ORALDENE GARGLE/MOUTHWASH 0.1 %w/v Oromucosal Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HEXETIDINE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

A01AB12

INN (International Name):

HEXETIDINE

Dosage:

0.1 %w/v

Pharmaceutical form:

Oromucosal Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiinfectives and antiseptics for local oral treatment

Authorization status:

Authorised

Authorization date:

1995-03-26

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.
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 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.
If you are pregnant or breast-feeding
n
Ask your doctor or pharmacist for advice
before using Oraldene if you are pregnant
or breast-feeding.
Some of the ingredients can cause
problems
n
Oraldene 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
wine at 12% vol. Harmful for those suffering
from alcoholism. To be taken into account
in p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oraldene 0.1% w/v Gargle/Mouthwash
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Hexetidine 0.10% w/v
Excipients with known effect: contain 4.3g Ethanol (96%) per 100ml ie:
up to 0.611g ethanol per 15ml dose and trace
amounts of Azorubine 85% (E122)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gargle/mouthwash
A clear, red coloured liquid for use as a gargle or mouthwash.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oraldene 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 can
also be used as an adjunct to systemic therapy of oropharyngeal
infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
USUAL DOSAGE IN 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 should not be taken internally.
Oraldene is for external use only; the solution must therefore not be
swallowed.
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