ORALDENE ICEMINT MOUTHWASH 0.1 %w/v Mouth Wash

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

HEXETIDINE

Disponível em:

McNeil Healthcare (Ireland) Ltd

Código ATC:

A01AB12

DCI (Denominação Comum Internacional):

HEXETIDINE

Dosagem:

0.1 %w/v

Forma farmacêutica:

Mouth Wash

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

Antiinfectives and antiseptics for local oral treatment

Status de autorização:

Authorised

Data de autorização:

2002-04-19

Folheto informativo - Bula

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
Always use this medicine exactly as described
in this leaflet or as your doctor, pharmacist or
nurse have told you.
n
Keep this leaflet. You may need to read it
again.
n
This medicine is used to relieve throat and
mouth infections.
n
This medicine is for use by adults and children
aged 6 years and over.
n
Ask your pharmacist if you need more
information or advice.
n
If you get any side-effects, talk to your doctor,
pharmacist or nurse. This include any side-
effects not listed in this leaflet. _See section 4_
n
Do not use this medicine:
n
If you have had a bad reaction to Oraldene
Icemint or any of the ingredients in it. _See _
_section 6_
n
Follow the dosage instructions carefully.
1
What the medicine is for
The mouthwash contains hexetidine, which is
an antibacterial and antifungal and is used to
help treat throat and mouth infections, including
mouth ulcers, thrush, sore or bleeding gums
(called gingivitis), bad breath (halitosis) or sore
throat. It can also be used before and after
dental surgery to help prevent infections.
2
Before using this medicine
This medicine is suitable for most people, but
a few people should not use it. If you are in any
doubt, talk to your doctor or pharmacist.
Do not use this medicine…
n
If you have ever had a bad reaction (e.g:
hypersensitivity or allergic reaction) to
Oraldene or any of its ingredients.
n
If there is evidence of increased
inflammation, the treatment should be
stopped.
If the above applies to you, get advice from
your doctor or pharmacist without using
Oraldene Icemint.
If you are pregnant or breast-feeding
n
If you are pregnant or breast-feeding,
think you may be pregnant or are planning
to have a baby, ask your doctor or
pharmacist for advice before using this
medicine.
Some of the ingredients can cause
problems
n
Oraldene Icemint contains 0.611 g of
ethanol (alcohol) per 15 ml dose, equivalent
to 15.48 ml of beer at 5% vol and 6.45 ml
of

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oraldene Icemint 0.1% w/v Gargle/Mouthwash Hexetidine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Hexetidine 0.10% w/v
Excipients with known effect: contain 4.3 g Ethanol (96%) per 100ml
i.e.: up to 0.611 g ethanol per 15ml dose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gargle/mouthwash
A clear, blue-green coloured liquid for use as a gargle, mouthwash and
oromucosal solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oraldene Icemint is recommended as a topical antiseptic in the
management of superficial infections of the oropharynx
and in their prophylaxis in the preoperative period of dental surgery
or pharyngeal surgery in geriatric nursing.
Oraldene Icemint can also be used as an adjunct to systemic therapy of
oropharyngeal infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
USUAL DOSAGE FOR ADULTS AND CHILDREN 6 YEARS AND OVER
Rinse the mouth or gargle with at least 15 ml of solution two or three
times daily or as directed. Do not swallow.
ELDERLY
As for adults.
Under 6 years: Not recommended
METHOD OF ADMINISTRATION
For oromucosal use
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Oraldene Icemint should not be taken internally.
Oraldene Icemint is for external use only; the solution must therefore
not be swallowed.
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