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3.    I he 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.    Havre 3

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

If you forget to use Benzydamine Spray 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 1 '/2 to 3 hours as before.

• Do not use double the amount of sprays to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Benzydamine Spray can cause side effects, although not everybody gets them. Side effects are generally minor.

If you have any of the following side effects while taking your medicine tell your doctor Immediately or go to hospital straight away: Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.

Itchy rash, sometimes with pale, raised areas of skin with red edges (urticaria).

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

Tightening of the throat or chest making it difficult to breathe.

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, dentist or pharmacist

See section 2 (Important information about some of the non-active ingredients in Benzydamine Spray) for side effects that may be caused by some of the non-active ingredients in your medicine. Reporting of side effects

If you get any side effects, talk to your doctor, dentist 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. By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Benzydamine Spray

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the carton and the base of the can. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the spray in the outer carton.

Once you have started using the spray, do nol keep it for more than 6 months.

Do not use if you notice any damage to the spray container or spray arm. Return it to your pharmacist. 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.

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6. Further information

What Benzydamine Spray contains

•    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 for important information about some of these non-active ingredients.)

What Benzydamine Spray looks like and contents of the pack 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 ol medicine) and nozzle (spray arm).

Each spray container holds 30ml of medicine. Marketing Authorisation Holder Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK.

Tel: 01283 495 280 Fax: 01283 495 290 Email: medinfo@focuspharma.co.uk Manufacturer PPF Hasco-Lek S.A, ul. Eugeniusza Kwiatkowskiego 9, 55-011 Siechnice, Poland.

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above. For information in large print, audio CD or Braille please telephone 01283 495 280 or email medinfo@focuspharma.co.uk.

This leaflet was last revised in March 2016.

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