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2. Parasolve Max 1000mg Soluble Tablets

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PATIENT INFORMATION LEAFLET PARACETAMOL 1000mg SOLUBLE TABLETS

The name of this medicine is Paracetamol 1000mg Soluble 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 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.

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.

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)

•    if you are already taking other medicines containing paracetamol

•    if you are under 12 years of age.

Take special care with Paracetamol Soluble

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.

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 Soluble and your doctor will be able to decide what is suitable for you.

Taking your medicine with food and drink

Paracetamol Soluble 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 Soluble

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.

3. HOW TO TAKE PARACETAMOL SOLUBLE_

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

The usual doses for Paracetamol Soluble 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.

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 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.

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.

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.

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

Paracetamol Soluble 1000mg 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:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Welllingborough, Northamptonshire, NN8 6GT UK

Manufacturer responsible for batch release:

Fannin (UK) Limited, 57 High Street, Odiham, Plants, RG29 1LF, UK.

This information is available in alternative formats upon request.

This leaflet was last approved in: November 2011