Oraldene 0.1% w/v Gargle/Mouthwash

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HEXETIDINE

Available from:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC code:

A01AB12

INN (International Name):

HEXETIDINE 0.1 % (W/V)

Pharmaceutical form:

GARGLE MOUTH WASH

Composition:

HEXETIDINE 0.1 % (W/V)

Prescription type:

OTC

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-08-10

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
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
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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF 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 4.052g Ethanol (96%) per 100ml
i.e. up to 0.6078g
ethanol per 15ml dose
Azorubine (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
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 u
NDER 6 YEARS:
Not recommended
METHOD OF ADMINISTRATION
For oromucosal use only. Do not swallow.
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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.
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,
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 effects in younger children, for example feeling sleepy.
If swallowed, the alcohol in this medicine may alter the e