Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Oral treatment of candidosis of the oropharynx.
Miconazole gel is for use in adults, children and infants 4 months and older.
Consideration should be given to official guidance on the appropriate use of antifungal agents.
For oral administration.
1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5 mL gel.
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.
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.
In the event of accidental overdose, vomiting and diarrhoea may occur.
Treatment is symptomatic and supportive. A specific antidote is not available.
Shelf life: 3 years.
Do not Store above 30°C.
Aluminium tubes containing 5g*, 15g*, 30g* 40g* or 80g gel.
A 5 ml plastic spoon, marked with a 2.5 ml graduation is provided.
* not marketed
Not applicable.
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