Daktarin oral gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MICONAZOLE

Available from:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC code:

A01AB09

INN (International Name):

MICONAZOLE

Pharmaceutical form:

ORAL GEL

Composition:

MICONAZOLE 20 milligram(s)/gram

Prescription type:

POM

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-12-21

Patient Information leaflet

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, ot her s i m i l a r an t i f un
gal m edi c i nes o r
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 t

Summary of Product characteristics

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