Summary of medicine characteristics - MPL BENZOCAINE SORE THROAT SPRAY 1.5 MG OROMUCOSAL SPRAY
1 NAME OF THE MEDICINAL PRODUCT
MPL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzocaine 1.5 mg per actuation.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oromucosal spray, solution (Oromucosal spray)
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic temporary relief of pain associated with sore throat pain and minor mouth infections.
4.2 Posology and method of administration
Adults (including elderly) and children from 13 years:
Spray two metered doses every two to three hours if required (not more than sixteen doses in every 24 hours) or as directed by the physician.
Children aged 6 – 12 years:
One metered dose every two to three hours if required (not more than eight doses in every 24 hours) or as directed by the physician.
Not suitable for children under 6 years.
Topical application to the mucosa of the mouth and throat by means of a metered dose aerosol.
The container should be shaken before use.
Before use it may be necessary to press the plunger 2–3 times to activate spray.
4.3
Known hypersensitivity to benzocaine or any of the other ingredients
Methaemoglobinaemia
Children under 6 years
Epiglottitis
4.4 Special warnings and precautions for use
Do not administer to children under 6 years
Do not use for more than 3 consecutive days
Do not spray into eyes
If sore throat is severe or persistent, or accompanied by fever, headache or nausea, consult your doctor.
You should experience temporary numbness in your throat after using the spray. This indicates that the product is working. Avoid eating or drinking as long as the numbness lasts.
Labelling will include the following information:
Do not use if you have any difficulty in breathing, noisy breathing or severe difficulty in swallowing.
Do not use if you have been told that you have a rare blood condition called methaemoglobaemia.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans in unknown. Therefore MPL Benzocaine Sore Throat Spray is not recommended during pregnancy or breast-feeding.
4.7 Effects on ability to drive and use machines
None expected.
4.8 Undesirable effects
Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling.
Methaemoglobinaemia has been reported with benzocaine use.
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 Overdose
4.9 OverdosePronounced reversible anaesthesia should be observed. No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine.
Treatment of overdose
N/A.
5.1 Pharmacodynamic properties
ATC code: R02A D01
Benzocaine is a local anaesthetic of the ester type. The mode of action is a reversible inhibition of the flux of sodium and potassium ions through the axonal membranes of peripheral pain receptors. As a consequence, the depolarisation and propagation of nerve impulses are inhibited.
The onset of action of benzocaine on the mucous membranes is rapid due to the spray delivery of the anaesthetic direct to the site of action, rapid absorption, and the surface analgesic effect. The local anaesthesia induced by benzocaine is temporary but MPL Benzocaine Sore Throat Spray has not been tested for duration of action.
5.2 Pharmacokinetic properties
Benzocaine is absorbed into the mucus membranes. After systemic absorption, which is negligible, the drug is thought to be metabolised to ethanol and aminobenzoic acid by plasma esterases. Aminobenzoic acid is excreted unchanged or conjugated with glycine to amoniohippuric acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine.
5.3 Preclinical safety data
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetylpyridinium chloride
glycerin
ethanol
clove bud oil
menthol crystals
sodium saccharin 450
peppermint
Cremophor RH40
water
6.2 Incompatibilities
None.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
White aluminium can with 100 mcl pumps, white high density polypropylene folding arm activator and white high density polyethylene cap.
Pack size: not less than 7.3 g (approximately 60 metered doses).
6.6 Special precautions for disposal
6.6 Special precautions for disposalTo help protect the environment, do not dispose of this medicine via wastewater or household waste. Ask a pharmacist for advice on disposal.