PATIENT INFORMATION LEAFLET

PARACETAMOL 1000mg EFFERVESCENT TABLETS

The name of this medicine is Paracetamol 1000mg Effervescent Tablets, which will be referred to as Paracetamol Effervescent 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 Paracetamol Effervescent 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 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

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.

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 (for sickness or stomach problems)

•    colestyramine (used to treat high cholesterol)

•    blood thinning medicines (anticoagulants) such as warfarin.

It may still be alright 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 Effervescent 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 586.11 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

Do not take Paracetamol Effervescent:

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

the tablets (these are listed in Section 6, Further Information)

•    if you are already taking other medicines containing paracetamol

•    if you are under 12 years of age.

Take special care with Paracetamol Effervescent

Ask your doctor before you take this medicine if you:

•    have severe liver or kidney disease

•    have an alchohol dependency

•    are on a low sodium diet.

Taking a painkiller for headaches too often or for too long can make them worse.

3. HOW TO TAKE PARACETAMOL EFFERVESCENT

Do not exceed the recommended doses. If symptoms persist consult your doctor. Dosage

The usual doses for Paracetamol Effervescent are as follows:

Adults and children over 12 years:

Take 1 tablet 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 these tablets for more than 3 days unless instructed by your doctor.

Not recommended for children under 12 years of age.

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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 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 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.

4. POSSIBLE SIDE-EFFECTS

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 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.

5. HOW TO STORE PARACETAMOL EFFERVESCENT

Do not store your tablets 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 (EXP). 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 1000mg Effervescent Tablets contain:

The active ingredient is paracetamol. Each tablet contains 1000mg paracetamol.

The other ingredients are anhydrous citric acid (E330), povidone, sodium bicarbonate (E500), sodium saccharin, anhydrous sodium carbonate, simeticone (E900), polysorbate 80 (E433) and aspartame (E951).

What Paracetamol 1000mg Effervescent Tablets look like and the contents of the pack:

Paracetamol 1000mg Effervescent Tablets are white, circular, flat bevelled effervescent tablets, which are plain on both sides.

Your medicine is available in blister packs of 8, 12 and 16 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer:

The Product Licence holder is STD Chemicals Ltd, Hillbrow House,

Hillbrow Road, Esher, Surrey, KT10 9NW.

The manufacturer responsible for batch release is Neolab Ltd, 57 High Street,

Odiham, Hants, RG29 1LF.

This leaflet is available in formats suitable for the blind and partially-sighted upon request.

This leaflet was last revised in May 2011.

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