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PARACETAMOL SOLUBLE 500MG TABLETS

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PATIENT INFORMATION LEAFLET PARACETAMOL SOLUBLE 500 mg TABLETS
The name of this medicine is Paracetamol Soluble 500 mg Tablets, which will be referred to as Paracetamol Soluble throughout this leaflet. Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use

Take special care with Paracetamol Soluble if: you have kidney or liver problems, including alcoholic liver disease Taking a painkiller for headaches too often or for too long can make them worse Taking other medicines Do not take these tablets if you are already taking other medicines containing paracetamol. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Certain medicines can interfere with the effectiveness of each other. It is particularly important to tell your doctor or pharmacist before taking this medicine if you are also on: metoclopramide or domperidone (often taken for sickness or stomach problems) colestyramine (used to treat high cholesterol) blood thinning medicines (anticoagulants) such as warfarin chloramphenicol an antibiotic used to treat eye infections It may still be all right for you to take Paracetamol Soluble and your doctor will be able to decide what is suitable for you. Taking your medicine with food and drink Paracetamol should be dissolved in at least half a glass of water and can be taken with or without a meal. Pregnancy and breast-feeding Although there is no evidence that these tablets cause any ill effects, your doctor should advise you about taking them if you are pregnant, likely to become pregnant or are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines. Driving and using machinery The effect of paracetamol on the ability to drive and operate machinery is not known. If you feel dizzy or drowsy do not drive or operate machinery. Important information about some of the ingredients of Paracetamol Soluble Each of these tablets contains about 438 mg of sodium and may interfere if you are on a low sodium diet.
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Paracetamol Soluble carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after three days. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet: 1. What Paracetamol Soluble is and what it is used for 2. Before you take Paracetamol Soluble 3. How to take Paracetamol Soluble 4. Possible side effects 5. How to store Paracetamol Soluble 6. Further information

1. WHAT PARACETAMOL SOLUBLE IS AND WHAT IT IS USED FOR
The active ingredient in Paracetamol Soluble is paracetamol. Paracetamol Soluble is used to relieve pain, including muscular and rheumatic pains, headache, migraine, neuralgia (severe burning or stabbing pain following the line of a nerve), toothache, sore throat, period pains, aches and pains, discomfort associated with influenza (flu), feverishness and feverish colds.

2. BEFORE YOU TAKE PARACETAMOL SOLUBLE
Do not take Paracetamol Soluble if you: are allergic (hypersensitive) to paracetamol or any of the other ingredients in the tablets (these are listed in Section 6, Further Information) are already taking other medicines containing paracetamol are on a low sodium diet
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This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.

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3. HOW TO TAKE PARACETAMOL SOLUBLE Do not exceed the recommended doses. If painful symptoms are not relieved in a few days, consult your doctor. Dosage The usual doses for Paracetamol Soluble are as follows: Adults and children over 12 years: Take 1 or 2 tablets up to 4 times a day. The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24-hour period. Do not continue to take these tablets for more than 3 days unless instructed by your doctor. Not recommended for children under 12 years of age Method of Administration For oral administration only. These tablets should be dissolved in at least half a glass of water before taking them. These tablets are meant to be dissolved first so dont try to swallow them whole. Stir before use. If you take more Paracetamol Soluble than you should: If you have accidentally taken more than the recommended dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. 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. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time your treatment may not be successful. If you have any further questions about this product ask your doctor or pharmacist.

5. HOW TO STORE PARACETAMOL SOLUBLE
Do not store your tablets above 25C. Store in the original package and protect from moisture. Do not take this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. Keep all medicines out of the reach and sight of children. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Paracetamol Soluble 500mg Tablets contain: The active ingredient is paracetamol. Each tablet contains 500mg paracetamol. The other ingredients are anhydrous citric acid (E330), povidone, sodium hydrogen carbonate (E500), saccharin sodium, anhydrous sodium carbonate, simeticone (E900), polysorbate 80 (E433), aspartame (E951) (a source of phenylalanine). Each tablet contains 438 mg of sodium. What Paracetamol Soluble 500mg Tablets look like and the contents of the pack: Paracetamol Soluble 500mg Tablets are white, circular effervescent tablets. Your medicine is available in blister packs of 12, 16, 24, 28 and 30 tablets (not all pack sizes may be marketed). Marketing Authorisation Holder: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK. Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK. This leaflet was last approved in October 2012.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Soluble can cause side effects although not everybody gets them. If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:


any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat. an acute allergic reaction (anaphylaxis) or swelling of the skin

The following side effects have also been reported: skin rashes very rare reports of blood problems, so if you notice unusual bleeding, you bruise more easily than normal, or you seem to be more susceptible to infections than usual, tell your doctor as soon as possible. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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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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