Paracetamol 500mg/5ml Oral Solution
If you have an allergic reaction to this medicine see a doctor straight away.
An allergic reaction may include:
• skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever
• sudden wheezing, fluttering or tightness of the chest or collapse.
If paracetamol is taken for a long time, it may lead to liver and kidney problems.
If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PARACETAMOL ORAL SOLUTION
• keep this medicine out of the sight and reach of children
• do not use Paracetamol Oral Solution after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month
• keep this medicine in a dry place
• do not store above 25°C. Do not refrigerate or freeze
• keep the bottle in the outer carton in order to protect from light
• do not use 3 months after you first open it. Take it back to the pharmacy.
Medicines should not be disposed of via wastewater. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Paracetamol Oral Solution contains
• the active substance is paracetamol, 500mg in 5ml
• the other ingredients are citric acid monohydrate, erythrosine (E127), macrogol 400, glycerol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, raspberry flavor No.1, saccharin sodium, sodium citrate, purified water.
What Paracetamol Oral Solution looks like and contents of the pack
Paracetamol Oral Solution is a clear, pink thick liquid, with the smell of raspberry. It is available in an amber glass bottle with child proof cap packed in an outer box. A plastic dosing syringe (pipette) is also included to help measure the dose. Bottle sizes are 200ml and 300ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London EC4N 7BL, UK
Manufactured By:
Laleham Health and Beauty Limited.,
Fairfield, Bradshaw Lane, Greenhalgh, Kirkham,
Preston, Lancashire, PR4 3JA, UK
This leaflet was last revised in December 2015.
101780/LF/139/05
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you.
This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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 symptoms worsen or do not improve after a few days.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Paracetamol 500mg/5ml Oral Solution. It will be referred to as Paracetamol Oral Solution for ease hereafter.
What is in this leaflet:
1. What Paracetamol Oral Solution is and what it is used for
2. What you need to know before you take Paracetamol Oral Solution
3. How to take Paracetamol Oral Solution
4. Possible side effects
5. How to store Paracetamol Oral Solution
6. Contents of the pack and other information
1. WHAT PARACETAMOL ORAL SOLUTION IS AND WHAT IT IS USED FOR
Paracetamol Oral Solution contains paracetamol. This medicine is a higher strength Paracetamol Oral Solution. It is used for mild to moderate pain when you cannot take other paracetamol formulations such as lower strength liquid paracetamol, effervescent tablets or tablets.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL ORAL SOLUTION
Do not take Paracetamol Oral Solution if:
• you know that you are allergic to paracetamol, or any of the other ingredients (refer to section 6 below)
• a liver disorder.
This medicine should not be given to children or adolescents under the age of 16 years.
Take special care and tell your doctor or pharmacist before taking Paracetamol Oral Solution if:
• you have liver problems, including those due to drinking too much alcohol
• you have kidney problems.
Do not take more than the recommended dose.
Other medicines and Paracetamol Oral Solution
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
• antidepressants, eg amitriptyline, imipramine
• barbiturates, eg phenobarbitone
• anticonvulsants, eg carbamazepine, sodium valproate
• metoclopramide (used to treat vomiting)
• domperidone (used to treat heart burn)
• colestyramine (used to treat gall bladder problems)
• zidovudine (used in HIV infections and AIDS)
• anticoagulants which are used to prevent blood clotting, eg warfarin. Some products which can be bought without a prescription may contain paracetamol, so always check the labels for ingredients.
Paracetamol Oral Solution with food and drink
Do not drink alcohol whilst taking Paracetamol Oral Solution. This is because taking alcohol and paracetamol together can increase the risk of liver damage.
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
There are no known effects on the ability to drive and use machines.
Important Information about some of the ingredients of Paracetamol Oral Solution
This medicine contains the following ingredients:
• glycerol which may cause headache, upset stomach and diarrhoea
• methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (the allergy may happen some time after starting the medicine)
• propylene glycol may cause alcohol like symptoms.
3. HOW TO TAKE PARACETAMOL ORAL SOLUTION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How to take
• this medicine contains 500mg of paracetamol in one 5ml dose
• take this medicine by mouth only
• shake the bottle for at least 10 seconds before use.
Make sure the tamper evident seal on the bottle is intact before use. Please use the oral syringe provided to deliver your specific dose (see instructions below). The syringe can be used to measure your dose by drawing the liquid to the correct mark on the syringe.
How to use the oral syringe:
1. Shake the bottle well, making sure the cap is firmly on the bottle.
2. Remove the cap.
use.
Note: Keep the cap nearby to close the bottle after each
3. Push the plastic adapter into the neck of the bottle.
4. Take the syringe and check the plunger is fully down.
5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter.
6. Turn the whole bottle with the syringe upside down.
7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger back up, to completely expel any large air bubble that may be trapped inside the oral syringe.
8. Then pull the plunger slowly back to the volume you need for your dose.
9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle.
10. The dose of medicine can now be swallowed directly from the oral syringe. Please ensure that you are sitting upright and the plunger must be pushed slowly to allow you to swallow the dose. After administration remove the adaptor from the bottle , wash it and allow to dry till you use it the next time.
11. Replace the child proof cap after use.
12. Cleaning: After use, wipe the tip of the syringe with a dry, clean tissue.
Do not give this medicine with any other paracetamol-
containing product.
Do not exceed the stated dose.
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Adults and young persons 16 years and over
500mg (5ml) to 10OOmg (10ml) up to three to four times a day, as required. Maximum daily intake should not exceed 4g (40ml).
How often to take
• take a dose of this medicine every 4 to 6 hours when needed
• do not take more than 4 doses in 24 hours.
Check with your doctor about this.
Paracetamol Oral Solution is not recommended for children under 16 years.
If you take more Paracetamol Oral Solution than you should
You should not take more than 40ml of Paracetamol Oral Solution in 24 hours. If you think you have taken too much medicine even if you feel well, contact your doctor or hospital immediately, take the remaining solution and this leaflet with you so that the medical staff knows what you have taken.
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.
If you forget to take Paracetamol Oral Solution
Do not take more than one dose at a time. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Oral Solution can cause side effects, although not everybody gets them. The following side effects are rare:
• bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder)
• severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation).
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