Patient leaflet - Benzydamine Hydrochloride 0.15 % w/v Oromucosal spray
1. WHAT BENZYDAMINE SPRAY IS AND WHAT IT IS USED FOR
The name of your medicine is Benzydamine hydrochloride 0.15%w/v oromucosal spray (called Benzydamine Spray in this leaflet). Benzydamine Spray contains the active substance
benzydamine hydrochloride and belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS.
Benzydamine 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENZYDAMINE SPRAY
Do not use Benzydamine Spray if:
- You are allergic to benzydamine hydrochloride
- You are allergic to any of the other ingredients in Benzydamine Spray (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Benzydamine Spray:
- If you have a history of asthma
- If you are allergic to aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory (NSAID) drugs.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Benzydamine Spray.
Other medicines and Benzydamine Spray
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 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 Benzydamine Spray 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. 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.
Benzydamine Spray contains:
This medicine contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
This medicine contains 14 mg of alcohol (ethanol) in each spray. The amount in 1 spray of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
3. HOW TO USE BENZYDAMINE SPRAY
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Do not use Benzydamine Spray in or near your eyes. If any spray gets in your eyes, wash them immediately with cold water.
Do not use Benzydamine Hydrochloride Spray for more than 7 days except under medical supervision.
How much Benzydamine Spray to use
- Adults, adolescents and elderly – spray 4 - 8 sprays to the sore area every 1½ to 3 hours.
Children 6-12 years of age – spray 4 sprays to the sore area every 1½ to 3 hours.
- Children under 6 years of age – spray 1 spray for every 4 kilograms of body weight, up to a maximum of 4 sprays, 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. The product requires the fitting of the extension arm before use.
- 2. To use the spray, hold the bottle in an upright position.
Package leaflet: Information for the user Benzydamine hydrochloride 0.15%w/v oromucosal spray
Benzydamine Hydrochloride
- 3.
Remove the protective cap.This will reveal the pump
spray. Remove the arm from
the carton and apply firmly
to the pump spray.
- 4.
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 
figure 2. Your spray is now
ready to use.
- 5.
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.
- 6.
Apply the correct number
of sprays according to the instruction above. Then wipe the end of the spray arm with a clean tissue. This helps to prevent your spray blocking.
- 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. No additional cleaning is required in use of the product.
If you use more Benzydamine Spray than you should
If you use too much or you accidentally swallow large quantities of Benzydamine Spray, contact your doctor or pharmacist for advice.
If you forget to use Benzydamine Spray
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 or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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:
Serious allergic reaction (anaphylactic shock), signs of which may include difficulty 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.
Other side effects include the following, if they get serious, please tell your doctor:
Uncommon (may affect up to 1 in 100 people):
- Numbness and/or stinging in the mouth and/or throat.
Very rare (may affect up to 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
- Allergic reaction (hypersensitivity)
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 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 website: 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.
5. HOW TO STORE BENZYDAMINE SPRAY Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions.
Do not use this medicine after the expiry date, which is stated on the bottle and carton.
Discard the opened spray 12 months after first using.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Benzydamine Spray contains
The active ingredient is benzydamine hydrochloride at a concentration of 0.15%w/v. Each spray contains 255 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.
What Benzydamine Spray looks like and contents of the pack
Benzydamine Spray is an oromucosal spray. It is a clear, colourless liquid, available in a bottle fitted with a metering pump, protective cap and dispenser. This means it provides a measured amount of spray each time it is used. Each bottle contains 30 ml of liquid.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Farmak Pharmaceuticals UK Ltd
First Floor, 47 Queen Street, Hull, HU1 1UU, United Kingdom