Friday, June 1, 2012

Difflam Spray





Difflam 0.15% Spray



Benzydamine hydrochloride






Read all of this leaflet carefully because it contains important information for you.



  • This medicine is available without prescription. However, you still need to use it carefully to get the best results.

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

  • Ask your doctor or pharmacist if you need more information or advice.

  • You must contact a doctor if your symptoms worsen or do not improve.




In this leaflet:



1. What Difflam Spray is for

2. Before you use Difflam Spray

3. How to use Difflam Spray

4. Possible side effects

5. How to store Difflam Spray

6. Further information.






What Difflam Spray is for



Difflam Spray belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS.



Difflam Spray works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the mouth or throat including:



  • Mouth ulcers

  • Teething

  • Sore throat

  • Sore tongue or gums

  • Discomfort associated with dentures or dental work.




Before you take Difflam Spray




Do not use Difflam Spray if:



  • You are allergic to benzydamine hydrochloride

  • You are allergic to any of the other ingredients

in Difflam Spray (listed in section 6).



If either of these applies to you, talk to your doctor or pharmacist.





Taking other medicines



Tell your doctor of pharmacist before using Difflam Spray if you are taking other medicines, even medicines obtained without a prescription.





Pregnancy and breastfeeding



If you are pregnant, trying to become pregnant or breastfeeding ask your doctor or pharmacist for advice before using Difflam Spray.



This product contains only a small amount of ethanol (alcohol), less than 100 mg per dose. Each puff contains 15 microlitres of ethanol.






How to use Difflam Spray




Important:



Always use Difflam Spray exactly as your pharmacist has told you.You should check with your doctor or pharmacist if you are not sure.



Do not use Difflam Spray in or near your eyes. If any spray gets in your eyes, wash them immediately with cold water.





How much Difflam Spray to use



  • Adults, adolescents and elderly – spray 4 - 8 puffs to the sore area every 1½ to 3 hours.

  • Children 6-12 years of age – spray 4 puffs to the sore area every 1½ to 3 hours.

  • Children under 6 years of age – spray 1 puff for every 4 kilograms of body weight, up to a maximum of 4 puffs, to the sore area every 1½ to 3 hours.

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





How to use the spray




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 you need to prime it. Point the spray-tube away from your face. Press down firmly on the green plunger 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 green plunger again. One press releases one puff.


5. After spraying the desired number of puffs, 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 hown in the diagram. This stops any puffs being accidentally released.





7. Do not push anything into the end of spray-tube if it becomes blocked. Return the spray to your pharmacist.







If you use more Difflam Spray than you should



It should not cause you any problems if you accidentally take too much or you swallow some of your medicine. If you have any concerns, contact your doctor or pharmacist.





If you forget to use Difflam Spray



Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.




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





Difflam Spray Side Effects



Like all medicines Difflam Spray can cause side effects, although not everybody gets them.



Where the spray is applied in the mouth and throat, you may experience the following:



  • Itching

  • Skin rash

  • Skin redness or swelling

  • Difficulty breathing and wheezing

  • Numbness or stinging in the mouth or throat.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How to store Difflam Spray



Keep out of the reach and sight of children.



Do not use Difflam Spray after the expiry date on the bottle. The expiry date refers to the last day of that month.



Store in an upright position. Do not store above 30 °C. Do not store in the refrigerator or freezer.



Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.





Further information




What Difflam Spray contains



The active substance is benzydamine hydrochloride at a concentration of 0.15%.



Each puff contains 262.5 micrograms of benzydamine hydrochloride.



The other ingredients are glycerol, saccharin, sodium bicarbonate, ethanol, methylhydroxybenzoate, mouthwash flavour, polysorbate 20 and purified water.



For advice on what to do if you are allergic to any of these ingredients see section 2.





What Difflam Spray looks like and content of the pack



Difflam Spray is an oromucosal or mouth spray. It is a clear, colourless liquid that comes 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 30 ml of liquid and comes in a carton.





Marketing Authorisation Holder




Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU





Manufacturer




3M Health Care Limited

3M House

Morley Street

Loughborough

Leicestershire

LE11 1EP




Aziende Chimiche Riunite

Angelini Francesco

SpA (Acraf)

Via Vecchia del Pinocchio

22 – 60100

Ancona
Italy





This leaflet was last updated on 03/2010.



If this leaflet is difficult to see or read or you would like it in a different format, please contact




Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU



932941



UK 56211100






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