Paracetamol 120mg/5ml Oral Suspension

1. What Paracetamol Oral Suspension is and what it is used for
2. What you need to know before you give Paracetamol Oral Suspension to a child
3. How to use Paracetamol Oral Suspension
4. Possible side effects
5. How to store Paracetamol Oral Suspension
6. Contents of the pack and other information

• If s/he is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
• If s/he is taking anything else with paracetamol in it
• If s/he is between 2-3 months old and is taking this medicine for other causes of pain and fever and:
  • weighs less than 4 kg or
  • was born before 37 weeks.

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

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.

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

• barbiturates (sleeping tablets)
• 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)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

If you are not sure about the medicine your child is taking, show the bottle or pack to your pharmacist. If any of these bullet points apply, talk to a doctor or pharmacist.

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 have liver problems, including those due to drinking too much alcohol, you may be more open 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 methyl and propyl parahydroxybenzoate, sucrose, propylene glycol and sorbitol.

• Methyl and propyl parahydroxybenzoates – may cause allergic reactions (possibly delayed).
• Sucrose. Contains 3g 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 162.4mg propylene glycol per 5ml spoonful. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. 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 682.0mg 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.

Check the tables below to see how much medicine to use

• This medicine contains 120mg of paracetamol in one 5ml spoonful.
• Take this medicine by mouth only.
• Never give more medicine than shown in 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 use the 1.25ml graduation marking on the spoon for dosing this product.
• Do not give this medicine with any other paracetamol-containing product.

For the relief of fever after vaccination at 2, 3 and 4 months

One 2.5 mL spoonful (small end).This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

Age

For post-vaccination fever for babies aged between 2 – 3 months

Dose

One 2.5mL spoonful (small end). If necessary, after 4-6 hours, give a second 2.5mL 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: 3 – 6 months, How Much: One 2.5 mL spoonful (small end), How often (in 24 hours): 4 times.

Child’s Age: 6 – 24 months, How Much: One 5 mL spoonful (large end), How often (in 24 hours): 4 times.

Child’s Age: 2 – 4 years, How Much: One 5.0 mL spoonful (large end) and one 2.5 mL spoonful (small end), How often (in 24 hours): 4 times.

Child’s Age: 4 – 8 years, How Much: Two 5.0 mL spoonfuls (large end), How often (in 24 hours): 4 times.

Child’s Age: 8 – 10 years, How Much: Three 5.0 mL spoonfuls (large end), How often (in 24 hours): 4 times.

Child’s Age: 10 – 12 years, How Much: Four 5.0 mL spoonfuls (large end), How often (in 24 hours): 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

• Immediate medical advice should be sought in the event of an overdose, even if your child seems 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), vomiting (being sick) and abdominal pain may occur.

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

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRAYellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is paracetamol.

The other ingredients are methyl and propyl parahydroxybenzoate (E218 and E216), propylene glycol (E1520), xanthan gum (E415), liquid sorbitol (E420), sucrose, mango flavour and purified water.

Paracetamol Suspension is a white to off-white liquid which smells of mango.

It comes in a brown glass bottle holding 100ml or 500ml of suspension.

The pack contains a 2.5ml/5ml double-ended measuring spoon to measure the dose correctly (do NOT use the 1.25ml graduation marking on the 2.5ml end of the spoon for dosing).