Oraldene

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HEXETIDINE

Available from:

McNeil Products Limited

ATC code:

A01AB12

INN (International Name):

HEXETIDINE

Pharmaceutical form:

OROMUCOSAL SOLUTION

Composition:

HEXETIDINE 0.1 percent weight/volume

Prescription type:

OTC

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-08-10

Patient Information leaflet

F309417
13/0005
_GINGIVITIS_
_MOUTH ULCERS_
_SORE GUMS_
_SORE THROAT_
ANTIBACTERIAL
MOUTHWASH
TO RELIEVE
Hexetidine
He
xe
tid
in
e
100
10
0 M M
L
Medicated Relief for
Me
dic
ate
d R
eli
ef 
fo
r
Mouth & Throat Infections
Mo
uth
 &
 Th
ro
at 
In
fe
cti
on
s
LOT                          EXP
Medicated Relief for
Medicated Relief for
Mouth & Throat Infections
Mouth & Throat Infections
Hexetidine
Hexetidine
Hexetidine
Hexetidine
100 ML
HOW TO USE THIS MEDICINE
CHECK THE TABLE BELOW TO SEE HOW MUCH MEDICINE 
CHECK THE TABLE BELOW TO SEE HOW MUCH MEDICINE 
TO USE.
TO USE.
ORALDENE IS FOR TOPICAL USE ONLY, WHICH MEANS THAT 
ORALDENE IS FOR TOPICAL USE ONLY, WHICH MEANS THAT 
IT SHOULD NOT BE SWALLOWED OR TAKEN INTERNALLY.
IT SHOULD NOT BE SWALLOWED OR TAKEN INTERNALLY.
CHILDREN UNDER 6 YEARS OLD
ORALDENE IS NOT RECOMMENDED FOR CHILDREN UNDER 
ORALDENE IS NOT RECOMMENDED FOR CHILDREN UNDER 
6 YEARS OF AGE.
6 YEARS OF AGE.
ADULTS AND CHILDREN AGED 6 YEARS AND 
OVER
IF ANYONE ACCIDENTALLY SWALLOWS THIS 
PRODUCT
IF ANYONE ACCIDENTALLY SWALLOWS THIS PRODUCT, 
IF ANYONE ACCIDENTALLY SWALLOWS THIS PRODUCT, 
CONTACT A DOCTOR OR YOUR NEAREST ACCIDENT 
CONTACT A DOCTOR OR YOUR NEAREST ACCIDENT 
AND EMERGENCY DEPARTMENT (CASUALTY) TAKING 
AND EMERGENCY DEPARTMENT (CASUALTY) TAKING 
THIS PACK WITH YOU.
THIS PACK WITH YOU.
IF YOU FORGET TO USE THE MEDICINE
USE THE NEXT DOSE AS SOON AS YOU REMEMBER 
USE THE NEXT DOSE AS SOON AS YOU REMEMBER 
UNLESS IT IS TIME TO USE IT AGAIN. DO NOT USE 
UNLESS IT IS TIME TO USE IT AGAIN. DO NOT USE 
TWO QUANTITIES IN ONE GO.
TWO QUANTITIES IN ONE GO.
THIS CARTON WAS REVISED AUGUST 2013. ©
THIS CARTON WAS REVISED AUGUST 2013. ©
ORALDENE IS A REGISTERED TRADE MARK.
ORALDENE IS A REGISTERED TRADE MARK.
PRODUCT LICENCE HOLDER: MCNEIL PRODUCTS LTD, 
PRODUCT LICENCE HOLDER: MCNEIL PRODUCTS LTD, 
MAIDENHEAD, BERKSHIRE, SL6 3UG, UK.
MAIDENHEAD, BERKSHIRE, SL6 3UG, UK.

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
ORALDENE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ORALDENE contains 0.1% w/v hexetidine.
3.
PHARMACEUTICAL FORM
Mouthwash.
A clear red solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ORALDENE is indicated for use in minor mouth infections including
thrush,
as an aid in the prevention and treatment of gingivitis, and in the
management
of sore throat and recurrent aphthous ulcers. ORALDENE is also of
value in
the alleviation of halitosis and pre- and post-dental surgery.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN 12 YEARS AND OVER
Shake well before use. Rinse the mouth, or gargle with at least 15 ml
of
undiluted solution, two to three times a day. Do not swallow the
solution but
spit out after use.
CHILDREN UNDER 12 YEARS
Not recommended.
METHOD OF ADMINISTRATION
For oromucosal use.
4.3.
CONTRAINDICATIONS
Hypersensitivity to hexetidine or to any of the excipients in
Oraldene.
Page 2 of 6
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
ORALDENE mouthwash is for external use only; the solution must
therefore
not be swallowed.
Not suitable for persistent symptoms.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interactions are known.
4.6.
FERTILITY, PREGNANCY AND LACTATION
No formal studies have been conducted in man. However, on the basis of
animal studies and, in theory, the negligible systemic absorption it
is
considered highly unlikely that the use of ORALDENE during pregnancy
will
present a risk to the foetus.
It is not known whether hexetidine is excreted in human breast milk,
however,
in view of the negligible amount of hexetidine which could be
predicted to be
systemically absorbed, it is unlikely that concentrations of
hexetidine in the
milk will present any risk to the neonate/infant.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
ORALDENE is unlikely affect ability to drive or operate machinery.
4.8.
UNDESIRABLE EFFECTS
ORALDENE is