Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Difflam Spray contains the active substance benzydamine hydrochloride and 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: e Mouth ulcers
Teething
Sore throat
Sore tongue or gums
Discomfort associated with dentures or dental work.
Do not use Difflam Spray if:
e You are allergic to benzydamine hydrochloride
e You are allergic to any of the other ingredients in Difflam Spray (listed in section 6).
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using
Difflam Spray:
e If you have a history of asthma
e If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID) drugs
If any of these apply, talk to your doctor or pharmacist.
Other medicines and Difflam 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 taking this medicine.
You should not use Difflam 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.
Difflam Spray Contains:
This medicine contains 14 mg of alcohol (ethanol) in each puff. The amount in 1 puff 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.
Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per dose of 8 puffs, that is to say essentially 'sodium-free'.
This medicine contains 0.025 mg benzyl alcohol in each 175 microlitre dose which is equivalent to 0.14 mg/ml. Benzyl alcohol may cause allergic reactions and mild local irritation.
This medicinal product contains mint flavour with benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, limonene and linalool. These substances may cause allergic reactions.
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
e Adults, adolescents and elderly — spray 4 - 8 puffs to the sore area every 12 to 3 hours.
e Children 6-12 years of age — spray 4 puffs to the sore area every 1/2 to 3 hours.
e 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 1/2 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 spraytube. 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 shown 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 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 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.
Like all medicines Difflam Spray 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 (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
— 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
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/
risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
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, methylhydroxy- benzoate, 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 Cooper Consumer Health B.V. Verrijn Stuartweg 60,
1112AX Diemen — Netherlands
Manufacturer
Aziende Chimiche Riunite, Angelini Francesco, SpA (Acraf), Via Vecchia del Pinocchio,
22 — 60100, Ancona, Italy
This leaflet was last revised in September 2025.
If this leaflet is difficult to see or read or you would like it in a different
format, please contact
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112AX Diemen — Netherlands
Difflam 0.15% w/v Spray comes as spray containing 0.15%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Difflam 0.15% w/v Spray is benzydamine hydrochloride.
Medicines with the same active substance include: Benzydamine 0.15% w/v Mouthwash, Benzydamine 0.15%w/v Oromucosal Spray, Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray, Benzydamine Hydrochloride 0.15% w/v Oromucosal solution spray. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Difflam 0.15% w/v Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Benzydamine Spray is a locally acting analgesic and anti-inflammatory treatment for the throat and mouth. It is especially useful for the relief of pain in traumatic conditions such as following tonsillectomy or the use of a naso-gastric tube, dental surgery.
Posology
Adults, adolescents and elderly: 4 to 8 puffs every 1½-3 hourly.
Children(6-12): 4 puffs every 1½-3 hourly.
Children under 6: One puff to be administered per 4 kg body weight, up to a maximum of 4 puffs, 1½-3 hourly.
Elderly: Because of the small amount of drug applied, elderly patients can receive the same dose as adults.
Method of administration
For oral use
Difflam Spray is contra-indicated in patients with:
Hypersensitivity to the active ingredient, benzydamine hydrochloride, or to any of the excipients listed in section 6.1.
None known.
Pregnancy
There are no clinical data from the use of Benzydamine Spray during pregnancy.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed.
It is not known if the systemic Benzydamine Spray exposure reached after topical administration can be harmful to an embryo/fetus.
Therefore, Benzydamine Spray should not be used during pregnancy unless clearly necessary. If used, the dose should be kept as low and duration of treatment as short as possible.
Breast-feeding
Benzydamine Spray should not be used during lactation unless considered essential by the physician.
None.
Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine ( > 300 mg)
Symptoms associated with overdose of ingested benzydamine are mainly gastrointestinal symptoms and symptoms of the central nervous system. Most frequent gastrointestinal symptoms are nausea, vomiting, abdominal pain and oesophageal irritation. Symptoms of the central nervous system include dizziness, hallucinations, agitation, anxiety and irritability.
In acute overdose only symptomatic treatment is possible. Patients should be kept under close observation and supportive treatment should be given. Adequate hydration must be maintained.
Benzydamine Spray is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. No special measures are required.
Ask anything about Difflam 0.15% w/v Spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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