Paracetamol 120mg/5ml Oral Suspension
PATIENT INFORMATION LEAFLET
ASDA INFANT PARACETAMOL ORAL SUSPENSION 120 mg/5 ml Paracetamol 120 mg/5 ml
Read all of this leaflet carefully because it contains important information for you and your child.
This medicine is available without prescription; however, you still need to give Asda Infant Paracetamol Oral Suspension 120 mg/5 ml carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see a doctor if your child’s symptoms worsen or do not improve after 3 days.
• 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.
In this leaflet:
1.
2.
3.
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6.
1.
What Paracetamol Suspension is and what it is used for
Before you give Paracetamol Suspension to your child
How to give Paracetamol Suspension to your child
Possible side effects
How to store Paracetamol Suspension
Further information
WHAT PARACETAMOL SUSPENSION IS AND WHAT IT IS USED FOR
Your medicine is called Asda Infant Paracetamol Oral Suspension 120 mg/5 ml. It will be referred to throughout this leaflet as 'Paracetamol Suspension’. Paracetamol Suspension contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Suspension can be used in babies and children for the treatment of mild or moderate pain and feverishness associated with teething, toothache, headache, colds and flu. It can also be used in babies who develop fever after vaccination.
2. BEFORE YOU GIVE PARACETAMOL SUSPENSION TO YOUR CHILD
DO NOT give Paracetamol Suspension if your child is taking any other paracetamol containing products, other flu, cold, cough or decongestant products, or alcohol.
DO NOT give Paracetamol Suspension to your child if he/she:
• is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Suspension (see Section 6 and end of Section 2).
• has kidney or liver problems
• has a rare hereditary problem of fructose intolerance.
If you are not sure about any of the above, please consult your doctor.
Take special care with Paracetamol Suspension
If your child does not get better, talk to your doctor.
Taking other medicines
Tell your doctor or pharmacist if your child is taking, or has recently taken, any other medicine, even those obtained without a prescription, but especially medicines which:
• are to treat 'flu’ or a cold, containing paracetamol and/or a decongestant
• thin the blood (e.g. warfarin)
• control nausea and vomiting (e.g. domperidone or metoclopramide)
• reduce levels of cholesterol and other fats in the blood (e.g. colestyramine)
• treat epilepsy (e.g. anti-convulsants)
• have been prescribed by your doctor to improve sleep (e.g. barbiturates), or for anxiety or depression (e.g. tricyclic antidepressants).
The effects of alcohol may be increased whilst taking Paracetamol Suspension.
Avoid alcohol when taking this medicine.
Pregnancy and breast-feeding
This medicine is intended for use in children.
Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breast-feeding.
Driving and using machines
This medicine is intended for use in children. However, it should be noted that Paracetamol Suspension is not expected to affect ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol Suspension
Paracetamol Suspension contains:
• Ethanol: This medicinal product contains small amounts of ethanol (alcohol) less than 100 mg per dose. (It contains up to 0.08 g of ethanol (alcohol) per 5 ml dose, equivalent to less than 2 ml beer or 1 ml wine per 5 ml dose).
• Hydrogenated glucose syrup (E965): if your child has an intolerance to some sugars, contact your doctor before giving this medicine.
• Amaranth (E123) (colouring): may cause allergic reactions.
3. HOW TO GIVE PARACETAMOL SUSPENSION TO YOUR CHILD
Check the tables overleaf 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 use
• Never give more medicine than shown in the table
• Do not overfill the spoon
• Always use the spoon supplied with the pack
• Do not give anything else containing paracetamol while giving this medicine 23LF01385PW
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Babies over 2 months in age
For the relief of fever after vaccination at 2, 3 and 4 months
2.5 ml. This dose may be given up to 4 times a day 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.
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 2.5 ml 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) |
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3 - 6 months |
2.5 ml |
4 times |
|
6 - 24 months |
5 ml |
4 times |
|
2 - 4 years |
7.5 ml (5 ml + 2.5 ml) |
4 times |
|
4 - 6 years |
10 ml (5 ml + 5 ml) |
4 times |
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• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses | ||
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• Do not give this medicine to your child for more than 3 days without | ||
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If your child takes more of this medicine than they should:
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.
If you forget to give this medicine:
If you miss a dose give it as soon as you remember and take any remaining doses for that day at evenly spaced times.
Do not take a double dose to make up for the missed dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Suspension can cause side effects although not everybody gets them.
You or your child may notice the following:
■ rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing, which may be signs of an allergic reaction.
STOP giving Paracetamol Suspension to your child immediately.
• blood disorders
Very rare cases of serious skin reactions have been reported.
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.
Keep all medicines out of the sight and reach of children.
Do not store above 25°C. Store in the original container. Keep the container in the outer carton.
Do not use this medicine after the expiry date which is stated on the label and/or carton. The expiry date refers to the last day of that month 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.
6. FURTHER INFORMATION
What Paracetamol Suspension contains
Each 5 ml of Paracetamol Suspension contains:
• The active ingredient: paracetamol 120 mg.
• The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, hydrogenated glucose syrup (E965), saccharin sodium (E954), xanthan gum, amaranth (E123), cherry flavour, sodium benzoate (E211), citric acid monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information).
What Paracetamol Suspension looks like and contents of the pack:
Paracetamol Suspension is a pink suspension with cherry odour and taste presented in 70 ml, with pilfer-proof screw caps. A 2.5 ml/5 ml measuring spoon is provided.
Marketing Authorisation Holder:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Product Licence Number: PL 04917/0009
Manufacturers:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.
100 ml, 150 ml and 200 ml amber glass bottles
June 2016
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