Paracetamol Tablets 500mg
Package Leaflet: Information for the User
PARACETAMOL 500MG TABLETS
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 you feel worse after 3 days.
Take special care before taking Paracetamol Tablets:
if you have severe kidney or liver problems including non-cirrhotic alcoholic liver disease if you have non-serious arthritis and need to take painkillers everyday
WHAT IS IN THIS LEAFLET
1. What Paracetamol Tablets is and what it is used for
2. What you need to know before you take Paracetamol Tablets
3. How to take Paracetamol Tablets
4. Possible side effects
5. How to store Paracetamol Tablets
6. Contents of the pack and further information
1. WHAT PARACETAMOL TABLETS IS AND WHAT IT IS USED FOR
Each Tablet contains 500 mg of the active ingredient Paracetamol. Paracetamol tablets belongs to a group of medicines called Analgesics and Antipyretics.
Paracetamol Tablets are used for the treatment of mild to moderate pain including headache, migraine, neuralgia (severe pain in nerves), toothache, period pains and the symptomatic relief of sprain, strain and rheumatic pains.
They also reduce temperature and used for the symptomatic relief of feverishness, feverish colds and influenza.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS
Do not take Paracetamol Tablets:
if you are allergic to paracetamol or any of the other ingredients (listed in Section 6).
• If you are taking any other medicines that contain Paracetamol
Other medicines and Paracetamol Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription.
Chloramphenicol (an antibiotic): paracetamol may increase the levels of chloramphenicol in the blood
Anticoagulant to thin your blood such e.g. warfarin
Medicines to control nausea and vomiting e.g. Metoclopramide or domperidone Medicines to control high lipid levels e.g. Colestyramine
Taking Paracetamol Tablets with alcohol
You should not drink alcohol whilst taking Paracetamol Tablets. Taking alcohol with paracetamol can increase your chances of getting side-effects
Pregnancy and breast-feeding:
Tell your doctor if you are pregnant or planning to become pregnant, or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any other medicine.
Paracetamol Tablets contains Sodium Metabisulphite.
Paracetamol Tablets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties
3. HOW TO TAKE PARACETAMOL TABLETS
Always take Paracetamol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For oral administration and short term use only. Swallow the tablets with water.
Dosage:
Adults, the elderly and children 16 years or older
Age
16 years and over
500mg tablet
How Often
One -Two
Do not take more than 8 tablets per day (24 hours).
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Paracetamol 500mg Tablets (FPL) I |
POM) | |
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Leaflet Size: 165 x 255 mm PLL9002NO | ||
Age
500mg tablet dose
6-8
years
Half
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours
8-10
years
Half
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours
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.
Pharmacode Reading Direction
10-12
years
One
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours
12-15
years
One-One & half
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours
Paracetamol Tablets should not be given to children under 6 years of age.
If you take more Paracetamol than you should
Talk to your doctor even if you feel well because of the risk of delayed, serious liver damage Always take any tablets left over with you, also the box and leaflet as this will allow easier identification of the tablets
If you forget to take Paracetamol Tablets:
If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose.
Remember to leave at least 4 hours between doses.
Like all medicines, Paracetamol can cause side effects, although not everybody gets them,
If you experience any of the following serious effects STOP taking this medicine immediately and contact your doctor or pharmacist:
Severe allergic reactions include:
• difficulty in breathing
• skin rash and itching
• swelling of the face and throat ■ runny nose
Rare cases of serious skin reactions have been reported with symptoms like skin reddening, blisters or rash.
Other possible side effects
If any of the following side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist:
Occasionally the blood does not clot well, which may result in easy bruising or bleeding. Rarely, a severe reduction in the number of white
blood cells, which makes infections more likely. Nausea, sudden weight loss, loss of appetite, abdominal pain and swelling, dark colored urine or stools and yellowing of skin and eyes.
• Do not store above 25°C. Store in original package.
Do not use your tablets after the expiry date stated on the label or carton.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Keep this medicine out of the sight and reach of children.
What Paracetamol Tablets contains
These tablets contain 500 mg of Paracetamol as the active ingredient.
They also contain pregelatinised ptarch, magnesium stearate (E572), stearic acid (E570) and sodium metabisulphite (E223).
What Paracetamol Tablets look like and contents of the pack.
Paracetamol Tablets are white to off white, circular flat bevelled edge tablet with a breakline on one side and plain on the other.
The tablet can be divided into equal doses. Paracetamol Tablets are available in blister packs of 100 tablets.
Marketing Authorisation Holder Flamingo Pharma (UK) Ltd.
1st Floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, UK.
Manufacturer:
Wave Pharma Ltd.
4"’ Floor Cavendish House,
369 Burnt Oak Broadway, Edgware,
HA8 5AW, United Kingdom.
If you would like this leaflet in different format information or want to report any side effects please contact marketing authorisation holder listed above.
This leaflet was last revised in November 2016
POM
PL 43461/0003
PLL9002NO
MH/DRUGS/AD-096
