What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00094/5016R.


Boots Mouth Ulcer Pastilles

Information for the user

Boots Mouth Ulcer Pastilles

(Benzalkonium Chloride, Compound Benzoin Tincture)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

  • Keep this leaflet, you may need to read it again
  • Ask your pharmacist if you need more information or advice
  • You must contact a pharmacist or doctor if your symptoms worsen or do not improve

What this medicine is for

This medicine contains Benzalkonium Chloride and Compound Benzoin Tincture, which belong to a group of medicines called antiseptics that kill bacteria.

It can be used to help relieve the pain of mouth ulcers and soothe sore gums.

Before you take this medicine

This medicine can be taken by adults and children of 3 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

  • If you are allergic to any of the ingredients (see “What is in this medicine”)
  • If under 3 years of age
  • If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sorbitol)

Talk to your pharmacist or doctor:

  • If you are pregnant or breastfeeding

If you take other medicines

This medicine is not expected to affect any other medicines that you might be taking or using at the same time.

If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before first use. If it is, do not take that pastille.

For adults and children of 3 years and over:

  • Take one pastille every 2 hours, if you need to.
  • Do not take more than 8 pastilles in 24 hours.

Allow one pastille to dissolve slowly in the mouth, keeping it near the painful area.

Do not give to children under 3 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too many pastilles: Talk to your doctor.

Possible side effects

Most people will not have problems, but some may get some. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.

If you get any of these serious side effects, stop taking the pastilles. See a doctor at once:

  • Allergic reaction (e.g. skin rash, red or itchy skin, swelling or irritation of the inside of the mouth)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

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.

How to store this medicine

Do not store above 25°C. Store in the original package in order to protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton. After this date, return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each pastille contains Benzalkonium Chloride Solution 1.11 mg and Compound Compound Benzoin Tincture 8.06 mg, which are the active ingredients.

As well as the active ingredients, the pastilles also contain sorbitol liquid non crystallising, acacia, peppermint oil, simethicone antifoam (water, polydimethyl siloxane and silica mix, polyoxyethylene 20 sorbitan monostearate, glyceryl monostearate, sodium carboxymethyl cellulose, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, hydrogen chloride), vegetable oil, carnauba wax, water.

The pack contains 24 light brown, flat pastilles.

Who makes this medicine

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by the Marketing Authorisation holder

Ernest Jackson & Co Ltd
High Street
Crediton
Devon
EX17 3AP

Leaflet prepared July 2014

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Mouth Ulcer Pastilles

Reference number: PL 00094/5016R

This is a service provided by the Royal National Institute of Blind People.