Suitable for

Adults and Children aged 6 years and over.

 

Age Restriction You must be at least 16 years old to purchase this product

How to use

Please read the enclosed leaflet carefully before use.

Patient Information Leaflets are updated periodically by the manufacturer.

Oraldene 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
Rinse the mouth or gargle for 30 seconds with at least 15 ml (approx. 1 tablespoonful) of undiluted Oraldene 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.

Hazards and Cautions

Keep out of the reach and sight of children

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.

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.

Possible side-effects
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


• 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.

Storage
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.
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.

Active ingredients

Hexetidine

Ingredients

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 (E122) sodium calcium edetate, sodium hydroxide (E524), and purified water.