BOOTS TEETHING GEL 3 MONTHS PLUS
Active substance: LIDOCAINE HYDROCHLORIDE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Boots Teething Gel 3 Months Plus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Lignocaine Hydrochloride Ph Eur Cetylpyridinium Chloride Ph Eur Quantity 0.6% w/w 0.02% w/w
3.
PHARMACEUTICAL FORM Gel
4.
4.1
CLINICAL PARTICULARS
Therapeutic indications For the relief of teething troubles.
4.2
Posology and method of administration Children over 3 months: Apply a small quantity of gel to the sore area. Repeat the application every three hours if necessary. For topical application to mouth and gums.
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.
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.
4.9
Overdose Overdosage with this medicine is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.
5.
5.1
PHARMACOLOGICAL PROPERTIES
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 -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 None stated.
6.
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Methocel E4 Premium Glycerin Sodium saccharin crystals Citric acid monohydrate Sorbic acid Sodium citrate Salt pure vacuum dried extra analysis Spearmint Naefco flay Firmench Purified water
6.2
Incompatibilities None stated.
6.3
Shelf life
36 months.
6.4
Special precautions for storage
Do not store above 30C
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: 13/15 gm
6.6
Instruction for use, handling and disposal None.
7
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8.
MARKETING AUTHORISATION NUMBER PL 00014/0392
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/10/2005
10
DATE OF REVISION OF THE TEXT
21/11/2012
1
NAME OF THE MEDICINAL PRODUCT
Boots Teething Gel 3 Months Plus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Lignocaine Hydrochloride Ph Eur Cetylpyridinium Chloride Ph Eur Quantity 0.6% w/w 0.02% w/w
3.
PHARMACEUTICAL FORM Gel
4.
4.1
CLINICAL PARTICULARS
Therapeutic indications For the relief of teething troubles.
4.2
Posology and method of administration Children over 3 months: Apply a small quantity of gel to the sore area. Repeat the application every three hours if necessary. For topical application to mouth and gums.
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.
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.
4.9
Overdose Overdosage with this medicine is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.
5.
5.1
PHARMACOLOGICAL PROPERTIES
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 -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 None stated.
6.
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Methocel E4 Premium Glycerin Sodium saccharin crystals Citric acid monohydrate Sorbic acid Sodium citrate Salt pure vacuum dried extra analysis Spearmint Naefco flay Firmench Purified water
6.2
Incompatibilities None stated.
6.3
Shelf life
36 months.
6.4
Special precautions for storage
Do not store above 30C
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: 13/15 gm
6.6
Instruction for use, handling and disposal None.
7
MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8.
MARKETING AUTHORISATION NUMBER PL 00014/0392
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/10/2005
10
DATE OF REVISION OF THE TEXT
21/11/2012
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
