Bertolix: Uses, Dosage & Side Effects
A benzydamine oral spray for pain and inflammation of the mouth and throat
Quick Facts About Bertolix
Key Takeaways About Bertolix
- Fast-acting local relief: Bertolix spray delivers benzydamine directly to the inflamed area in the mouth and throat, providing rapid pain relief and reducing inflammation at the site of application
- Short-term use only: Treatment should not exceed 7 days. Consult a doctor if symptoms do not improve within 3 days or if you develop fever
- Adults only: Bertolix 3 mg/ml spray is not approved for children or adolescents under 18 years of age
- Temporary numbness is normal: A brief tingling or numbness in the mouth and throat may occur immediately after use – this is a normal effect of the medicine and resolves quickly
- Avoid during pregnancy and breastfeeding: Bertolix should not be used during pregnancy unless absolutely necessary, and must not be used while breastfeeding
What Is Bertolix and What Is It Used For?
Bertolix is an oromucosal spray containing benzydamine hydrochloride, a non-steroidal anti-inflammatory drug (NSAID) that acts locally in the mouth and throat. It is used for short-term treatment of pain, redness, and swelling (inflammation) in the oral cavity and pharynx, as well as irritation of the oral and throat mucous membranes.
Benzydamine, the active ingredient in Bertolix, is a unique member of the NSAID family because it exerts its effects primarily through local action rather than systemic absorption. Unlike traditional NSAIDs such as ibuprofen or diclofenac that work by inhibiting cyclooxygenase (COX) enzymes throughout the body, benzydamine works through a distinct mechanism. It stabilizes cell membranes, inhibits the local production of pro-inflammatory cytokines including tumor necrosis factor alpha (TNF-α) and interleukin-1 beta (IL-1β), and provides local anesthetic effects through reversible interaction with sodium channels.
This locally targeted mechanism of action means that benzydamine provides a triple therapeutic benefit at the site of application: anti-inflammatory (reducing swelling and redness), analgesic (relieving pain), and local anesthetic (numbing the affected area). Because the drug acts topically with minimal systemic absorption, it carries a lower risk of the gastrointestinal and cardiovascular side effects typically associated with oral NSAIDs taken systemically.
Bertolix is commonly used for the following conditions in adults:
- Sore throat (pharyngitis) – pain and inflammation of the pharynx caused by viral or bacterial infection, providing symptomatic relief alongside appropriate antimicrobial treatment when indicated
- Tonsillitis – inflammation and pain of the tonsils, often accompanying upper respiratory tract infections
- Mouth ulcers (aphthous stomatitis) – painful ulcerations on the oral mucosa, where benzydamine helps reduce pain and inflammation to support healing
- Oral mucositis – inflammation and ulceration of the mouth lining, including that caused by radiation therapy or chemotherapy for head and neck cancers. Multiple clinical studies support the use of benzydamine for prevention and management of radiation-induced oral mucositis
- Post-procedural inflammation – pain and irritation following dental procedures, tonsillectomy, or other oral and throat surgeries
- Gingivitis and periodontal inflammation – localized gum inflammation and irritation
- Denture-related irritation – soreness and mucosal irritation caused by ill-fitting dentures or oral prostheses
Benzydamine has been available as a pharmaceutical product since the 1960s and is marketed worldwide under various brand names. It is included in clinical guidelines for the management of oral mucositis by the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO), which recommend benzydamine mouthwash for the prevention and treatment of radiation-induced oral mucositis in patients with head and neck cancer receiving moderate-dose radiation therapy.
You should speak to a doctor if your symptoms do not improve within 3 days or if you feel worse. If you develop fever, persistent sore throat, difficulty swallowing, or new symptoms during treatment, seek medical advice promptly, as these may indicate an underlying condition requiring different treatment.
Bertolix spray typically begins to provide pain relief within 1–5 minutes of application, thanks to its local anesthetic and anti-inflammatory effects. The numbing sensation is often noticed immediately, while the anti-inflammatory effect builds up with continued use over the course of treatment. Maximum local effect is usually achieved within minutes. The pain-relieving effect from each application typically lasts for 1.5–3 hours, which is why the dosing interval is recommended at 1.5 to 3 hours between applications.
What Should You Know Before Using Bertolix?
Before using Bertolix, be aware that you must not use it if you are allergic to benzydamine or any other ingredient in the product. People with a history of asthma or allergic reactions to aspirin or other NSAIDs should exercise particular caution. Bertolix should not be used during pregnancy unless absolutely necessary and must not be used during breastfeeding.
While Bertolix is available over the counter and is considered safe for short-term topical use at recommended doses, there are important situations where you should not use it, or where you should take extra precautions. Understanding these contraindications and warnings before starting treatment is essential for safe and effective use of the product.
Contraindications
You must not use Bertolix if the following applies to you:
- Allergy to benzydamine hydrochloride or any other ingredient in the product, including methyl parahydroxybenzoate (E 218), polysorbate 80, sodium cyclamate (E 952), glycerol (E 422), or any other excipient
Warnings and Precautions
Speak to your doctor or pharmacist before using Bertolix in the following situations:
Aspirin and NSAID sensitivity: If you are hypersensitive to acetylsalicylic acid (aspirin) or other NSAIDs, you may have an increased risk of developing a hypersensitivity reaction to benzydamine. This includes people who have experienced asthma, urticaria (hives), nasal congestion, or facial swelling after taking aspirin or similar medicines. While benzydamine acts locally rather than systemically, cross-reactivity is possible, and you should discuss use with your healthcare provider before starting Bertolix.
Asthma and bronchial allergy: If you have or have ever had asthma or bronchial allergy, you are at greater risk of developing bronchospasm (tightening of the airways) or bronchial allergic reactions when using benzydamine products. Though rare, laryngospasm (spasm of the voice box) and bronchospasm have been reported with benzydamine use. If you have a history of reactive airway disease, consult your doctor before using Bertolix.
Treatment duration: Do not use Bertolix for longer than 7 days without medical supervision. If your symptoms do not improve or if you feel worse after 3 days, if you develop fever, or if new symptoms appear, stop using the product and consult a doctor. Persistent sore throat or mouth inflammation lasting longer than one week may indicate a more serious underlying condition that requires medical evaluation and potentially different treatment.
Although rare, serious allergic reactions can occur with Bertolix, including angioedema (swelling of the face, hands, feet, eyes, lips, and/or tongue causing difficulty breathing or swallowing), generalized hypersensitivity, and in very rare cases anaphylactic shock. If you experience any signs of an allergic reaction, stop using Bertolix immediately and seek emergency medical care. Signs of anaphylaxis include difficulty breathing, chest tightness, dizziness, severe skin rash, and swelling of the face, lips, tongue, or throat.
Bertolix spray must not come into contact with the eyes. If accidental eye exposure occurs, rinse the affected eye(s) thoroughly with clean running water. If irritation persists, seek medical advice. When using the spray, direct the nozzle toward the back of the mouth rather than upward toward the eyes.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using Bertolix.
Pregnancy: Bertolix should not be used during pregnancy unless it is absolutely necessary and specifically recommended by your doctor. While benzydamine is applied topically with limited systemic absorption, sufficient safety data for use during pregnancy is lacking. If treatment is required, the lowest effective dose should be used for the shortest possible duration. As with all NSAIDs, particular caution is advised, and alternative treatments should be considered first.
Breastfeeding: Bertolix must not be used during breastfeeding. It is not known whether benzydamine or its metabolites pass into breast milk when used as an oral spray. As a precautionary measure, breastfeeding mothers should not use this product. If treatment for mouth or throat inflammation is needed while breastfeeding, consult your doctor for alternative options that are considered safe during lactation.
Fertility: There is no specific data on the effects of topical benzydamine on fertility. However, given the minimal systemic absorption of Bertolix when used as directed, significant effects on fertility are not expected.
Driving and Operating Machinery
Bertolix is not expected to affect your ability to drive or operate machinery. However, you are personally responsible for assessing whether you are in suitable condition to perform activities requiring alertness. If you experience any unexpected effects, review all the information in this guide and discuss with your doctor or pharmacist if you are uncertain.
Important Information About Excipients
Bertolix contains several excipients that some individuals may need to be aware of:
| Excipient | Amount per Puff (0.17 ml) | Relevant Information |
|---|---|---|
| Ethanol (96%) | 13.84 mg | Equivalent to less than 0.4 ml beer or 0.2 ml wine per puff. The small amount of alcohol in this medicine will not produce any noticeable effects. |
| Methyl parahydroxybenzoate (E 218) | Present as preservative | May cause allergic reactions, which may be delayed. If you have a known allergy to parabens, consult your doctor before use. |
| Polysorbate 80 | Present as emulsifier | May cause allergic reactions in sensitive individuals. |
| Sodium | <1 mmol (23 mg) | Essentially sodium-free. No concern for patients on sodium-restricted diets. |
How Does Bertolix Interact with Other Drugs?
No clinically significant drug interactions have been established for Bertolix (benzydamine) oral spray. Because benzydamine acts locally in the mouth and throat with minimal systemic absorption, it has a very low potential for interactions with other medicines. However, you should always inform your doctor or pharmacist about all medicines you are currently taking.
One of the notable advantages of Bertolix compared to systemically acting NSAIDs is its very low interaction potential. Traditional oral NSAIDs such as ibuprofen, naproxen, and diclofenac have numerous clinically important drug interactions because they are absorbed into the bloodstream and affect prostaglandin synthesis throughout the body. Benzydamine, when used as an oromucosal spray, acts primarily at the local tissue level with only trace amounts reaching the systemic circulation.
As a result, clinical studies and post-marketing surveillance have not established that benzydamine spray affects the efficacy of other medicines, or that other medicines significantly alter the effect of benzydamine when applied locally. This is particularly reassuring for patients who are taking multiple medications and need a short-term treatment for mouth or throat pain.
Theoretical Considerations
Despite the absence of established interactions, the following theoretical considerations apply:
| Drug / Situation | Theoretical Concern | Clinical Advice |
|---|---|---|
| Other oral NSAIDs (ibuprofen, naproxen, aspirin) | Additive anti-inflammatory effects in the oropharynx. Minimal concern given local action of benzydamine. | Generally safe to use concurrently. No dose adjustment needed for either medicine. |
| Anticoagulants (warfarin, apixaban) | Systemic NSAIDs increase bleeding risk, but benzydamine spray has negligible systemic absorption. | No established interaction. Safe to use at recommended doses. |
| Other throat sprays or lozenges | Potential for additive local numbing effects when used together. | Avoid using multiple local anesthetic/anti-inflammatory throat products simultaneously. Choose one product at a time. |
| Chlorhexidine mouthwash | Concurrent use may reduce the efficacy of one or both products if used at the same time. | If both are needed, space their use apart by at least 30 minutes. |
| Immunosuppressants (in oral mucositis patients) | Patients receiving chemotherapy may be more susceptible to local adverse effects. | Use under medical supervision. Benzydamine is recommended by MASCC/ISOO guidelines for radiation-induced oral mucositis. |
Numbness in the mouth or throat may occur immediately after applying Bertolix spray. Because of this numbing effect, you should avoid eating and drinking until the numbness has completely resolved to prevent accidental biting of the tongue or cheeks and to reduce the risk of aspiration. For best results, use Bertolix after meals and after drinking. This ensures the medicine remains in contact with the oral and throat mucosa for the longest possible time without being washed away by food or beverages.
What Is the Correct Dosage of Bertolix?
The recommended adult dose of Bertolix is 2–4 puffs (sprays) per application, 2–6 times daily, with at least 1.5–3 hours between doses. Do not exceed the recommended dose. Do not use for more than 7 days without medical supervision. Bertolix is for adults only and should not be used in children or adolescents under 18 years.
Always use Bertolix exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure about how to use it, consult your pharmacist. One press of the pump delivers one puff (spray) of 0.17 ml, containing 510 micrograms of benzydamine hydrochloride (equivalent to 456 micrograms of benzydamine).
Adults
Standard Dosing for Mouth and Throat Inflammation
- Dose per application: 2–4 puffs (sprays)
- Frequency: 2–6 times daily
- Minimum interval: 1.5–3 hours between applications
- Maximum duration: 7 days (without prescription)
- Each puff delivers: 510 micrograms benzydamine hydrochloride in 0.17 ml solution
The dosing frequency depends on the severity of your symptoms. For mild discomfort, 2 puffs taken 2–3 times daily may be sufficient. For more intense pain or inflammation, you may use up to 4 puffs per application up to 6 times daily. Always start with the lowest effective dose and increase only if necessary. If your symptoms improve, consider reducing the frequency of use.
Children and Adolescents
Not Recommended for Under 18 Years
Bertolix 3 mg/ml oromucosal spray is not intended for use in children or adolescents under 18 years of age. For children with sore throat or mouth inflammation, consult a doctor or pharmacist for age-appropriate alternatives. In some countries, lower-concentration benzydamine formulations may be available for pediatric use, but these are different products with different dosing instructions.
How to Use the Spray
Proper technique ensures that the medicine reaches the affected areas effectively. Follow these steps each time you use Bertolix:
- Position the nozzle horizontally – hold the spray bottle upright and ensure the nozzle is in a horizontal position pointing toward the back of the mouth
- Prime the pump (first use only) – if using the product for the first time, hold the bottle upright and press the pump firmly 5 times to achieve an even spray pattern. For subsequent uses, press 2 times to reprime
- Place the nozzle in the mouth – insert the nozzle into the oral cavity, directing it toward the affected area (back of the throat for pharyngitis, or toward the affected area of the mouth for stomatitis)
- Spray and hold your breath – press the pump firmly to deliver each puff. Hold your breath while spraying to prevent inhalation of the spray into the lungs
- Wait before eating or drinking – do not eat or drink until any numbness in the mouth or throat has completely resolved
Missed Dose
If you forget to take a dose, use it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for a forgotten dose. Bertolix is used for symptomatic relief, so you can use it as needed within the recommended dosing parameters.
Overdose
If you accidentally use more Bertolix than recommended, or if a large amount is swallowed accidentally (for example, by a child), contact your doctor, hospital, or poison control center immediately for an assessment of risk and advice. While serious toxicity from oral benzydamine spray is unlikely due to the small amounts per dose, accidental ingestion of large volumes – especially by children – warrants medical evaluation.
Symptoms of benzydamine overdose, primarily reported with accidental ingestion of benzydamine mouthwash or oral forms, may include agitation, hallucinations, tremors, nausea, and vomiting. Treatment is supportive and symptomatic.
Do not exceed the recommended dose. Treatment should not exceed 7 days unless your doctor has specifically prescribed a longer course. If symptoms persist or worsen after 3 days, or if you develop fever or additional symptoms, stop using Bertolix and consult your doctor. Persistent or worsening throat pain may be a sign of a more serious condition such as a bacterial infection requiring antibiotics.
What Are the Side Effects of Bertolix?
Like all medicines, Bertolix can cause side effects, although not everyone experiences them. The most common effect is temporary numbness or tingling in the mouth and throat immediately after use, which is a normal part of the medicine's action. Uncommon side effects include photosensitivity. Rare effects include dry mouth and a burning sensation. Very rarely, serious allergic reactions including angioedema and laryngospasm can occur.
Benzydamine oromucosal spray is generally well tolerated when used at the recommended dose for the recommended duration. Because it acts locally with minimal systemic absorption, the side effect profile is considerably more favorable than that of orally administered NSAIDs. Most of the reported effects are mild and transient, resolving spontaneously after the product is discontinued or as the body adjusts to treatment.
The numbness and tingling that may occur immediately after spraying Bertolix into the mouth and throat is not technically a side effect – it is a predictable pharmacological effect of benzydamine's local anesthetic action. This sensation typically resolves within a few minutes. In occasional cases, nausea or vomiting may occur due to throat irritation from the spray itself; these symptoms resolve once the product is discontinued.
Stop using Bertolix and seek immediate medical attention if you experience any of the following:
- Swelling of the face, hands, feet, eyes, lips, and/or tongue that may cause difficulty breathing or swallowing (angioedema – very rare)
- Signs of a severe allergic reaction: difficulty breathing, chest pain or tightness, dizziness, severe itching, raised rash on the skin, swelling of the face, lips, tongue, or throat (anaphylactic shock – frequency not known)
- Difficulty breathing or swallowing due to spasm of the voice box or airways (laryngospasm/bronchospasm – very rare)
Side Effects by Frequency
Uncommon
- Increased sensitivity to sunlight (photosensitivity) – manifesting as exaggerated sunburn, skin rash, or itching after sun exposure
Rare
- Burning sensation in the mouth
- Dry mouth (xerostomia)
Very Rare
- Angioedema – swelling of the face, lips, tongue, and/or throat
- Laryngospasm – spasm of the voice box causing difficulty breathing
- Bronchospasm – tightening of the airways causing wheezing or breathlessness
Expected Effects (Not Classified as Side Effects)
The following effects are related to the normal pharmacological action of benzydamine and are not considered adverse reactions:
- Numbness or tingling in the mouth and throat – this is the expected local anesthetic effect of benzydamine, occurring immediately after application. It typically resolves within a few minutes and does not require any action other than avoiding food and drink until the sensation passes.
- Occasional nausea or vomiting – may occur due to throat irritation from the spray. These symptoms resolve spontaneously when the product is discontinued and do not indicate an allergic reaction.
Photosensitivity Precaution
Although photosensitivity (increased sun sensitivity) is classified as uncommon, it is worth noting because patients may not expect it from a throat spray. If you notice that your skin becomes unusually sensitive to sunlight or develops a rash during treatment with Bertolix, protect exposed skin from direct sunlight and ultraviolet light, and consider discontinuing use. Inform your pharmacist or doctor if this occurs. The photosensitivity resolves after treatment is stopped.
It is important to report suspected side effects after a medicine has been authorized. This enables continuous monitoring of the medicine's benefit–risk balance. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority or drug regulatory agency. In the EU, reports can be made through national reporting systems. In the UK, the Yellow Card Scheme can be used. In the US, adverse events can be reported to the FDA's MedWatch program.
How Should You Store Bertolix?
Store Bertolix at temperatures not exceeding 30°C (86°F). Once opened, the bottle can be used for up to 160 days. Keep the product out of the sight and reach of children. Do not use after the expiry date printed on the label and carton.
Proper storage of Bertolix ensures that the medicine remains effective and safe throughout its usable life. Like all pharmaceutical products, benzydamine spray can degrade if exposed to excessive heat, direct sunlight, or moisture, potentially reducing its efficacy or altering its safety profile.
Follow these storage guidelines:
- Temperature: Store at temperatures not exceeding 30°C (86°F). Do not freeze. Avoid leaving the product in a hot car, on a windowsill in direct sunlight, or near heat sources such as radiators.
- After opening: Once the bottle has been opened and the pump primed, Bertolix remains usable for 160 days (approximately 5 months). After this period, the product should be discarded even if solution remains in the bottle. Consider writing the date of first use on the carton for reference.
- Expiry date: Do not use Bertolix after the expiry date (EXP) stated on the label and carton. The expiry date refers to the last day of that month.
- Keep out of reach of children: Store the product where children cannot see or reach it. The pump mechanism may be attractive to young children, and accidental spraying or ingestion could occur.
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired products to your pharmacist for proper disposal. This protects the environment from pharmaceutical contamination.
Bertolix is supplied as a clear, colorless liquid with a characteristic peppermint scent. If you notice any change in the appearance, color, or smell of the solution, do not use the product and consult your pharmacist. Available pack sizes include a 15 ml bottle (75 sprays) and a 30 ml bottle (150 sprays) in a white HDPE plastic bottle with a white LDPE/HDPE nozzle and white PP pump adapter, packed in a cardboard carton.
What Does Bertolix Contain?
The active substance in Bertolix is benzydamine hydrochloride at a concentration of 3 mg per milliliter. Each spray puff delivers 510 micrograms of benzydamine hydrochloride (equivalent to 456 micrograms of benzydamine). The inactive ingredients include methyl parahydroxybenzoate, sodium cyclamate, glycerol, peppermint flavoring, and ethanol among others.
Active Ingredient
Each milliliter of Bertolix oromucosal spray solution contains 3 mg of benzydamine hydrochloride, corresponding to 2.68 mg of benzydamine (free base). Each pump actuation delivers 0.17 ml, providing 510 micrograms of benzydamine hydrochloride (equivalent to 456 micrograms of benzydamine) per spray puff.
Inactive Ingredients (Excipients)
The other ingredients in Bertolix are:
- Methyl parahydroxybenzoate (E 218) – preservative
- Sodium cyclamate (E 952) – sweetener
- Glycerol (E 422) – humectant and viscosity agent
- Sodium hydrogen carbonate – pH buffer
- Polysorbate 80 – emulsifying agent
- Ethanol 96% – solvent (13.84 mg per spray puff)
- Peppermint flavoring (containing peppermint oil, ethanol, menthol) – for taste
- Concentrated phosphoric acid – pH regulator
- Purified water – vehicle
Product Description
Bertolix is a clear, colorless liquid with a characteristic peppermint smell. It is supplied in a white HDPE (high-density polyethylene) plastic bottle with a white LDPE/HDPE nozzle and a white PP (polypropylene) adapter for the pump mechanism. The product is available in two pack sizes: 15 ml (75 sprays) and 30 ml (150 sprays). Not all pack sizes may be marketed in all countries.
Marketing Authorization
The marketing authorization holder for Bertolix is Bausch Health Ireland Limited, Dublin, Ireland. The product is manufactured by ICN Polfa Rzeszów S.A. in Poland. Local distribution is handled through Zentiva Denmark ApS.
Frequently Asked Questions About Bertolix
Medical References & Sources
This article is based on peer-reviewed research, international clinical guidelines, and official regulatory documents. All claims are verified against the following sources:
- European Medicines Agency (EMA). Summary of Product Characteristics – Benzydamine hydrochloride oromucosal spray. Available at: www.ema.europa.eu
- Quane PA, Graham GG, Ziegler JB. Pharmacology of benzydamine. Inflammopharmacology. 1998;6(2):95–107. doi:10.1007/s10787-998-0026-0
- Epstein JB, Silverman S Jr, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875–885. doi:10.1002/1097-0142(20010815)92:4<875::AID-CNCR1396>3.0.CO;2-1
- Multinational Association of Supportive Care in Cancer / International Society of Oral Oncology (MASCC/ISOO). Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. Updated 2020.
- British National Formulary (BNF). Benzydamine hydrochloride – oromucosal spray. Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Available at: www.who.int
- Sironi M, Massimiliano L, Transidico P, et al. Differential effect of benzydamine on pro-versus anti-inflammatory cytokine production: lack of interference with IL-10 production. Int J Clin Lab Res. 2000;30(1):17–19.
- Karavana (Syıkı) S, Sezer B, Güncü GN, et al. Efficacy of topical benzydamine hydrochloride gel on oral mucosal ulcers: an in vivo animal study. Int J Oral Maxillofac Surg. 2011;40(9):973–978.
- Cheng KKF, Yuen JKT. A pilot study of chlorhexidine and benzydamine oral rinses for the prevention and treatment of irradiation mucositis in patients with head and neck cancer. Cancer Nurs. 2006;29(5):423–430.
- Bausch Health Ireland Limited. Bertolix – Patient Information Leaflet. Last revised January 2026.
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