Document: leaflet MAH GENERIC_PL 20417-0066 change

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Pharmacode

PATIENT INFORMATION LEAFLET PARACETAMOL EFFERVESCENT 500mg TABLETS

The name of this medicine is Paracetamol Effervescent 500mg 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.

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.

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)

•    are already taking other medicines containing paracetamol

•    are on a low sodium diet

Page 1

Take special care with Paracetamol Effervescent 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

•    chloramphenical an antibiotic to treat eye infections

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 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 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.

BXP065FUB

XX

Page 2

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Paracetamol packinsert keylines back side Size - 297 x 210 mm

OPP inventory code & artwork representation as

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3.    HOW TO TAKE PARACETAMOL EFFERVESCENT

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 Effervescent are as follows:

Adults and children over 16 years:

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

Children 12-15 years of age: One tablet maximum.

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 Effervescent than you should:

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 the pack and any remaining tablets with you.

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:

•    Very rare cases of serious skin reactions have been reported.

•    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.

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems so tell your doctor if this happens to you) blood tests may show abnormal liver function.

Reporting of side effects

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 United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

Page 3

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. The expiry date refers to the last day of that month.

Keep all medicines 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.

What Paracetamol Effervescent 500mg Tablets contain:

The active ingredient is paracetamol. Each tablet contains 500 mg 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 Effervescent 500mg Tablets look like and the contents of the pack:

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

Your medicine is available in blister packs of:

PL 20417/0065 - 24, 32, 60 and 100 tablets PL 20417/0066 - 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:

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K. Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last approved in May 2015.

BXP065FUB

XX

Page 4

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140 mm

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.

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)

•    are already taking other medicines containing paracetamol

•    are on a low sodium diet

Take special care with Paracetamol Effervescent 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

•    chloramphenical an antibiotic to treat eye infections

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 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 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.

3.    HOW TO TAKE PARACETAMOL EFFERVESCENT

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 Effervescent are as follows:

Adults and children over 16 years:

Take 1 or 2 tablets up to 4 times a day, or as instructed by your doctor. Children 12-15 years of age: One tablet maximum.

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.

140 mm

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:

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 the pack and any remaining tablets with you.

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:

•    Very rare cases of serious skin reactions have been reported.

•    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.

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems so tell your doctor if this happens to you) blood tests may show abnormal liver function.

Reporting of side effects

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 United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE PARACETAMOL EFFERVESCENT

Do not store your tablets above 25°C. Store in the original package and protect from moisture.

i

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 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 500mg Tablets contain:

The active ingredient is paracetamol. Each tablet contains 500 mg 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 Effervescent 500mg Tablets look like and the contents of the pack:

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

Your medicine is available in blister packs of:

PL 20417/0065 - 24, 32, 60 and 100 tablets PL 20417/0066 - 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:

Special Product’s Line S.p.A., Via Paduni, 240 - 03012 Anagni (Frosinone) - Italy.

This leaflet was last approved in September 2016.

SPLXP065FUB