ANBESOL ANAESTHETIC ANTISEPTIC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ; CHLOROCRESOL ; CETYLPYRIDINIUM CHLORIDE ; ETHANOL

Available from:

Alliance Pharmaceuticals Ltd.

ATC code:

N01BB52

INN (International Name):

LIDOCAINE HYDROCHLORIDE ; CHLOROCRESOL ; CETYLPYRIDINIUM CHLORIDE ; ETHANOL

Dosage:

0.9/0.1/0.

Pharmaceutical form:

Oromucosal Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

lidocaine, combinations

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

Artwork Information
Product Title:
Anbesol liquid ROI PIL
Date:
02-10-14
Product Size:
148.5mm x 105mm
Label Number:
13-382
Version 2
Colours Used:
Black
Fonts Used:
Hevletica light condensed & bold condensed, Arial Bold
Font size: (min,max)
6.75pt, 11pt
Guides, Dimensions and Cutter guide are NOT to be printed.
P
ATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
•
Keep this leaflet. You may need 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.
•
You must talk to a doctor if you do not feel better or if
you feel worse after 3 days.
WHAT IS IN THIS LEAFLET:
1. What Anbesol Anaesthetic Antiseptic Oromucosal
solution is and what it is used for
2. What you need to know before you use Anbesol
Anaesthetic Antiseptic Oromucosal solution
3. How to use Anbesol Anaesthetic Antiseptic
Oromucosal solution
4. Possible side effects
5. How to store Anbesol Anaesthetic Antiseptic
Oromucosal solution
6. Contents of pack and other information
1. WHAT ANBESOL ANAESTHETIC ANTISEPTIC
OROMUCOSAL SOLUTION IS AND WHAT IT IS USED FOR
Anbesol Anaesthetic Antiseptic Oromucosal solution
contains
0.90% w/w of lidocaine hydrochloride, 0.10% 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 Anaesthetic Antiseptic Oromucosal solution is used for
the relief of pain caused by mouth ulcers and sore gums.
Anbesol Anaesthetic Antiseptic Oromucosal solution can be
used by adults, the elderly and adolescents and children aged
10-18 years old.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL
ANAESTHETIC ANTISEPTIC OROMUCOSAL SOLUTION
Do not use Anbesol Anaesthetic Antiseptic Oromucosal
solution:
•
If you are allerg

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anbesol Anaesthetic Antiseptic Oromucosal Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Each 1ml of the product contains 2.76 micrograms of
amaranth (E123) and 2.58 micrograms of sunset
yellow (E110) and 68.239%w/w of ethanol 96%w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal Solution
A clear yellow liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Properties:
A local anaesthetic/antiseptic combination.
Indications for use:
In the symptomatic relief of mouth ulcers and sore gums.
Anbesol Anaesthetic Antiseptic Oromucosal Solution is indicated in
adults, the elderly and adolescents and children
aged 10 to 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oromucosal
FOR ADULTS, THE ELDERLY, ADOLESCENTS AND CHILDREN AGED 10 TO 18 YEARS
Apply undiluted to the affected area with the fingertip.
Two applications immediately will normally be sufficient to
obtain pain relief.
It should not be used more frequently than every 3 hours or as
directed by the physician or dentist.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, anaesthetics of the
amide-type or to any of the excipients listed in section 6.1.
Lidocaine is considered to be unsafe in patients with porphyria
because it has been shown to be porphyrinogenic in
animals.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Excessive dosage, or short intervals between doses, may result in high
plasma levels and serious adverse effects (see
Section 4.9).
Anbesol should be used with caution in patients with wounds or
traumatised mucosa in the region of the
proposed application.
Lidocaine Hydrochloride
0.90
% w/w
Chlorocresol
0.10
% w/w
Cetylpyridinium Chloride
0.02
% w/w
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__