Skip to Content

BOOTS TEETHING GEL 3 MONTHS PLUS

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE / CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE / CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Boots Teething Gel 3 Months Plus

2.

3.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

Quantity

Lignocaine Hydrochloride Ph Eur
Cetylpyridinium Chloride Ph Eur

0.6% w/w
0.02% w/w

PHARMACEUTICAL FORM
Gel

4.

CLINICAL PARTICULARS

4.1

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.
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
Overdosage 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 α-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.

PHARMACEUTICAL PARTICULARS

6.1

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 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: 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
04/06/2015

Expand view ⇕

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.

Hide