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CALGEL TEETHING GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE

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Transcript
2 Before giving the
medicine to your child
Teething Gel
lidocaine, cetylpyridinium

This medicine provides relief from the symptoms of
teething pain.
■ The medicine is OK for most babies 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



This medicine is not recommended for babies
under 3 months.

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

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

Talk to your doctor or pharmacist…


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.

Babies from 3 months and over
Age

Dose

Babies 3 months
and over

Approximately one-third
of an inch (7.5 mm).
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 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.








This product contains sorbitol. If your child has
an intolerance to some sugars, consult your
doctor before using this product.
This product contains small amounts of ethanol
(alcohol), less than 100 mg per dose.
Xylitol may have a laxative effect.
The castor oil may cause stomach upsets and
diarrhoea.

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

Babies under 3 months

Do not give your child this medicine…

Some of the ingredients can cause problems
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’ gums. It also
contains cetylpyridium chloride (a mild antiseptic) to
help prevent infection.



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




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

4 Possible side-effects

6 Further information

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

What’s in this medicine?

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




Swelling of the mouth, gums or tongue.
Difficulty in breathing.
Rash.

If your child experiences any side-effects not
included in this leaflet, or you are not sure of
anything, talk to your doctor or pharmacist.

5 Storing this medicine
Keep the product out of reach and sight of children.
Do not store above 25ºC.
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.

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
Calgel Teething Gel is a yellowish-brown gel,
available in 10 g tubes.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orléans, Cedex 2, France.
This leaflet was revised December 2009.
Calgel Teething Gel is a registered trade mark.

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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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