Summary of Product Characteristics Updated 21-Feb-2017 | ADVANZ Pharma
Oroeze Spray 0.15% w/v Oromucosal Spray
Benzydamine 0.15% w/v Oromucosal Spray
Benzydamine hydrochloride 0.15% w/v.
Each spray contains 262.5 micrograms of benzydamine hydrochloride.
Excipients with known effect
Ethanol (96%) 8.1 %w/v
Methyl parahydroxybenzoate 0.1 %w/v
It also contains propylene glycol.
For the full list of excipients, see Section 6.1
A clear solution with an odour of peppermint in a multidose spray container fitted with a metering pump and nozzle.
Oroeze 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.
ADULTS AND ELDERLY: 4 to 8 sprays, 1½ - 3 hourly.
CHILDREN (6-12): 4 sprays, 1½ - 3 hourly.
CHILDREN UNDER 6: One spray to be administered per 4 kg body weight, up to a maximum of 4 sprays, 1½ - 3 hourly.
Because of the small amount of drug applied, elderly patients can receive the same dose as adults.
Method of administration
Hypersensitivity to active substance or to any of the excipients, listed in section 6.1
Avoid contact with the eyes.
Oroeze Spray/Benzydamine 0.15% w/v Oromucosal Spray contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). It also contains propylene glycol which may cause skin irritation.
Oroeze Spray/Benzydamine 0.15% Oromucosal Spray should not be used in pregnancy
Oroeze Spray/Benzydamine 0.15% Oromucosal Spray should not be used during lactation unless considered essential by the physician.
There is no evidence of a teratogenic effect in animal studies.
Oroeze Spray/Benzydamine 0.15% Oromucosal Spray has no or negligible influence on the ability to drive and use machines.
Adverse events are listed by System Organ Class:
Frequencies are defined using the following convention:
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.
System organ class
Immune system disorders
Anaphylactic reaction which can be potentially life-threatening and hypersensitivity reactionsii
Respiratory, thoracic and mediastinal disorders
Laryngospasm or bronchospasm
Oral numbness and a stinging feeling in the mouthi
Skin and subcutaneous tissue disorders
Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash
i) The stinging has been reported to disappear upon continuation of the treatment, however if it persists it is recommended that treatment be discontinued.
ii) Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisations 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.
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.
Pharmacotherapeutic group: 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.
Following oral administration, benzydamine is rapidly absorbed from the gastrointestinal tract and maximum plasma levels reached after 2-4 hours. The most important aspect of the tissue distribution of benzydamine is its tendency to concentrate at the site of inflammation.
About half of the benzydamine is excreted unchanged via the kidney at a rate of 10% of the dose within the first 24 hours. The remainder is metabolised, mostly to N-Oxide.
2 years unopened.
Use within 6 months of opening.
There are no special requirements for storage.
White HDPE multidose spray container, fitted with a metering pump and nozzle, containing 30ml Oroeze.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Focus Pharmaceuticals Ltd
85 King William Street,
London EC4N 7BL
PL 20046/ 0049
Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK
+44 (0)208 588 9131
08700 70 30 33
+44 (0)208 588 9273
+44 (0)208 588 9200
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