Summary of medicine characteristics - BOOTS SORE THROAT AND MOUTH 0.15%W/V OROMUCOSAL SPRAY, BENZYDAMINE HYDROCHLORIDE 0.15%W/V OROMUCOSAL SPRAY, ORAL SOOTHE 0.15%W/V OROMUCOSAL SPRAY
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oromucosal Spray Solution
A clear, colourless liquid with a characteristic mint odour and a pH of between 5 – 7 in a multidose spray container fitter with a metering pump
4.1 Therapeutic indications
Benzydamine Spray is a locally acting analgesic and anti-inflammatory treatment for the throat and mouth.
It is used to treat various painful oropharyngeal conditions such as mouth ulcers, sore throat, sore mouth or gums, dental pain.
4.2 Posology and method of administration
Posology
Adults, adolescents and elderly: 4 to 8 sprays, 1−3 hourly
Children (6–12years): 4 sprays, 1−3 hourly
Children under 6 years: One spray to be administered per 4kg bodyweight, up to a maximum of 4 sprays, 1−3 hourly
Elderly: Because of the small amount of drug applied, elderly patients can receive the same dose as adults
Method of administration
For oral administration. The spray must be primed before use. No less than 3 actuations are required for priming. The full dose is obtained on the fourth actuation.
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.
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.
Contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed)
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Pregnancy
There is a limited amount of data from the use of benzydamine hydrochloride in pregnant women. There is no evidence of a teratogenic effect in animal studies (see section
5.3). Benzydamine Spray should not be used in pregnancy unless the clinical condition of the woman requires treatment with benzydamine hydrochloride.
Breastfeeding
It is unknown whether benzydamine hydrochloride / metabolites are excreted in human milk. Benzydamine Spray should not be used during breastfeeding unless considered essential by the physician.
Fertility
There is no evidence of a teratogenic effect in studies (see section 5.3). It is not known whether treatment with Benzydamine Spray affected fertility in humans.
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 the decreasing seriousness
The following frequency categories are 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.
Respiratory, thoracic and mediastinal disorders
Very rare: Laryngospasm or bronchospasm
Gastrointestinal disorders
Uncommon: Oral numbness (hypoesthesia) and a stinging feeling in the mouth (oral pain)
Skin and subcutaneous tissue disorders
Very rare: pruritus, urticaria, photosensitivity reaction and a rash
Frequency not known: Angioedema
Immune system disorders
Frequency not known: Anaphylactic reaction which can be potentially life-threatening.
Hypersensitivity reactions
Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
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.
4.9
Benzydamine is unlikely to cause adverse systemic effects, even if accidental ingestion should occur. Intoxication is only to be expected if large quantities of Benzydamine Spray are swallowed (>300mg).
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 esophageal 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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other agents for local oral treatment, ATC code: A01AD02.
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 pro-inflammatory cytokines including tumour necrosis factor-alpha (TNF-a) and Interleukin-lß (IL-1ß) 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 Difflam 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 30ml 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 Difflam 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 6.
Overall, benzydamine was well tolerated in clinical trials.
5.2 Pharmacokinetic properties
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Ethanol 96%
Methyl parahydroxybenzoate (E218)
Saccharin sodium (E954)
Sodium hydrogen carbonate
Polysorbate 20
Mint flavour SC-5230-AT (maltodextrin and menthol)
Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
3 years unopened
Use within 12 months of opening
6.4 Special precautions for storage
There are no special requirements for storage
6.5 Nature and contents of container
6.5 Nature and contents of container15ml or 30ml class III amber glass bottle with a plastic metering pump and protective cap consisting of PP/POM/Rubber/Stainless steel/LDPE/PE/PEK
15ml bottle will allow for approximately 85 actuations
30ml bottle will allow for approximately 170 actuations
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Manx Healthcare Ltd
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 14251/0056
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
25/04/2019