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CALGEL TEETHING GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE

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2 Before giving the
medicine to your child
Teething Gel
lidocaine hydrochloride
cetylpyridinium chloride
This medicine provides relief from the symptoms of
teething pain.
■ The medicine is OK for most babies and toddlers
over 3 months.
■ Do not give it to anyone on this list:


Not to anyone who has ever had a bad
reaction to any of the ingredients.
See section 6 ➤
■ Follow the dosage instructions carefully. These
are shown in the table. See section 3 ➤


Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might need
it again.

1 What the medicine is for
Calgel Teething Gel provides relief from the symptoms
of teething pain. The lidocaine (a local anaesthetic) in
the Calgel Teething Gel is used to help relieve
teething pain and soothe infants' and toddlers'
gums. It also contains cetylpyridium chloride (a mild
antiseptic) to help prevent infection.

F309475 - Leaflet CALGEL Teething Gel 10G UKV8.6.indd 1

This medicine is suitable for most children, but a few
children should not use it. If you are in any doubt, talk
to your doctor or pharmacist.



3 How to use this medicine



Do not give your child this medicine…


This medicine is not recommended for babies
under 3 months.

If this applies, get advice from a doctor or
pharmacist without using Calgel.


If your child has an intolerance to some sugars

If this bullet point applies now or in the past, speak
to a doctor or pharmacist.

If your child is using any other medicines
No interactions with other medicines are currently known.

If you are pregnant or breast-feeding
The following advice is included in case an older
child or adult is taking this medicine.
■ If you are pregnant or breast-feeding only use
this medicine on the advice of your doctor.

Some of the ingredients can cause problems
T his product contains sorbitol. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicinal product.
■ This product contains small amounts of ethanol
(alcohol), less than 100 mg per dose.
■ Xylitol may have a laxative effect.


For topical use only.
Do not give more than the dose stated below.

Babies under 3 months

If s/he has ever had an allergic reaction to the
product, chamomile, or any of the ingredients.

Talk to your doctor or pharmacist…

T he castor oil may cause stomach upsets
and diarrhoea.

Babies from 3 months and over
Age

Dose

Babies and toddlers Approximately one-third
3 months
of an inch (7.5mm).
and over
Place the quantity of gel onto
a clean pad of cotton wool or
the tip of a clean finger and
gently rub onto the affected
area of the gum.



If necessary, repeat the dose after 20 minutes
Do not use more than 6 times in one day.

If anyone has used too much
If anyone uses more Calgel Teething Gel than
they should, or if large quantities of the gel are
accidentally swallowed, contact a doctor or
your nearest Accident Emergency Department
(Casualty) taking this leaflet and pack with you,
even if the child seems well.

turn over

04/04/16 10:59

4 Possible side-effects
Calgel Teething Gel can have side-effects, like all
medicines, although these are rare and usually mild.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

If your child experiences any of the following,
stop using the medicine and seek immediate
medical help:

What’s in this medicine?

Swelling of the mouth, gums or tongue.
Difficulty in breathing.
■ Rash.
■ Inflammation of the skin.
■ Reddening of the skin.



Reporting of the side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

6 Further information
The active ingredients in Calgel Teething Gel are:
Lidocaine hydrochloride 0.33% w/w and
Cetylpyridinium chloride 0.10% w/w.
Other ingredients are: Sorbitol solution (70%) (E420),
xylitol (E967), ethanol 96%, glycerol, hydroxyethyl
cellulose 5000, macrogolglycerol hydroxystearate
(castor oil polyoxyl hydrogenated), macrogol lauryl
ether 9, macrogol 300, saccharin sodium,
levomenthol, pharmaceutical liquid flavour (containing
chamomile), caramel (E150), citric acid monohydrate,
sodium citrate dihydrate and purified water.
Sorbitol content 15% w/w.

What the medicine looks like

5 Storing this medicine

Calgel Teething Gel is a yellowish-brown gel,
available in 10 g tubes.

Keep this medicine out of the sight and reach of
children.

Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.

Do not store above 25ºC.

Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orléans, Cedex 2, France.

Keep the tube tightly closed.
Store in the original package.
Do not use your medicine after the date shown as an
expiry date on the packaging.

F309475 - Leaflet CALGEL Teething Gel 10G UKV8.6.indd 2

This leaflet was revised March 2016.
Calgel Teething Gel is a registered trade mark.
F309475
13/0015

Job Number: 13/0015
Dimension: 148 x 210mm
Date: 04/04/2016
Version Number: v8.6

04/04/16 10:59

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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