Calpol Infant Suspension

CALPOL ® Infant Suspension is a sugar free, strawberry flavoured oral suspension for children to help your child feel better and relieve the symptoms of fever, colds and flu and other common conditions.

CALPOL ® Infant Suspension provides soothing relief from pain and fever for your child, when they need it most. It starts to work on fever in just 15 minutes but is still gentle on children's delicate tummies. Trusted by parents for over 50 years, CALPOL ® Infant Suspension is gentle enough to use from 2 months of age. Each pack comes with an easy dose syringe which helps when dispensing the correct dose of suspension. It relieves the symptoms of fever, cold and flu, teething, headache, toothache, earache, sore throat and other aches and pains. CONTAINS PARACETAMOL.

• Calpol can be given to children for the following reasons:
• Relieving mild to moderate pain such as headache, toothache, teething, earache or sore throat.
• Reducing a high temperature (fever).
• Relieving aches, pains, fever and general discomfort associated with colds and flu or following childhood vaccinations.

For babies and children aged from 2 months to 6 years weighing more than 4kg and not premature. CALPOL ® Infant Suspension provides soothing relief from pain and fever for your children, when they need it most. It starts to work on fever in just 15 minutes but is still gentle on delicate tummies.

Contains paracetamol. For babies and children aged from 2 months to 6 years weighing more than 4kg and not premature. CALPOL ® Infant Suspension provides soothing relief from pain and fever for your children, when they need it most. Do not give to babies under 2 months old.

This product is intended for use in children aged 2 months to 6 years. For oral use only. For the relief of fever after vaccination at 2, 3 and 4 months - See the leaflet in the box. For the relief of pain and other causes of fever - refer to dosing tables.
It is important to shake the bottle for at least 10 seconds before use. Always use the syringe supplied with the pack. Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.

Children aged 2-3 months

• Child's Age: 2-3 months, How much: 2.5 ml
• Do not give to babies less than 2 months old.
• Only give if your baby weighs over 4 kg and was born after 37 weeks. Leave at least 4 hours between doses.
• Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.

Children aged 3 months - 6 years

• Child's Age: 3-6 months, How much: 2.5 ml, How often (in 24 hours): Up to 4 times
• Child's Age: 6-24 months, How much: 5 ml, How often (in 24 hours): Up to 4 times
• Child's Age: 2-4 years, How much: 7.5 ml (5 ml 2.5 ml), How often (in 24 hours): Up to 4 times
• Child's Age: 4-6 years, How much: 10 ml (5 ml 5 ml), How often (in 24 hours): Up to 4 times
• Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

CONTAINS PARACETAMOL

Do not give anything else containing paracetamol while giving this medicine. Talk to a doctor at once if your child takes too much of this medicine, even if they seem well.

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product. Please see leaflet. Keep out of the sight and reach of children. Check that the cap on the bottle is securely engaged at all times.

• This medicine brings down high temperatures (also called fever) and relieves pain.
• The medicine is OK for most babies over 2 months and children up to 6 years.
• Do not give it to children on this list:
• Not to babies or children taking some other medicines.
• Not to anyone who is allergic to the ingredients. See section 6
• Follow the dosage instructions carefully. Children of different ages need different amounts.
• Speak to your doctor if anything in this list applies:
• If a child is not getting better, or needs more medicine than recommended for their age
• If a child gets a rash, breathing problems, diarrhoea or gets very tired.

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

The paracetamol in CALPOL® Sugar Free Infant Suspension is used to relieve pain and / or bring down fever (high temperature) in many conditions including post-immunisation fever, teething, headache, cold and flu, toothache, earache, sore throat and other aches and pains. 2 Before giving the medicine to your child This medicine is suitable for most people but a few people 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 a bad reaction to any of the ingredients.
• If s/he is taking anything else with paracetamol in it.
• If s/he is between 2-3 months old and is taking this medicine for other causes of pain and fever and:
• Weighs less than 4 kg or
• Was born before 37 weeks

If any of these applies, get advice from a pharmacist or doctor without using CALPOL®.

Talk to your doctor or pharmacist…

• If your child has serious kidney or liver problems.
• If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars.
• If your child is taking any other medicines including: metoclopramide or domperidone (used to treat nausea and vomiting)
• cholestyramine (used to treat high cholesterol)
• anticoagulants (drugs that thin the blood, such as warfarin)
• anticonvulsants (drugs to treat epilepsy)

If you are not sure about the medicine your child is taking, show the bottle or pack to your pharmacist. If any of these bullet points apply, talk to a doctor or pharmacist. If adults take this medicine: The following additional warnings are included in case an adult takes this product.

• You can use this medicine while you are taking oral contraceptives ('the pill'), but it may not work so well on your pain or fever.
• If you drink large amounts of alcohol, you may be more open to the side-effects of paracetamol. If this applies to you, talk to a doctor before use.
• Ask your doctor or pharmacist for advice before taking this medicine if you might be pregnant or breast-feeding. Some of the ingredients can cause Problems
• Methyl (E218), propyl (E216) and ethyl (E214) parahydroxybenzoate may cause allergic reactions which could possibly be delayed.
• The sorbitol (E420) and maltitol content of this product means that this product is unsuitable for people with inherited intolerance to fructose.
• This medicine contains 967 mg of sorbitol liquid (E420) per 5 ml dose which is equivalent to 193 mg/ml and 2.72 g maltitol liquid.
• Sorbitol is a source of fructose. If your doctor has told you that your child has an intolerance to some sugars or if your child has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before your child receives this medicine.
• Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• Maltitol may have a mild laxative effect. Calorific values: 2.6 kcal/g sorbitol and 2.3 kcal/g maltitol.
• Carmoisine (E122) may cause allergic reactions.

For more information please refer to the patient information leaflet.

Possible side effects of Calpol Sugar Free Infant Suspension:

A rare side effect of paracetamol can be skin rashes.

CALPOL® Sugar Free Infant Suspension can have side-effects, like all medicines, although these don’t affect everyone and are usually mild.

Tell your doctor as soon as possible if you notice any of these:

• allergic reactions including swelling of the face, tongue or throat, difficulty swallowing, unexplained wheezing, shortness of breath which may be accompanied by skin rash or hives.
• becoming unusually tired, unexpected bruising or bleeding and getting more infections (such as colds) than usual. These are very rare effects in people taking paracetamol.
• very rare cases of serious skin reactions have been reported. Symptoms may include: skin reddening, blisters, rash. If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.

If your child shows any of these signs, stop giving paracetamol and talk to your doctor right away. Long term use: People who use medicines containing paracetamol every day for a long time (several months or more) could get certain side-effects, including liver and kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems, but liver function tests may be affected. If you notice any side-effects not included in this leaflet please tell your doctor or pharmacist.

Each 5 ml contains 120 mg of Paracetamol

Also contains: Maltitol, E420, E214, E216. E218 and E122