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 Mouthwash
⚠ 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 0.15%w/v Mouthwash (called Benzydamine Mouthwash throughout the rest of the leaflet) is used for treating pain and inflammation (redness, swelling and a feeling of heat) in the throat or mouth. Benzydamine Mouthwash contains benzydamine hydrochloride, one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
What this medicine does Benzydamine Mouthwash 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 Mouthwash 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.
2.
What you need to know before you take it
e Benzydamine Mouthwash Do not use Benzydamine Mouthwash 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 Mouthwash If you have a history of asthma If you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory (NSAID) drugs Be careful not to splash the mouthwash in your eyes. If you get it in your eyes accidentally, wash them immediately with cold water. Other medicines and Benzydamine Mouthwash 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 Mouthwash 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 Mouthwash has negligible influence on the ability to drive and use machines. Benzydamine Mouthwash 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) The alcohol (ethanol) content in Benzydamine Mouthwash is 8.1% w/v which is equivalent to 1215 mg per 15 ml of solution Propylene glycol – this may cause skin irritation. 3.
How to take it
Benzydamine Mouthwash 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 the mouthwash continuously for more than 7 days, except if your doctor tells you to. The mouthwash should generally be used undiluted, but if 'stinging' occurs you can dilute it with water to reduce this effect.
Benzydamine Mouthwash is for use in the throat or mouth. It should be rinsed around the mouth or used as a gargle according to the following instructions: The recommended dose is: Adults including the elderly The usual dose is 15ml used every 11⁄2 to 3 hours. Using the measuring cup provided pour out 15ml of the mouthwash (up to the top mark on the cup saying 15). Rinse the 15ml of mouthwash around your mouth or use it as a gargle, for 20 to 30 seconds then spit it out. Do not swallow the mouthwash. Wash the measuring cup after use and keep it safe ready for your next dose. Use in children and adolescents This mouthwash should not be used by children aged 12 years or under. Children over 12 should follow the instructions given above for adults. If you use more Benzydamine Mouthwash than you should If you use too much Benzydamine Mouthwash or if you accidentally swallow it, contact your doctor or pharmacist for advice. If you forget to use Benzydamine Mouthwash If you forget to use your mouthwash, do not worry. Use it as soon as you remember and then carry on using it every 11⁄2 to 3 hours as before. Do not use double the amount of mouthwash to make up for a forgotten dose. 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. If you have any of the following side effects while taking your medicine tell your doctor immediately or go to hospital straight away: Allergic reaction (Hypersensitivity) 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
Tightening of the throat or chest making it difficult to breathe.
Other side effects seen with Benzydamine Mouthwash, which may occur: Uncommon: may affect up to 1 in 100 people A feeling of numbness in your mouth. A stinging feeling in your mouth – the mouthwash may be diluted with water if you experience stinging. This should help to reduce the stinging effect.
Very rare: may affect up to 1 in 10,000 people Itchy rash, sometimes with pale, raised areas of skin with red edges (urticaria). Your skin becoming more sensitive to sunlight than normal causing an itchy, red, scaly rash, sometimes with blisters. See section 2 (Benzydamine Mouthwash contains methyl parahydroxybenzoate, ethanol and propylene glycol) for side effects that may be caused by some of the non-active ingredients in your medicine. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
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 Mouthwash
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 bottle label (indicated by "EXP"). The expiry date refers to the last day of that month. Do not store above 25oC. Keep the bottle in the outer carton. Once you have opened the mouthwash do not keep it for more than 6 months. Do not use this medicine if you notice any visible signs of deterioration of your medicine such as discolouration or the solution becoming cloudy. 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.
6.
Contents of the pack and other information
What Benzydamine Mouthwash contains The active substance is benzydamine hydrochloride. Each 15ml dose contains 22.5mg benzydamine hydrochloride. The other ingredients are glycerol, polysorbate 20, sacharrin sodium, ethanol 96%, methyl parahydroxybenzoate, quinoline yellow (E104), patent blue V (E131), aniseed flavour (contains ethanol 95%), peppermint flavour (contains propylene glycol), water. (See section 2, Benzydamine Mouthwash contains methyl parahydroxybenzoate, ethanol and propylene glycol.)
What Benzydamine Mouthwash looks like and contents of the pack Benzydamine Mouthwash is a clear green mouthwash with a smell of peppermint. It is contained in a clear glass bottle fitted with a tamper-evident, child-resistant closure. A measuring cup is also provided. Each bottle of Benzydamine Mouthwash contains 300ml of mouthwash. Marketing Authorisation Holder Focus Pharmaceuticals Limited, 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.
Frequently asked questions about Benzydamine 0.15% w/v Mouthwash
What is the active substance in Benzydamine 0.15% w/v Mouthwash?
The active substance in Benzydamine 0.15% w/v Mouthwash is benzydamine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Benzydamine 0.15% w/v Mouthwash, 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 Mouthwash 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/Benzydamine 0.15% w/v Mouthwash is indicated in adults and children aged 13 years and over.
A locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including:
Traumatic conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube.
Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy.
Dentistry: For use after dental operations.
4.2. Posology and method of administration
Posology
Adults and elderly: Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1½ to 3 hours as required for pain relief.
The solution should be expelled from the mouth after use.
Oroeze/Benzydamine 0.15% w/v Mouthwash should generally be used undiluted, but if 'stinging' occurs the rinse may be diluted with water.
Uninterrupted treatment should not exceed seven days, except under medical supervision.
Paediatric population
Oroeze/Benzydamine 0.15% w/v Mouthwash should not be used in children aged 12 years or under.
Method of administration
Oromucosal administration.
4.3. Contraindications
Hypersensitivity to the 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
Caution should be exercised in patients suffering from or with a previous history of bronchial asthma.
Oroeze/Benzydamine 0.15% w/v Mouthwash should generally be used undiluted, but if 'stinging' occurs the rinse may be diluted with water.
Avoid contact with eyes.
Oroeze/Benzydamine 0.15% w/v Mouthwash contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains propylene glycol which may cause skin irritation.
The alcohol (ethanol) content in Benzydamine Mouthwash is 8.1% w/v. which is equivalent to 1215 mg per 15 ml of solution.
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/Benzydamine 0.15% w/v Mouthwash 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/Benzydamine 0.15% w/v Mouthwash exposure reached after topical administration can be harmful to an embryo/fetus.
Therefore, Oroeze/Benzydamine 0.15% w/v Mouthwash 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/Benzydamine 0.15% w/v Mouthwash 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/Benzydamine 0.15% w/v Mouthwash 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 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 reactionsi
Respiratory, thoracic and mediastinal disorders
Very rare
Laryngospasm or bronchospasm
Gastrointestinal disorders
Uncommon
Oral numbness (hypothesia) and a stinging feeling in the mouth (oral pain)
Skin and subcutaneous tissue disorders
Very rare
Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash
Not known
Angiodema
i) Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Reporting of suspected adverse reactions
Reporting 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/Benzydamine 0.15% w/v Mouthwash is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine (> 300 mg).Intoxication is only to be expected if large quantities of Oroeze/Benzydamine 0.15% w/v Mouthwash are swallowed.
Symptoms associated with ingested overdose of 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
- 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
- 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 Smak cytrynowyBenzydamini hydrochloridum · taken by mouth
- Tantum Verde Smak eukaliptusowyBenzydamini hydrochloridum · 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. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Benzydamine 0.15% w/v Mouthwash. 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.