PARACETAMOL CAPLETS 500 MG
Active substance: PARACETAMOL
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PATIENT INFORMATION LEAFLET PARACETAMOL CAPLETS 500MG Read all of this leaflet carefully because it contains important information for you. You need to take Paracetamol Caplets 500mg carefully to get the best results from them. o o o o 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 Caplets 500mg (called paracetamol throughout this leaflet). It belongs to a group of medicines called painkillers (analgesics). It is used for: o Mild to moderate pain including headache, toothache, period pain and pain caused by rheumatism o Relief of symptoms from colds and flu o Lowering high temperature (fever) 2. BEFORE YOU TAKE PARACETAMOL
Do not take paracetamol if: o You are allergic (hypersensitive) to paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information) o You are taking anything else with paracetamol in it. o You have liver disease due to a dependence on alcohol If you are not sure, talk to your doctor or pharmacist before taking paracetamol. Take special care with paracetamol if: o You have severe kidney or liver problems 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:
o o o
o
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 ingredients in Paracetamol This medicine contains the ingredient sodium metabisulphite. hypersensitivity reactions and bronchospasm (difficulty breathing). 3. HOW TO TAKE PARACETAMOL
This may rarely cause severe
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 o Swallow the caplets with a drink of water. How much to take Adults and children over 12 years The usual dose is 1 or 2 caplets up to four times a day as required. o Wait at least 4 to 6 hours before taking another dose. o Do not take more than four doses in 24 hours. o Do not take these caplets for more than 3 days unless your doctor tells you to. o Do not take other medicines which contain paracetamol while taking these caplets. Children from 6 to 12 years of age The usual dose is half to one caplet 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. Do not exceed the recommended dose. 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. 4. 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: o
o
Skin rash or other signs of allergy. Unexpected bruising or bleeding, or 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. o o o o 6. 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. Do not store above 25C. Keep the container tightly closed. FURTHER INFORMATION
What Paracetamol contains The active substance of Paracetamol Caplets 500mg is paracetamol. Each caplet contains 500mg of paracetamol. The other ingredients are: maize starch, sodium metabisulphite, magnesium stearate and colloidal anhydrous silica. What Paracetamol looks like and contents of the pack Paracetamol Caplets 500mg are round, white caplets with a break line on one side. They are available in packs of 16, 32, and 100 caplets. Marketing Authorisation Holder The holder of the marketing authorisation is Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. PL 30464/0065-67 Date leaflet last revised: August 2012
1.
WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Paracetamol Caplets 500mg (called paracetamol throughout this leaflet). It belongs to a group of medicines called painkillers (analgesics). It is used for: o Mild to moderate pain including headache, toothache, period pain and pain caused by rheumatism o Relief of symptoms from colds and flu o Lowering high temperature (fever) 2. BEFORE YOU TAKE PARACETAMOL
Do not take paracetamol if: o You are allergic (hypersensitive) to paracetamol or any of the other ingredients in your medicine (listed in Section 6: Further information) o You are taking anything else with paracetamol in it. o You have liver disease due to a dependence on alcohol If you are not sure, talk to your doctor or pharmacist before taking paracetamol. Take special care with paracetamol if: o You have severe kidney or liver problems 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:
o o o
o
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 ingredients in Paracetamol This medicine contains the ingredient sodium metabisulphite. hypersensitivity reactions and bronchospasm (difficulty breathing). 3. HOW TO TAKE PARACETAMOL
This may rarely cause severe
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 o Swallow the caplets with a drink of water. How much to take Adults and children over 12 years The usual dose is 1 or 2 caplets up to four times a day as required. o Wait at least 4 to 6 hours before taking another dose. o Do not take more than four doses in 24 hours. o Do not take these caplets for more than 3 days unless your doctor tells you to. o Do not take other medicines which contain paracetamol while taking these caplets. Children from 6 to 12 years of age The usual dose is half to one caplet 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. Do not exceed the recommended dose. 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. 4. 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: o
o
Skin rash or other signs of allergy. Unexpected bruising or bleeding, or 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. o o o o 6. 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. Do not store above 25C. Keep the container tightly closed. FURTHER INFORMATION
What Paracetamol contains The active substance of Paracetamol Caplets 500mg is paracetamol. Each caplet contains 500mg of paracetamol. The other ingredients are: maize starch, sodium metabisulphite, magnesium stearate and colloidal anhydrous silica. What Paracetamol looks like and contents of the pack Paracetamol Caplets 500mg are round, white caplets with a break line on one side. They are available in packs of 16, 32, and 100 caplets. Marketing Authorisation Holder The holder of the marketing authorisation is Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland. PL 30464/0065-67 Date leaflet last revised: August 2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
