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.

2 Before giving the medicine to your child

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.

□ Do not give your child this medicine...

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

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

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.

If your child is using any other medicines

No interactions with other medicines are currently known.

A 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.

^ksome of the ingredients can cause problems

■    This 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.

■    The castor oil may cause stomach upsets and diarrhoea.

3 How to use this medicine

■    For topical use only.

■    Do not give more than the dose stated below.

o Babies under 3 months

This medicine is not recommended for babies under 3 months.

o 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^

4    Possible side-effects

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

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.

■    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.

5    Storing this medicine

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

Do not store above 25°C.

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.

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.

6 Further information

What’s in this medicine?

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 Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised March 2016.

Calgel Teething Gel is a registered trade mark.

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Products LM.

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

F309475 - Leaflet CALGEL Teething Gel 10G UKV8.6.indd 2 04/04/16 10:59