Benzydamine Hydrochloride 0.15% w/v Oromucosal solution spray

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

1. What Benzydamine Spray is and what it is used for
2. What you need to know before you use Benzydamine Spray
3. How to use Benzydamine Spray
4. Possible side effects
5. How to store Benzydamine Spray
6. Contents of the pack and other information

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

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.

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.

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 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.

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.

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

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.

• 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

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 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 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.

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.

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.