Patient leaflet - Benzydamine 0.15% w/v Oromucosal spray
1.WHAT BENZYDAMINE IS AND WHAT IT IS USED FOR
Benzydamine Spray 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 painful conditions
affecting the throat or mouth including:
- Sore throat
Sore tongue or gums
- Mouth ulcers
- Discomfort caused by dentures or after dental work
- WHAT YOU NEED TO KNOW
BEFORE YOU USE BENZYDAMINE SPRAY
Do not use Benzydamine Spray
- If you are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).
Take special care with Benzydamine Spray
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 to other anti-inflammatory painkillers called NSAIDs.
Important information about some of the ingredients of Benzydamine Spray
- Benzydamine Spray contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
- This medicine contains 8.5mg of alcohol (ethanol) in each puff. The amount in 1 puff of this medicine is equivalent to less than 1ml beer or 1ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Package leaflet: Information for the user
Benzydamine 0.15% w/v Oromucosal Spray
benzydamine hydrochloride
Read all of this leaflet carefully before you start taking this medicine 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 from it. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Please see section 2 for information on some of the ingredients.
What Benzydamine Spray looks like and content of the pack.
Benzydamine Spray is an oromucosal spray (mouth or throat spray). It is a clear solution that comes in a plastic bottle fitted with a metered dose valve pump. Each bottle contains 30ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Phoenix Labs
Suite 12, Bunkilla Plaza
Bracetown Business Park
Clonee, Co. Meath
Ireland
Manufacturer
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy, Ul. Chłodna 56/60,
Warsaw, 00-872,
Poland
For any information about this medicine, please contact the Marketing Authorisation Holder, details provided above.
This leaflet was last revised in October 2025
Other medicines and Benzydamine Spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
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.
You should not use Benzydamine Spray during pregnancy unless clearly neces-sary and advised by your doctor. If you need treatment the lowest dose for the shortest time possible should be used.
3. HOW TO USE BENZYDAMINE SPRAY
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist told you. Check with your doctor or pharmacist if you are not sure.
Avoid contact with your eyes. If any spray gets in your eyes, wash them immediately with cold water.
How much Benzydamine Spray to take
Benzydamine Spray should be sprayed onto the sore area of the mouth or throat according to the following recommended dosage: Adults including the elderly (and children over 12 years): Spray 4 to 8 puffs every 1½ to 3 hours.
Children aged 6 to 12 years: Spray 4 puffs every 1½ to 3 hours.
Children under 6 years of age: Spray 1 puff for every 4 kilograms of body weight, up to maximum of 4 puffs, every 1½ to 3 hours.
Do not use the spray continuously for more than 7 days, except if your doctor or dentist tells you to.
How to use Benzydamine Spray
The first time you use the spray you need to press the metering pump down firmly several times to fill the dispenser and produce a proper spray.
- 1.
Turn the spray arm as shown in
picture 1.
- 2.
Point the spray arm at the sore part
of your mouth as shown in picture 2.
- 3.
Press the plunger down firmly with
your thumb or index finger. Apply the correct number of sprays, according to the instructions on dosage.
Talk to your doctor or pharmacist if you feel that the medicine is too strong or too weak.
If you use more Benzydamine Spray than you should
It should not cause you any problems if you accidentally swallow a dose of your medicine. However, if you take too much or you accidentally swallow large quantities of your medicine, contact immediately your doctor or pharmacist for advice.
If you forget to use Benzydamine Spray
Do not take double dose to make up for a missed dose. Do not worry. Take the next dose as planned.
If you have any further questions on 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 medical help IMMEDIATELY:
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 which may be potentially life-threatening.
If any of the below side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
- 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 (an anaphylactic reaction) which may be potentially life-threatening. In this case you should seek immediate medical assistance or go to hospital straight away.
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, website: 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.
5. HOW TO STORE BENZYDAMINE SPRAY
Keep this medicine out of the sight and reach of children.
Benzydamine Spray may be used for 6 months after first application, providing that the expiry date has not passed. Do not use this medicine after the expiry date which is stated on the bottle after ‘’EXP’’. The expiry date refers to the last day of that month.
Do not store above 25⁰C. Do not refrigerate or freeze. Store in the original package.
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. FURTHER INFORMATION
What Benzydamine Spray contains The active substance is 0.15% w/v benzydamine hydrochloride.
The other ingredients are glycerol, sodium saccharin, ethanol (96%), sodium hydrogen carbonate, polysorbate 20, methyl parahydroxybenzoate (E218), fresh peppermint mouthwash flavour and purified water.