Summary of Product Characteristics (SmPC) - Benzydamine 0.15% w/v Oromucosal spray
1 NAME OF THE MEDICINAL PRODUCT
Benzydamine 0.15% w/v Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 1.5mg of benzydamine hydrochloride. Each puff (0.17 ml) contains 255 micrograms of benzydamine hydrochloride (0.15% w/v).
Excipient(s) with known effect:
Contain methyl parahydroxybenzoate and ethanol. For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray. A metered dose pump spray solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an adjunct in the symptomatic relief of painful inflammatory conditions of the throat and mouth.
4.2 Posology and method of administration
For oromucosal administration.
ADULTS AND ELDERLY: 4 to 8 puffs, 1½-3 hourly.
CHILDREN (6-12): 4 puffs, 1½-3 hourly.
CHILDREN UNDER 6: One puff to be administered per 4 kg body weight, up to a maximum of 4 puffs, 1½-3 hourly.
Because of the small amount of drug applied, elderly patients can receive the same dose as adults.
4.3 Contraindications
Hypersensitivity to benzydamine hydrochloride or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Avoid contact with the eyes.
Hypersensitivity reaction can occur with local use of medicinal products, especially in prolonged exposure. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
This medicinal product contains 5% w/v ethanol.
4.5 Interaction with other medicinal products and other forms of interaction
Fibrates:
None known.
4.6 Fertility, pregnancy and lactation
Benzydamine 0.15% w/v Oromucosal Spray should not be used in pregnancy or lactation unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies.
Pregnancy
There are no clinical data from the use of Benzydamine 0.15% w/v Oromucosal Spray 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 Benzydamine 0.15% w/v Oromucosal Spray exposure reached after topical administration can be harmful to an embryo/fetus.
Therefore, Benzydamine 0.15% w/v Oromucosal 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.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Adverse events are ranked under the heading of the frequency:
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 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 and a stinging feeling in the mouth.
The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued.
Skin and subcutaneous tissue disorders
Very rare: Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash
Frequency not known: Angioedema
Immune system disorders
Frequency not known: Anaphylactic reaction which can be potentially life- threatening.
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 Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Benzydamine 0.15% w/v Oromucosal Spray is unlikely to cause adverse systemic effects when used locally, and risk of overdose is negligible. No special measures are required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Non-steroidal anti-inflammatory drug.
ATC code: A01AD02 (Other agents for local oral treatment). Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis.
Benzydamine is an indolic nonsteroidal anti-inflammatory drug (NSAID) for systemic and local use. Benzydamine 0.15% w/v Oromucosal Spray contains benzydamine and is intended for local use. Benzydamine is lipophilic at pH 7.2, has an affinity for membranes and shows membrane stabilising properties with local anaesthetic effects.
Contrary to other NSAIDs, benzydamine does not inhibit the cyclo- nor the lipoxygenase (10(-4) mol/l). In studies on rats, benzydamine was shown to have no ulcerogenic effect on the GI tract. Nacrophage PGE2 synthesis is enhanced at 10(-4) mol/l. Phospholipase A2 as well as the lysophosphatide-acyltransferase is slightly inhibited at benzydamine concentrations greater than 10(-4) mol/l. Benzydamine inhibits the production of proinflammatory cytokines, and can be therefore considered to have an anti-inflammatory action.
5.2 Pharmacokinetic properties
Following local use, benzydamine is very well absorbed through the skin and mucosa and moves into the underlying inflamed tissues to reach concentrations higher than following oral administration. Following local administration, benzydamine is absorbed to the bloodstream to a very limited extent (up to 5 per cent of the dose) and has a negligible systemic effect. Benzydamine is mainly secreted with urine as inactive metabolites or conjugated compounds.
5.3 Preclinical safety data
Preclinical safety data reveal low toxicity of benzydamine. Limited data indicate that benzydamine has no genotoxic and carcinogenic properties. It has no teratogenic effect. Reduced reproduction can be observed in pregnant female rats which are administered doses much higher than those used in human.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Sodium saccharin
Ethanol (96 per cent)
Sodium hydrogen carbonate
Polysorbate 20
Methyl parahydroxybenzoate (E218) Fresh peppermint mouthwash flavour Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
Shelf-life after first opening the container: 6 months.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Store in the original package.
6.5 Nature and contents of container
Benzydamine 0.15% w/v Oromucosal Spray is presented in a box containing a 30 ml HDPE bottle with a spray pump.
6.6 Special precautions for disposal
None required.
7 MARKETING AUTHORISATION HOLDER
Phoenix Labs
Suite 12
Bunkilla Plaza
Bracetown Business Park
Clonee, Co. Meath
Ireland
.
8 MARKETING AUTHORISATION NUMBER(S)
PL 35104/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/08/2025
10 DATE OF REVISION OF THE TEXT
15/10/2025