Paracetamol 500mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 mgTABLETS
Read all of this leafet carefully because it contains important information for you.
- This medicine is available without prescription. However, you still need to take Paracetamol 500 mg Tablets 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 after 3 days.
- 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 500 mg Tablets are and what they are used for
2. Before you take Paracetamol 500 mg Tablets
3. How to take Paracetamol 500 mg Tablets
4. Possible side effects
5. How to store Paracetamol 500 mg Tablets
6. Further information
1. WHAT PARACETAMOL 500 mg TABLETS ARE AND WHAT THEY ARE USED FOR
Paracetamol 500 mg 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. BEFORE YOU TAKE PARACETAMOL 500 mg TABLETS DO NOT take Paracetamol 500 mg 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.
Take special care with Paracetamol 500 mg Tablets
Consult your doctor before taking these tablets if you:
• have kidney or liver problems
• are an alcoholic.
Taking other medicines
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 500 mg 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).
• chloramphenicol (an antibiotic).
Taking Paracetamol 500 mg Tablets with food and drink
Avoid alcoholic drinks whilst taking these tablets.
Pregnancy and Breast Feeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning to become pregnant or breast-feeding.
Driving and using machines
Paracetamol 500 mg Tablets are not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol 500 mg Tablets
Lactose - if you know you have an intolerance to some sugars, inform your doctor before use.
3. HOW TO TAKE PARACETAMOL 500 mg TABLETS
Always take Paracetamol 500 mg Tablets exactly as your doctor has told you. Swallow each tablet with a drink of water.
Adults and the elderly:
Take one or two tablets every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period. Children aged 10 - 15 years:
Take one tablet every 4 to 6 hours, up to a maximum of 4 tablets in any 24 hour period.
Children aged under 10 years:
This medicine is NOT recommended for children of this age.
The dose should not be repeated more frequently than 4 hourly intervals. You should not take Paracetamol 500 mg Tablets for longer than 3 days.
WARNING: DO NOT EXCEED THE STATED DOSE Contains paracetamol. Do not take with other paracetamol containing products.
If symptoms persist consult your doctor. Do not use for more than 3 days without consulting your doctor.
If you take more Paracetamol 500 mg 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.
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.
If you forget to take Paracetamol 500 mg 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.
4. Possible side effects
Like all medicines, Paracetamol 500 mg Tablets can cause side effects, although not everybody gets them.
You may suffer an allergic reaction, symptoms of which include skin rashes, hives and itching. If this happens to you, stop taking the tablets immediately and seek urgent medical help.
There have been few reports of blood abnormalities including pancreatitis (inflammation of the pancreas) in patients taking paracetamol, but these were not necessarily due to the paracetamol treatment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store PARACETAMOL 500 mg TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not use Paracetamol 500 mg 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. FURTHER INFORMATION
What Paracetamol 500 mg Tablets contain
The active substance is paracetamol 500 mg.
The other ingredients are maize starch, povidone K-30, sodium metabisulphite (E223), sodium starch glycollate, colloidal anhydrous silica and magnesium stearate (see also end of Section 2 on ‘Important information about some of the ingredients of Paracetamol 500 mg Tablets’).
What Paracetamol 500 mg Tablets look like and contents of the pack
The tablets are white with a break-line on one face and embossed ‘P500’ on the other face. They are supplied in:
• blister packs of 4, 8 and 16 tablets
• tamper-evident bottles of 4, 8 and 16 tablets.
Marketing Authorisation Holder JCSH Pharma Ltd 47 Bloomfield Close, Knaphill Woking, Surrey, GU21 2BL United Kingdom
Marketing Authorisation Number: PL 46447/0010 This leaflet was last revised in November 2016
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