INFACOL

Active substance: SIMETICONE

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Simeticone 40 mg per 1 ml Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for your baby.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– You must contact a doctor if your baby’s symptoms worsen or do not improve.
– If any side effects occur, please tell your doctor or pharmacist.
In this leaflet:
1. What Infacol is and what it is used for
2. Before you give Infacol
3. How to give Infacol
4. Possible side effects
5. How to store Infacol
6. Further information
1. WHAT INFACOL IS AND WHAT IT IS USED FOR
Your baby’s medicine is called Infacol. It is an antiflatulent which
means that it helps to bring up wind or air trapped in the tummy.
Infacol is given to babies to relieve griping pain, infant colic or
wind due to trapped air. It can be given from birth onwards. The
pain associated with colic may be caused by the build-up of small
gas bubbles trapped in your baby’s tummy. Simeticone, the active ingredient in Infacol,
helps all the little trapped gas bubbles join into bigger bubbles which your baby can easily
bring up as wind.
2. BEFORE YOU GIVE INFACOL
Do not give Infacol and get advice from a doctor if your baby is being treated for a thyroid
disorder.
Do not give Infacol if you think your baby might be allergic (hypersensitive) to any of the
ingredients of Infacol (see section 6 of this leaflet).
Using other medicines
If your baby is being treated with levothyroxine for a thyroid disorder using Infacol might
reduce the amount of this type of medicine that is absorbed and weaken the effect of their
treatment.
3. HOW TO GIVE INFACOL
Follow the instructions about when and how to use the product. You should check with
your doctor or pharmacist if you are not sure.
Dose
Infacol is very simple to give, even when your baby is crying. The normal dose is one
dropper full (0.5ml) which should be given before each feed. If after 3 or 4 days your baby’s
colic still seems to be upsetting, you can double the dose to two droppers full (1ml). This
may be especially useful at night, before the evening feed.
Infacol should be used for several days to achieve the best results, as treatment may show a
progressive effect. Continued use may help to prevent a further build up of wind. You can
continue to use Infacol for several weeks. However, if despite having increased the dose to
two droppers full there is no improvement, or your baby seems to be getting worse, speak
to your health visitor or doctor.
Administration
outside of the dropper run back into the bottle.

your baby’s tongue.
Do not use the dropper for other medicines. Keep it for Infacol only.
If you give more Infacol than you should
If your baby (or an adult) accidentally swallows a large quantity of Infacol (such as a whole
advice.
If you forget to give Infacol
Do not worry if you forget to give your baby one or more doses. Simply give the next dose
before the baby’s next feed.
4. POSSIBLE SIDE EFFECTS
Simeticone, the active ingredient in Infacol, is not absorbed into the baby’s body and is very

this medicine, please tell your doctor, health visitor or pharmacist.
5. HOW TO STORE INFACOL
Keep out of the reach and sight of children.
Do not use Infacol after the expiry date which is stated on the bottle and carton after the

pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Infacol contains
The active ingredient is simeticone at a concentration of 40mg/ml.
The other ingredients are saccharin sodium, hypromellose, orange flavour, methyl
What Infacol looks like and contents of the pack

The Marketing Authorisation Holder is
Forest Laboratories UK Limited

The Manufacturer is
Laleham Healthcare Ltd

This leaflet was last approved in September 2011
To listen to or to request a copy of this leaflet in Braille, large print
or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product Name
Infacol 40mg/ml Oral Suspension

Reference Number
0108/0100

This is a service provided by the Royal National Institute for Blind People

SU3478P

IN/UK/LFT/1/B

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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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