Daktarin 20mg/g oromucosal gel

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Miconazole

Disponible des:

Johnson & Johnson Ltd

Codi ATC:

A01AB09

Designació comuna internacional (DCI):

Miconazole

Dosis:

20mg/1gram

formulario farmacéutico:

Oromucosal gel

Vía de administración:

Oromucosal; Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 12030200; GTIN: 5012674021422

Informació per a l'usuari

TOP
miconazole
_ SUGAR FREE_
_2% ORAL GEL_
■
This medicine is used to treat fungal and bacterial infections of the
mouth and throat.
■
This medicine is for use by adults, children and infants aged 4 months
and over.
■
Do not take this medicine:
■
Some people should not use this medicine._ _To fi nd out if you are
one of them _See Section 2 _
c
■
If you are allergic to the active substance, other similar antifungal
medicines or any of the other
ingredients of this medicine (listed in section 6)
■
Speak to your doctor:
■
If you suffer from any of the conditions mentioned in section 2. _See
Section 2 _
c
■
If you are taking any other medicines. _See Section 2 _
c
■
Follow the dosage instructions carefully. Children of different ages
and adults need different amounts.
These are shown in the dosage table. _See Section 3 _
c
■
If you are giving the gel to a child or infant, ensure that the gel
does not become a choking hazard by
making sure you place the gel at the front of the mouth. _See Section
3 _
c
Now read this whole leafl et carefully before you use this medicine.
Keep the leafl et: you might need it again.
1 What the medicine is for
Daktarin Sugar Free 2% Oral Gel is a medicine which is used to treat
fungal and bacterial infections of the
mouth and throat. The gel contains miconazole which works by
destroying the fungus and associated
bacteria which may be present.
This medicine is for use in adults, children and infants aged 4 months
and over.
2 Before using this medicine
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 this medicine…
■
If you are allergic to the active substance, other similar antifungal
medicines or any of the other
ingredients of this medicine (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.
■
If you are taking any of the following medicines:
■
_Warfarin _(a

Fitxa tècnica

OBJECT 1
DAKTARIN SUGAR FREE 2% ORAL GEL
Summary of Product Characteristics Updated 08-Aug-2017 | McNeil
Products Ltd
1. 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.
For a 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 fungal infections of the oropharynx and of
superinfections due to Gram-positive
bacteria in adults and paediatric patients 4 months and older (see
_Contraindications_ and _Warnings and _
_Precautions_).
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.
4.3 Contraindications
Hypersensitivity to the active substance(s), other imidazole
derivatives or to any of the excipients listed in
section 6.1.
In infants less than 4 months of age or in those whose swallowing
reflex is not sufficiently developed (see
section 4.4).
In patients with liver dysfunction.
Coadministration of the following drugs that are subject to metabolism
by CYP3A4 or CYP2C