Anbesol Adult Strength gel

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride

Tilgjengelig fra:

Alliance Pharmaceuticals Ltd

ATC-kode:

D04AB

INN (International Name):

Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride

Dosering :

20mg/1gram ; 1mg/1gram ; 200microgram/1gram

Legemiddelform:

Oromucosal gel

Administreringsrute:

Oromucosal; Gingival

Klasse:

No Controlled Drug Status

Resept typen:

Never Valid To Prescribe As A VMP

Produkt oppsummering:

BNF: 12030100; GTIN: 5038483197301

Informasjon til brukeren

L150 - 140 x 150mm
Artwork Information
Keylines, Guides, Dimensions and Cutter guide are NOT to be printed.
Product Title:
Anbesol Adult Gel
Date:
09-07-21
Product Size:
140mm x 150mm
Label Number:
20-0514
Colours Used:
BLACK
Fonts Used:
Arial, Arial Bold
Font size (min):
7pt
Version:
3
ANBESOL
®
ADULT STRENGTH GEL
Lidocaine Hydrochloride, Chlorocresol
and Cetylpyridinium Chloride
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 ADULT STRENGTH GEL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL ADULT STRENGTH GEL
3. HOW TO USE ANBESOL ADULT STRENGTH GEL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ANBESOL ADULT STRENGTH GEL
6. CONTENTS OF PACK AND OTHER INFORMATION 1.
WHAT ANBESOL ADULT STRENGTH GEL IS AND WHAT IT IS USED FOR
Anbesol Adult Strength Gel contains 2.0%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 Adult Strength Gel is used for temporary relief of
pain caused by recurrent MOUTH ULCERS and DENTURE
IRRITATION for adults and children over 12 years. 2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL
ADULT STRENGTH GEL
DO NOT USE ANBESOL ADULT STRENGTH GEL:
•
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).
WAR

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Anbesol Adult Strength Gel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride 2.0% w/w
Chlorocresol 0.1% w/w
Cetylpyridinium Chloride 0.02% w/w
Excipients with known effect:
Each 1ml of the product contains 100 micrograms of Ponceau 4R (E124)
and
66.605%w/w of ethanol 96% (equivalent to 63.9% w/w ethanol 100%)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oromucosal gel
A soft pink clear gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of pain caused by recurrent mouth ulcers,
denture irritation.
Not for use in children under 12 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oromucosal
Adults, the elderly and children over 12 years: apply a small amount
to the affected
area with a clean fingertip. One application should be sufficient. It
should not be
used more frequently than every 3 hours.
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
Not suitable for treatment of teething in children.
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.
This medicinal product contains chlorocresol and the azo dye Ponceau
4R (E124)
which may cause allergic reactions in sensitive individuals.
This medicinal product contains 66.605% w/w of ethanol 96% (alcohol)
(equivalent
to 63.9% w/w ethanol 100%). The small amount of alcohol in this
medicine w