Benzydamine Hydrochloride 0.15%w/v mouthwash – patient leaflet, side effects, dosage

1. WHAT BENZYDAMINE MOUTHWASH IS AND WHAT IT IS USED FOR

The name of your medicine is Benzydamine 0.15%w/v Mouthwash (called Benzydamine Mouthwash in this leaflet). Benzydamine Mouthwash contains the active substance benzydamine hydrochloride, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs.

Benzydamine Mouthwash works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including:

• Mouth ulcers
• Sore throat
• Discomfort associated with dentures or dental work.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENZYDAMINE MOUTHWASH

Do not use Benzydamine Mouthwash if:

• if you are allergic (hypersensitive) to benzydamine hydrochloride or any of the other ingredients of Benzydamine Mouthwash (listed in Section 6).

Warnings and precautions:

Talk to your doctor or pharmacist before using Benzydamine Mouthwash:

• If you have a history of asthma
• If you are allergic to aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory (NSAID) drugs.

If you are not sure if any of the above applies to you, talk to your doctor, dentist or pharmacist before using Benzydamine Mouthwash.

Other medicines and Benzydamine Mouthwash

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Benzydamine Mouthwash during pregnancy unless clearly necessary and advised by your doctor. If you need treatment the lowest dose for the shortest time possible should be used. Do not take Benzydamine Mouthwash if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.

If taken for more than a few days from 20 weeks of pregnancy onward, Benzydamine Mouthwash can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Benzydamine Mouthwash contains:

This medicine contains methyl

parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

This medicinal product contains 10.1 vol % ethanol (alcohol), i.e. up to 1200mg per dose, equivalent to 30ml beer, 12.5ml wine per dose.

The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

3. HOW TO USE BENZYDAMINE MOUTHWASH

Always use Benzydamine Mouthwash exactly as your doctor, dentist or pharmacist has told you. You should check with your doctor, dentist or pharmacist if you are not sure.

Do not get Benzydamine Mouthwash in or near your eyes. If any Benzydamine Mouthwash gets into your eyes, wash them immediately with cold water.

Package leaflet: Information for the user Benzydamine Hydrochloride 0.15%w/v Mouthwash

Benzydamine Hydrochloride

continued How much Benzydamine Mouthwash to use

• Adults, adolescents and elderly: The usual dose is 15 ml of solution to be used every 1½ to 3 hours. Use the measuring cup provided to measure the dose. Rinse the measuring cup thoroughly with water after administration.

• Children: This medicine is not suitable for children aged 12 years or under.

How to use the Mouthwash

The solution should be rinsed around the mouth or used as a gargle for 20 to 30 seconds and then spat out. This solution should not be swallowed. This solution should not be used for more than 7 days unless your doctor or dentist tells you to.

If your symptoms worsen or do not improve contact your doctor or dentist.

If you use more Benzydamine Mouthwash than you should

If you take too much or you accidentally swallow large quantities of your medicine, contact immediately your doctor or pharmacist for advice.

If you forget to use Benzydamine Mouthwash

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Benzydamine Mouthwash can cause side effects, although not everybody gets them.

Some side effects could be serious. If you have any of the side effects listed below, seek immediate medical help:

• Serious allergic reaction (anaphylactic shock), signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, and which may be potentially life threatening.

Other side effects include the following, if they get serious, please tell your doctor:

Uncommon (affects 1 in 1,000 people):

• Numbness and/or stinging in the mouth and/or throat.

Very rare (affects less than 1 in 10,000 people):

• Difficulty breathing and wheezing
• Itching
• Skin rash.

Not known (frequency cannot be estimated from the available data)

• Skin redness or swelling
• Allergic reaction (Hypersensitivity).

If this solution stings your mouth, the next dose can be diluted with some water to reduce this effect.

Some people may react after using the product with a severe allergic reaction experiencing symptoms as described above (a so-called anaphylactic reaction) which may be potentially life-threatening. In this case you should seek immediate medical assistance.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE BENZYDAMINE MOUTHWASH Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date, which is stated on the bottle and carton.

Discard the opened mouthwash 12 months after first using.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Benzydamine Mouthwash contains

The active ingredient is benzydamine hydrochloride. Each 15 ml contains 22.5 mg benzydamine hydrochloride.

The other ingredients are glycerol, ethanol, methyl parahydroxybenzoate (E218), saccharin sodium (E954), sodium hydrogen carbonate, polysorbate 20, mint flavour, and purified water.

What Benzydamine Mouthwash looks like and contents of the pack

Benzydamine Mouthwash is a clear, colourless liquid, available in a 300 ml bottle with a child-resistant screw cap and a plastic measuring cup.

Marketing Authorisation Holder and Manufacturer

Farmak Pharmaceuticals UK Ltd

First Floor, 47 Queen Street,

Hull, HU1 1UU, United Kingdom

This leaflet was last revised in December 2025

For information in large print, audio CD or Braille, please telephone +44 1482 738200 or email med.info@farmak.uk

URN: BEN001-PIL-01-121225