INFACOL

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 babys 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 babys 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 babys 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 babys 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 babys 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 babys next feed. 4. POSSIBLE SIDE EFFECTS Simeticone, the active ingredient in Infacol, is not absorbed into the babys 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

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IN/UK/LFT/1/B