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PARACETAMOL 500MG EFFERVESCENT TABLETS.
Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL
PARACETAMOL 500 mg
File Prepared: 11.01.17
FILE VERSION : V9 UK
Font used: HELVETICA Condensed (Med, Bold & Italic)
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Printed two sides in Back
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Patient Information Leaflet for
PARACETAMOL 500 mg EFFERVESCENT TABLETS
Read all of this leaflet carefully before you start taking this medicine 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
• Do not pass this medicine on to others. It may harm them, even if their signs of illness 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.
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
3. How to take paracetamol
4. Possible side effects
5. How to store paracetamol
6. Contents of the pack and other information
1. WHAT PARACETAMOL IS AND WHAT
The name of your medicine is Paracetamol 500mg Soluble Tablets (called paracetamol
throughout this leaflet). This medicine contains paracetamol. It belongs to a group of medicines called
analgesics (painkillers) and is used to treat pain (including headache, toothache and period pain) and cold or
YOU NEED TO
KNOW BEFORE YOU TAKE PARACETAMOL
Do not take these tablets if you:
• Are allergic (hypersensitive) to the active substance or any of the other ingredients in your medicine
(listed in section 6)
Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of
the legs, arms, face, throat or tongue.
Paracetamol 500mg Effervescent Tablets must not be given to children under 10 years of age.
Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking paracetamol.
Warnings and precautions
Take special care and check with your doctor before taking paracetamol if:
• You have severe kidney or liver problems
• You have a liver problem caused by alcohol
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this
Other medicines and paracetamol
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect
the way some other medicines work. Also, some other medicines can affect the way paracetamol works.
While taking paracetamol you should not take any other medicines which contain paracetamol.
This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines
available from your doctor and more widely in shops.
Tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as Warfarin
• Metoclopramide and Domperidone ( used to stop you feeling sick (nausea) or being sick (vomiting))
• Colestyramine (for lowering blood cholesterol levels)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
Paracetamol with alcohol
You should not drink alcohol while you are taking these tablets. Taking alcohol with paracetamol can increase
your chances of getting side effects.
Pregnancy and breast-feeding
Talk to your doctor before taking these tablets if:
• You are pregnant, think you may be pregnant or plan to get pregnant
• You are breast-feeding or planning to breast-feed
Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain
and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or
fever are not reduced or if you need to take the medicine more often.
Paracetamol tablets contain:
Sodium: There is 433.3mg of sodium per effervescent tablet. This may be harmful to people on a low
sodium or low salt diet.
3. HOW TO TAKE
Dosage in adults and children over 16 years:
Take one or two tablets every four to six hours when necessary to a maximum of four doses in 24 hours.
• The tablets must be dissolved in half a glass of water (100ml). The tablets dissolve more quickly in warm
water or if stirred.
• Wait atleast 4 hours before taking another dose
Dosage in children 10 – 15 years:
Take one tablet every four to six hours when necessary to a maximum of four doses in 24 hours.
Do not give the tablets to children aged under 10 years unless told to by your doctor.
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.
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have
If you forget to take paracetamol:
If you forget to take a dose at the right time, take it as soon as you remember. However, do not take a
double dose to make up for a forgotten dose. Remember to leave atleast 4 hours between doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Stop taking paracetamol and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or
breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticarial)
This may mean you are having an allergic reaction to paracetamol
• You get serious skin reactions. Very rare cases have been reported.
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
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF
PACK AND OTHER INFORMATION
What Paracetamol 500mg Effervescent tablets contain
The active ingredient in these tablets is paracetamol 500 mg.
The inactive ingredients are anhydrous Citric acid, Povidone, Sodium Cyclamate, Polyethylene Glycol 6000,
Sodium Bicarbonate, Anhydrous Sodium Carbonate and Sodium Saccharin
Available in packs of 16, 20, 24, 60 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aspar pharmaceuticals Ltd.,
Capitol way, Colindale, London NW9 0EQ.
Text Revised: January 2017
Item Code 31028070
Always take paracetamol exactly as it says in this leaflet. Check with your doctor or pharmacist if
you are not sure.
• Do not take more than the recommended dose
• If you need to use this medicine for more than three days at a time, see your doctor
Source: Medicines and Healthcare Products Regulatory Agency