Calpol Infant Suspension Calpol Infant Suspension

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. See section 2
• Not to anyone who is allergic to the ingredients. See section 6
• Follow the dosage instructions carefully. Children of different ages need different amounts. These are shown in the tables. See section 3
• Speak to your doctor if anything in this list applies:
• If a child is not getting better, or needs more medicine than shown in the table. See section 3
• If a child gets a rash, breathing problems, diarrhoea or gets very tired. See section 3

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

1 What the medicine is for The paracetamol in CALPOL® 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®.

• 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.

Carmoisine (E122) may cause allergic reactions.

Possible side effects of Calpol Infant Suspension:

A rare side effect of paracetamol can be skin rashes.

CALPOL® 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:

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.

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 - If necessary, after 4-6 hours, give a second 2.5 ml dose
• 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.

The active ingredient is: Paracetamol 120 mg per 5 ml.

Other ingredients are: Sucrose, sorbitol liquid (E420), glycerol, polysorbate 80, asulfame potassium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethyl parahydroxybenzoate (E214), dispersible cellulose, xanthan gum and purified water. The flavouring is strawberry and colouring is carmoisine (E122).

Each 5 ml of this product contains 2.2 g of sucrose.