Anbesol teething gel

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride

Dostupno od:

Alliance Pharmaceuticals Ltd

ATC koda:

D04AB

INN (International ime):

Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride

Doziranje:

10mg/1gram ; 1mg/1gram ; 200microgram/1gram

Farmaceutski oblik:

Oromucosal gel

Administracija rute:

Oromucosal; Gingival

Razred:

No Controlled Drug Status

Tip recepta:

Never Valid To Prescribe As A VMP

Proizvod sažetak:

BNF: 12030100; GTIN: 0000096032909

Uputa o lijeku

ANBESOL
® TEETHING 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 TEETHING GEL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL
TEETHING GEL
3.
HOW TO USE ANBESOL TEETHING GEL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ANBESOL TEETHING GEL
6.
CONTENTS OF PACK AND OTHER INFORMATION
1. WHAT ANBESOL TEETHING GEL IS AND WHAT IT IS USED FOR
Anbesol Teething Gel contains 1.0%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 Teething Gel 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 for the temporary relief of pain
caused by recurrent MOUTH ULCERS and DENTURE IRRITATION.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL
TEETHING GEL
DO NOT USE ANBESOL TEETHING 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).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Anbesol Teething Gel:
•
If you have open wounds or damaged areas in

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Anbesol Teething Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine hydrochloride
1.0%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%
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 and
denture
irritation.
For relief of pain and discomfort associated with teething in children
from 5 months
of age, 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 a small amount to the affected area with
a clean
fingertip. Two applications immediately will normally be sufficient to
obtain pain
relief. It should not be used more frequently than every 3 hours.
BABIES TEETHING AND CHILDREN: Apply a pea-sized amount (0.2 grams) of
Anbesol
teething gel with a clean finger to the affected area.
The dose may be repeated if necessary after 3 hours, up to a maximum
of 6 doses 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. The dose may be repeated if necessary after 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
Do not use more than one product containing lidocaine at the same
time.
Excessi