CALPOL SUGAR FREE INFANT SUSPENSION
Active substance: PARACETAMOL
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Do not give your child this medicine
Sugar Free Infant Suspension
Contains 120 mg Paracetamol per 5 ml
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.
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. Maltitol may have a mild laxative effect. It has a calorific value of 2.3kcal/g. Carmoisine (E122) may cause allergic reactions.
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 c Not to anyone who is allergic to the ingredients. See section 6 c Follow the dosage instructions carefully. Children of different ages need different amounts. These are shown in the tables. See section 3 c 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 c If a child gets a rash, breathing problems, diarrhoea or gets very tired. See section 3 c
3 How to use this medicine
Check the tables to see how much medicine to use.
For oral use only. Always use the syringe supplied with the pack. It is important to shake the bottle for at least 10 seconds before use. Never give more medicine than shown in the tables. Do not give this medicine with any other paracetamolcontaining product.
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) colestyramine (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.
i
How to use the syringe
Shake the bottle for at least 10 seconds and remove the cap. There is a plug with a hole in the neck of the bottle. Insert the end of the syringe in to the hole and ensure it is secure.
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
If any of these bullet points apply, talk to a doctor or pharmacist.
1 What the medicine is for
The paracetamol in Calpol Sugar Free Infant Suspension is used to relieve pain and / or bring down fever (high temperature) in many conditions including postimmunisation fever, teething, headache, cold and flu, toothache, earache, sore throat and other aches and pains.
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. Ask your doctor or pharmacist for advice before taking this medicine if you might be pregnant or breast-feeding.
Hold the syringe in place and turn the bottle upside down and gently pull down the plunger to either 2.5 ml or 5ml as appropriate (see tables for the correct dose).
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.
Some of the ingredients can cause problems
Turn the bottle the right way up. Remove the syringe by holding onto the bottle and twisting out gently.
Methyl (E218), propyl (E216) and ethyl (E214)
turn over
F308604-PIL-CALPOLSF100200ml-UKv8.6.indd 1
30/01/12 12:03
3 How to use this medicine (continued)
Place the syringe inside the child's mouth against the cheek and press the plunger slowly to gently release the medicine. After use, the plug should remain in the neck of the bottle. Wipe the plug and neck clean and rinse the cap before replacing. The syringe should be washed and dried after use. It can be cleaned by hand or in a dishwasher.
i
Children over 6 years
Ask a pharmacist to recommend a suitable product.
Speak to your doctor:
If your baby needs more than the doses shown in the table, or if fever doesnt go away, speak to your doctor as soon as possible. If you are not sure of the cause of your childs illness or it is accompanied by a rash, breathing difficulties, diarrhoea or excessive tiredness or lethargy, speak to your doctor straight away. Do not give Calpol until you get medical advice.
kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems. If you notice any side-effects not included in this leaflet please tell your doctor or pharmacist.
5 Storing this medicine
Keep the product out of the reach and sight of children. Do not store above 25C. Keep bottle in the outer carton. Do not use after the end of the month shown as an expiry date on the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
i
Babies under 2 months
Do not give to babies under 2 months old. Consult your doctor.
If anyone has too much
Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.
Babies 2 - 3 months
Child's age - 2-3 months 1. Post-vaccination fever How much 2.5 ml If necessary, after 4-6 2. Other causes of pain and fever hours, give a second - if your baby weighs over 4 kg 2.5 ml dose. and was born after 37 weeks Do not give to babies less than 2 months of age. Do not give more than 2 doses. Leave at least 4 hours between doses. If further doses are needed, talk to your doctor or pharmacist.
If you forget to give the medicine
Give the next dose when needed, provided that the last dose was given at least 4 hours ago. Do not give a double dose.
6 Further information
Whats in this medicine?
The active ingredient is: Paracetamol 120 mg per 5 ml Other ingredients are: Maltitol liquid, glycerol, polysorbate 80, sorbitol solution (E420), 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).
4 Possible side effects
Calpol Sugar Free Infant Suspension can have side effects, like all medicines, although these dont affect everyone and are usually mild.
Children from 3 months to 6 years
Child's age 3-6 months 6-24 months 2-4 years 4-6 years
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. If your child shows any of these signs, stop giving paracetamol and talk to a doctor.
What the medicine looks like
Calpol Sugar Free Infant Suspension is a pink liquid, available in 100 ml and 200 ml bottles. It contains 120 mg of the active ingredient paracetamol in every 5 ml of medicine. The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is Famar Orleans, 5 avenue de Concyr, 45071 Orlans, Cedex 2, France. This leaflet was revised January 2012. Calpol is a registered trade mark. F308604 11-0189
How much - up to 4 times a day 2.5 ml 5 ml 7.5 ml (5 ml + 2.5 ml) 10 ml (5 ml + 5 ml)
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.
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
F308604-PIL-CALPOLSF100200ml-UKv8.6.indd 2
30/01/12 12:03
Sugar Free Infant Suspension
Contains 120 mg Paracetamol per 5 ml
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.
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. Maltitol may have a mild laxative effect. It has a calorific value of 2.3kcal/g. Carmoisine (E122) may cause allergic reactions.
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 c Not to anyone who is allergic to the ingredients. See section 6 c Follow the dosage instructions carefully. Children of different ages need different amounts. These are shown in the tables. See section 3 c 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 c If a child gets a rash, breathing problems, diarrhoea or gets very tired. See section 3 c
3 How to use this medicine
Check the tables to see how much medicine to use.
For oral use only. Always use the syringe supplied with the pack. It is important to shake the bottle for at least 10 seconds before use. Never give more medicine than shown in the tables. Do not give this medicine with any other paracetamolcontaining product.
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) colestyramine (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.
i
How to use the syringe
Shake the bottle for at least 10 seconds and remove the cap. There is a plug with a hole in the neck of the bottle. Insert the end of the syringe in to the hole and ensure it is secure.
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
If any of these bullet points apply, talk to a doctor or pharmacist.
1 What the medicine is for
The paracetamol in Calpol Sugar Free Infant Suspension is used to relieve pain and / or bring down fever (high temperature) in many conditions including postimmunisation fever, teething, headache, cold and flu, toothache, earache, sore throat and other aches and pains.
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. Ask your doctor or pharmacist for advice before taking this medicine if you might be pregnant or breast-feeding.
Hold the syringe in place and turn the bottle upside down and gently pull down the plunger to either 2.5 ml or 5ml as appropriate (see tables for the correct dose).
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.
Some of the ingredients can cause problems
Turn the bottle the right way up. Remove the syringe by holding onto the bottle and twisting out gently.
Methyl (E218), propyl (E216) and ethyl (E214)
turn over
F308604-PIL-CALPOLSF100200ml-UKv8.6.indd 1
30/01/12 12:03
3 How to use this medicine (continued)
Place the syringe inside the child's mouth against the cheek and press the plunger slowly to gently release the medicine. After use, the plug should remain in the neck of the bottle. Wipe the plug and neck clean and rinse the cap before replacing. The syringe should be washed and dried after use. It can be cleaned by hand or in a dishwasher.
i
Children over 6 years
Ask a pharmacist to recommend a suitable product.
Speak to your doctor:
If your baby needs more than the doses shown in the table, or if fever doesnt go away, speak to your doctor as soon as possible. If you are not sure of the cause of your childs illness or it is accompanied by a rash, breathing difficulties, diarrhoea or excessive tiredness or lethargy, speak to your doctor straight away. Do not give Calpol until you get medical advice.
kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems. If you notice any side-effects not included in this leaflet please tell your doctor or pharmacist.
5 Storing this medicine
Keep the product out of the reach and sight of children. Do not store above 25C. Keep bottle in the outer carton. Do not use after the end of the month shown as an expiry date on the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
i
Babies under 2 months
Do not give to babies under 2 months old. Consult your doctor.
If anyone has too much
Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.
Babies 2 - 3 months
Child's age - 2-3 months 1. Post-vaccination fever How much 2.5 ml If necessary, after 4-6 2. Other causes of pain and fever hours, give a second - if your baby weighs over 4 kg 2.5 ml dose. and was born after 37 weeks Do not give to babies less than 2 months of age. Do not give more than 2 doses. Leave at least 4 hours between doses. If further doses are needed, talk to your doctor or pharmacist.
If you forget to give the medicine
Give the next dose when needed, provided that the last dose was given at least 4 hours ago. Do not give a double dose.
6 Further information
Whats in this medicine?
The active ingredient is: Paracetamol 120 mg per 5 ml Other ingredients are: Maltitol liquid, glycerol, polysorbate 80, sorbitol solution (E420), 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).
4 Possible side effects
Calpol Sugar Free Infant Suspension can have side effects, like all medicines, although these dont affect everyone and are usually mild.
Children from 3 months to 6 years
Child's age 3-6 months 6-24 months 2-4 years 4-6 years
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. If your child shows any of these signs, stop giving paracetamol and talk to a doctor.
What the medicine looks like
Calpol Sugar Free Infant Suspension is a pink liquid, available in 100 ml and 200 ml bottles. It contains 120 mg of the active ingredient paracetamol in every 5 ml of medicine. The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. The manufacturer is Famar Orleans, 5 avenue de Concyr, 45071 Orlans, Cedex 2, France. This leaflet was revised January 2012. Calpol is a registered trade mark. F308604 11-0189
How much - up to 4 times a day 2.5 ml 5 ml 7.5 ml (5 ml + 2.5 ml) 10 ml (5 ml + 5 ml)
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.
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
F308604-PIL-CALPOLSF100200ml-UKv8.6.indd 2
30/01/12 12:03
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
