Patient Leaflet Updated 24-Oct-2019 | Rosemont Pharmaceuticals Limited
Paracetamol Adult 500mg/5ml Oral Suspension
Patient Information Leaflet
Paracetamol Adult 500mg/5ml Oral Suspension
Read all of this leaflet carefully before you start taking this medicine.
What is in this leaflet
1. What Paracetamol Oral Suspension is and what it is used for
2. What you need to know before you take Paracetamol Oral Suspension
3. How to take Paracetamol Oral Suspension
4. Possible side effects
5. How to store Paracetamol Oral Suspension
6. Contents of the pack and other information
1. What Paracetamol Oral Suspension is and what it is used for
Paracetamol belongs to a group of medicines called pain-killers or analgesics. This medicine is a higher strength Paracetamol Oral Suspension. It is used for mild to moderate pain when you cannot take other paracetamol formulations such as a lower strength liquid paracetamol, effervescent tablets or tablets.
2. What you need to know before you take Paracetamol Oral Suspension
Do not take this medicine if you have:
This medicine should not be given to children or adolescents under the age of 16 years.
Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol.
Warning and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
You may be more at risk of the side effects of paracetamol. Speak to your doctor or pharmacist if any of these apply to you.
Medicines containing paracetamol should only be used for a few days without advice from your doctor or dentist.
If you have a high fever, signs of a secondary infection or if symptoms persist for more than three days, consult your doctor.
Prolonged use of paracetamol, especially in combination with other pain killing medicinal products, may cause kidney problems.
Other medicines and Paracetamol
You must not take any other medicines that contain paracetamol while you are taking this medicine.
Tell your doctor if you are taking any of these medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Paracetamol Oral Suspension with food and drink
Do not drink alcohol while taking paracetamol. This is because taking alcohol and paracetamol together can increase the risk of liver damage.
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.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine should not affect your ability to drive or use machines.
Paracetamol Oral Suspension contains methyl and propyl parahydroxybenzoate, propylene glycol and liquid maltitol
Paracetamol Oral Suspension contains:
3. How to take Paracetamol Oral Suspension
Take 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.
How to take
Measuring your dose:
1. Open the bottle: press the cap and turn it anticlockwise.
2. Insert the syringe adaptor into the bottle neck.
3. Take the syringe and put it in the adaptor opening.
4. Turn the bottle upside down.
5. Fill the syringe with a small amount of solution by pulling the piston down. Then push the piston upward in order to remove any possible bubbles. Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.
6. Turn the bottle the right way up.
7. Remove the syringe from the adaptor. Put the end of the syringe into your mouth and push the piston slowly back in to take the medicine.
8. Wash the syringe with water and let it dry before you use it again.
9. Close the bottle with the plastic screw cap.
How much to take
How often to take
Do not exceed the stated dose.
If you take more paracetamol than you should (overdose):
If you forget to take this medicine:
Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, paracetamol can cause side effects, although not everybody gets them. The side effects below may sometimes happen.
If you have an allergic reaction to this medicine see a doctor straight away.
An allergic reaction may include:
If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:
Tell your doctor if you get any of these side effects:
If paracetamol is taken for a long time, it may lead to liver and kidney problems.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Paracetamol Oral Suspension
6. Contents of the pack and other information
What Paracetamol Oral Suspension contains
The active substance is paracetamol. Each 5ml contains 500mg paracetamol.
The other ingredients are methyl and propyl parahydroxybenzoate (E218 and E216), propylene glycol (E1520), liquid maltitol (E965), saccharin sodium, acesulfame potassium (E950), sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, magnesium aluminium silicate, masking flavour, strawberry flavour and purified water.
What Paracetamol Oral Suspension looks like and contents of the pack
Paracetamol Oral Suspension is a pink-brown liquid which smells of strawberry. It comes in a brown glass bottle holding 150ml of oral suspension with a 5ml purple syringe and an adaptor
The Marketing Authorisation Holder and Manufacturer is
This leaflet was last revised in 09/2019
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Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
http://www.rosemontpharma.com
+44 (0)113 245 3567
+44 (0)7836 557 879