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PARACETAMOL 500MG SOLUBLE TABLETS

Active substance(s): PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 500 mg Soluble Tablets
(paracetamol)
Read all of this leaet 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 side effects not listed in this leaflet. See section 4.
• You must contact a doctor if your symptoms do not go away after 3 days
What is in this leaet:
1. What Paracetamol 500 mg Soluble Tablets are and what they are used for
2. What you need to know before you take Paracetamol 500 mg Soluble
Tablets
3. How to take Paracetamol 500 mg Soluble Tablets
4. Possible side effects
5. How to store Paracetamol 500 mg Soluble Tablets
6. Contents of the pack and other information
1. What Paracetamol 500 mg Soluble Tablets are and what they are used
for
These tablets contain paracetamol which is an analgesic (pain-killer) and
antipyretic (brings down the body temperature in case of fever).
Paracetamol Soluble Tablets are used for headache, migraine, tension
headaches, toothache, neuralgia, rheumatic and muscle pain, period pain, sore
throat and for relieving the fever, aches and pains of cold and flu.

Other medicines and Paracetamol 500 mg Soluble Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Paracetamol may affect or be affected by some other medicines. For example:
• Metoclopramide or domperidone for feeling sick or being sick (may increase
the pain relief effect of paracetamol)
• Colestyramine for reducing blood fat levels (may reduce pain relief effect of
paracetamol)
• Warfarin or other blood thinners - If you take warfarin you can take
occasional amounts of this medicine, but talk to your doctor first before you
take it on regular basis.
If you are unsure about interactions with any other medicines, talk to your
pharmacist. This includes medicines prescribed by your doctor and medicine
you have bought for yourself, including herbal and homeopathic remedies.
Pregnancy and breast-feeding
Talk to your doctor before taking Paracetamol 500mg Soluble Tablets if you are
pregnant. You can take this product whilst breast feeding.
Driving and using machines
These tablets are unlikely to have any effect on your ability to drive and use
machines.
Paracetamol 500 mg Soluble Tablets contains lactose and sodium
• Lactose - if you know you have an intolerance to some sugars, contact your
doctor before taking this medicine.
• Sodium- there is 392mg of sodium per soluble tablet. If you are on low
sodium diet, contact your doctor before taking this medicine.
3. How to take Paracetamol 500 mg Soluble Tablets

2. What you need to know before you take Paracetamol 500 mg Soluble
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.
Dissolve the tablets in glass of water, stir and then drink the solution.

Do not take Paracetamol 500 mg Soluble Tablets if you:
• are allergic to paracetamol or to any of the other ingredients of this
medicine (listed in Section 6 and end of Section 2)
• are taking any other products that contain paracetamol

Adults, elderly and children 16 years and over:
Take one to two tablets dissolved in glass of water every four to six hours as
required. Do not take more than 8 tablets in 24 hours.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol 500 mg Soluble
Tablets if you:
• suffer from severe liver disease (including alcoholic liver disease).
• suffer from severe kidney disease.

Children 12-15 years:
Take one tablet every 4-6 hours when necessary to a maximum of 4 doses in
24 hours.

Do not give for more than 3 days at a time, unless your doctor tells you to.
• Do not take more frequently than every 4 hours.
• Do not take more than the recommended dose.
• Do not give to children under 12 years.

carton, after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container. Keep the container
tightly closed at dry place.
Protect from moisture and heat.

If you take more Paracetamol 500 mg Soluble Tablets than you should
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 or
anyone takes more than the correct number of tablets (overdose), contact your
doctor, pharmacist or hospital emergency department immediately. Always take
the box or any tablets left over with you, if you can.

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.

Symptoms of an overdose include feeling or being sick, loss of appetite,
stomach pain.
If you forget to take Paracetamol 500 mg Soluble Tablets
If you forget to take a dose, take it as soon as you remember, then continue as
usual. 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 other medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking these tablets and seek medical help immediately if you
experience any of the following reactions:
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe
allergic reactions)
• Very rare cases of serious skin reactions have been reported.
If you get any of the following side effects see your pharmacist or doctor:
• Unusual bruising, or infections such as sore throats - this may be a sign of
very rare changes in the blood.
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these
may be signs of liver problems)
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.
5. How to store Paracetamol 500 mg Soluble Tablets
Keep all medicines away from the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or

6. Contents of the pack and other information
What Paracetamol 500 mg soluble tablets contains
The active substance is paracetamol, 500 mg
The other ingredients are citric acid anhydrous, sodium sulphate anhydrous,
lactose monohydrate, sodium hydrogen carbonate, povidone K25, simethicone,
saccharin sodium, lemon flavour H & R 213841 and macrogol 6000.
What Paracetamol 500 mg Soluble Tablets looks like and content of the
pack
The tablets are white, biplane with facets on the both sides.
They are available in the tube pack of 8, 12 and 16 tablets.
Marketing Authorisation Holder and Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip, HA4 6QD
United Kingdom
This leaet was last revised in 09/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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