CARE INFANT PARACETAMOL 120 MG / 5ML SUSPENSION - patient leaflet, side effects, dosage

Patient leaflet - CARE INFANT PARACETAMOL 120 MG / 5ML SUSPENSION

TEXT FOR CARE INFANT PARACETAMOL 120MG/5ML SUSPENSION LEAFLET

PL 00240/0133

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. B

Has an allergy to any of the ingredients listed in section 6.

Is taking any other product containing paracetamol.

ATalk to your doctor or pharmacist if your child has..

Severe kidney or severe liver problems.
An intolerance to some sugars or if they have hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose (as sorbitol is a source of fructose)

ATalk 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.

A Pregnant or breastfeeding…

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding.

If necessary, 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.”

A Important information about some of the ingredients

This medicine contains maltitol and 260mg sorbitol per 5ml dose. May have a mild laxative effect. Calorific value 2.3kcal/g maltitol.
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially

| ‘sodium-free’.

This medicine contains 8mg propylene glycol in each 5ml dose.

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

Dose

Pain and other causes of fever – if your baby weighs over 4 kg and was born after 37 weeks

2.5 ml

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

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.

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.

A 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.

A 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: or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

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