Paracetamol 120 Mg/5 Ml Oral Suspension
PATIENT INFORMATION LEAFLET PARACETAMOL 120 mg/5 ml ORAL SUSPENSION 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 Paracetamol 120 mg/5 ml Oral Suspension 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. What Paracetamol Oral Suspension is and what it is used for
2. Before you give Paracetamol Oral Suspension to your child
3. How to give Paracetamol Oral Suspension to your child
4. Possible side effects
5. How to store Paracetamol Oral Suspension
6. Further information
Paracetamol 120 mg/5 ml Oral Suspension (“Paracetamol Oral Suspension") contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Oral 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.
DO NOT give Paracetamol Oral Suspension If your child Is taking any other paracetamol-containing products, other flu, cold, cough or decongestant products, or alcohol.
DO NOT give Paracetamol Oral Suspension to your child If he/she:
• is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Oral Suspension (see Section 6 and end of Section 2).
• has kidney or liver problems
If you are not sure about any of the above, please consult your doctor.
Take special care with Paracetamol Oral 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 Oral Suspension.
Avoid alcohol while 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 Oral Suspension is not expected to affect ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol Oral Suspension
Paracetamol Oral Suspension contains:
• Ethanol: This medicinal product contains small quantities of ethanol (alcohol), less than 100 mg per 5 ml. (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).
• Liquid Maltitol (E965): if your child has an intolerance to some sugars, contact your doctor before giving this medicine.
3. HOW TO GIVE PARACETAMOL ORAL 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 . c „„„„
Do not overfill the spoon 23LI-U123UPw
Always use the spoon supplied with the pack
Do not give anything else containing paracetamol while giving this medicine
|
Age |
Dose |
|
For post-vaccination fever for babies aged between 2 - 3 months |
One 2.5 ml spoonful (small end) If necessary, after 4-6 hours, give a second 2.5 ml dose |
|
• 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 | |
|
Child’s Age |
How Much |
How often (in 24 hours) |
|
3 - 6 months |
One 2.5 ml spoonful (small end) |
4 times |
|
6 - 24 months |
One 5 ml spoonful (large end) |
4 times |
|
2 - 4 years |
One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end) |
4 times |
|
4 - 8 years |
Two 5 ml spoonfuls (large end) |
4 times |
|
8-10 years |
Three 5 ml spoonfuls (large end) |
4 times |
|
10-12 years |
Four 5 ml spoonfuls (large end) |
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 • If your child does not get better, talk to your doctor | ||
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 Oral 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 Oral 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. HOW TO STORE PARACETAMOL ORAL SUSPENSION
Keep all medicines out of reach and sight 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 Oral Suspension contains
Each 5 ml of Paracetamol Oral Suspension contains:
• The active ingredient: paracetamol 120 mg.
• The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, liquid
maltitol (E965), saccharin sodium (E954), xanthan gum, cherry flavour, sodium benzoate (E211), citric acid monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information).
What Paracetamol Oral Suspension looks like and contents of the pack:
Paracetamol Oral Suspension is a cream to brown oral suspension with cherry odour and taste presented in 70 ml, 100 ml,
150 ml and 200 ml amber glass bottles with pilfer-proof screw caps. A 2.5 ml/5 ml measuring spoon is provided. This medicinal product is a colour free and sugar free product.
Marketing Authorisation Holder:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Product Licence Number: PL 04917/0028 Manufacturers:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.
Date of revision: June 2014 23LF01230PW
