DAKTARIN ORAL 20mg/g MG/5ml Oral Gel

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

MICONAZOLE

Sẵn có từ:

McNeil Healthcare (Ireland) Ltd

Mã ATC:

A01AB09

INN (Tên quốc tế):

MICONAZOLE

Liều dùng:

20mg/g MG/5ml

Dạng dược phẩm:

Oral Gel

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Antiinfectives and antiseptics for local oral treatment

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2010-05-07

Tờ rơi thông tin

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Package leaflet: Information for the user
DAKTARIN
®
 20 MG/G ORAL GEL
MICONAZOLE
READ ALL OF THIS LEAFLET CAR
EFULLY BEFOR
E YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFOR
MATION 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. Y
ou may need to r
ead it again.
■ 
Ask your pharmacist if you need mor
e information or advice.
■ 
If you get any side ef
fects, talk to your doctor
, pharmacist or nurse. This includes any possible side 
ef
fects 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 befor
e you use Daktarin Oral Gel
3. How to use Daktarin Oral Gel
4. Possible side ef
fects
5. How to stor
e 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 tr
eat fungal and bacterial infections of the mouth and 
thr
oat. The gel contains miconazole which works by destr
oying the fungus and associated bacteria which 
may be pr
esent.
Daktarin Oral Gel may also be used to pr
event and tr
eat fungal and bacterial infections of the 
gastr
ointestinal tract, in childr
en and adults who have dif
ficulty swallowing tablets. 
This medicine is for adults, childr
en and infants aged 4 months and over
. 
2
  WHAT YOU NEED TO KNOW BEFOR
E YOU USE DAKTARIN ORAL GEL
This medicine is suitable for most adults and childr
en but a few people should not use it. If you ar
e in any doubt,

talk to your doctor 
or pharmacist.

DO NOT USE DAKTARIN ORAL GEL
■
 if you ar
e aller
gic to the active substance, other similar antifungal medicines or any
of the other 
ingr
edients of this medicines (listed in section 6). 
■ 
If you suf
fer fr
om 
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 in

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daktarin 20mg/g Oral Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 124 mg miconazole.
Each gram contains 20 mg miconazole.
Excipients with known effect
Ethanol 96% 7.59 mg/g
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 fungal infections of the oral cavity and gastro-intestinal tract in adults and paediatric patients 4
months and older.
Miconazole is effective against some Gram positive bacteria in adults and paediatric patients 4 months and older,
including Streptococcus pyrogenes, Staphylococcus aureus and Erysipelothrix.
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