Bonjela Junior gel

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Lidocaine hydrochloride; Cetylpyridinium chloride

Tilgjengelig fra:

Reckitt Benckiser Healthcare (UK) Ltd

ATC-kode:

N01BB52

INN (International Name):

Lidocaine hydrochloride; Cetylpyridinium chloride

Dosering :

5mg/1gram ; 250microgram/1gram

Legemiddelform:

Oromucosal gel

Administreringsrute:

Oromucosal; Gingival

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 15020100; GTIN: 5000158069671

Informasjon til brukeren

Lidocaine (Lignocaine) Hydrochloride,
Cetylpyridinium chloride
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist have
told 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 (see section 4).
You must talk to a doctor if you do not feel better or if
you feel worse.
IN THIS LEAFLET:
1. WHAT BONJELA JUNIOR GEL IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE BONJELA JUNIOR GEL
3. HOW TO USE BONJELA JUNIOR GEL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BONJELA JUNIOR GEL
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
1.
WHAT BONJELA JUNIOR GEL IS AND WHAT IT IS
USED FOR
bonjela Junior gel is an oromucosal gel and is used to
relieve the pain and discomfort of common mouth
ulcers. Bonjela Junior gel is a clear, almost colourless
gel, which is applied to the inside of the mouth or gums.
It contains a local anaesthetic called lidocaine
hydrochloride, which relieves pain and irritation and
an antiseptic called cetylpyridinium chloride, which
kills bacteria and helps prevent infection.
BONJELA JUNIOR GEL IS INTENDED FOR ADULTS, THE
ELDERLY AND CHILDREN OVER 5 MONTHS.
2.
BEFORE YOU USE BONJELA JUNIOR GEL
As with all medicines, bonjela Junior gel may not be
suitable for everybody.
DO NOT
·
use if you or your child are allergic to lidocaine,
cetylpyridinium chloride or any of the other
ingredients of this medicine (listed in section 6).
·
use if you or your child are allergic to other local
anaesthetics
·
give to babies under 5 months of age
·
use if you suffer from abnormal blood pigment
levels
Bonjela Junior gel is not suitable for treatment of
teething in children.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this
pro

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bonjela Junior gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine hydrochloride 0.5% w/w
Cetylpyridinium chloride 0.025% w/w
Excipients with known effect:
Ethanol 96% 242.2 mg/1g
Fragrances containing allergens (Eugenol)*
*in banana flavour
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oromucosal gel
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of pain from common mouth ulcers and denture
irritation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oromucosal
Adults, the elderly and children over 5 months:
Apply a little gel to the sore area with either a clean fingertip or
swab. This
may be repeated after twenty minutes and then every three hours.
4.3
CONTRAINDICATIONS
Hypersensitivity to lidocaine or to any of the excipients listed in
section 6.1.
Known hypersensitivity to local anaesthetics of the amide type.
Babies under 5 months.
In patients who have a history of or are suspected to have
methaemoglobinaemia (see
section 4.8).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
To be used with caution in patients with hepatic or cardiac
dysfunction.
Do not exceed the stated dose. Not recommended for infants under five
months.
Keep out of the reach and sight of children. If symptoms persist
consult your doctor
or dentist.
Excessive dosage, short intervals between doses or use on traumatised
mucosa may
result in high plasma levels and serious adverse effects (see Section
4.9).
WARNINGS RELATED TO EXCIPIENTS:
This medicine contains 242.2 mg of alcohol (ethanol) per 1g. The
amount in each 1g
of this medicine is equivalent to less than 7 ml beer or 3 ml of wine.
The small amount of alcohol in this medicine will not have any
noticeable effects.
It may cause burning sensation on damaged skin.’
This medicine contains less than 1 mmol sodium (23 mg) in each 1g,
that is to
say essentially ‘sodium-free’.
This medicine contains fragrance with Eugenol. Eugenol may cause
allergic
reactions