- Approval Id
- f5d18839f9180584
- Drug Approval Emc Name
- Boots Severe Sore Throat Relief 2% w/v Oromucosal Spray
- Drug Name
- Boots Severe Sore Throat Relief 2% w/v Oromucosal Spray
- Company Address
- 1 Thane Road West, Beeston, Nottingham, NG2 3AA
- Company Telephone
- +44 (0)1159 595 165
- Legal Category
- Pharmacy
- Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Authorisation Number
- PL 00014/0430
- Authorisation Date
- | | |
| --- | --- |
| Date of First Authorisation: Date of Last Renewal: | 26/01/1996 04/10/2006 |
- Instruction Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Instruction Authorisation Number
- PL 00014/0430
- Instruction Authorisation Date
- | | |
| --- | --- |
| Date of First Authorisation: Date of Last Renewal: | 26/01/1996 04/10/2006 |
- Instruction Composition
- | | |
| --- | --- |
| Active ingredient Lidocaine hydrochloride monohydrate (Lignocaine hydrochloride monohydrate) | %w/v 2.0 |
| Excipients of known effect Sorbitol solution 70% (non-crystalising) Sodium Citrate Alcohol 96% | % 15 w/v 0.035 w/v 30 % v/v |
For a full list of excipients, see section 6.1
- Instruction Dosage Form
- Oromucosal spray
- Instruction Clinical Particulars
- 4.1 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 Contraindications
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, breastfeeding 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.
Information about some of the ingredients:
This medicine contains 60 mg sorbitol in each 0.40 g dose.
This medicine contains less than 1 mmol sodium (23 mg) per 0.40 g dose, that is to say essentially 'sodium-free'.
This medicine contains 120 mg of alcohol (ethanol) in each 0.40 g dose. The amount in each 0.40 g dose of this medicine is equivalent to less than 6.0 ml beer or 2.4 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.4.6 Pregnancy and lactation
The safety of this 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.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.
- Instruction Pharmacology
- 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.
- Instruction 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 Purified6.2 Incompatibilities
None stated.6.3 Shelf life
36 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 size: 20, 30 millilitres.6.6 Special precautions for disposal and other handling
On first use or after prolonged storage, spray 3 times away from the face into a sink.
Swing nozzle through 90° and spray on the back of the throat.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Active ingredient Lidocaine hydrochloride monohydrate (Lignocaine hydrochloride monohydrate) | %w/v 2.0 |
| Excipients of known effect Sorbitol solution 70% (non-crystalising) Sodium Citrate Alcohol 96% | % 15 w/v 0.035 w/v 30 % v/v |
For a full list of excipients, see section 6.1
## Pharmaceutical Form
Oromucosal spray
## Clinical Particulars
4.1 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 Contraindications
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, breastfeeding 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.
Information about some of the ingredients:
This medicine contains 60 mg sorbitol in each 0.40 g dose.
This medicine contains less than 1 mmol sodium (23 mg) per 0.40 g dose, that is to say essentially 'sodium-free'.
This medicine contains 120 mg of alcohol (ethanol) in each 0.40 g dose. The amount in each 0.40 g dose of this medicine is equivalent to less than 6.0 ml beer or 2.4 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.4.6 Pregnancy and lactation
The safety of this 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.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.
## 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.
## 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 Purified6.2 Incompatibilities
None stated.6.3 Shelf life
36 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 size: 20, 30 millilitres.6.6 Special precautions for disposal and other handling
On first use or after prolonged storage, spray 3 times away from the face into a sink.
Swing nozzle through 90° and spray on the back of the throat.
- Company Detail Path
- /organization/9cddebe8fac0f397/the-boots-company-plc
