Patient leaflet - PARACETAMOL 500 MG TABLETS, ACTAVIS PARACETAMOL 500 MG TABLETS
PARACETAMOL 500mg TABLETS
Read all of this leaflet carefully because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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1. What Paracetamol Tablets are and what they are used for
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2. What you need to know before you take Paracetamol Tablets
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3. How to take Paracetamol Tablets
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4. Possible side effects
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5. How to store Paracetamol Tablets
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6. Contents of the pack and other information
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1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
Paracetamol Tablets contain the active ingredient paracetamol and are used for the relief of mild to moderate pain including:
- rheumatic aches and pains
- neuralgia (severe nerve pain), period pain
- migraine, headache
- sore throat, toothache
- fevers, colds, flu and influenza.
2. what you need to know before you take paracetamol tablets
DO NOT take Paracetamol Tablets if you are:
- allergic (hypersensitive) to Paracetamol, other pain relievers or any of the other ingredients in the product (see Section 6 and end of Section 2)
- taking any other Paracetamol-containing medicines, i.e. over-the-counter cold remedies.
This medicine is NOT recommended for children under 6 years of age.
Warnings and precautions
Consult your doctor before taking these tablets if you:
- have kidney or liver problems
- are an alcoholic.
Other medicines and Paracetamol Tablets
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:
- other products containing paracetamol (see 'DO NOT take Paracetamol Tablets’)
- warfarin and other drugs which thin the blood
- cholestyramine (reduces blood cholesterol levels)
- metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems).
3. HOW TO TAKE PARACETAMOL TABLETS
4. POSSIBLE SIDE EFFECTS
Always take Paracetamol Tablets exactly as your doctor has told you. Swallow each tablet with a drink of water.
Adults, the elderly and children over 16 years:
Take one or two tablets every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period.
Children 12–15 years of age:
Take one to one & half tablets every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.
200 mm
Children 10–12 years of age:
Take one tablet every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.
Children 6–10 years of age:
Take half tablet every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.
Do not give this medicine to children under 6 years of age, except on medical advice.
The dose should not be repeated more frequently than 4 hourly intervals. You should not take Paracetamol Tablets for longer than 3 days.
WARNING: DO NOT EXCEED THE STATED DOSE Contains paracetamol. Do not take with other paracetamol containing products.
Do not exceed the treatment for more than 3 days and if symptoms persist seek medical advice before continuing treatment.
If symptoms persist for more than 3 days, speak to your doctor.
If you take more Paracetamol Tablets than you should
It is extremely important to follow the dosage instructions that have been given to you. Do not change your dose without discussing it with your doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If you accidentally take more than the recommended dose, or know someone who has, contact your doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.
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.
If you forget to take Paracetamol Tablets
If you miss a dose, take it as soon as you remember. NEVER take a double dose to make up for the dose you have forgotten.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Paracetamol Tablets can cause side effects, although not everybody gets them.
You may suffer an allergic reaction, symptoms of which include skin rashes, hives. If this happens to you, stop taking the tablets immediately and seek urgent medical help.
There have been few reports of blood abnormalities in patients taking Paracetamol, but these were not necessarily due to the Paracetamol treatment.
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 via the Yellow Card Scheme at 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.
5. how to store paracetamol tablets
Keep out of sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use Paracetamol Tablets after the expiry date shown on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other information
What Paracetamol Tablets contain
The active substance is paracetamol 500mg.
The other ingredients are povidone, lactose, starch (maize), magnesium stearate, sodium starch glycollate, colloidal anhydrous silica (see also end of Section 2 on 'Important information about some of the ingredients of Paracetamol Tablets’).
What Paracetamol Tablets look like and contents of the pack
Paracetamol Tablets are white capsule shaped tablets with break-line. They are supplied in child-resistant blister packs of 16s, 24s, 32s, 48s, 96s and 100s (not all pack sizes may be marketed).
Marketing Authorisation Holder: Fourrts (UK) Pharmacare Ltd,
5, Braemore Court, Cockfosters Road, Barnet, Hertfordshire, EN4 OAE, UK.
Manufacturer: i
Rx Farma Limited, Unit 3 colonial Way, Watford, Hertfordshire, £
WD24 4YR, UK.
Marketing Authorisation Number: PL 39484/0038
This leaflet was last revised in November/2019.
Name of the artwork