Benzydamine Hydrochloride 0.15%w/v Mouthwash

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• ■ Keep this leaflet. You may need to read it again

• ■ Ask your pharmacist if you need more information or advice

• ■ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

• ■ You must talk to a doctor if you do not feel better or if you feel worse after 7 days

What is in this leaflet

1. What Benzydamine Mouthwash is and what it is used for

2. What you need to know before you use Benzydamine Mouthwash

3. How to use Benzydamine Mouthwash

4. Possible side effects

5. How to store Benzydamine Mouthwash

6. Contents of the pack and other information

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 antiinflammatory 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

• ■ Pain after dental surgery

2. what you need to know before you use benzydamine mouthwash

Do not use Benzydamine Mouthwash:

• ■ 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, dentist or pharmacist before using Benzydamine Mouthwash:

• ■ if you have a history of asthma

• ■ if you are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

If you are not sure if any of the above applies to you, talk to your doctor, dentist or pharmacist before using Benzydamine Mouthwash. Be careful not to splash the mouthwash into your eyes. If you get it in your eyes accidentally, wash then immediately with cold water.

Other medicines and Benzydamine Mouthwash Please tell your doctor, dentist or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor, dentist or pharmacist before using any medicine.

Benzydamine Mouthwash contains:

This product contains glycerol which may cause headache, stomach upset and diarrhoea.

This product 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. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

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.

Do not use the mouthwash continuously for more than 7 days , except if your doctor or dentist has told you to.

Benzydamine Mouthwash should generally be used undiluted, but if ‘stinging’ occurs you can dilute it with water to reduce this effect.

Benzydamine Mouthwash is for use in the throat or mouth. It should be rinsed around the mouth or used as a gargle according to the following instructions:

Adults, the elderly and children over 12 years: the usual dose is 15ml every 11/z to 3 hours. Rinse or gargle, then spit out. Do not swallow.

Use the measuring cup provided to measure the dose.

Children under 12 years: this medicine should not be used by children under 12 years

Contact your doctor, dentist or pharmacist if your symptoms worsen or they do not improve.

If you use more Benzydamine Mouthwash than you should

If you use too much or you accidentally swallow large quantities of Benzydamine Mouthwash, contact your doctor, dentist or pharmacist for advice.

If you forget to use Benzydamine Mouthwash Do not use a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any further questions about the use of this medicine, ask your doctor, dentist or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• ■ Serious allergic reaction (anaphylactic shock) signs of which may include difficulty in 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, 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 in breathing and wheezing

• ■ Itching

• ■ Skin rash

• ■ Your skin becoming more sensitive to sunlight than normal causing an itchy, red, scaly rash, sometimes with blisters

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

• ■ Skin redness or swelling

• ■ Allergic reaction (hypersensitivity)

If this mouthwash stings your mouth, the next dose may be diluted with water to reduce this effect.

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 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. Store in the original package.

This medicinal product does not require any special temperature 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 frst 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 15ml contains 22.5mg benzydamine hydrochloride.

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

What Benzydamine Mouthwash looks like and contents of the pack

Benzydamine Hydrochloride 0.15%w/v Mouthwash

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• ■ Keep this leaflet. You may need to read it again

• ■ Ask your pharmacist if you need more information or advice

• ■ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

• ■ You must talk to a doctor if you do not feel better or if you feel worse after 7 days

What is in this leaflet

1. What Benzydamine Mouthwash is and what it is used for

2. What you need to know before you use Benzydamine Mouthwash

3. How to use Benzydamine Mouthwash

4. Possible side effects

5. How to store Benzydamine Mouthwash

6. Contents of the pack and other information

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 antiinflammatory 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

Pain after dental surgery

2. what you need to know before you use benzydamine mouthwash

Do not use Benzydamine Mouthwash:

• ■ 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, dentist or pharmacist before using Benzydamine Mouthwash:

• ■ if you have a history of asthma

• ■ if you are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

If you are not sure if any of the above applies to you, talk to your doctor, dentist or pharmacist before using Benzydamine Mouthwash. Be careful not to splash the mouthwash into your eyes. If you get it in your eyes accidentally, wash then immediately with cold water.

Other medicines and Benzydamine Mouthwash

Please tell your doctor, dentist or pharmacist if you are taking, have recently taken or might take any — other medicines, including medicines obtained ““ without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor, dentist or pharmacist before using any medicine.

Benzydamine Mouthwash contains:

This product contains glycerol which may cause headache, stomach upset and diarrhoea.

This product 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. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

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.

Do not use the mouthwash continuously for more than 7 days , except if your doctor or dentist has told you to.

Benzydamine Mouthwash should generally be used undiluted, but if ‘stinging’ occurs you can dilute it with water to reduce this effect.

Benzydamine Mouthwash is for use in the throat or mouth. It should be rinsed around the mouth or used as a gargle according to the following instructions:

Adults, the elderly and children over 12 years: the usual dose is 15ml every 11/z to 3 hours. Rinse or gargle, then spit out. Do not swallow.

Use the measuring cup provided to measure the dose.

Children under 12 years: this medicine should not be used by children under 12 years

Contact your doctor, dentist or pharmacist if your symptoms worsen or they do not improve.

If you use more Benzydamine Mouthwash than you should

If you use too much or you accidentally swallow large quantities of Benzydamine Mouthwash, contact your doctor, dentist or pharmacist for advice.

If you forget to use Benzydamine Mouthwash Do not use a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any further questions about the use of this medicine, ask your doctor, dentist or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• ■ Serious allergic reaction (anaphylactic shock) signs of which may include difficulty in 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, 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 in breathing and wheezing

• ■ Itching

• ■ Skin rash

• ■ Your skin becoming more sensitive to sunlight than normal causing an itchy, red, scaly rash, sometimes with blisters

5. how to store benzydamine mouthwash

Keep this medicine out of the sight and reach of children. Store in the original package.

This medicinal product does not require any special temperature 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 frst 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 15ml contains 22.5mg benzydamine hydrochloride.

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

What Benzydamine Mouthwash looks like and contents of the pack

Benzydamine Mouthwash is a clear, colourless liquid, available in a 100ml and 300ml bottle with a screw cap and a plastic measuring cup.

Not all pack sizes may be marketed.

MA Holder

Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA.

Manufacturer

Beltapharm SpA

Via Stelvio 66, 20095 Cusano Milanino, Milan, Italy

Other formats

To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.

This leaflet was last revised in June 2020

URN GBZ05B-PIL-01–150620

Package leaflet: Information for the user

Benzydamine Hydrochloride 0.15%w/v Mouthwash

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• ■ Keep this leaflet. You may need to read it again

• ■ Ask your pharmacist if you need more information or advice

• ■ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

• ■ You must talk to a doctor if you do not feel better or if you feel worse after 7 days

What is in this leaflet

• 1. What Benzydamine Mouthwash is and what it is used for

• 2. What you need to know before you use Benzydamine Mouthwash

• 3. How to use Benzydamine Mouthwash

• 4. Possible side effects

• 5. How to store Benzydamine Mouthwash

• 6. Contents of the pack and other information

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 antiinflammatory 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

Pain after dental surgery

2. what you need to know before you use benzydamine mouthwash

Do not use Benzydamine Mouthwash:

• ■ 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, dentist or pharmacist before using Benzydamine Mouthwash:

• ■ if you have a history of asthma

• ■ if you are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

If you are not sure if any of the above applies to you, talk to your doctor, dentist or pharmacist before using Benzydamine Mouthwash. Be careful not to splash the mouthwash into your eyes. If you get it in your eyes accidentally, wash then immediately with cold water.

Other medicines and Benzydamine Mouthwash

Please tell your doctor, dentist or pharmacist if you are taking, have recently taken or might take any — other medicines, including medicines obtained ““ without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor, dentist or pharmacist before using any medicine.

Benzydamine Mouthwash contains:

This product contains glycerol which may cause headache, stomach upset and diarrhoea.

This product 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. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

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.

Do not use the mouthwash continuously for more than 7 days , except if your doctor or dentist has told you to.

Benzydamine Mouthwash should generally be used undiluted, but if ‘stinging’ occurs you can dilute it with water to reduce this effect.

Benzydamine Mouthwash is for use in the throat or mouth. It should be rinsed around the mouth or used as a gargle according to the following instructions:

Adults, the elderly and children over 12 years: the usual dose is 15ml every 11/z to 3 hours. Rinse or gargle, then spit out. Do not swallow.

Use the measuring cup provided to measure the dose.

Children under 12 years: this medicine should not be used by children under 12 years

Contact your doctor, dentist or pharmacist if your symptoms worsen or they do not improve.

If you use more Benzydamine Mouthwash than you should

If you use too much or you accidentally swallow large quantities of Benzydamine Mouthwash, contact your doctor, dentist or pharmacist for advice.

If you forget to use Benzydamine Mouthwash Do not use a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any further questions about the use of this medicine, ask your doctor, dentist or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• ■ Serious allergic reaction (anaphylactic shock) signs of which may include difficulty in 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, 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 in breathing and wheezing

• ■ Itching

• ■ Skin rash

• ■ Your skin becoming more sensitive to sunlight than normal causing an itchy, red, scaly rash, sometimes with blisters