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Paracetamol 500 Mg Effervescent Tablets

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Document: leaflet MAH GENERIC_PL 36390-0007 change

In this leaflet:

1.    What Paracetamol Effervescent is and what it is used for

2.    Before you take Paracetamol Effervescent

3.    How to take Paracetamol Effervescent

4.    Possible side-effects

5.    How to store Paracetamol Effervescent

6.    Further information


1. WHAT PARACETAMOL EFFERVESCENT IS AND WHAT IT IS USED FOR


PATIENT INFORMATION LEAFLET PARACETAMOL 500 mg EFFERVESCENT TABLETS

The name of this medicine is Paracetamol 500 mg Effervescent Tablets, which will be referred to as Paracetamol Effervescent throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass this medicine on to others; it may harm them, even if their symptoms are the same as yours.

•    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.

The active ingredient in Paracetamol Effervescent is paracetamol.

Paracetamol Effervescent 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.

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, as they may decrease or increase the effect of Paracetamol Effervescent :

•    metoclopramide or domperidone (often taken for sickness or stomach problems)

•    colestyramine (for high blood lipid levels)

•    anticoagulants to reduce blood clotting (e.g. warfarin)

It may still be all right for you to take Paracetamol Effervescent 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 breastfeeding. 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 Effervescent

Each of these tablets contains about 438 mg of sodium and may interfere if you are on a low sodium diet.

This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.

2. BEFORE YOU TAKE PARACETAMOL EFFERVESCENT


3. HOW TO TAKE PARACETAMOL EFFERVESCENT


Do not take Paracetamol Effervescent if you:

•    are allergic (hypersensitive) to paracetamol or any of the other ingredients in the

tablets (listed in section 6)

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Effervescent if you:

•    have severe kidney or liver problem

•    have a liver problem caused by alcohol

•    are taking any other paracetamol containing medicines

•    are on a low sodium diet

Do not exceed the recommended doses.

Dosage

The usual doses for Paracetamol Effervescent are as follows:

Adults and children over 12 years:

Take 1 or 2 tablets up to 4 times a day. or as instructed by your doctor.

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 the tablets for more than 3 days without consulting a doctor.

Not recommended for children under 12 years of age.

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Method of Administration

5. HOW TO STORE PARACETAMOL EFFERVESCENT


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 don't try to swallow them whole. Stir before use.

If you take more Paracetamol Effervescent than you should:

If you have accidentally taken more than your prescribed 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.

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.

If you forget to take Paracetamol Effervescent

If you forget to take one or more doses, take your next dose when you remember. Do not take a double dose to make up for a forgotten dose and ensure that 4 hours passes before you take another dose.

If you have any further questions about this product ask your doctor or pharmacist.

Do not store above 25°C. 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 out of the sight and reach 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 Effervescent Tablets 500 mg contain:

4. POSSIBLE SIDE-EFFECTS


The active ingredient is paracetamol. Each tablet contains 500mg paracetamol.

Like all medicines, Paracetamol Effervescent 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 effects have been reported:

•    Skin rashes

•    Increased tendency to infections

There have been very rare reports of blood problems, so if you notice unusual bleeding or you bruise easily, tell your doctor as soon as possible.

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.

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 Effervescent Tablets 500 mg look like and the contents of the pack:

Paracetamol Effervescent Tablets 500 mg are white, circular effervescent tablets.

Your medicine is available in blister packs of 16, 24, 32, 60 and 100 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom Manufacturer

Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom This leaflet was last revised in May 2014.

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