VARI-MICONAZOLE 2 % M/M ORAL GEL

Држава: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Доступно од:

BARRS PHARMACEUTICAL INDUSTRIES (PTY) LTD

Дозирање:

See ingredients

Фармацеутски облик:

GEL

Састав:

EACH 1,0 g GEL CONTAINS MICONAZOLE 20,0 mg

Статус ауторизације:

Registered

Датум одобрења:

2012-07-12

Информативни летак

Barrs Pharmaceutical Industries (Pty) Ltd
20 mg miconazole
VARI MICONAZOLE 2 % _m/m_ ORAL GEL
Oral Gel
Date of revision: 24 August 2023
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S2
VARI MICONAZOLE 2 % _M/M_ ORAL GEL
Miconazole
Contains sweetener (3,06 mg sodium saccharin in each gram).
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
VARI MICONAZOLE 2 % _M/M_ ORAL GEL is available without a doctor’s
prescription, for you to
treat a mild illness.
Nevertheless, you still need to use VARI MICONAZOLE 2 % _M/M_ ORAL GEL
carefully to get best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share VARI MICONAZOLE 2 % _M/M_ ORAL GEL with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see your doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1.
What VARI MICONAZOLE 2 % _M/M_ ORAL GEL is and what it is used for.
2.
What you need to know before you use VARI MICONAZOLE 2 % _M/M_ ORAL
GEL.
3.
How to use VARI MICONAZOLE 2 % _M/M_ ORAL GEL.
4.
Possible side effects.
5.
How to store VARI MICONAZOLE 2 % _M/M_ ORAL GEL.
6.
Contents of the pack and other information.
1.
WHAT VARI MICONAZOLE 2 % _M/M_ ORAL GEL IS AND WHAT IT IS USED FOR
VARI MICONAZOLE 2 % _M/M_ ORAL GEL is an antifungal gel used to treat
fungal infections in
the mouth such as thrush or inflammation of the mouth.
Barrs Pharmaceutical Industries (Pty) Ltd
20 mg miconazole
VARI MICONAZOLE 2 % _m/m_ ORAL GEL
Oral Gel
Date of revision: 24 August 2023
Page 2 of 9
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VARI MICONAZOLE 2 % M/M ORAL GEL
DO NOT APPLY VARI MICONAZOLE 2 % _M/M_ ORAL GEL:
•
If you are hypersensitive (allergic) to miconazole or any of the
inactive ingredients of VARI
MICONAZOLE 2 % _M/M_ ORAL GEL (see section 6).
•
If you have liver problems.
•
If you are taking any of the following medicines:
-
Medicines for hayfever or allergies called terfenadine, astemizole or
mizolasti

Карактеристике производа

Barrs Pharmaceutical Industries (Pty) Ltd
20 mg miconazole
VARI MICONAZOLE 2 % _m/m_ ORAL GEL
Oral Gel
Date of revision: 24 August 2023
Page 1 of 10
PROFESSIONAL INFORMATION FOR VARI MICONAZOLE 2 % _M/M_ ORAL GEL
SCHEDULING STATUS:
S2
1.
NAME OF THE MEDICINE
VARI MICONAZOLE 2 % _M/M_ ORAL GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 20 mg miconazole.
_Excipients with known effects: _
Contains sweetener: 3,06 mg sodium saccharin in each gram.
Contains preservatives: 0,2 % _m/m_ methyl paraben and 0,02 % _m/m_
propyl paraben.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral gel.
A translucent, homogeneous gel, free from any visible contaminants,
with a pineapple flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VARI MICONAZOLE 2 % _M/M_ ORAL GEL is indicated for the treatment of
fungal infections of the
mouth (oral candidiasis or thrush) and for fungal stomatitis occurring
in association with dentures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Full term infants: 4 – 24 months:_ 1,25 mL (¼ measuring spoon) of
gel, applied four times a day
after meals. Each dose is to be divided into smaller portions and the
gel applied to the affected
area(s) with a clean finger. The gel is not to be swallowed
immediately but kept in the mouth as
Barrs Pharmaceutical Industries (Pty) Ltd
20 mg miconazole
VARI MICONAZOLE 2 % _m/m_ ORAL GEL
Oral Gel
Date of revision: 24 August 2023
Page 2 of 10
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 is not to be swallowed immediately
but kept in the mouth as long
as possible.
VARI MICONAZOLE 2 % _M/M_ ORAL GEL should be spread evenly over the
affected areas of the
oropharyngeal mucosa and tongue taking care to properly cover oral
ulcerations and other lesions.
Apply after meals.
The application of VARI MICONAZOLE 2 % _M/M_ ORAL GEL should be
repeated three to four
times daily depending upon the severity of the infection. Apply th