Anbesol liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetylpyridinium chloride; Chlorocresol; Lidocaine hydrochloride

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

N01BB52

INN (International Name):

Cetylpyridinium chloride; Chlorocresol; Lidocaine hydrochloride

Dosage:

200microgram/1gram ; 1mg/1gram ; 9mg/1gram

Pharmaceutical form:

Oromucosal solution

Administration route:

Oromucosal; Gingival

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 12030400; GTIN: 0000096032916 0000096032930 5036631001340 0000096183458

Patient Information leaflet

Guides, Dimensions and Cutter guide are NOT to be printed.
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before using this medicine
as it contains important information for you.
•
Keep this leaflet. You may wish to read it again
•
Ask your pharmacist if you need more
information or advice
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Anbesol Liquid is and what it is used for
2. What you need to know before you use
Anbesol Liquid
3. How to use Anbesol Liquid
4. Possible side effects
5. How to store Anbesol Liquid
6. Contents of pack and other information
1. WHAT ANBESOL LIQUID IS AND WHAT IT IS USED FOR?
Anbesol Liquid contains 0.9%w/w of lidocaine
hydrochloride, 0.1%w/w of chlorocresol and 0.02%w/w of
cetylpyridinium chloride.
Lidocaine hydrochloride is a local anaesthetic which
works by stopping the sensation of pain. Chlorocresol and
cetylpyridinium chloride kill bacteria.
Anbesol Liquid is used to help relieve pain and discomfort
associated with teething, in children from 5 months of
age, when other non-medicinal methods such as
massaging of the gums or use of teething rings do not
provide necessary relief.
The product may also be used by adults, children and
the elderly for the temporary relief of pain caused by
recurrent mouth ulcers and denture irritation.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
ANBESOL LIQUID
Do not use Anbesol Liquid:
•
If you are allergic to lidocaine hydrochloride,
chlorocresol, cetylpyridinium chloride, other
anaesthetics similar to lidocaine or any of the other
ingredients in this medicine (listed in Section 6)
•
You have porphyria (a disease which causes stomach
pain, constipation, changes in the colour of urine,
skin rashes and disturbed behaviour)
•
If your child is under 5 months old
•
At the same time as other products containing
lidocaine.
Do not use more Anbesol Liquid than recommended (as
listed in Section 3) as this may result

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Anbesol Liquid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine hydrochloride
0.9%w/w
Chlorocresol
0.1%w/w
Cetylpyridinium chloride
0.02%w/w
Excipients with known effect:
Each 1ml of the product contains 2.76 micrograms of amaranth (E123),
2.58
micrograms of sunset yellow (E110) and 68.24%w/w of ethanol 96%
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oromucosal solution (oromucosal liquid)
A clear yellow liquid
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS, THE ELDERLY AND CHILDREN: For the temporary relief of pain
caused by
recurrent mouth ulcers and denture irritation.
IN CHILDREN FROM 5 MONTHS OF AGE: For relief of pain and discomfort
associated with
teething where non-pharmacological treatments have failed to provide
sufficient
relief.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oromucosal
ADULTS AND THE ELDERLY: Apply to the affected area, a small undiluted
amount of
Anbesol Liquid, by covering the bottle mouth with a clean fingertip,
inverting once
and returning the bottle to the upright position. Two applications
immediately will
normally be sufficient to obtain pain relief. The application may be
repeated if
necessary after 3 hours.
BABIES TEETHING AND CHILDREN: Apply once to the affected area, 0.25 ml
of undiluted
Anbesol Liquid, by covering the bottle mouth with a clean fingertip,
inverting once
and returning the bottle to the upright position. The application may
be repeated if
necessary after 3 hours, up to a maximum of 6 applications 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. One application may be repeated if necessary after 3
hours.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances, anaest