Package leaflet: Information for the patient

Difflam 0.15 % Sore Throat Rinse

Benzydamine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told 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.

•    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.

What is in this leaflet:

1.    What Difflam Sore Throat Rinse is and what it is used for

2.    What you need to know before you use Difflam Sore Throat Rinse

3.    How to use Difflam Sore Throat Rinse

4.    Possible side effects

5.    How to store Difflam Sore Throat Rinse

6.    Contents of the pack and other information.

1. What Difflam Sore Throat Rinse is and what it is used for

Difflam Sore Throat Rinse contains the active substance benzydamine hydrochloride and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs or NSAIDS. Difflam Sore Throat Rinse works by stopping pain and swelling (inflammation). It is used to treat many painful conditions of the throat including:

•    Sore throat.

2. What you need to know before you use Difflam Sore Throat Rinse Do not use Difflam Sore Throat Rinse if

•    you are allergic to benzydamine hydrochloride

•    you are allergic to any of the other ingredients of Difflam Sore Throat Rinse (see section 6).

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

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using Difflam Sore Throat Rinse:

•    If you have a history of asthma

•    If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID) drugs

If any of these apply, talk to your doctor, dentist or pharmacist.

Other medicines and Difflam Sore Throat Rinse

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

This medicine contains glycerol which may cause headache, stomach upset and diarrhoea. This product contains only a small amount of ethanol (alcohol). Each 15 ml of solution contains 1.5 ml of ethanol.

3. How to use Difflam Sore Throat Rinse Important:

Always use Difflam Sore Throat Rinse exactly as your pharmacist has told you. You should check with your doctor, dentist or pharmacist if you are not sure.

If you get Difflam Sore Throat Rinse in your eyes

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

How much Difflam Sore Throat Rinse to use

•    Adults, adolescents and elderly: The usual dose is 15 ml of solution to be used every 1% to 3 hours. Use the measuring cup provided to measure the dose.

•    Children: This medicine is not suitable for children aged 12 years or under.

How to use the Sore Throat Rinse

The solution should be rinsed around the mouth or used as a gargle for 20 to 30 seconds and then spat out.

If your symptoms worsen or do not improve contact your doctor or dentist.

If you use more Difflam Sore Throat Rinse 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 Sore Throat Rinse

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.

4. Possible side effects

Like all medicines Difflam Sore Throat Rinse

can cause side effects, although not everybody gets them.

Some side effects could be serious. If you have any of the side effects listed below, seek immediate medical help:

•    severe allergic reaction (anaphylaxis) seen as swelling of throat and mouth, difficulty in swallowing or speaking, alterations in heart rate, severe asthma, collapse and unconsciousness

Other side effects include the following, if they get serious, please 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 breathing and wheezing

•    Itching

•    Skin rash

Not known: (frequency cannot be estimated from the available data)

•    Skin redness or swelling

If this solution stings your mouth, the next dose can be diluted with some water to reduce this effect.

Some people may react after using the product with a severe allergic reaction experiencing symptoms as described above (a so called anaphylactic reaction) which may be potentially life-threatening. In this case you should seek immediate medical assistance.

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 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.

5. How to store Difflam Sore Throat Rinse

Keep out of the sight and reach of children.

Do not use Difflam Sore Throat Rinse 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. If you store the product without the original carton, make sure it is kept out of direct sunlight. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6. Contents of the pack and other information

What Difflam Sore Throat Rinse contains

The active substance is benzydamine hydrochloride. Each 15 ml contains 22.5 mg benzydamine hydrochloride.

The other ingredients are ethanol, glycerol, saccharin sodium, mouthwash flavour 52 503/T, polysorbate 20, methyl hydroxybenzoate, Quinoline Yellow (E104)and Patent Blue V (E131), purified water. For advice on what to do if you are allergic to any of these ingredients see section 2.

What Difflam Sore Throat Rinse looks like

Difflam Sore Throat Rinse is a clear, green coloured gargle solution. It comes in a 200 ml bottle with a measuring cup.

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

This leaflet was last revised in May 2016.

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.

6204 2497 4 56UK1812210-02

209 mini

0715_GI_Difflam Sore Throat Rinse_56UK1812210-02.indd 3 23.05.16 13:24