Paracetamol Tablets Bp 500mg
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Patient Information Leaflet
PARACETAMOL 500 MG TABLET
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 has 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.
What is in this leaflet?
1 What Paracetamol is and what it is 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
1. What Paracetamol is and what it is used for
• Paracetamol belongs to a group of drugs called analgesics (pain killers).
• Paracetamol is a mild analgesic and antipyretic (lowers body temperature).
• Paracetamol is used for the treatment of mild to moderate pain, including headache, migraine, and neuralgia, toothache, sore throat and dysmenorrhoea (period pain).
• Symptomatic relief of rheumatic aches and pains, muscular ache and pains, sciatica, fibrositis, lumbago, joints swelling and stiffness.
• Symptomatic relief of influenza, feverish, colds and feverishness associated with childhood infections such as chicken pox, whooping coughs, measles and mumps.
• Symptomatic relief of febrile (feverish) reaction due to vaccination and immunization.
2. What you need to know before you take Paracetamol 500mg tablets
Do not take Paracetamol if you:
• are allergic (sensitive) to Paracetamol or to any of the other ingredients (listed in section 6). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of legs, arms, face, throat or tongue
• suffer from alcoholic liver disease
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol tablets if you:
• have severe liver or kidney disease
IMPORTANT: Do not take with any other Paracetamol- containing product
Patients who are alcohol dependent (a strong or overpowering urge to drink alcohol) or have glucose-6-phosphate dehydrogenase deficiency (disease characterized by abnormally low levels of glucose) should talk to their doctor or pharmacist before taking paracetamol.
Children
Paracetamol 500mg tablets are not recommended for children under 6 years of age.
Other medicines and Paracetamol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
• any other paracetamol containing medicines
• metoclopramide, chloaminphenicol or domperidone used to treat nausea and vomiting
• cholestyramine used to treat high cholesterol
• anti-coagulants (drugs to thin the blood e.g. warfarin)
• chloramphenicol (an antibiotic): paracetamol may increase the levels of chloramphenicol in the blood
• non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation such as aspirin or other salicylates as these may increase the risk of kidney problems when taken with paracetamol
• busulfan (an anticancer drug)
• enzyme inhibiting drugs such as carbamazepine
Paracetamol may interfere with a number of laboratory tests results. If you are having any blood or urine tests done, please tell the doctor or nurse that you are taking paracetamol tablets.
Paracetamol tablets with food, drink and alcohol
You are advised NOT to drink alcohol whilst taking Paracetamol.
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 is not expected to affect your ability to drive or to operate machinery.
3. How to take Paracetamol 500mg tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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The recommended dose is...
Adults including elderly:
Take 1 to 2 tablets every 4-6 hours as required. Do not take more frequently than every four hours. Do not take more than 8 tablets in 24 hours.
Children (6 to 12 years):
Half to one tablet every 4-6 hours as required. Not more than 4 tablets should be given in 24 hours.
Children under 6 years: not recommended.
Do not take or give this medicine to a child for more than 3 days without consulting a doctor.
Do not take more medicine than the label or leaflet tells you to.
If you take more Paracetamol than you should:
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:
If you forget to take a dose leave out the dose completely and take your next dose at the normal time when it is due. 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.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Serious Side Effects
If you experience any of these side effects
contact your doctor IMMEDIATELY or go to
your nearest hospital casualty department:
• difficulty breathing
• swelling of the face, throat, lips or tongue, feet, ankle or throat which may cause difficulty in swallowing or breathing
• skin rashes and itching
• very rare cases of serious skin reactions with symptoms like skin reddening, blisters or rash
• unusual bruising or bleeding, throat and mouth ulcers or bleeding gums accompanied by tiredness and flu like symptoms
• changes to your liver which may cause yellowing of the skin and / or eyes
Other Side effects:
• rarely renal colic (kidney pain)
• sterile pyuria (pus in the urine)
• azotaemia and ureamia (kidney problems leading to a buildup of urea in the blood. In severe cases symptoms such as tiredness, weakness, nausea and vomiting and fluid retention may be seen)
• acute pancreatitis (inflammation of the pancreas)
• hepatitis (liver inflammation)
• blood - changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor. These effects should go away once you stop taking the medicine
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paracetamol 500mg tablets
Keep this medicine out of the sight and
reach of children
• Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Store in a cool dry place.
• Protect from light.
• Do not throw away medicines via waste water or household waste. Ask your pharmacists how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Paracetamol 500mg Tablets contain:
• The active substance is paracetamol. Each tablet contains 500mg of paracetamol.
• The other ingredients are: Starch, povidone, talc, stearic acid, aerosol and sodium starch glycollate.
What Paracetamol Tablets look like and contents of the pack:
Paracetamol 500mg tablets are white, flat; beveled edge tablets with break line on one face.
Pack sizes are: 25, 50, 100, 1000, 5000 and 10000’s tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.
Telephone: 02089975444 Fax: 02089975433
To request a copy of this leaflet in large print or audio format, please contact the licence holder at the address (or telephone, fax) above
PL 04556/0004
Reference No: 00041215/02
This leaflet was last revised in December 2015
