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 Hydrochloride 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 The name of this medicine is Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray (called Benzydamine Hydrochloride throughout this leaflet). It contains the active substance benzydamine hydrochloride, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDS. Benzydamine Hydrochloride 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.
What you need to know before you take it
e Benzydamine Hydrochloride Do not use Benzydamine Hydrochloride if you are:
- allergic to benzydamine hydrochloride
- allergic to any of the other ingredients in Benzydamine Hydrochloride (listed in section 6) Warnings and precautions Talk to your doctor, pharmacist or nurse before using Benzydamine Hydrochloride if you:
- have a history of asthma
- 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 Benzydamine Hydrochloride 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. Do not take benzydamine hydrochloride 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. You should not take benzydamine hydrochloride during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, benzydamine hydrochloride 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. Driving and using machines Benzydamine Hydrochloride does not affect the ability to drive or to operate machines. Benzydamine Hydrochloride contains methyl parahydroxybenzoate, ethanol and sodium Each puff (0.18 ml) of the spray delivers 0.18 mg of methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Each puff (0.18 ml) of the spray delivers 14.58 mg of ethanol 96%. The amount in one 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. This medicine contains less than 1 mmol sodium (23 mg) in each puff (0.18ml), that is to say essentially 'sodium-free'. 3. How to use Benzydamine Hydrochloride Important: Always use Benzydamine Hydrochloride exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Do not use Benzydamine Hydrochloride in or near your eyes. If any spray gets in your eyes, wash them immediately with cold water. How much Benzydamine Hydrochloride to use
- Adults adolescents and elderly – spray 4 – 8 puffs to the sore area every 1.5 – 3 hours.
- Children 6 to 12 years of age spray 4 puffs to the sore area every 1.5 – 3 hours.
- Children less than 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 1.5 – 3 hours. Contact your doctor if your symptoms worsen or they do not improve.
How to take it
the spray 1. Hold the bottle in an upright position. 2. You need to prime the spray the first time you use it (max. 5 sprays). Point the spraytube away from your face. Press down firmly until a fine spray appears from the end of the spray-tube. 3. Aim the spray-tube at the affected area and press down. One press releases one actuation. 4. After spraying the desired number of actuations, wipe the end of the spray-tube with a tissue. This prevents the spray-tube becoming blocked. 5. Do not push anything into the end of spray-tube if it becomes blocked. Return the spray to your pharmacist. If you use more Benzydamine Hydrochloride 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 Benzydamine Hydrochloride 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 on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, Benzydamine Hydrochloride 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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
- The other excipients are: sodium bicarbonate, polysorbate 20, ethanol 96%, glycerol, saccharin sodium, methyl parahydroxybenzoate (E218), peppermint oil and purified water. What Benzydamine Hydrochloride looks like and contents of the pack It is a mouth spray. It is a clear, colourless solution with mint odor that comes in an amber glass bottle fitted with a metered dose pump and a stopper-lid on the neck of sprayer. 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 Zentiva Pharma UK Limited 12 New Fetter Lane, London EC4A 1JP, United Kingdom Manufacturer Interpharma Services Ltd. 43A Cherni Vrach Bvld., Sofia 1407, Bulgaria This leaflet was last revised in September 2025
How to store it
Benzydamine Hydrochloride 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 label and bottle after EXP. The expiry date refers to the last day of that month. This medical product does not require any special storage condition. Do not freeze. Store in an upright position. Once opened use within 6 months. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Benzydamine Hydrochloride contains
- The active substance is benzydamine hydrochloride at a concentration of 0.15% w/v.
- Each metered dose pump spray delivers benzydamine hydrochloride 0.15 % w/v, approximately 180 microlitres per puff.
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Frequently asked questions about Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray
How do I take Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray?
Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray comes as spray. 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 Hydrochloride 0.15 % w/v Oromucosal Spray?
The active substance in Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray is benzydamine hydrochloride.
Are there equivalent medicines to Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray?
Medicines with the same active substance, strength and form include: Benzydamine Hydrochloride 0.15% w/v Oromucosal solution spray. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Benzydamine Hydrochloride 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 Hydrochloride 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
Benzydamine Hydrochloride 0.15 % w/v Oromucosal 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, adolescents and elderly : 4 - 8 puffs every 1.5 – 3 hourly.
Children (6 - 12): 4 puffs every 1.5 – 3 hourly.
Children under 6: One puff to be administered per 4 kg of body weight, up to a maximum of 4 puffs, 1.5 – 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
4.3. Contraindications
Benzydamine Hydrochloride 0.15 % w/v Oromucosal 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.
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.
This medicine contains 14.58 milligrams of ethanol 96% in each puff. The amount in one 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.
This medicine contains 1 mg/ml of methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium-free'.
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 Benzydamine spray during pregnancy. Benzydamine spray should not be used in pregnancy unless considered essential by the physician.
From the 20th week of pregnancy onward, benzydamine spray use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Benzydamine Spray should not be given unless clearly necessary. If benzydamine spray is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to benzydamine spray for several days from gestational week 20 onward. Benzydamine spray should be discontinued if oligohydramnios or ductus arteriosus constriction are found.
During the third trimester of pregnancy, allprostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction (see above);
the mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, benzydamine spray is contraindicated during the third trimester of pregnancy (see sections 4.3)
It is not known if the systemic Benzydamine spray exposure reached after topical administration can be harmful to an embryo/foetus. 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.
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The following rate values have been used: Very common (≥ 1/10), Common (≥ 1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000), 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
Adverse reaction
Immune system disorders
Not known
Anaphylactic reactions, Hypersensitivity reactions [20].
Respiratory, thoracic and mediastinal disorders
Very rare
Laryngospasm or bronchospasm
Gastrointestinal disorders
Uncommon
Oral numbness and a stinging feeling in the mouth.
The stinging has been reported to disappear upon continuation of the of the treatment, however if it persists it is recommended that treatment be discontinued.
Skin and subcutaneous tissue disorders
Very rare
Pruritus, urticaria, photosensitivity reaction and rash
Not known
Angioedema
Reporting of suspected adverse reactions
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. By reporting side effects, you can help provide more information on the safety of this medicine.
4.9. Overdose
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 about this leaflet
Ask anything about Benzydamine Hydrochloride 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.