Origin: UK

Name of the medicinal product

DAKTARIN Sugar Free 2% Oral Gel

2. Qualitative and quantitative composition

Each gram of Daktarin Sugar Free 2% Oral Gel contains 20 mg of miconazole.

Excipient(s) with known effect:

Ethanol 7.58 mg

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral gel.

White gel with orange taste.

4. Clinical particulars

4.1 Therapeutic indications

Oral treatment of superficial fungal (e.g. Candida) infections of the oropharynx in adults and paediatric patients 4 months and older.

4.2 Posology and method of administration

For oral administration.

1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5mL gel.

For topical treatment of the oropharynx.

Infants: 4 – 24 months: 1.25 ml (¼ measuring spoon of gel) applied four times a day after meals. Each dose should be divided into smaller portions and the gel should be applied to the affected area(s) with a clean finger. The gel should not be applied to the back of the throat due to possible choking. The gel should not be swallowed immediately, but kept in the mouth as long as possible.

Adults and children 2 years of age and older: 2.5 ml (½ measuring spoon of gel) applied four times a day after meals. The gel should not be swallowed immediately, but kept in the mouth as long as possible/.

The treatment should be continued for at least a week after the symptoms have disappeared.

For oral candidosis, dental prostheses should be removed at night and brushed with the gel.

UK Imported Daktarin 2% Oral Gel