Dentinox Teething Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CETYLPYRIDINIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE

Available from:

DDD Limited 94 Rickmansworth Road, Watford Herts WD18 7JJ, United Kingdom

ATC code:

N01BB52

INN (International Name):

CETYLPYRIDINIUM CHLORIDE 0.1 % (W/W) LIDOCAINE HYDROCHLORIDE 0.33 % (W/W)

Pharmaceutical form:

DENTAL GEL

Composition:

CETYLPYRIDINIUM CHLORIDE 0.1 % (W/W) LIDOCAINE HYDROCHLORIDE 0.33 % (W/W)

Prescription type:

OTC

Therapeutic area:

ANESTHETICS

Authorization status:

Suspended

Authorization date:

2006-03-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet, you may need to read it again. If you need more
information
or advice speak to your health visitor, pharmacist or doctor.
IN THIS LEAFLET:
1. What Dentinox Teething Gel is and what it is used for
2. Before you use Dentinox Teething Gel
3. How you use Dentinox Teething Gel
4. Possible side effects
5. How to store Dentinox Teething Gel
6. Further information
1. WHAT DENTINOX TEETHING GEL IS AND WHAT IT IS USED FOR
Dentinox Teething Gel contains the active ingredients lidocaine and
cetylpyridinium.
Lidocaine is one of a group of medicines called local anesthetics,
which numb pain.
Cetylpyridinium is an antiseptic that is used to treat minor wounds
and minor infections
of the mouth.
Dentinox Teething Gel relieves teething pain and soothes the gums from
birth onwards.
2. BEFORE YOU USE DENTINOX TEETHING GEL
You should not use Dentinox Teething Gel if your baby is allergic
(hypersensitive)
to lidocaine, cetylpyridinium or any other ingredients (see list of
ingredients in
Section 6). See a doctor at once if you notice the following: rash,
swelling of the
face, neck, tongue or throat (severe allergic reaction).
DO NOT USE Dentinox Teething Gel if the seal on the nozzle is broken.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if your baby is taking, or has
recently taken,
any other medicines, including medicines obtained without a
prescription.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF DENTINOX
TEETHING GEL
Dentinox Teething Gel contains SORBITOL. If you have been told by your
doctor that your
baby has AN INTOLERANCE TO SOME SUGARS, contact your doctor before
using this product.
This medicine also contains small amounts of ethanol, less than 100mg
per dose.
DENTINOX TEETHING GEL LIDOCAINE HYDROCHLORIDE/CETYLPYRIDINIUM CHLORIDE
STUDIO DETAILS
Client: Dendron
Job No: 26378-01
Version No: V2
Date: 09/04/2015
Originator:
Dave Simpson
Am
ended by:
-
Description/Public

Summary of Product characteristics

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT.
Dentinox Teething Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride 0.33%w/w
Cetylpyridium Chloride BP 0.10%w/w.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM.
Dental gel
Greenish yellow brown gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dentinox Gel relieves the pain of baby’s teething and soothes the
gums.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION.
Place a small quantity of Dentinox Teething Gel on a pad of cotton
wool or a clean
finger and rub gently on baby’s gum. Repeat after 20 minutes if
necessary. Use when
necessary during the teething period.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
Keep all medicines out of the reach of children.
Do not use if seal on nozzle is broken.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION.
None known.
Page 2 of 4
4.6
PREGNANCY AND LACTATION
Not applicable.
4.7
EFFECT AND ABILITY TO DRIVE AND USE MACHINES.
Not applicable.
4.8
UNDESIRABLE EFFECTS.
None known.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via ADR Reporting:
Website: www.medicinesauthority.gov.mt/adrportal
4.9
OVERDOSE
No apparent problems with overdosage.
5.
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES.
Cetylpyridium chloride is a cationic disinfectant which is used for
minor wounds,
treating superficial infections of the mouth and preserving the
product.
Lidocaine hydochloride is a local anaesthetic. It works by blocking
nerve conduction
when applied topically to nerve tissue. It acts on any part of the
nervous system and on
every type of nerve fibre. For example, when it is applied to the
motor cortex,