Paracetamol 250mg/5ml Oral Suspension
PATIENT INFORMATION LEAFLET
PARACETAMOL 250 mg/5 ml ORAL SUSPENSION Paracetamol 250 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 250 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 Suspension is and what it is used for
2. Before you give Paracetamol Suspension to your child
3. How to give Paracetamol Suspension to your child
4. Possible side effects
5. How to store Paracetamol Suspension
6. Further information
Paracetamol 250 mg/5 ml Oral Suspension (“Paracetamol Suspension") contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Suspension can be used in children aged 6 years and older and adults for the treatment of mild or moderate pain and feverishness associated with teething, toothache, headache, colds and flu. It is suitable for adults who have difficulty swallowing tablets.
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
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)
• are used to prevent pregnancy (e.g. oral steroidal contraceptives)
The effects of alcohol may be Increased whilst taking Paracetamol Suspension.
Avoid alcohol when taking this medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breast-feeding.
Driving and using machines
Paracetamol Suspension is not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol Suspension
Paracetamol Suspension contains:
• Ethanol: This medicinal product contains up to 0.15 g per 5 ml dose of ethanol (alcohol), equivalent to 3.6 ml beer or 1.5 ml wine per 5 ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
• Hydrogenated glucose syrup (E965): if you or your child have an intolerance to some sugars, contact your doctor before giving this medicine.
• Sunset yellow (E110): may cause allergic reactions.
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3. HOW TO GIVE PARACETAMOL SUSPENSION TO YOUR CHILD
Check the table 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 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
|
Child’s Aae |
How Much |
How often (in 24 hours) |
|
6 - 8 years |
One 5 ml spoonful (large end) |
4 times |
|
8-10 years |
One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end) |
4 times |
|
10-12 years |
Two 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 • Do not give to children under the age of 6 years. | ||
Children aged 12-16 years: Two - three 5 ml spoonfuls (large end) up to 4 times a day Adults and children over 16 years: Two - four 5 ml spoonfuls (large end) up to 4 times a day.
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. HOW TO STORE PARACETAMOL 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 Suspension contains
Each 5 ml of Paracetamol Suspension contains:
• The active ingredient: paracetamol 250 mg.
• The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate,
hydrogenated glucose syrup (E965), saccharin sodium (E954), xanthan gum, sunset yellow (E110), orange flavour, sodium benzoate (E211), citric acid monohydrate, polysorbate 80 and purified water (see end of Section 2 for further in forma tion).
What Paracetamol Suspension looks like and contents of the pack:
Paracetamol Suspension is an orange to orange/brown suspension with orange odour and taste presented in either:
• 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.
• 500 ml, 1 litre and 2 litre amber glass bottles with pilfer-proof screw caps or in 500 ml, 1 litre and 2 litre HDPE bottles with tamper evident caps.
Marketing Authorisation Holder: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Product Licence Number: PL 04917/0010 MH/DRUGS/AD/091 220782 P-389/2 106231/3 23LF01282WK
Manufacturers: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.
Date of revision: April 2015
