Daktarin 20mg/g oromucosal gel

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Miconazole

Tilgjengelig fra:

McNeil Products Ltd

ATC-kode:

A01AB09

INN (International Name):

Miconazole

Dosering :

20mg/1gram

Legemiddelform:

Oromucosal gel

Administreringsrute:

Oromucosal; Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 12030200; GTIN: 5012674021477

Informasjon til brukeren

- 1 -
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.
•
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours
•
If you get side effects and they become serious or if you notice any
side
effects not listed in this leaflet, please tell your doctor or
pharmacist
IN THIS LEAFLET
1. What Daktarin oral gel is and what it is used for
2. 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. Further 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, throat, gullet, stomach or gut. 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. BEFORE YOU USE DAKTARIN ORAL GEL
DO NOT USE DAKTARIN ORAL GEL:
•
If you are allergic to miconazole, any of the other ingredients of
this medicine
(listed in section 6) or to other similar antifungal medicines
•
If you suffer 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 off the child's or infant's throat as they could choke
on it. You
should place the gel at the front of the mouth – never put it at the
back of the
throat.
- 2 -
If your infant is being treated with Daktarin or

Preparatomtale

OBJECT 1
DAKTARIN ORAL GEL
Summary of Product Characteristics Updated 24-Jul-2017 | Janssen-Cilag
Ltd
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 fungal infections of the oropharynx and
gastrointestinal tract.
Miconazole gel is for use in adults, children and infants 4 months and
older.
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.
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 20 mg per kg body weight per day, administered
in four divided doses. The daily
dose should not exceed 250 mg (10 mL Oral Gel) four times a day.
The treatment should be continued for at least a week after the
symptoms have disappeared.
4.3 Contraindications
Known hypersensitivity to miconazole, other im