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Document: leaflet MAH BRAND 2_PL 44673-0083 change

Panadol Soluble 500mg Tablets PL 00071/0072R to PL 44673/0083

Panadol® Soluble 500mg Tablets

Paracetamol

Please read right through this leaflet before you start using this medicine.

This medicine is available without prescription, but you still need to use Panadol Soluble 500mg Tablets carefully to get the best results from them.

•    Keep this leaflet, you may need to read it again.

•    If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leaflet:

1.    What Panadol Soluble 500mg Tablets do

2.    Check before you take Panadol Soluble 500mg Tablets

3.    How to take Panadol Soluble 500mg Tablets

4.    Possible Side Effects

5.    How to store Panadol Soluble 500mg Tablets

6.    Further information

1.    What Panadol Soluble 500mg Tablets do

Panadol Soluble 500mg Tablets are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve sore throat and the fever, aches and pains of colds and flu.

The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have a fever.

2.    Check before you take Panadol Soluble 500mg Tablets

<X symbol> Do not take Panadol Soluble 500mg Tablets:

•    if you have ever had an allergic reaction to paracetamol, or to any of the other ingredients (listed in Section 6)

•    if you are taking other medicines containing paracetamol.

<! symbol> Ask your doctor before you take this medicine:

•    if you have liver or kidney disease, including alcoholic liver disease

•    if you have been told by your doctor that you have an intolerance to some sugars

•    if you are on a controlled sodium diet. Each tablet contains 427 mg of sodium.

<! symbol>    If you are taking other medicines

Talk to a doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Panadol Soluble 500mg Tablets at the same time as anticoagulants.

<! symbol> Pregnancy and breast feeding

Talk to your doctor before taking Panadol Soluble 500mg Tablets if you are pregnant. You can take this product whilst breast feeding.

3. How to take Panadol Soluble 500mg Tablets <Tick symbol> Adults and children aged 12 years and over:

Take 1 to 2 tablets dissolved in a tumbler of water every 4 hours as needed. Do not take more than 8 tablets in 24 hours.

<Tick symbol> Children aged 6-12 years:

Give % to 1 tablet dissolved in water every 4 hours as needed.

Do not give more than 4 tablets in 24 hours.

Do not give for more that 3 days at a time, unless your doctor tells you to.

<! symbol> • Do not take more frequently than every 4 hours.

•    Do not take more than the recommended dose.

•    Do not give to children under 6 years.

If you take too many tablets

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.

If your symptoms continue or your headache becomes persistent, see your doctor.

4. Possible side effects

Like all medicines, Panadol Soluble 500mg Tablets can have side effects but not everybody gets them.

A small number of people have had side effects.

Stop taking the medicine and tell your doctor immediately if you experience:

•    Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath

•    Skin rash or peeling or mouth ulcers

•    Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin

•    Unexplained bruising or bleeding

•    Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.

5. How to store Panadol Soluble 500mg Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the 'EXP' date shown on the pack. Store below 25oC.

6. Further information

Active ingredient: Each tablet contains Paracetamol 500 mg.

Other ingredients: Sorbitol powder (E 420), saccharin sodium, sodium bicarbonate, polyvidone, sodium lauryl sulphate, dimeticone, citric acid and sodium carbonate.

Packs of Panadol Soluble 500mg Tablets contain 16 effervescent tablets.

The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or Famar SA, Anthousis Av., 153 44 Pallini Attikis, Greece.

This leaflet was last revised in March 2016

Panadol is a registered trade mark owned by or licensed to the GSK group of companies.

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