an aid in the prevention of dental caries.

4.5.    Interactions with other Medicinal Products and other Forms of Interaction None known.

4.6.    Pregnancy and Lactation No adverse effects known.

4.7.    Effects on Ability to Drive and Use Machines None known.

4.8. Undesirable Effects

None known.

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 at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Symptoms

Doses of fluoride of 5mg/kg (equivalent to 11mg/kg sodium fluoride) and greater may cause serious or life-threatening symptoms. Severe nausea, vomiting and diarrhoea have been reported.

Electrolyte disturbances including hypocalcaemia can occur, followed by rhythm disturbances and circulatory collapse.

Life-threatening symptoms may occur several hours after apparent recovery. Fatalities have been reported.

Treatment

Fluoride is rapidly absorbed from the stomach and intestines. Absorption of fluoride may be reduced by the oral administration of milk (minor effect) or stomach antacid tablets containing e.g. aluminium hydroxide or calcium/ magnesium.

Monitoring of serum Ca and administration of IV calcium gluconate in case of hypocalcaemia is necessary in cases of potentially severe poisoning. Urea, LFTS and other electrolytes should be monitored also. If symptoms occur, appropriate supportive measures should be employed.

Patients should be observed for several hours after ingestion even if there had been vomiting.

Contact the National Poisons Information Service (NPIS) for specific advice, especially for cases of severe poisoning.

5. Pharmacological Properties

5.1. Pharmacodynamic Properties

The use of sodium fluoride in the prevention of dental caries is well established.

5.2. Pharmacokinetic Properties

Not applicable.

5.3. Preclinical Safety Data

The safety of sodium fluoride is well documented in the literature. It is considered safe for oral use in the controlled amounts recommended for fluoridation of drinking water supplies and in fluoride supplements.

6. Pharmaceutical Particulars

6.1.    List of Excipients

Citric acid monohydrate BP Saccharin sodium BP Blackcurrant flavour witham F HSE Thymol BP Menthol BP Carmoisine E122 HSE Sodium methylparaben BP Sodium propylparaben BP Water BP

6.2.    Incompatibilities None known.

6.3.    Shelf Life

36 months.

10 DATE OF REVISION OF THE TEXT

19/06/2015