Oraldene Icemint 0.1% w/v Gargle/Mouthwash Hexetidine

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hexetidine

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

A01AB; A01AB12

INN (International Name):

Hexetidine

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Gargle/mouthwash

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiinfectives and antiseptics for local oral treatment; hexetidine

Authorization status:

Marketed

Authorization date:

2002-04-19

Patient Information leaflet

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.
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Keep this leaflet. You may need to read it again.
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This medicine is used to relieve throat and mouth
infections.
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This medicine is for use by adults and children
aged 6 years and over.
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Ask your pharmacist if you need more information
or advice.
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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_
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Do not use this medicine:
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If you have had a bad reaction to Oraldene
Icemint or any of the ingredients in it.
_See section 6_
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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…
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If you have ever had a bad reaction (e.g:
hypersensitivity or allergic reaction) to Oraldene
Icemint or any of its ingredients.
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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
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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
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This medicine contains 623.5 mg of alcohol
(ethanol) in each 15 ml dose. The amount in
15 ml of dose of this medicine is e

Summary of Product characteristics

Health Products Regulatory Authority
09 May 2023
CRN00D5Y4
Page 1 of 5
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 4.052g Ethanol (96%) per 100ml
i.e.: up to 0.6078g 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
ADULTS AND CHILDREN 6 YEARS AND OVER
Rinse the mouth or gargle with at least 15 ml of solution two to three
times daily or as directed. Do not swallow the solution
but spit out after use. An adult should supervise use in children to
ensure that product is administered correctly.
ELDERLY
As for adults.
Children under 6 years: Not recommended
METHOD OF ADMINISTRATION
For oromucosal use only. Do not swallow.
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.
This medicine contains 607.8 mg of alcohol (ethanol) in each 15 ml
dose. The amount in 15 ml of dose of this medicine is
equivalent to 15 ml beer or 6 ml wine.
If swallowed, the amount of alcohol in this medicine is not likely to
have an effect in adults and adolescents, and its effects in
children are not likely to be noticeable. It may have some effe