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Panadol Extra Tablets

Document: leaflet MAH BRAND_PL 44673-0191 change

Package leaflet: Information for the user

Panadol® Extra Tablets

Paracetamol + Caffeine

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 Extra 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 Extra Tablets do

2.    Check before you take Panadol Extra Tablets

3.    How to take Panadol Extra Tablets

4.    Possible side effects

5.    How to store Panadol Extra Tablets

6.    Further information

1. What Panadol Extra Tablets do

Panadol Extra Tablets are used for the relief of headache, migraine, backache, rheumatic pain, toothache and period pain. They also relieve the fever aches and pains of colds and flu.

The tablets contain two active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol.

2. Check before you take Panadol Extra Tablets

<X symbol>    Do not take Panadol Extra Tablets:

   if you have ever had an allergic reaction to paracetamol, caffeine 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.

<! symbol>    If you are taking other medicines

Talk to your doctor or pharmacist before taking these tablets if you are taking

any prescribed medicines; particularly metoclopromide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol). If you take blood thinning drugs (anticoagulants eg. 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 Extra Tablets at the same time as anticoagulants.

<! symbol> Pregnancy and breast-feeding

Due to the caffeine content of this product it should not be used if you are pre gnant or bre ast fee ding.

3. How to take Panadol Extra Tablets

< Ssymbol> Adults and children aged 12 years and over:

Swallow 2 tablets every 4 hours as needed.

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

•    Do not take more than 8 tablets in 24 hours.

•    Do not take more than the recommended dose.

•    Do not give to children under 12 years.

•    Avoid too much caffeine in drinks like coffee and tea.

High caffeine intake can cause difficulty in sleeping, shaking and an uncomfortable feeling in the chest.

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 Extra 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 ofappetite 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 Extra 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 25°C.

6. Further information

Active ingredients: Each tablet contains Paracetamol 500mg and Caffeine 65 mg. Other ingredients: Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate (E 202), purified talc, stearic acid, croscarmellose sodium, hypromellose and triacetin.

Packs of Panadol Extra Tablets contain 8, 12, 16 or 32 tablets.

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

The manufacturer is GlaxoSmithKline Dungarvan Ltd. Co. Waterford, Ireland or GlaxoSmithKline GmbH & Co. KG, BenzstraBe 25, 71083, Herrenberg, Germany.

This leaflet was last revised in July 2016.

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

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