Oraldene
LQ402001-LAB ORALDENE ORIGINAL 200MLv9.0.pdf 1 31/05/2016 09:46
Oraldene 200 ml Component number: LQ402001 Version: 9.0
Dimensions: 50 x 90 mm Client code: 16-0177 Minimum font size: 8 pts
IMPORTANT!
STAMPING MENTIONS AREA
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CONTENTS: The solution contains Hexetidine 0.1g/100 ml. Other ingredients: Polysorbate 80, citric acid, saccharin sodium, levomenthol, eucalyptus oil, ethanol 96%, azorubin (E122) sodium calcium edetate, sodium hydroxide (E524), and purified water.
Sodium content: 0.016 g/100 ml.
Oraldene has an antibacterial and antifungal action which relieves mouth and throat infections, including: mouth ulcers • sore and bleeding gums • symptoms of sore throats • bad breath Oraldene can also be used before and after dental surgery.
Read and retain carton for full instructions. Oraldene is a registered trade mark.
PL holder: McNeil Products Ltd, Ma Berkshire, SL6 3UG, UK.
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Oraldene*
Hexetidine
Medicated Relief for Mouth & Throat Infections
Do not use if bottle seal is broken when purchased.
Keep out of the sight and reach of children.
Mouthwash to relieve
gingivitis mouth ulcers sore gums sore throat
DIRECTIONS: Mouthwash for topical use only. DO NOT SWALLOW SHAKE WELL BEFORE USE.
ADULTS AND CHILDREN 6 YEARS AND OLDER
Rinse the mouth or gargle for 30 seconds with at least 15 ml (appro: 1 tablespoonful) of undiluted Oralden two to three times a day. CHILDREN UNDER 6 YEARS - not recommended If symptoms persist discontinue treatment and consult your doctor or dentist.
• Do not dilute.
• Do not store above 30°C.
Use within 6 months of opening.
Keep the bottle in the outer c
200 ml order to protect from light.
arton in
BRAILLE
Oraldene 200 ml Component number: LE303801 Version: 10.3
Dimensions: 60 x £30 x IEJEj men
Code: 16-0176
Minimum font size: 7.5 pts
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Oraldene can have side-effects, like all medicines, although these don't affect everyone and are usually mild.
If you experience the following, stop using the medicine and talk to your doctor:
■ Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing ■ Allergic reactions including itchy rash
Reporting of side-effects
Age
Dose
Adults and Rinse the mouth or gargle for children 30 seconds with at least 15 ml aged 6 years (approx. 1 tablespoonful) of and over undiluted Oraldene two to three
times a day or as otherwise directed
■ Do not dilute.
■ Do not swallow.
■ Shake well before use.
If you are pregnant or breast-feeding
■ Ask your doctor or pharmacist for advice before using Oraldene if you are pregnant or breast-feeding.
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LE303801
16-0176
Oraldene*
Hexetidine
How to use this medicine
Check the table below to see how much medicine to use.
Oraldene is for topical use only, which means that it should not be swallowed or taken internally.
(i) Children under 6 years old
Oraldene is not recommended for children under 6 years of age.
i Adults and Children aged 6 years and over
Oraldene’
Hexetidine
Medicated Relief for Mouth & Throat Infections
IMPORTANT!
ring or
^ g itchy
■ Irritation, tingling or numbness of the tongue and/or tissues inside the mouth ■ Shortness of breath ■ Cough ■ Dry mouth ■ Feeling sick (nausea)
■ Sickness (vomiting) ■ Salivary gland enlargement
■ Taste disturbance or loss of taste ■ Pain, swelling, redness or heat ■ Tongue or tooth discolouration
■ Blistering or ulceration
If you get any side effects, talk to your doctor, pharmacist or nurse.
If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/yellowcard.
By reporting side-effects you can help provide more information on the safety of this medicine.
Do not use if bottle seal is broken when purchased. Do not store above 30°C.
Use within 6 months of opening.
Keep the bottle in the outer carton in order to
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Oraldene is a clear red solution available in 200 ml bottles. It contains 0.1 g of the active ingredient in every 100 ml of medicine.
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.
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...
■ If you have ever had a bad reaction to Oraldene or any of its ingredients. If this applies to you, get advice from your doctor or pharmacist without using Oraldene.
■ If your symptoms persist talk to your doctor or pharmacist.
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Some of the ingredients can cause problems
■ Ethanol (96%) may cause irritation or dry skin if frequently applied to the skin.
■ Azorubin (E122) can cause allergic reactions, including asthma. Reactions are more common in people who are allergic to aspirin.
■ Sodium content: 0.016 g/100 ml.
This carton was revised June 2016. ©
Oraldene is a registered trade mark.
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.
PL 15513/0067 MA 100/00401