Paracetamol 120 mg / 5 ml oral suspension, Well Pharmaceuticals Paracetamol 120 mg / 5 ml oral suspension, Fennings Paracetamol 120 mg / 5 ml oral suspension – patient leaflet, side effects, dosage

1. What this medicine is for

2. Before using this medicine

Children aged 3 months – 6 years:

P1400T

Fennings Paracetamol belongs to a group of medicines called analgesics that help to ease pain. It is used to treat mild to moderate pain and other conditions such as headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and to bring down fever (high temperature) including fever caused by immunisation.

Talk to your doctor or pharmacist if your child…

• has serious kidney or liver problems.

• has an inherited intolerance to some sugars.

  If adults take this medicine:

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 as well on your pain or fever.

• If you drink large amounts of alcohol, you may be more open to the side effects of Fennings Paracetamol.

  If you give more Fennings 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.

  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.

  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 this medicine

  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 not sure of the cause of your child’s illness or it is accompanied by a rash, breathing difficulties, diarrhoea or excessive tiredness or lethargy, speak to your doctor straight away. Do not give Fennings Paracetamol until you get medical advice. Taking other medicines:

Tell your doctor or pharmacist if your child is taking any other medicines including herbal medicines and those that you may have bought yourself. Fennings Paracetamol can interfere with the action of some other drugs and some drugs can have an effect on Fennings Paracetamol. The drugs which can cause some problems when taken together with Fennings Paracetamol are:

• colestyramine (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)

• anticonvulsants (drugs to treat epilepsy).

  • 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.

5ml 2.5ml 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.
• breast-feeding.

If necessary, Fennings Paracetamol Oral Suspension 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.

Important information about some of the ingredients of Fennings

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). Driving and using machines

Your medicine is unlikely to affect your ability to drive or to operate machinery.

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.
• Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.
• Do not give anything else containing paracetamol while giving this medicine.
• 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.

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

One 2.5ml 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.

3. How to take this medicine

P1400T Fennings Paracetamol 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 Fennings Paracetamol Oral Suspension and tell your doctor immediately or go to the casualty department at your nearest hospital.

• allergic reactions including swelling of the face, tongue or throat, difficulty swallowing, unexplained wheezing, shortness of breath which may be accompanied by skin rash or hives.
• becoming unusually tired, unexpected bruising or bleeding and getting more infections (such as colds) than usual. These are very rare effects in people taking Fennings Paracetamol.
• very rare cases of serious skin reactions have been reported. Symptoms may include: skin reddening, blisters, rash. If skin reactions occur or existing skin symptoms worsen, stop use and seek medical help right away.

If your child shows any of these signs, stop giving Fennings Paracetamol and talk to a doctor right away.

Long term use:

People who use medicines containing Fennings Paracetamol every day for a long time (several months or more) could get certain side effects, including liver and kidney damage.

People taking Fennings Paracetamol in the usual way for shorter periods have not had these problems, but liver function tests may be affected.

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 or search for MHRA Yellow 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.

• Keep out of the sight and reach of children.
• Do not store above 25ºC. Store the container in the outer carton. Discard after 2 months of first opening.
• Do not use Fennings 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. 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

5. Storing your medicine

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.

Each bottle contains 100ml of oral suspension. The Marketing Authorisation for Fennings Paracetamol Oral Suspension (PL 20416/0523) is held by Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.

It is manufactured by Crescent Manufacturing Ltd., 2 Cunard Road, Park Royal, London, NW10 6PN, UK.

If you would like this leaflet in a different format, please contact the authorisation holder at the address above.

Leaflet Updated: March 2020

6. Further information