Medine.co.uk

Panadol Period Pain 500 Mg/65 Mg Tablets

Document: label-leaflet MAH BRAND_PL 00071-0660 change

FRONT


BACK

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 Extra Advance Tablets provide extra effective pain relief:

▼    headache ▼ migraine ▼ helps reduce temperature

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

▼    backache ▼ period pain ▼ rheumatic pain ▼ feverishness

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. HOWTOTAKE

Adults and children aged 12 years and over:

Swallow 2 tablets every 4 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 8 tablets in 24 hours.

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._ J

Do not exceed the stated dose.

Immediate medical advice should be sought in the event of an overdose, i .....

even if you feel well, because of the risk of delayed, serious liver damage.

If symptoms persist consult your doctor. -

INGREDIENTS


Panadol


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.

GlaxoSmithKline PL 00071/0660 k    40U820D



Advance


500mg/65 mg Tablets Paracetamol + Caffeine


Fast absorption >/ Migraine headache S Back and muscular aches >/ Easy on the stomach S


Panadol Extra Advance Tablets are faster absorbed than standard paracetamol and caffeine tablets and are used for the relief of headache, migraine, backache, rheumatic pain, toothache and period pain. 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.

CHECK BEFORE YOU TAKE PANADOL EXTRA ADVANCE TABLETS

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Like all medicines Panadol Extra Advance Tablets can have side effects but not everybody gets them. A small number of people have had side effects. Stop taking the medicine and

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

40U820D

*GIaxoSmith Kline


4. FURTHER INFORMATION


Do not take Panadol Extra Advance Tablets:

• if you have ever had an allergic reaction

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

n 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 Extra Advance Tablets at the same time as anticoagulants.

I Pregnancy and breast feeding

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

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.

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 Extra Advance Tablets contain 8,14, or 32 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 last revised in January 2012.

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

IMPORTANT

GlaxoSmithKline

FOR CONTENT ONLY

Please refer to existing colour standard.


GSK Market is responsible for this product, its design and content.

Ensure the artwork is thoroughly checked, all the text proof-read and approved.

RSC GSK is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise RSC in case changes required impact the followings:

Formulation, Tablet embossing, Storage conditions, Shelf Life

Item Number: 40U820D


C 485 K 2765


List Colours:


Manufacturing Site: GSK-IRL-Dungarvan (OTC)-IEDUN


(include sample in fields provided; e.g. spot / spot-CMYK equivalent)



Market or Pack Owner:

CH-United Kingdom-GBR; CH-UK Regulatory-GBR Technical Reference No(s).:


OTCUC018

(do NOT include the technical reference doc[s] version no[s].)


Colour Standard Reference Number:


N/A



Artwork copyright is the property of the GlaxoSmithKline Group of Companies

All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers. The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.


ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION

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PANADOL

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A D V A N C E

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TABLETS

Only Braille text, will not be printed


GlaxoSmithKline

Market Trade Name:

No. of Colours: 5

Artwork Information Panel for Consumer Healthcare

Panadol Extra advance

(does NOT include Varnish, if applicable)

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


To Ensure Accurate PDF Viewing and Printing:

FOR SCREEN VIEWING: Use Adobe Acrobat 5 Professional or Adobe Acrobat Reader, Standard or Professional (higher than 5).

Overprint Preview must be activated for accurate on screen viewing.

FOR PRINTING: Use only Acrobat Professional version 5 or higher. "Apply Overprint Preview" or "Simulate Overprinting" must be activated in the print settings for printing accurate hard copies.

180 mm Measuring Bar

If a status identification banner DOES NOT appear on this document, THEN this document has NOT been printed from the Global Pack Management system.

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IMPORTANT

GlaxoSmithKline

FOR CONTENT ONLY

Please refer to existing colour standard.


BACK

OUTSIDE


FRONT




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INSIDE





GSK Market is responsible for this product, its design and content.

Ensure the artwork is thoroughly checked, all the text proof-read and approved.

RSC GSK is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise RSC in case changes required impact the followings:

Formulation, Tablet embossing, Storage conditions, Shelf Life

GlaxoSmithKline

Market Trade Name:

No. of Colours: 5

Artwork Information Panel for Consumer Healthcare

Panadol Extra advance

(does NOT include Varnish, if applicable)


Item Number: 40U820D

List Colours:

(include sample in fields provided; e.g. spot / spot-CMYK equivalent)

C

485

K

2765

Manufacturing Site: GSK-IRL-Dungarvan (OTC)-IEDUN

187

Market or Pack Owner:

CH-United Kingdom-GBR; CH-UK Regulatory-GBR

Technical Reference No(s).: OTC.UC.018

(do NOT include the technical reference doc[s] version no[s].)


□□BEEBE

P A N A D 0 L

□ □BED


EXTRA

Colour Standard Reference Number: N/A



Artwork copyright is the property of the GlaxoSmithKline Group of Companies

All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts/software used in conjunction with GSK artwork. The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers. The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.


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A D V A N C E

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TABLETS

ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION • ATTENTION

Only Braille text, will not be printed


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


To Ensure Accurate PDF Viewing and Printing:

FOR SCREEN VIEWING: Use Adobe Acrobat 5 Professional or Adobe Acrobat Reader, Standard or Professional (higher than 5).

Overprint Preview must be activated for accurate on screen viewing.

FOR PRINTING: Use only Acrobat Professional version 5 or higher. "Apply Overprint Preview” or "Simulate Overprinting” must be activated in the print settings for printing accurate hard copies.

180 mm Measuring Bar

If a status identification banner DOES NOT appear on this document, THEN this document has NOT been printed from the Global Pack Management system.

Page 2 of 3

Page 2 of 3

Pharma code Ref. No. 1195


Pharma code Ref. No. 1195


Pharma code Ref. No. 1195


Pharma code Ref. No. 1195


500 mg/65 mg Tablets

Paracetamol + Caffeine

_GlaxoSmithKline_

Consumer Healthcare 40F559B


IMPORTANT


GSK Market is responsible for this product, its design and content.

Ensure the artwork is thoroughly checked, all the text proof-read and approved.

RSC GSK is responsible for site technical requirements and pre-press suitability.


GlaxoSmithKline


GSK Market

is responsible to advise RSC in case changes required impact the followings:

Formulation Tablet embossing Storage conditions Shelf Life


Dungarvan Additional Information Panel

Reel Unwind Direction

N/A

TEXT SIZE CONTAINED IN THIS ARTWORK


Body text size: 6.0pt Smallest text size: 6.0pt Microtext: N


Dungarvan - Additional Artwork Information Panel

Pharmacode No.

1195

Varnish Type

N/A

Generic Specification Reference No.

OTC.FL.SPEC.006


GlaxoSmithKline Artwork Information Panel

RSC A/W Version:

5

Item Number: 40F559B

Manufacturing Site: GSK-IRL-Dungarvan (OTC)-IEDUN

Market or Pack Owner: CH-United Kingdom-GBR; CH-UK Regulatory-GBR

Market Trade Name: Panadol Extra advance

Colour Standard Reference Number: N/A

Technical Reference No(s).: OTC.FL.004

(do NOT include the technical reference doc[s] version no[s].)

Printing Process: Flexography

Substrate:

Aluminium Foil 30 Micron

Substrate

(Aluminium)

Colours

Total: 1

2765

Varnishes

Total: N/A

Special Finishes

Total: N/A

Artwork copyright is the property of the GlaxoSmithKline Group of Companies

All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork.

The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.

The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.

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ATTENTION • ATTENTION


To Ensure Accurate PDF Viewing and Printing: FOR SCREEN VIEWING: Use Adobe Acrobat 7 Professional or Adobe Acrobat Reader, Standard or Professional (higher than 7). Overprint Preview must be activated for accurate on screen viewing. FOR PRINTING: Use only Acrobat Professional version 7 or higher. "Apply Overprint Preview" or "Simulate Overprinting" must be activated in the print settings for printing accurate hard copies.


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ADVANCEMENT DIRECTION

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