Paracetamol 120mg/5ml Oral Suspension
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Read all of this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you still need to use Mandanol Infant Paracetamol Oral Suspension (now called Paracetamol Oral Suspension throughout the leaflet) 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 contact a doctor if your or your childs symptoms worsen or do not improve after 3 days.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What this medicine is for
2. Before using this medicine
3. How to take this medicine
4. Possible side effects
5. Storing your medicine
6. Further information
1. What this medicine is for
Paracetamol belongs to a group of medicines called analgesics that help to ease pain.
It is used to treat mild to moderate pain including teething pain. It is also used to bring down fever (high temperature) including fever caused by immunisation.
2. Before using this medicine
This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
□ Do not take or give your child this medicine...
• if you/your child has ever had a bad reaction to any of the ingredients (see section 6).
• if you/your child is taking anything else with paracetamol in it. Paracetamol is often included in cold and flu remedies, and in other medicines you can buy, (such medicines have "contains paracetamol" printed on the pack).
If any of these applies, get advice from a pharmacist or doctor without using Paracetamol Oral Suspension.
A Talk to your doctor or pharmacist...
• If you/your child has serious kidney or liver problems.
• If you/your child are dependent on alcohol
A Taking other medicines:
Tell your doctor or pharmacist if you are taking any other medicines including herbal medicines and those that you may have bought yourself.
Paracetamol can interfere with the action of some other drugs and some drugs can have an effect on paracetamol. The drugs which can cause some problems when taken together with paracetamol are:
- barbiturates (sleeping tablets)
-tricyclic antidepressants (e.g. amitriptyline)
- cholestyramine (used in the treatment of high cholesterol levels)
- warfarin (used to thin the blood and prevent clotting)
- domperidone and metoclopramide (used in the treatment of nausea and vomiting).
A Pregnancy and Breast-feeding
• Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or think you might be pregnant.
• Ask your doctor or pharmacist for advice before taking this medicine if you are breast-feeding.
Driving and using machines Your medicine is unlikely to affect your ability to drive or to operate machinery.
A Important information about some of the ingredients of Paracetamol Oral Suspension
• Maltitol liquid: If you have been told by your doctor that you or your child have intolerance to some sugars, contact your doctor before taking this medicine.
• Sodium methyl parahydroxybenzoate (E219) and Sodium propyl parahydroxybenzoate (E217): May cause allergic reactions (possibly delayed).
3. How to take this medicine
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 that shown in the table
• Do not give this medicine with any other paracetamol-containing product
• Do not overfill the spoon.
• Always use the spoon supplied with the pack. The big spoon measures 5ml and the small spoon measures 2.5ml.
5ml ^ <4— 2.5ml
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.
For Pain and Fever Relief:
|
Child’s age |
How much to give |
|
3 - 6 months: |
One 2.5ml spoonful (small end) four times a day. |
|
6 - 24 months: |
One 5ml spoonful (large end) four times a day. |
|
2 - 4 years: |
One 5ml spoonful (large end) and one 2.5ml spoonful (small end) four times a day. |
|
4 - 6 years: |
Two 5ml spoonfuls (large end) four times a day. |
• 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.
A ^ you give more Paracetamol Oral Suspension than you should
If you accidentally take/or give an overdose of this medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified. Immediate medical advice should be sought in the event of an overdose even if the child does feel well because of the risk of delayed, serious liver damage.
There may be no symptoms during the first 24 hours although loss of colour, feeling sick, vomiting and abdominal pain may occur.
If you forget to give Paracetamol Oral Suspension
Give the next dose when needed provided that the last dose was given at least 4 hours ago. Do not give a double dose.
If you are worried, or not sure of when or how to use this medicine, ask your doctor or pharmacist for advice.
4. Possible side effects
Paracetamol Oral Suspension can have side effects, like all medicines, although these don’t affect everyone and are usually mild.
If any of the following happen, stop giving Paracetamol Oral Suspension and tell your doctor immediately or go to the casualty department at your nearest hospital.
• Swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing.
These are all very serious side effects. If you or your child have them, you may have a serious allergic reaction to Paracetamol Oral Suspension. You may need urgent medical attention or hospitalisation.
All of these very serious side effects are very rare.
Tell your doctor as soon as possible if you notice any of these:
• skin rashes or other signs of allergy.
• becoming unusually tired, unexpected bruising or bleeding and getting more infections (such as colds) than usual.
These are very rare side effects in people taking paracetamol.
If your child shows any of these signs, stop giving paracetamol and talk to your doctor.
Long term use:
People who use medicines containing paracetamol every day for a long time (several months or more) could get certain side effects, including liver and kidney damage.
People taking paracetamol in the usual way for shorter periods have not had these problems.
If you notice any side effects not included in this leaflet please tell your doctor or pharmacist.
Each bottle contains 100ml or 200ml of oral suspension.
The Marketing Authorisation for Paracetamol Oral Suspension (PL 20941/0001) is held by Edict Consulting Ltd., 49 Ivinghoe Road, Bushey, Herts WD23 4SW.
It is manufactured by Orbis Consumer Products Ltd, Cunard Road, Park Royal, London NW10 6PN.
It is distributed by M&A Pharmachem Ltd Bolton BL5 2AL
Contact us at the above address for information in large print, audio or braille
Leaflet Updated: May 2011
5. Storing your medicine
• Keep out of the reach and sight of children
• Do not store above 25°C. Store the container in the outer carton. Discard after 2 months of first opening.
• Do not use Paracetamol Oral Suspension after the expiry date which is stated on the bottle after Exp:. The expiry date refers to the last day of that month.
• Medicines should not be disposed 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
Each 5ml of suspension contains 120mg Paracetamol.
It also contains glycerol, polysorbate 80, xanthan gum (E415), maltitol liquid (E965), sodium saccharin (E954), citric acid monohydrate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), strawberry flavour (containing propylene glycol) and purified water.
3047/2/MA