Carton (label-leaflet)

Front of pack (second panel from the left)

Oraldene®

ICEMINT

Hexetidine

Medicated Relief for Mouth & Throat Infections

Antibacterial Mouthwash to relieve

gingivitis mouth ulcers sore gums sore throat

200 ml e

Back panel (fourth panel from the left)

Oraldene®

ICEMINT

Hexetidine

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.

X Do not use this medicine...

■    If you have ever had a bad reaction to Oraldene Icemint or any of its ingredients. If this applies to you, get advice from your doctor or pharmacist without using Oraldene Icemint.

■    If symptoms persist talk to your doctor or pharmacist.

If you are pregnant or breast-feeding

■    Ask your doctor or pharmacist for advice before using Oraldene if you are pregnant or breast-feeding.

Some of the ingredients can cause problems

■    Ethanol (96%) may cause irritation or dry skin if frequently applied to the skin.

■    Sodium content: 0.016 g/100 ml.

Left panel (first panel from the left)

How to use this medicine

Check the table below to see how much medicine to use.

Oraldene Icemint is for topical use only, which means that it should not be swallowed or taken internally.

Children under 6 years old

Oraldene is not recommended for children under 6 years of age. Adults and Children aged 6 years and over

Age	Dose
Adults and children aged 6 years	Rinse the mouth or gargle for 30 seconds with at least 15 ml
and over	(approx. 1 tablespoonful) of undiluted Oraldene Icemint two to three
	times a day or as otherwise directed.
■ Do not dilute.
■ Do not swallow.
■ Shake well before use.

If anyone accidentally swallows this product

If anyone accidentally swallows this product, contact a doctor or your nearest Accident and Emergency department (Casualty) taking this pack with you.

If you forget to use the medicine

Use the next dose as soon as you remember unless it is time to use it again. Do not use two quantities in one go.

This carton was revised April 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.

Right panel (third panel from the left)

Possible side-effects

Oraldene Icemint 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 ■ 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.

Reporting of side-effects

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.gov.uk/yellowcard.

By reporting side-effects you can help provide more information on the safety of this medicine.

Storing 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 protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Retain carton for full instructions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Further information What’s in this medicine?

The active ingredient is: Hexetidine 0.1 g/100 ml Other ingredients are: Polysorbate 60, citric acid, saccharin sodium, ethanol 96%, quinoline yellow (E104), patent blue V (E131), levomenthol, sodium calcium edetate, sodium hydroxide (E524) and purified water.

What the medicine looks like

Oraldene Icemint is a clear blue-green solution available in 200 ml bottles. It contains 0.1 g of the active ingredient in every 100 ml of medicine.

Label

Front of pack

Oraldene®

ICEMINT

Hexetidine

Medicated Relief for Mouth & Throat Infections

Antibacterial Mouthwash to relieve

gingivitis mouth ulcers sore gums sore throat

200 ml e

Left panel

CONTENTS: The solution contains Hexetidine 0.1 g/100 ml. Other ingredients: Polysorbate, saccharin sodium, citric acid, quinoline yellow, patent blue V, levomenthol, sodium calcium edetate, sodium hydroxide (E524), ethanol 96%, water.

Sodium content: 0.016 g/100 ml.

Oraldene Icemint has an antibacterial and antifungal action which relieves mouth and throat infections. It can also be used before and after dental surgery.

Store below 30°C. Keep the bottle in the outer carton in order to protect from light.

Read and retain carton for full instructions.

Oraldene is a registered trade mark.

PL holder: McNeil Products Ltd,

Maidenhead, Berkshire, SL6 3UG, UK.

PL 15513/0107

Right panel

Do not use if bottle seal is broken when purchased.

Keep out of the sight and reach of children.

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 (approx. 1 tablespoonful) of undiluted Oraldene Icemint two to three times a day.

CHILDREN UNDER 6 YEARS - not recommended.

If symptoms persist discontinue treatment and consult your doctor.

• Do not dilute.