Paracetamol 500mg Soluble Tablets (GSL)

• 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. See section 4.

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

• 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

Children

Paracetamol 500mg Soluble 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.

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 medicine.

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.

Please inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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 or 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.

You should not drink alcohol while you are taking these tablets. Taking alcohol with paracetamol can increase your chances of getting side effects.

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

If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your 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.

• Sodium: This medicine contains 388 mg sodium (main component of cooking/table salt) in each soluble tablet. This is equivalent to 19.4 % of the recommended maximum daily dietary intake of sodium for an adult.
• Sorbitol: This medicine contains 50 mg sorbitol in each soluble tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

• The usual dose of paracetamol is 2 effervescent tablets
• Dissolve the effervescent tablets in a full glass of water before taking
• Wait at least 4 hours before taking another dose
• Do not take more than 4 doses in any 24-hour period

Paracetamol 500mg Soluble Tablets should not be given to children under 10 years of age.

Children aged 10 to 15 years

Take one tablet every four to six hours when necessary to a maximum of four doses in 24 hours.

• 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 taken

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 at least 4 hours between doses.

• 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 (urticaria)
  This may mean you are having an allergic reaction to paracetamol
• You get serious skin reactions. Very rare cases have been reported.

• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia). This side effect has only happened in a few people taking paracetamol

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is paracetamol. Each tablet contains 500mg of paracetamol.
• The other ingredients are sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, sodium bicarbonate, povidone, and dimeticone.

Paracetamol 500mg Soluble Tablets come in cartons of 12, 16, 24, 32, 48, 60 and 100. Not all pack sizes may be sold.