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BOOTS ANAESTHETIC SORE THROAT RELIEF 2 % W/V SPRAY

Active substance(s): LIDOCAINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Anaesthetic Throat Spray
Boots Anaesthetic Sore Throat Relief 2 % w/v Spray

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

% w/v

Lidocaine hydrochloride

2.0

(Lignocaine hydrochloride)

3

PHARMACEUTICAL FORM
Oromucosal spray

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
For the symptomatic relief of severe sore throats.

4.2.

Posology and Method of Administration
Adults and children over 12 years: Three sprays.
Aim nozzle at back of throat and spray on to the affected area. Repeat the dose
every three hours as needed up to a maximum of six times in 24 hours.
Children under 12 years: Should not be given to children less than 12 years of
age.

Elderly: There is no need for dose reduction in the elderly.

4.3.

Contra-indications
Hypersensitivity to any of the ingredients. Patients suffering from asthma or
bronchospasm. Children under 12 years.

4.4

Special warnings and precautions for use
Do not use if you are sensitive to any of the ingredients.
Avoid contact with the eyes.
Children under 12 years of age should not be given this medicine.
Do not inhale whilst using the spray.
Do not exceed the stated dose.
Keep all medicines out of the reach of children.
Seek medical advice if symptoms persist or are accompanied by high fever,
headache, nausea or vomiting.
Seek medical advice before using this product if you are pregnant, breast
feeding or receiving any medical treatment.
This product may cause numbness of the tongue and therefore care should be
taken in eating and drinking hot foods.

4.5.

Interactions with other Medicaments and other forms of Interaction
No clinically significant interactions are known.

4.6.

Pregnancy and Lactation
The safety of the medicinal product for use in human pregnancy has not been
established. Experimental animal studies are insufficient to assess the safety
with respect to the development of the embryo or foetus; the course of
gestation and peri- and post-natal development. The product is, therefore, not

recommended during pregnancy and lactation except under medical
supervision.

4.7.

Effects on Ability to Drive and Use Machines
No adverse effects are known.

4.8

Undesirable effects
Occasional hypersensitivity reactions.
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.

4.9

Overdose
Symptoms of overdose include yawning, restlessness, excitement,
nervousness, dizziness, nystagmus, tinnitus, blurred vision, nausea, vomiting,
muscle twitching, tremors and convulsions. Excitation may be transient and
followed by depression with drowsiness, respiratory failure and coma. There
may be simultaneous effects on the cardiovascular system with myocardial
depression and peripheral vasodilatation, resulting in hypotension, arrhythmias
and cardiac arrest.
Very rarely, methaemoglobinaemia may occur with excessive exposure to
some local anaesthetics. This is much more commonly seen with benzocaine
and prilocaine than with lidocaine. Risk is increased in patients with
hereditary methaemoglobinaemia and when used with other oxidising agents.
Treatment consists essentially of maintaining the circulation and respiration
and controlling convulsions. The circulation may be maintained with
infusions of plasma or suitable electrolyte solutions. Convulsions may be
controlled by the intravenous administration of diazepam. If necessary,
suxamethonium together with endotracheal intubation and artificial respiration
may be used if convulsions persist. Methaemoglobinaemia may be treated by
intravenous administration of 1-4 mg/kg methylene blue injection.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Lidocaine is a local anaesthetic of the amide type.

5.2.

Pharmacokinetic Properties
Lidocaine is readily absorbed from mucous membranes. The plasma
elimination half-life is about two hours.
Lidocaine undergoes significant first pass metabolism in the liver and is
rapidly de-ethylated to the active metabolite monoethylglycinexylidide and
then hydrolysed to various metabolites including glycinexylidide. Less than
10% is excreted unchanged by the kidneys. The metabolites are also excreted
in the urine.

5.3.

Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sorbitol solution 70% (non-crystallising)
Levomenthol
Peppermint Flavour
Aniseed Flavour
Sodium Citrate
Saccharin
Alcohol 96%
Patent Blue V E131
Quinoline Yellow E104
Water Purified

6.2.

Incompatibilities

None stated.

6.3.

Shelf Life
24 months.

6.4.

Special Precautions for Storage
None.

6.5.

Nature and Contents of Container
A clear, glass bottle fitted with metering valve spray pump with an extended
polypropylene nozzle.
Pack sizes: 20 30 millilitres

6.6.

Instruction for Use/Handling
On first use or after prolonged storage, spray 3 times away from the face into a
sink.
Swing nozzle through 90 degrees and spray on back of throat.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
Trading as: Boots Pharmacy
Trading as: BCM

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0430

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/10/2006

10

DATE OF REVISION OF THE TEXT
16/03/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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