Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Benzydamine 0.15%w/v Oromucosal Spray
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Benzydamine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Benzydamine Spray is used for treating pain and inflammation (redness, swelling and a feeling of heat) in the throat or mouth. Benzydamine Spray contains benzydamine hydrochloride, one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). What this medicine does Benzydamine Spray is used to treat many painful conditions affecting the throat or mouth including: Sore throat Sore tongue or gums Mouth ulcers Discomfort caused by dentures Pain after dental surgery Benzydamine Spray works in the throat or mouth to help stop pain and inflammation (redness, swelling and a feeling of heat). It does this by stopping the formation of prostaglandins. Prostaglandins are natural substances made by the body when it is injured or has an infection. They cause an increase in the blood supply to the area of injury or infection. This results in pain, redness, swelling and a feeling of heat in that area. Stopping the formation of prostaglandins reduces these effects.
What you need to know before you take it
e 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). 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 acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID) drugs Do not use this spray near your eyes. If you get it in your eyes accidentally, wash them immediately with cold water.
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Other medicines and Benzydamine Spray Tell your doctor or pharmacist if you are using, have recently used or might use 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 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. Driving and using machines Benzydamine Spray has negligible influence on the ability to drive and use machines. Benzydamine Spray contains methyl parahydroxybenzoate, ethanol and propylene glycol Some of the non-active ingredients in your medicine may cause side effects: Methyl parahydroxybenzoate – this may cause allergic reactions (possibly delayed) Propylene glycol – this may cause skin irritation EthanolThis medicinal product contains 0.0175 ml ethanol (96%) per 0.175 ml of Spray, equivalent to 351 μl (0.351ml) of beer, 140 μl (0.140ml) of wine per dose of 1 spray. 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. Benzydamine Spray is for use in the throat or mouth. It should be sprayed onto the sore area of the mouth or throat according to the following instructions: The recommended dose is: Adults including the elderly Use 4 to 8 sprays every 11⁄2 to 3 hours. Use in children and adolescents Children aged 6 to 12 years Use 4 sprays every 11⁄2 to 3 hours. Children over 12 should use the adult dose. Children under 6 years of age The dose is based on how much the child weighs. Do not use more than 4 sprays at any one time. Use one spray for each 4 kilograms that the child weighs but do not use more than 4 sprays at any one time. This dose should be used every 11⁄2 to 3 hours.
How to take it
the spray 1. Always use the spray in the upright position. 2. Turn the spray arm, in either direction, until it is at right angles (90 degrees) to the body of the spray container as shown in picture 1. Do not use the spray arm in any other position, as the medicine may not come out properly.
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3. 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 picture 2. Your spray is now ready to use.
4. 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. 5. Apply the correct number of sprays according to the instructions above. Then wipe the end of the spray arm with a clean tissue. This helps to prevent your spray blocking. 6. Turn the spray arm down into the closed position as shown in picture 3. This stops any more sprays of your medicine being released accidentally.
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. If you use more Benzydamine Spray than you should If you use too many sprays of Benzydamine Spray, contact your doctor or pharmacist for advice. If you forget to use Benzydamine Spray If you forget to use your spray, do not worry. Apply the correct number of sprays as soon as you remember and then carry on using the spray every 11⁄2 to 3 hours as before. Do not use double the amount of sprays to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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, red and lumpy skin rash, swelling of 3
the face, mouth, lips, tongue, eyelids and /or throat, unexplained high temperature (fever) and feeling faint. and which may be potentially life-threatening. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away. Other side effects: Uncommon: may affect up to 1 in 100 people A feeling of numbness in your mouth A stinging feeling in your mouth:
- this stinging usually disappears as you continue to use the spray
- if the stinging does not go away stop using the spray and talk to your doctor or pharmacist Very rare may affect up to 1 in 10,000 people Your skin becoming more sensitive to sunlight than normal causing an itchy, red, scaly rash, sometimes with blisters. 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 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 it
Benzydamine Spray
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the base of the can. The expiry date refers to the last day of that month. Do not store above 25oC. Keep the spray in the outer carton. Once you have started using the spray, do not keep it for more than 6 months. Do not use this medicine if you notice any damage to the spray container or spray arm. Return it to your pharmacist. 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.
Contents of the pack and other information
What Benzydamine Spray contains The active substance is benzydamine hydrochloride. Each spray from the spray arm contains 262.5 micrograms of benzydamine hydrochloride. The other ingredients are glycerol, polysorbate 20, saccharin sodium, ethanol 96%, methyl parahydroxybenzoate, aniseed flavour (contains ethanol 95%), peppermint flavour (contains propylene glycol), water. (See section 2, Benzydamine Spray contains methyl parahydroxybenzoate and propylene glycol.) What Benzydamine Spray looks like and contents of the pack Benzydamine Spray is an oromucosal spray (a spray for use in the throat or mouth). It is a clear solution with a smell of peppermint. It is contained in a spray container fitted with a metering pump (a pump that delivers a measured amount of medicine) and nozzle (spray arm). Each spray container holds 30ml of medicine. Marketing Authorisation Holder Focus Pharmaceuticals Limited
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Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer PPF Hasco-Lek S.A, ul. Eugeniusza Kwiatkowskiego 9, 55-011 Siechnice, Poland. This leaflet was last revised in September 2025
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Frequently asked questions about Benzydamine 0.15%w/v Oromucosal Spray
How do I take Benzydamine 0.15%w/v Oromucosal Spray?
Benzydamine 0.15%w/v Oromucosal 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.
What is the active substance in Benzydamine 0.15%w/v Oromucosal Spray?
The active substance in Benzydamine 0.15%w/v Oromucosal Spray is benzydamine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Benzydamine 0.15%w/v Oromucosal Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Benzydamine 0.15%w/v Oromucosal Spray without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: benzydamine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Oroeze 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.
4.2. Posology and method of administration
Posology
Adults and elderly: 4 to 8 sprays, 1½ - 3 hourly.
Paediatric population
Children (6-12): 4 sprays, 1½ - 3 hourly.
Children under 6: One spray to be administered per 4 kg body weight, up to a maximum of 4 sprays, 1½ - 3 hourly.
Because of the small amount of drug applied, elderly patients can receive the same dose as adults.
Method of administration
Oromucosal administration.
4.3. Contraindications
Hypersensitivity to active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients.
Avoid contact with the eyes.
If the condition is aggravated or not improved use should cease.
Oroeze Spray/Benzydamine 0.15% w/v Oromucosal Spray contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains propylene glycol which may cause skin irritation.
This medicinal product contains 0.0175 ml ethanol (96%) per 0.175 ml of Spray, equivalent to 351 µl (0.351ml) of beer, 140 µl (0.140ml) of wine per dose of 1 spray. The small amount of alcohol in this medicine will not have any noticeable effects.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no clinical data from the use of Oroeze Spray/Benzydamine 0.15% w/v Oromucosal 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 Oroeze Spray/Benzydamine 0.15% w/v Oromucosal Spray exposure reached after topical administration can be harmful to an embryo/fetus.
Therefore, Oroeze Spray/Benzydamine 0.15% w/v Oromucosal 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
Oroeze Spray/Benzydamine 0.15% Oromucosal Spray should not be used during lactation unless considered essential by the physician.
Fertility
There is no evidence of a teratogenic effect in animal studies.
4.7. Effects on ability to drive and use machines
Oroeze Spray/Benzydamine 0.15% Oromucosal Spray has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse events are listed by System Organ Class:
Frequencies are defined using the following convention:
Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from the available data).
The most common side effects are numbness and a stinging feeling in the mouth.
System organ class
Frequency
Undesirable effects
Immune system disorders
Not known
Anaphylactic reaction which can be potentially life-threatening and hypersensitivity reactionsii
Respiratory, thoracic and mediastinal disorders
Very rare
Laryngospasm or bronchospasm
Gastrointestinal disorders
Uncommon
Oral numbness and a stinging feeling in the mouthi
Skin and subcutaneous tissue disorders
Very rare
Pruritus, urticaria, photosensitivity reaction and rash
Not known
Angioedema
i) The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued.
ii) Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisations 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 Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Oroeze Spray/Benzydamine 0.15% Oromucosal Spray is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. No special measures are required. 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.
Management
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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- OROCALMIN CU AROMA DE LAMAIE 3 mg over the counterBENZYDAMINUM · taken by mouth
- OROCALMIN CU AROMA DE PORTOCALA SI MIERE 3 mg over the counterBENZYDAMINUM · taken by mouth
- TANTUM VERDE CU AROMA DE MENTA 3 mg over the counterBENZYDAMINUM · taken by mouth
- TANTUM VERDE CU AROMA DE LAMAIE 3 mg over the counterBENZYDAMINUM · taken by mouth
- BENZIDAMINA GEISER PHARMA 1,5 mg/ml over the counterBENZYDAMINUM · taken by mouth
- FARINGOCALM MIERE SI PORTOCALA over the counterBENZYDAMINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Tantum RosaBenzydamini hydrochloridum · rectal / vaginal
- Tantum VerdeBenzydamini hydrochloridum · taken by mouth
- Tantum Verde Smak miętowyBenzydamini hydrochloridum · taken by mouth
- HascoseptBenzydamini hydrochloridum · taken by mouth
- Tantum Verde Smak miodowo-pomarańczowyBenzydamini hydrochloridum · taken by mouth
- Tantum Verde ForteBenzydamini hydrochloridum · inhaler / nebuliser
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Benzydamine 0.15%w/v Oromucosal 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.