- Approval Id
- 7178f56de949f739
- Drug Approval Emc Name
- Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray
- Drug Name
- Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray
- Company Address
- First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
- Company Website
- https://www.zentiva.co.uk/contact/mi-form
- Company Medical Info Direct Line
- +44 (0)800 090 2408
- Company Medical Info Email
- [email protected]
- Company Customer Care Direct Line
- +44 (0)844 8793 188
- Atc Code
- M01AX07
- Legal Category
- Pharmacy
- Authorisation Holder
- 7. Marketing authorisation holder Zentiva Pharma UK Limited 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
- Authorisation Number
- 8. Marketing authorisation number(s) PL 17780/1251
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 06/09/2023
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Zentiva Pharma UK Limited 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 17780/1251
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 06/09/2023
- Instruction Composition
- 2. Qualitative and quantitative composition Each metered dose pump spray delivers Benzydamine hydrochloride 0.15 % w/v, approximately 180 microlitres per puff. Excipient(s) with known effect: methyl parahydroxybenzoate, 1.00 mg/ml and ethanol, 81.00 mg/ml. Each puff (0.18 ml) of the spray delivers 0.18 milligrams of methyl parahydroxybenzoate and 14.58 milligrams of ethanol 96%. For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- 3. Pharmaceutical form Oromucosal spray, solution Colorless and clear solution with mint odor.
- Instruction Clinical Particulars
- 4. Clinical particulars 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.
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non- steroids/Anti-inflammatory preparations, non-steroids for topical use, ATC code: M01AX07. Mechanism of action The indazole analogue benzydamine has physicochemical properties and pharmacological activities which differ from those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is a weak base. In further contrast, benzydamine is a weak inhibitor of the prostaglandin synthesis. Only at concentration of 1mM and above benzydamine effectively inhibits cyclooxygenase and lipooxygenase enzyme activity. It mostly exerts its effects through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels. Pharmacodynamic effects Benzydamine specifically acts on the local mechanisms of inflammation such as pain, oedema or granuloma. Benzydamine topically applied demonstrates anti- inflammatory activity reducing oedema as well as exudate and granuloma formation. Further, it exhibits analgesic properties if pain is caused by an inflammatory condition and local anaesthetic activity. Hyperthermia, which is indicative of systemic functional involvement, is poorly affected by benzydamine. Clinical efficacy and safety In a clinical study in 24 patients with pharyngitis following tonsillectomy rinsing with benzydamine hydrochloride 0.15 % 5 times a day for 6 days significantly better and more rapidly relieved throat pain, difficulty in swallowing and improved clinical signs including hyperaemia and oedema versus placebo on day 7. Similar results were found in other studies in patients with tonsillitis or pharyngitis or following dental surgery. The gargling with 30 ml 0.075% benzydamine prior to the induction of anaesthesia in 58 adults undergoing general anaesthesia with endotracheal tube intubation significantly reduced postoperative sore throat versus water control for the first 24 hours whereas aspirin gargles reduced it for 4 hours. In a clinical study with 48 patients rinsing four times daily with 0.15% benzydamine during a 3 to 5 week radiotherapy of oral cancer provided significant pain relief and reduction of size and severity of mucositis in the oropharynx. Similar effects were seen in a study in patients undergoing chemotherapy for oral cancer. In a study in 67 patients with severe oropharyngeal mucositis following radiotherapy who rinsed with benzydamine solution pain with swallowing, hyperaemia and severity of mucositis were significantly reduced compared to placebo treatment within the first three treatment days. A higher incidence of transient numbness and stinging was noted among the patients using benzydamine that was attributed to the medication's local anaesthetic effect. The topical application of benzydamine hydrochloride cream 3% 3 times daily for 6 days in 50 patients with soft tissue injuries significantly better relieved pain, tenderness, erythema, functional impairment and swelling compared to placebo on day
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Sodium bicarbonate Polysorbate 20 Ethanol 96 % Glycerol Saccharin sodium Methyl parahydroxybenzoate (E218) Peppermint oil Water, purified 6.2 Incompatibilities None. 6.3 Shelf life 3 years. After first opening of the medicinal product: 6 months. 6.4 Special precautions for storage This medical product does not require any special storage condition. Do not freeze. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5 Nature and contents of container Amber glass bottle (Type III) with metered dose pump. Pack size: 30 ml 6.6 Special precautions for disposal and other handling No special requirements.
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Each metered dose pump spray delivers Benzydamine hydrochloride 0.15 % w/v, approximately 180 microlitres per puff. Excipient(s) with known effect: methyl parahydroxybenzoate, 1.00 mg/ml and ethanol, 81.00 mg/ml. Each puff (0.18 ml) of the spray delivers 0.18 milligrams of methyl parahydroxybenzoate and 14.58 milligrams of ethanol 96%. For the full list of excipients, see section 6.1.
## Pharmaceutical Form
3. Pharmaceutical form Oromucosal spray, solution Colorless and clear solution with mint odor.
## Clinical Particulars
4. Clinical particulars 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.
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non- steroids/Anti-inflammatory preparations, non-steroids for topical use, ATC code: M01AX07. Mechanism of action The indazole analogue benzydamine has physicochemical properties and pharmacological activities which differ from those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs which are acids or metabolised to acids, benzydamine is a weak base. In further contrast, benzydamine is a weak inhibitor of the prostaglandin synthesis. Only at concentration of 1mM and above benzydamine effectively inhibits cyclooxygenase and lipooxygenase enzyme activity. It mostly exerts its effects through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels. Pharmacodynamic effects Benzydamine specifically acts on the local mechanisms of inflammation such as pain, oedema or granuloma. Benzydamine topically applied demonstrates anti- inflammatory activity reducing oedema as well as exudate and granuloma formation. Further, it exhibits analgesic properties if pain is caused by an inflammatory condition and local anaesthetic activity. Hyperthermia, which is indicative of systemic functional involvement, is poorly affected by benzydamine. Clinical efficacy and safety In a clinical study in 24 patients with pharyngitis following tonsillectomy rinsing with benzydamine hydrochloride 0.15 % 5 times a day for 6 days significantly better and more rapidly relieved throat pain, difficulty in swallowing and improved clinical signs including hyperaemia and oedema versus placebo on day 7. Similar results were found in other studies in patients with tonsillitis or pharyngitis or following dental surgery. The gargling with 30 ml 0.075% benzydamine prior to the induction of anaesthesia in 58 adults undergoing general anaesthesia with endotracheal tube intubation significantly reduced postoperative sore throat versus water control for the first 24 hours whereas aspirin gargles reduced it for 4 hours. In a clinical study with 48 patients rinsing four times daily with 0.15% benzydamine during a 3 to 5 week radiotherapy of oral cancer provided significant pain relief and reduction of size and severity of mucositis in the oropharynx. Similar effects were seen in a study in patients undergoing chemotherapy for oral cancer. In a study in 67 patients with severe oropharyngeal mucositis following radiotherapy who rinsed with benzydamine solution pain with swallowing, hyperaemia and severity of mucositis were significantly reduced compared to placebo treatment within the first three treatment days. A higher incidence of transient numbness and stinging was noted among the patients using benzydamine that was attributed to the medication's local anaesthetic effect. The topical application of benzydamine hydrochloride cream 3% 3 times daily for 6 days in 50 patients with soft tissue injuries significantly better relieved pain, tenderness, erythema, functional impairment and swelling compared to placebo on day
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Sodium bicarbonate Polysorbate 20 Ethanol 96 % Glycerol Saccharin sodium Methyl parahydroxybenzoate (E218) Peppermint oil Water, purified 6.2 Incompatibilities None. 6.3 Shelf life 3 years. After first opening of the medicinal product: 6 months. 6.4 Special precautions for storage This medical product does not require any special storage condition. Do not freeze. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5 Nature and contents of container Amber glass bottle (Type III) with metered dose pump. Pack size: 30 ml 6.6 Special precautions for disposal and other handling No special requirements.
- Company Detail Path
- /organization/sanofi-ilac-sanayi-ve-ticaret-anonim-sirketi
