Summary of medicine characteristics - BOOTS TEETHING GEL 5 MONTHS PLUS
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTBoots Teething Gel 5 Months Plus
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Quantity
Lignocaine Hydrochloride Ph Eur 0.6% w/w
Cetylpyridinium Chloride Ph Eur 0.02% w/w
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORMGel
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief of pain and discomfort associated with teething in children from 5 months of age, where non-pharmacological treatments have failed to provide sufficient relief.
4.2 Posology and method of administration
Children over 5 months:
Apply a pea-sized amount (0.2 grams) of this medicine with a clean finger to the affected area of gum.
The dose may be repeated if necessary after 3 hours, up to a maximum of 6 doses in 24 hours.
Treatment should be stopped once symptoms have resolved.
Not to be used for more than 7 days.
Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.
In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately. The dose may be repeated if necessary after 3 hours.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep all medicines out of the reach of children.
Do not use more than one product containing lidocaine at the same time
4.5 Interactions with other medicinal products and other forms of interaction
There are no clinically significant interactions.
4.6 Pregnancy and lactation
The safety of this medicine during pregnancy and lactation has not been established, but use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Hypersensitivity reactions due to lignocaine have been reported rarely and to cetylpyridinium chloride occasionally.
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 OverdoseOverdosage with this medicine is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Lignocaine is a local anaesthetic of the amide type. Cetylpyridinium Chloride is a cationic antiseptic.
5.2 Pharmacokinetic properties
Lignocaine is readily absorbed from mucous membranes. The plasma elimination half life is about two hours. Lignocaine is bound to plasma proteins, including a-1 acid glycoprotein. Extent of binding is between 60 and 80%.
Lignocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethyiglycinexylidide 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
5.3 Preclinical safety dataNone stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hypromellose
Glycerol (E422)
Saccharin Sodium
Citric acid
Sorbic acid (E200)
Sodium citrate
Sodium Chloride
Natural flavour (Spearmint)
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 30°C
6.5 Nature and contents of container
An internally lacquered collapsible aluminium tube with a membrane seal and either a polyethylene or polypropylene white wadless screw cap with a piercer device.
Pack sizes: 10grams
6.6 Instruction for use, handling and disposal
6.6 Instruction for use, handling and disposalNone.
7 MARKETING AUTHORISATION HOLDER
7 MARKETING AUTHORISATION HOLDERThe Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
8. MARKETING AUTHORISATION NUMBER
8. MARKETING AUTHORISATION NUMBERPL 00014/0392