Daktarin 20 mg/g Oral Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Miconazole

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

A01AB; A01AB09

INN (International Name):

Miconazole

Dosage:

20 milligram(s)/gram

Pharmaceutical form:

Oral gel

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiinfectives and antiseptics for local oral treatment; miconazole

Authorization status:

Marketed

Authorization date:

1979-07-10

Patient Information leaflet

Package leaflet: Information for the user
DAKTARIN® 20 MG/G ORAL GEL
miconazole
Read all of this leaflet carefully before you start using this
medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse have told you.
▪
Keep this leaflet. You may need to read it again.
▪
Ask your pharmacist if you need more information or advice.
▪
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Daktarin Oral Gel is and what it is used for
2.
What you need to know before you use Daktarin Oral Gel
3.
How to use Daktarin Oral Gel
4.
Possible side effects
5.
How to store Daktarin Oral Gel
6.
Contents of the pack and other information
1
WHAT DAKTARIN ORAL GEL IS AND WHAT IT IS USED FOR
Daktarin Oral Gel is a medicine which is used to treat superficial
fungal infections of the mouth
and throat.
The gel contains miconazole which works by destroying the fungus.
Daktarin Oral Gel may also be used to prevent and treat fungal
infections of the gastrointestinal
tract, in children and adults who have difficulty swallowing tablets.
This medicine is for adults, children and infants aged 4 months and
over.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE DAKTARIN ORAL GEL
This medicine is suitable for most adults and children but a few
people should not use it. If you
are in any doubt, talk to your doctor or pharmacist.
DO NOT USE DAKTARIN ORAL GEL
▪
If you are allergic to the active substance, other similar antifungal
medicines or any of
the other ingredients of this medicines (listed in section 6).
▪
If you suffer from LIVER DYSFUNCTION.
▪
If it is for an infant under 4 MONTHS of age because of the risk of
choking.
▪
The lower age limit should be increased to 5 - 6 months of age for
infants who are
premature or have slow development.
▪
In infants who have difficulty swallowing.
▪
If you are taking a

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2023
CRN00D4VC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daktarin 20 mg/g Oral Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 124 mg of miconazole.
Each gram contains 20 mg miconazole.
Excipients with known effect
Ethanol 7.85 mg/g
0.17 mg/g orange flavour containing allergens (citral, citronellol,
d-limonene, geraniol, linalool)
0.46 mg/g cocoa flavour containing allergens (benzyl benzoate and
benzyl alcohol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral gel.
White homogeneous gel having an orange taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of superficial fungal (e.g. _Candida_) infections of
the oral cavity and gastro-intestinal tract in adults and
paediatric patients 4 months and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
OROPHARYNGEAL CANDIDOSIS
1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5
mL gel.
Infants: 4-24 months: 1.25ml (1/4 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: 2.5ml (1/2 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.
GASTROINTESTINAL TRACT CANDIDOSIS
The gel may be used for infants (≥4 months of age), children and
adults who have difficulty swallowing tablets. The dosage is
20mg per kg body weight per day, administered in four individual
doses