PARACETAMOL 250 MG / 5ML ORAL SUSPENSION - patient leaflet, side effects, dosage

1. what paracetamol oral suspension is and what it is used for

Paracetamol belongs to a group of medicines called pain-killers or analgesics.

• It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains.
• It is also used to relieve the symptoms of cold and flu
• It is also used to help reduce a fever (high temperature).

2. what you need to know before you use paracetamol oral suspension

Do not give this medicine to a child:

• If s/he is allergic to paracetamol or any of the ingredients listed in section 6.

An allergic reaction can include a rash, itching or shortness of breath.

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• If s/he has taken any other medicine that contains paracetamol.

Speak to your doctor or pharmacist if any of these apply to your child.

Warnings and precautions

Talk to your doctor or pharmacist before giving Paracetamol to a child:

• If s/he has kidney problems
• If s/he has liver problems
• If s/he has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars.

Your child may be more at risk of the side effects of paracetamol.

Speak to your doctor or pharmacist if any of these apply to your child.

Other medicines and Paracetamol:

Tell your doctor if your child is taking any of these medicines:

• barbiturates (sleeping tablets)

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• tricyclic antidepressants (such as amitriptyline)
• colestyramine (used to treat high cholesterol)
• warfarin (used to thin the blood and prevent clotting)
• zidovudine (used in HIV infections and AIDS)
• domperidone and metoclopramide (used to treat nausea and vomiting)
• anticonvulsants (medicines used to treat epilepsy or fits).

The following additional warnings are included in case an adult takes this product:

• you can use this medicine while you are taking oral contraceptives “the pill”, but it may not work so well on your pain or fever.
• if you drink large amounts of alcohol, talk to your doctor before you take this medicine. You may be more susceptible to the side-effects of paracetamol. If this applies to you talk to a doctor before use.
• if you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.
• if necessary Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.
• this medicine should not affect your ability to drive or use machines.

Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Paracetamol Suspension contains tartrazine and carmoisine, methyl and propyl parahydroxyben­zoate, sucrose, propylene glycol and sorbitol.

This medicine contains:

• Tartrazine and carmoisine (in the flavouring) – these may cause allergic reactions.
• Methyl and propyl parahydroxyben­zoates – may cause allergic reactions (possibly delayed).

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• Sucrose. Contains 2.5g of sucrose per 5ml spoonful. This should be taken into account if you have diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• Propylene glycol. This medicine contains 144.8mg propylene glycol per 5ml spoonful. If you are pregnant, breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
• Sorbitol. This medicine contains 680.5mg sorbitol per 5ml spoonful. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• This medicine contains less than 1mmol sodium per ml, that is to say essentially ‚sodium-free‘..

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3. how to use paracetamol oral suspension

Use this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Using this medicine

Check the table below to see how much medicine to use

• This medicine contains 250mg of paracetamol in one 5ml spoonful.
• Take this medicine by mouth only.
• Never give more medicine than shown in the table.
• It is important to shake the bottle for at least 10 seconds before use.
• Always use the spoon supplied with the pack. Do not overfill the spoon.
• Do not give this medicine with any other paracetamol-containing product.
• 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 Do not give to children under the age of 6 years.
• 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 Do not give to children under the age of 6 years.
• Immediate medical advice should be sought in the event of an overdose, even if you or your child seem well. This is because too much paracetamol can cause delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.
• There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), sweating, vomiting (being sick), loss of appetite and abdominal pain may occur.

If you forget to take this medicine:

Take the next dose when needed, provided that the last dose was taken at least 4 hours ago. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

5. How to store Paracetamol Oral Suspension

6. Contents of the pack and other information

What Paracetamol Suspension looks like and contents of the pack

Paracetamol Suspension is a white to off-white liquid which smells of mango and pineapple. It comes in a brown glass bottle holding 100ml or 500ml of suspension.

A 2.5ml/5ml double ended spoon is provided to measure the dose.

The Marketing Authorisation Holder and Manufacturer is:

Rosemont Pharmaceuticals Ltd,

Yorkdale Industrial Park,

Braithwaite Street,

Leeds, LS11 9XE, UK.

Tel: + 44 (0) 113 244 1400

This leaflet was last revised in October 2021