UK_Oraldene_Original_200ml_Carton [BV3420]-Product Name-Net Contents

19.11.2020 English
402069192_r2 ETU033
Box/Carton (includes Card), Tetra Pack 60 x 60 x 136 mm
CHILD

XXXXXX EM-Delpharm_Orleans_France
LE303802 N/A
N/A Offset Printing
XXXXXX N/A
EMEA_2020_00025024_001 N/A EXP LOT
200 ml
Mouth & Throat Infections
Medicated Relief for
Hexetidine
Cyan Magenta PANTONE Black VARNISH Braille XXXXXX
877 C FREE
OFFSET PRINTING OFFSET PRINTING OFFSET PRINTING OFFSET PRINTING - -
REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval.

Possible side-effects What the medicine is for

Like all medicines, Oraldene can cause side-effects The mouthwash contains hexetidine, which is an
although not everybody gets them. antibacterial and antifungal and is used to help treat
If you experience the following, stop using the medicine throat and mouth infections, including mouth ulcers,
and talk to your doctor: thrush, sore or bleeding gums (called gingivitis), bad
■ Swelling of the face, lips, mouth, tongue or throat breath (halitosis) or sore throat. It can also be used before
Hexetidine Hexetidine which may cause difficulty in swallowing or breathing ■ and after dental surgery to help prevent infections.
Allergic reactions including itchy rash ■ Irritation,
How to use this medicine
tingling or numbness of the tongue or inside the mouth Before using this medicine
Check the table below to see how much medicine to use.
Medicated Relief for ■ Shortness of breath ■ Cough ■ Dry mouth ■ Feeling
sick (nausea) ■ Sickness (vomiting) ■ Salivary gland This medicine is suitable for most people, but a few
people should not use it. If you are in any doubt, talk to
Mouth & Throat Infections enlargement ■ Taste disturbance or loss of taste ■ Pain,
your doctor or pharmacist.
i Children under 12 years old swelling, redness or heat ■ Tongue or tooth
discolouration ■ Blistering or ulceration Do not use this medicine…
Oraldene is not recommended for children under 12
years of age. Reporting of side-effects ■ If you have ever had a bad reaction to Oraldene or
If you get any side-effects, talk to your doctor, pharmacist or any of its ingredients. If this applies to you, get
advice from your doctor or pharmacist without
i Adults and Children aged 12 years and over nurse. This includes any possible side- effects not listed in
this carton. You can also report side-effects directly via the using Oraldene.
Hexetidine Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or
Age Dose search for MHRA Yellow Card in the Google Play or Apple If you are pregnant or breast-feeding
App Store. By reporting side-effects you can help provide ■ Ask your doctor or pharmacist for advice before
How to use this medicine Adults and Rinse the mouth or gargle for more information on the safety of this medicine. using Oraldene if you are pregnant
children 30 seconds with at least 15 ml (approx. or breast-feeding.
Check the table below to see how much medicine to use. aged 12 years 1 tablespoonful) of undiluted Oraldene Storing this medicine Excipients with known effect
and over two to three times a day or as
i Children under 12 years old otherwise directed. Do not use if bottle seal is broken when purchased.
Store below 30°C.
■ This medicine contains 623.5 mg of alcohol
Oraldene is not recommended for children under 12 (ethanol) in each 15 ml. The amount in 15
■ Do not swallow. Use within 6 months of opening. ml of this medicine is equivalent to less than
years of age. Keep the bottle in the outer carton in order to protect from 16 ml beer or 7 ml wine. The small amount
■ Shake well before use. light. of alcohol in this medicine will not have any
i Adults and Children aged 12 years and over ■ If symptoms persist discontinue use and talk Antibacterial Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
noticeable effects.
to your doctor or dentist. ■ Azorubin (E122) may cause allergic reactions.
Age Dose
Mouthwash stated on the label. The expiry date refers to the last day of ■ This medicine contains less than 1 mmol sodium
to relieve that month. (23 mg) per 15 ml, that is to say essentially
Adults and Rinse the mouth or gargle for ! If anyone accidentally swallows this Retain carton for full instructions. ‘sodium-free’.
children 30 seconds with at least 15 ml (approx. product Do not throw away any medicines via wastewater or
aged 12 years 1 tablespoonful) of undiluted Oraldene Contact a doctor or your nearest Accident and gingivitis household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
This carton was revised November 2020. ©
Oraldene is a registered trade mark.
and over two to three times a day or as Emergency department (Casualty) taking this pack
otherwise directed. with you. mouth ulcers protect the environment. Product Licence holder: McNeil Products Ltd, High
Wycombe, HP12 4EG.
! If you forget to use the medicine Further information
■ Do not swallow.
■ Shake well before use.
sore gums What’s in this medicine?
Manufacturer: Delpharm Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
Use the next dose as soon as you remember unless PL 15513/0067
■ If symptoms persist discontinue use and talk
to your doctor or dentist.
it is time to use it again. Do not use two quantities
in one go. sore throat The active ingredient is: Hexetidine 0.1 g/100 ml
Other ingredients are: Polysorbate 80, citric acid, saccharin
sodium, levomenthol, eucalyptus oil, ethanol 96%, azorubin
oraldene

oraldene

(E122) sodium calcium edetate, sodium hydroxide (E524),

! If anyone accidentally swallows this and purified water.
product
Contact a doctor or your nearest Accident and
What the medicine looks like
oraldene

Emergency department (Casualty) taking this pack Oraldene is a clear red solution available in 200 ml bottles. It
with you. contains 0.1 g of the active ingredient in every 100 ml of
medicine.
! If you forget to use the medicine
Use the next dose as soon as you remember unless 200 ml
it is time to use it again. Do not use two quantities
in one go.

3 574661 475301
Frutiger-Bold ZapfDingbatsITC Smallest Text Size
Frutiger-BoldItalic 5.5pt
Frutiger-Cn Ave. Text Size
Fonts used

Frutiger-Light
6.5pt
Frutiger-Roman
Helvetica
Largest Text Size
MetaPlusBlack-Roman 12.0pt
 UK_Oraldene_Original_200ml_Label [BV3420]
05.10.2020 English
402069243_r1 N/A
Label 50 x 90 mm
CHILD

XXXXXX EM-Delpharm_Orleans_France
LQ402002 N/A CONTENTS: The solution contains Do not use if bottle
Hexetidine 0.1g/100 ml. Other seal is broken
N/A Flexo ingredients: Polysorbate 80, citric acid, when purchased.
saccharin sodium, levomenthol, Keep out of the
XXXXXX N/A

XXXXXX
eucalyptus oil, ethanol 96%, azorubin Hexetidine sight and reach of children.
(E122) sodium calcium edetate, sodium DIRECTIONS: Mouthwash
EMEA_2020_00025028_001 N/A for topical use only. DO NOT
hydroxide (E524), and purified water. Medicated Relief for SWALLOW. SHAKE WELL
Oraldene has an antibacterial and Mouth & Throat BEFORE USE.
antifungal action which relieves mouth
and throat infections. Infections ADULTS AND CHILDREN 12
YEARS AND OLDER
It can also be used before and after Rinse the mouth or gargle for
dental surgery. 30 seconds with at least 15 ml

EXP
Read and retain carton for full instructions. (approx. 1 tablespoonful) of
Oraldene is a registered trade mark. undiluted Oraldene 2 to 3 times a
day. CHILDREN UNDER 12 YEARS -
Cyan Magenta PANTONE Black Varnish PL holder: McNeil Products Ltd, not recommended.
877 C Free High Wycombe, HP12 4EG. Antibacterial
Mouthwash to relieve
If symptoms persist discontinue use
and talk to your doctor or dentist.
FLEXO FLEXO FLEXO FLEXO - gingivitis mouth ulcers Store below 30°C.
REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. sore gums sore throat Use within 6 months of opening.
PL 15513/0067 Keep the bottle in the outer carton

LOT
200 ml in order to protect from light.

Frutiger-Bold Smallest Text Size

Frutiger-BoldCn 4.5pt
Frutiger-BoldItalic Ave. Text Size
Fonts used

Frutiger-Cn
6.5pt
Frutiger-Roman
Helvetica
Largest Text Size
10.0pt
2020-09-30 15:07:58