Panadol Extra Advance 500 Mg/65 Mg Tablets

Document: label-leaflet MAH BRAND 2_PL 00071-0660 change

OUTSIDE

Please read through the information on the outside and inside of this pack before you start using this medicine.

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

WHAT ARE THEY FOR?

Panadol Period Pain Tablets provide extra effective pain relief from:

▼ period pain ▼ headache ▼ migraine ▼ backache

▼ toothache ▼ sore throat ▼ aches and pains of colds and flu

▼ rheumatic pain ▼ feverishness ▼ helps reduce temperature

TAKE SPECIAL CARE

| CONTAINS PARACETAMOL. Do not take with any other paracetamol-containing products. | Ask your doctor before you take this medicine:

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

HOW TO TAKE

Adults and children aged 12 years and over:

Swallow 2 tablets every 4 hours as needed. _a

Do not take more frequently than every 4 hours. $

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

Do not give to children under 12 years. ^

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

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

Do not exceed the stated dose. '

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 symptoms persist consult your doctor.

INGREDIENTS

Each tablet contains the active ingredients Paracetamol 500 mg and Caffeine 65 mg. Also includes a mixture of sodium methyl (E 219), sodium ethyl (E 215) and sodium propyl (E 217) parahydroxybenzoates.

Store below 25°C.

Keep out of the reach and sight of children.

GlaxoSmithKline Consumer Healthcare,

Brentford,TW8 9GS, U.K.

Panadol

Period Pain

V 500mg/65 mg Tablets

Paracetamol + Caffeine

Fast absorption S Period pain >/ Backache and headache S Easy on the stomach S

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panadol

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tablets

Only Braille text, will not be printed

The Market is fully responsible for the approval and certification of the Braille translation and content

INSIDE

1. WHAT PANADOL PERIOD PAIN TABLETS DO

Panadol Period Pain Tablets are faster absorbed than standard paracetamol and caffeine tablets and are used for the relief of period pain, backache, migraine, headache, rheumatic pain and toothache. They also relieve sore throat and the fever, aches and pains of colds and flu.

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

2. CHECK BEFORE YOU TAKE PANADOL PERIOD PAIN TABLETS

Do not take Panadol Period Pain Tablets:

• if you have ever had an allergic reaction

to paracetamol, caffeine or to any of the other ingredients (listed in Section 4).

If you are taking other medicines

Talk to your 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 Period Pain Tablets at the same time as anticoagulants.

Pregnancy and breast feeding

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

3. POSSIBLE SIDE EFFECTS

Like all medicines Panadol Period Pain 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 information, tell your doctor or pharmacist.

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

Active ingredients: Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

Other ingredients: Starch pregelatinised, povidone k-25, calcium carbonate, crospovidone, alginic acid, magnesium stearate and sodium methyl (E 219), sodium ethyl (E 215) and sodium propyl (E 217) parahydroxybenzoates.

The tablet coating contains titanium dioxide (E 171), hypromellose, macrogol, polysorbate 80 and carnauba wax.

The parahydroxybenzoates may cause allergic reactions (possibly delayed).

Packs of Panadol Period Pain Tablets contain 14 tablets.

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

The manufacturer is GlaxoSmithKline Dungarvan Ltd.,

Co. Waterford, Ireland.

This information was prepared in July 2012.

Panadol, Optizorb and the Triangle device are registered trade marks of the GlaxoSmithKline group of companies.

40U854A ^^▼GlaxoSmithKline