Daktarin oral gel 20mg

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

MICONAZOLE

Disponible desde:

Johnson & Johnson Hellas Consumer AE Aegialias & Epidavrou 4, Maroussi, 15125, Athens, Greece

Código ATC:

A01AB09

Designación común internacional (DCI):

MICONAZOLE 20 mg/g

formulario farmacéutico:

ORAL GEL

Composición:

MICONAZOLE 20 mg/g

tipo de receta:

POM

Área terapéutica:

STOMATOLOGICAL PREPARATIONS

Estado de Autorización:

Authorised

Fecha de autorización:

2006-12-21

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
DAKTARIN
®
ORAL GEL
Miconazole
Daktarin is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on
to others. It may
harm them, even if their signs of illness are the same as yours
• If you get any side e
ff
ects, talk to your doctor or pharmacist. 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 e
ff
ects
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 fungal
infections of the mouth
and throat. The gel contains miconazole which works by destroying the
fungus that
is present.
This medicine is for use in adults and children aged 4 months and
over.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DAKTARIN ORAL GEL
DO NOT USE DAKTARIN ORAL GEL:
If you are allergic to miconazole, other similar antifungal medicines
or any of the
other ingredients of this medicine (listed in section 6).
• If you su
ff
er from liver problems
• If it is for an infant under 4 months of age because of risk of
choking
Do not use this medicine if the above applies to you. If you are not
sure, talk to your
doctor or pharmacist before using Daktarin oral gel.
TAKE SPECIAL CARE WITH DAKTARIN ORAL GEL
Daktarin oral gel is sticky. This ensures that it stays in the mouth
for as long as
possible. If you are giving the gel to a child or infant, make sure
that the gel does not
close o
ff
the child's or infant's throat as they could choke on it. You should
place the gel at the fro

Ficha técnica

Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DAKTARIN Oral Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Daktarin Oral Gel contains 20 mg of miconazole.
Excipients with known effect:
Alcohol
7.59 mg/g
For the full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Oral gel.
White gel with orange taste.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5
mL gel.
_Oropharyngeal candidosis _
Infants: 4-24 months: 1.25 mL (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: 2.5 mL (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.
For oral candidosis, dental prostheses should be removed at night and
brushed with the gel.
Page 2
The treatment should be continued for at least a week after the
symptoms have
disappeared.
4.3
CONTRAINDICATIONS
Known hypersensitivity to miconazole, 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 yet
sufficiently developed (see section 4.4)
In patients with liver dysfunction.
Coadministration of the following drugs that are subject to metabolism
by CYP3A4: (See
Section 4.5 Interaction with other medicinal products and other forms
of int