Paracetamol 500mg Tablets
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Read all of this leaflet carefully because it contains important information for you.
You need to take Paracetamol 500mg Tablets BP carefully to get the best results from them.
• 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.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What paracetamol is and what it is used for
2. Before you take paracetamol
3. How to take paracetamol
4. Possible side effects
5. How to store paracetamol
6. Further information
1. What paracetamol is and what it is used for
The name of your medicine is Paracetamol 500mg Tablets (called paracetamol throughout this leaflet). It belongs to a group of medicines called painkillers (analgesics).
It is used for:
• Mild to moderate pain including headache, neuralgia, toothache and pain caused by rheumatism
• Relief of symptoms from colds and flu
• Lowering high temperature (fever)
2. Before you take paracetamol
Do not take paracetamol if:
• You are allergic (hypersensitive) to paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information)
• You are taking anything else with paracetamol in it.
If you are not sure, talk to your doctor or pharmacist before taking paracetamol.
Take special care with paracetamol if:
• You have severe kidney or liver problems
• You have liver disease due to a dependence on alcohol
If you are not sure if this applies to you, talk to your doctor or pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol and some medicines can affect the way each other work.
In particular, tell your doctor if you are taking any of the following:
• Metoclopramide or domperidone - used for nausea (feeling sick), vomiting (being sick) and other stomach problems.
• Colestyramine - used for high cholesterol and other fats in the blood.
• Anti-coagulants - used to thin the blood (such as warfarin). You can take an occasional dose of paracetamol while taking anti-coagulants. However, if you need to take pain-killers every day, talk to your doctor.
• Other medicines containing Paracetamol. You should not take other medicines containing Paracetamol at the same time as taking this medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Pregnancy and breast-feeding
There have been no ill effects due to paracetamol in pregnancy, when used in the recommended doses. However, you should talk to your doctor or pharmacist before taking any medicine if you are pregnant or planning to become pregnant.
You may take paracetamol if you are breast-feeding.
Important information about some of the ingredients of your paracetamol
Paracetamol contains:
• Lactose: If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine. Each tablet contains 6.7mg of lactose.
3. How to take paracetamol
If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or you are not sure, ask your doctor or pharmacist.
Taking this medicine
• Swallow the tablets with a drink of water.
How much to take
Adults and children over 12 years
The usual dose is 1 or 2 tablets up to four times a day as required.
• Wait at least 4 to 6 hours before taking another dose.
• Do not take more than four doses in 24 hours.
• Do not take these tablets for more than 3 days unless your doctor tells you to.
• Do not take other medicines which contain paracetamol while taking these tablets
Children from 6 to 12 years of age
The usual dose is half to one tablet up to four times a day as required.
Children under 6 years of age
Do not give paracetamol to children under 6 years of age unless the doctor advises you to.
If you take more paracetamol than you should
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed serious liver damage. Take the medicine pack with you so the doctor knows what you have taken.
Possible side effects
As with all medicines, paracetamol can cause side effects, although not everybody gets them and they are usually mild.
Stop taking paracetamol and tell your doctor as soon as possible if you notice any of the following:
• Skin rash or other signs of allergic reaction such as swelling of the lips, tongue or throat.
• Becoming unusually tired, unexpected bruising or bleeding, blood in the urine, mouth ulcers, a rash of pinpoint red spots and getting more infections (such as colds) than usual. These are very rare effects in people taking paracetamol.
If you show any of these signs stop taking paracetamol immediately and talk to a doctor.
5. How to store paracetamol
• Keep out of the reach and sight of children, preferably in a locked cupboard or medicine cabinet.
• Do not use paracetamol after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.
6. Further information
What Paracetamol contains
• The active substance of Paracetamol 500mg Tablets is paracetamol. Each caplet contains 500mg of paracetamol.
• The other ingredients are: starch, lactose, povidone, magnesium stearate, sodium starch glycollate and aerosil.
What Paracetamol looks like and contents of the pack
Paracetamol 500mg Tablets are white capsule-shaped tablets. They are available in packs of 100 tablets.
Marketing Authorisation Holder
Zanza Laboratories (Holdings) Ltd, UNIT 2A Sefton Business Park, Aintree, Liverpool, L30 IRD, UK.
Distributed by: Zanza Laboratories Ltd, Liverpool, UK
Date leaflet last revised: July 2011
173/02