Benzydamine 0.15%w/v Oromucosal Spray

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 or pharmacist. 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

Benzydamine Spray is used to treat many painful conditions affecting the throat or mouth including:

• Sore throat
• Sore tongue or gums
• Mouth ulcers
• Discomfort caused by dentures
• Pain after dental surgery

Benzydamine Spray works in the throat or mouth to help stop pain and inflammation (redness, swelling and a feeling of heat). It does this by stopping the formation of prostaglandins.

Prostaglandins are natural substances made by the body when it is injured or has an infection. They cause an increase in the blood supply to the area of injury or infection. This results in pain, redness, swelling and a feeling of heat in that area. Stopping the formation of prostaglandins reduces these effects.

If you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before using Benzydamine Spray

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

Do not use this spray near your eyes. If you get it in your eyes accidentally, wash them immediately with cold water.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

Benzydamine Spray has negligible influence on the ability to drive and use machines.

Some of the non-active ingredients in your medicine may cause side effects:

• Methyl parahydroxybenzoate - this may cause allergic reactions (possibly delayed)
• Propylene glycol – this may cause skin irritation
• Ethanol-
  This medicinal product contains 0.0175 ml ethanol (96%) per 0.175 ml of Spray, equivalent to 351 μl (0.351ml) of beer, 140 μl (0.140ml) of wine per dose of 1 spray. The small amount of alcohol in this medicine will not have any noticeable effects.

1. Always use the spray in the upright position.
2. Turn the spray arm, in either direction, until it is at right angles (90 degrees) to the body of the spray container as shown in picture 1. Do not use the spray arm in any other position, as the medicine may not come out properly.

3. The first time you use the spray, point the spray arm away from you and anyone else. Then press the white plunger down firmly several times until a fine spray appears out of the end of the spray arm as shown in picture 2. Your spray is now ready to use.

4. Point the spray arm at the sore part of your throat or mouth and press the white plunger down firmly. One press releases one spray of medicine.
5. Apply the correct number of sprays according to the instructions above. Then wipe the end of the spray arm with a clean tissue. This helps to prevent your spray blocking.
6. Turn the spray arm down into the closed position as shown in picture 3. This stops any more sprays of your medicine being released accidentally.

7. If your spray blocks or stops working properly, return it to your pharmacist. Do not push anything into the end of the spray arm to try to clear a blockage.

If you use too many sprays of Benzydamine Spray, contact your doctor or pharmacist for advice.

• If you forget to use your spray, do not worry. Apply the correct number of sprays as soon as you remember and then carry on using the spray every 1½ to 3 hours as before.
• Do not use double the amount of sprays to make up for a forgotten dose.

Uncommon: may affect up to 1 in 100 people

• A feeling of numbness in your mouth
• A stinging feeling in your mouth:
  • this stinging usually disappears as you continue to use the spray
  • if the stinging does not go away stop using the spray and talk to your doctor or pharmacist

Very rare may affect up to 1 in 10,000 people

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

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 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 substance is benzydamine hydrochloride. Each spray from the spray arm contains 262.5 micrograms of benzydamine hydrochloride.
• The other ingredients are glycerol, polysorbate 20, saccharin sodium, ethanol 96%, methyl parahydroxybenzoate, aniseed flavour (contains ethanol 95%), peppermint flavour (contains propylene glycol), water. (See section 2, Benzydamine Spray contains methyl parahydroxybenzoate and propylene glycol.)

Benzydamine Spray is an oromucosal spray (a spray for use in the throat or mouth). It is a clear solution with a smell of peppermint. It is contained in a spray container fitted with a metering pump (a pump that delivers a measured amount of medicine) and nozzle (spray arm).

Each spray container holds 30ml of medicine.