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CARE INFANT PARACETAMOL 120MG/5ML SUSPENSION

Active substance(s): PARACETAMOL / PARACETAMOL

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TEXT FOR CARE INFANT PARACETAMOL 120MG/5ML SUSPENSION
LEAFLET
PL 00240/0133
Care Infant Paracetamol 120mg/5ml Suspension
Important information about Care Infant Paracetamol 120mg/5ml Suspension
● This medicine reduces fever and relieves mild to moderate pain in infants and children
between 3 months and 6 years old.
● Follow the dosage instructions carefully. Children of different ages need different amounts.
See section 3.
Do not give….
● With any other products containing paracetamol.
● For longer than 3 days without seeing your doctor.
Seek immediate medical help in the event of an overdose. See section 3.
Now read the rest of the leaflet before you use this medicine. It includes other information
which might be especially important for you.
● Keep this leaflet. You may need to read it again.
● Ask your pharmacist if you need any more information or advice.
● If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
1. What the medicine is for
Care Infant Paracetamol Suspension relieves mild to moderate pain including teething pains. It
also reduces fever including high temperatures caused by vaccinations.
This medicine contains paracetamol which has pain relieving properties and also acts to bring
down high temperature.
2. Before you use this medicine
Do not use the medicine if your child….
● Has an allergy to any of the ingredients listed in section 6.
● Is taking any other product containing paracetamol.
Talk to your doctor or pharmacist if your child has….
● Severe kidney or severe liver problems.
Talk to your doctor or pharmacist if your child is taking….
● Domperidone or metoclopramide for nausea and sickness.
● Colestyramine mainly used for high cholesterol.
● Medicines used to prevent blood clotting such as warfarin.

● Medicines used to treat seizures such as carbamazepine, fosphenytoin, phenobarbital,
phenytoin and primidone
Can adults take this medicine?
This product is intended for use by children under 6 years old. However, the following additional
warnings are included in case an adult is taking this medicine.
This medicine may be harmful if you have alcoholic liver disease.
Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or
breastfeeding.
Care Infant Paracetamol Suspension can be used during pregnancy. You should use the lowest
possible dose that reduces your pain and/or your fever and use it for the shortest time possible.
Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take the
medicine more often.”
Important information about some of the ingredients
● This medicine contains maltitol and sorbitol. If you have been told by your doctor that your
child has an intolerance to some sugars, contact your doctor before giving this medicine.
● It also contains sodium parahydroxybenzoates (E217 & E219) which may cause allergic
reactions (possibly delayed).
3. How to use this medicine
Check the tables below to see how much of the medicine to use.
● For oral use only.
● It is important to shake the bottle for at least 10 seconds before each use.
● Never give more medicine than shown in the table.
● Always use the syringe supplied with the pack.
● Do not give anything else containing paracetamol while giving this medicine.
How to use the syringe
● Shake the bottle for at least 10 seconds.
● With the bottle in the upright position remove the cap.
● Insert the syringe into the bottle.
● Holding the syringe in place, gently pull up the plunger to fill the syringe then remove it from
the bottle.
● Remove surplus liquid from the outside of the syringe using a tissue.
● Adjust the amount to the 2.5ml or 5ml mark as appropriate (see table for correct dose).
● Place the syringe inside the child’s mouth against the cheek and press the plunger slowly to
gently release the medicine.
● After use, wipe the bottle 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.

For the relief of fever after vaccinations at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more
than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this
medicine two days after receiving the vaccine talk to your doctor or pharmacist.
Age : 2 – 3 months
Pain and other causes of fever – if your baby
weighs over 4 kg and was born after 37 weeks
● Do not give to babies less than 2 months of age
● 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.

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

Children aged 3 months – 6 years:
Child’s Age
How Much
How often (in 24 hours)
3–6 months
2.5 ml
4 times
6–24 months
5ml
4 times
2–4 years
7.5ml (5ml + 2.5ml)
4 times
4–6 years
10ml (5ml + 5ml)
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.

Do not give more medicine than the label tells you to.
If your child does not get better, talk to your doctor.
If you give too much
Talk to a doctor at once if your child takes too much of this medicine even if they seem well.
This is because too much paracetamol can cause delayed, serious liver damage.
Take the pack with you to show which medicine your child has swallowed.
If you forget a dose
Give the next dose as soon as you remember. Do not give a double dose. You can then carry on with the
normal dose at the correct time.
4. Possible side effects
Like all medicines, Care Infant Paracetamol Suspension can have side effects, although not everybody
gets them.
Important side effects:
● If you think your child has any of the following serious side effects or symptoms, stop using this
medicine and see a doctor as soon as possible.

● Allergic reactions (swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing,
skin rash).
Very rare side effects:
● Changes in the blood may occur which may cause unusual bruising or an increase in the number of
infections (e.g. sore throats) which your child gets.
● Very rare cases of serious skin reactions have been reported.
If you notice these or any other side effect not included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing this medicine
● Keep it out of the sight and reach of children.
● Do not store above 25°C but do not refrigerate.
● Protect from light. Store in the original package.
● Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that
month.
● Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of any unused medicine. These measures will help to protect the environment.
6. Further information
What the medicine contains
The active ingredient per 5ml is: paracetamol 120mg.
The other ingredients are: sodium methyl parahydroxybenzoate (E219), sodium propyl
parahydroxybenzoate (E217), citric acid anhydrous, saccharin sodium, glycerol, dispersible cellulose,
strawberry flavour (contains propylene glycol), acesulphame K, carmine (E210), maltitol liquid (which
contains maltitol E965 and sorbitol E420), xanthan gum (E415), potassium hydroxide and purified water.
What the medicine looks like
Care Infant Paracetamol Suspension is a pale pink cloudy suspension which tastes of strawberry.
It is supplied in 100ml bottles.
Marketing authorisation holder and manufacturer
Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK
This leaflet was last revised in February 2017

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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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