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Paracetamol And Caffeine 500 Mg/65 Mg Tablets

Document: leaflet MAH GENERIC_PL 44673-0085 change

Package leaflet: Information for the user

Paracetamol and Ca ffeine 500 mg/65 mg Tablets.

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

•    This medicine is available without prescription, but you still need to use Paracetamol and Caffeine 500 mg/65 mg 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 Paracetamol and Caffeine 500 mg/65 mg Tablets do.

2.    Check before you take Paracetamol and Caffeine 500 mg/65 mg Tablets

3.    How to take Paracetamol and Caffeine 500 mg/65 mg Tablets

4.    Possible side effects

5.    How to store Paracetamol and Caffeine 500 mg/65 mg Tablets

6.    Further information

1. What Paracetamol and Caffeine 500 mg/65 mg Tablets do

Paracetamol and Caffeine 500 mg/65 mg Tablets are used for the relief of headache, migraine, backache, pain of osteoarthritis, toothache and period pain. They also relieve discomfort in colds, flu, and sore throat and help reduce temperature.

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 Paracetamol and Caffeine 500 mg/65 mg Tablets

<X symbol>    Do not take Paracetamol and Caffeine

500 mg/65 mg 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

•    if you are under 12 years

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

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

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 (for lowering 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 Paracetamol and Caffeine 500 mg/65 mg Tablets at the same time as anticoagulants.

<! symbol> Pregnancy and breast-feeding

Paracetamol and Caffeine 500 mg/65 mg Tablets are not recommended for use during pregnancy or if breast feeding.

3. How to take Paracetamol and Caffeine 500 mg/65 mg 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.

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

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, Paracetamol and Caffeine 500 mg/65 mg Tablets can have side effects, but not everybody gets them.

The following side effects may occur but are rare, if you get them stop taking this medicine and tell your doctor.

Allergic reactions such as skin rash, or peeling, itching or mouth ulcers, swelling of the lips, tongue, throat or face.

If you have previously experienced breathing problems with aspirin or other painkillers like ibuprofen and have experienced a similar reaction with this product. You get unexplained bruising or bleeding.

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

5. How to store Paracetamol and Caffeine 500 mg/65 mg Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack. Do not store above 25°C

6. Further information

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

Packs of Paracetamol and Caffeine 500 mg / 65 mg 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. Benzstrasse 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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