Paracetamol 500mg Tablets
200 x180mm - sidel
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL 500mg TABLETS Paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet
1. What Paracetamol 500mg Tablets are and what they are used for
2. What you need to know before you take Paracetamol 500mg Tablets
3. How to take Paracetamol 500mg Tablets
4. Possible side effects
5. How to store Paracetamol 500mg Tablets
6. Contents of the pack and other information
Paracetamol 500mg Tablets contain the active ingredient paracetamol which belongs to group of medicines called analgesics. They are used for the relief of mild to moderate pain, including:
• rheumatic aches (joint pain) and pains
• neuralgia (severe nerve pain), period pain
• migraine, headache
• sore throat, toothache
• fevers, colds, flu and influenza.
DO NOT take Paracetamol 500mg Tablets:
• If you are allergic (hypersensitive) to Paracetamol, other pain relievers or any of the other ingredients in the product (listed in section 6)
This medicine is NOT recommended for children under 10 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol 500mg
Tablets:
• If you have kidney or liver problems
• If you are an alcoholic.
• If you are taking any other Paracetamol-containing medicines, i.e. over-the-counter cold remedies.
Other important warning:
If you are taking painkillers for headaches too often or for too long can make them worse
Other medicines and Paracetamol 500mg Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:
• other products containing paracetamol.
• warfarin and other drugs which thin the blood.
• cholestyramine (reduces blood cholesterol levels). Should not be taken at least one hour before and after taking paracetamol.
• metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems).
• chloramphenicol (an antibiotic).
• Imatinib (used to treat leukemia and some stomach tumors).
Paracetamol 500mg Tablets with food and drink
Avoid alcoholic drinks whilst taking these tablets.
Pregnancy and Breast Feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Driving and using machines
Paracetamol 500mg Tablets are not expected to affect your ability to drive or operate machinery.
Paracetamol 500mg Tablets (JCSH - 0005) PIL
Size: 200(h) x 180(w)mm
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Paracetamol 500mg Tablets contains Sodium metablsulphlte (E223)
Sodium Metabisulphite (E223) - may cause severe hypersensitivity reactions and bronchospasm (narrowing of airways in the lungs, causing difficulty in breathing).
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow each tablet with a drink of water.
Adults, the elderly and children 16 years and over:
One or two tablets to be taken up to four times daily.
Maximum dose of 8 tablets in 24 hours.
Children 10 to 15 years of age: One tablet to be taken up to four times a day
Children under 10 years of age: Not recommended. Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500mg.
The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hour period.
You should not take Paracetamol 500mg 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 500mg 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 (loss of appetite), feeling or being sick, liver damage 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 500mg Tablets
If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
- 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 (changes in number of blood cells). If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections, pancreatitis (inflammation of the pancreas) in patients taking paracetamol, but these were not necessarily due to the paracetamol treatment. At the recommended dosages drowsiness, impairment of mental function and methaemoglobinaemia have been observed.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Paracetamol 500mg Tablets can cause side effects, although not everybody gets them.
What Paracetamol 500mg Tablets contain The active substance is paracetamol 500mg.
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 Tablets').
What Paracetamol 500mg Tablets look like and contents of the pack
The tablets are white with a breakline on one face and embossed ‘P500’ on the other face. They are supplied in:
• cartons containing blister strips of 24 and 32 tablets
• bottles of 25 tablets
Marketing Authorisation Holder:
JCSH Pharma Ltd., 47 Bloomfield Close, Knaphill, Surrey GU21 2BL, UK.
Marketing Authorisation Number: PL 46447/0005
This leaflet was last revised in October 2016. Item code
Paracetamol 500mg Tablets (JCSH - 0005) PIL
Size: 200(h) x 180(w)mm
Main Heading (page 1)type style: 13pt Helvetica Bold Caps Sub Heading type style: 11pt Helvetica Bold Caps Text type style: 9pt Helvetica Light & Bold u&lc Amended: v3 07.11.2016