What it is and what it is used for

for

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

What you need to know before you take it

e Benzydamine Spray Do not use Benzydamine Spray:

• if you are allergic (hypersensitive) to benzydamine hydrochloride or any of the other ingredients of Benzydamine Spray (listed in Section 6). Warnings and precautions Talk to your doctor, dentist or pharmacist before using Benzydamine Spray:
• if you have a history of asthma
• if you are allergic to aspirin or other non-steroidal 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 Spray. Other medicines and Benzydamine Spray 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, ask your doctor or pharmacist for advice before taking this medicine. You should not use Benzydamine Spray 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 this product 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. You should not take Benzydamine Spray during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Benzydamine Spray 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 Spray contains: This medicine contains less than 1 mmol sodium (23 mg) per dose of 8 puffs, that is to say essentially 'sodium-free'. 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 product contains only a small amount of ethanol (alcohol), less than 100mg per dose.

How to take it

Benzydamine Spray

Always use Benzydamine Spray 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 use Benzydamine Spray in or near your eyes. If any spray gets into your eyes, wash them immediately with cold water. Spray directly onto the affected area of the mouth or throat as follows:

• Adults, the elderly and children over 12 years: 4 to 8 sprays every 11⁄2-3 hours
• Children (6-12 years): 4 sprays every 11⁄2-3 hours
• Children under 6 years: 1 spray for each 4kg of bodyweight, to a maximum of 4 sprays, every 11⁄2-3 hours Contact your doctor, dentist or pharmacist if your symptoms worsen or they do not improve. URN:xxxx

1. To use the spray, hold the bottle in an upright position. 2. Lift the spray-tube through 90° until it is horizontal. Do not raise the spray-tube more than shown in the diagram. 3. The first time you use the spray or after a long period of not using the spray, you need to prime it. Point the spray-tube away from your face. Press down firmly on the plunger at least 3 times until a fine spray appears from the end of the spray tube. The spray is now ready to use. 4. Aim the spray-tube at the sore part of your mouth or throat and press down on the plunger again. One press releases one spray of medicine. 5. After spraying the correct number of sprays according to dosage above, wipe the end of the spray-tube with a tissue. This helps to stop it becoming blocked. 6. Push the spray-tube back down as shown in the diagram. This stops any sprays being accidentally released. 7. Do not push anything into the end of the spray-tube if it becomes blocked. Return the spray to your pharmacist. If you use more Benzydamine Spray than you should If you use too much or you accidentally swallow large quantities of Benzydamine Spray, contact your doctor, dentist or pharmacist for advice. If you forget to use Benzydamine Spray 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 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) 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

Possible side effects

directly via the Yellow Card Scheme at 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.

How to store it

Benzydamine Spray

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 spray 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.

Contents of the pack and other information

What Benzydamine Spray contains The active ingredient is benzydamine hydrochloride at a concentration of 0.15%w/v. Each spray contains 225 micrograms of 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 Spray looks like and contents of the pack Benzydamine Spray is an oromucosal spray. It is a clear, colourless liquid, available in a plastic bottle fitted with a metered dose valve pump. This means it provides a measured amount of spray each time it is used. Each bottle contains 15ml or 30ml of liquid. Not all pack sizes may be marketed. Marketing Authorisation Holder: Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom Manufacturer: Manx Healthcare Ltd, Unit 2, Bosworth Avenue, Tournament Fields, Warwick, CV34 6UQ United Kingdom Distributed by: The Boots Company PLC, Nottingham, NG2 3AA Other formats To request a copy of this leaflet in Braille, large print or audio please call 0800 970 6115. This leaflet was last revised in February 2026.

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