Anbesol Anaesthetic Antiseptic Oromucosal Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride

Dostupné z:

Alliance Pharma (Ireland) Limited

ATC kód:

N01BB; N01BB52

INN (Medzinárodný Name):

Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride

Dávkovanie:

.

Forma lieku:

Oromucosal solution

Terapeutické oblasti:

Amides; lidocaine, combinations

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2012-05-11

Príbalový leták

Anbesol Anaesthetic PIL ROI 008
ANBESOL
TM ANAESTHETIC ANTISEPTIC OROMUCOSAL SOLUTION
Lidocaine hydrochloride 0.90%w/w, Chlorocresol 0.10%w/w,
Cetylpyridinium Chloride 0.02%w/w
PATIENT 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.
Anbesol Anaesthetic PIL ROI 008
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 allergic to lidocaine hydrochloride, chlorocresol,
cetylpyridinium
chloride, other anaesthetics similar to lidoc

Súhrn charakteristických

Health Products Regulatory Authority
19 October 2021
CRN00C9MH
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anbesol Anaesthetic Antiseptic Oromucosal Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride
0.90 % w/w
Chlorocresol
0.10 % w/w
Cetylpyridinium Chloride
0.02 % w/w
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. A damaged mucosa will permit increased systemic
absorption resulting in systemic effects, such as convulsions,
particularly if excessive quantities are used.
Health