Paediatric Paracetamol Elixir Bp
PATIENT INFORMATION LEAFLET PAEDIATRIC PARACETAMOL ELIXIR BP Paracetamol 120 mg/5 ml
Read all of this leaflet carefully because it contains important information for you and your child.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or your childs.
• 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 Elixir is and what it is used for
2. Before you give Paracetamol Elixir to your child
3. How to give Paracetamol Elixir to your child
4. Possible side effects
5. How to store Paracetamol Elixir
6. Further information
1. WHAT PARACETAMOL ELIXIR IS AND WHAT IT IS USED FOR
Paediatric Paracetamol Elixir (“Paracetamol Elixir”) contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Elixir can be used in babies and children for the treatment of mild or moderate pain and feverishness, and also in babies who develop fever after vaccination.
2. BEFORE YOU GIVE PARACETAMOL ELIXIR TO YOUR CHILD
DO NOT give Paracetamol Elixir if your child is taking any other paracetamol containing products, other flu, cold, cough or decongestant products, or alcohol.
DO NOT give Paracetamol Elixir to your child if he/she:
• is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Elixir (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 Elixir
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 Elixir
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 Elixir is not expected to affect ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol Elixir
Paracetamol Elixir contains:
• Ethanol: This medicinal product contains 0.5 g of ethanol (alcohol) per 5 ml dose, equivalent to 12 ml beer or 5 ml wine per 5 ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
• Sorbitol: if your child has an intolerance to some sugars, contact your doctor before giving this medicine.
• Propylene glycol: may cause alcohol-like symptoms, so you should supervise your child after giving this medicine.
3. HOW TO GIVE PARACETAMOL ELIXIR 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
|
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 |
4 times |
|
one 2.5 ml spoonful (small end) | ||
|
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 t • Leave at least 4 hoi • Do not give this m< doctor or pharmaci • If your child does r |
ian 4 doses in any 24 hour period urs between doses idicine to your child for more than 3 days without speaking to your st iot 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 Elixir 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 Elixir 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 ELIXIR 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 Elixir contains
Each 5 ml of Paracetamol Elixir contains:
• The active ingredient: paracetamol 120 mg.
• The other ingredients are: ethanol, propylene glycol, glycerol (E422), sorbitol solution, acesulfame K, saccharin sodium (E954), xanthan gum, quinoline yellow (E104), banana liquid flavour, sodium citrate, citric acid and purified water (see end of Section 2 for further information).
What Paracetamol Elixir looks like and contents of the pack:
Paracetamol Elixir is a pale clear to slightly opalescent yellow viscous liquid with an odour and taste of banana presented in 500 ml, 1 litre or 2 litre amber glass bottles with pilfer-proof screw caps, or in 500 ml, 1 litre or 2 litre HDPE bottles with tamper evident caps.
Marketing Authorisation Holder: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Product Licence Number: PL 04917/0008
Manufacturers:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.