Medine.co.uk

Panadol Actifast

Document: leaflet MAH BRAND_PL 44673-0082 change

Pharma code Ref. No. 618




2. Check before you take Panadol ActiFast



Do not take Panadol ActiFast:


ActiFast

Paracetamol


•    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.



Ask your doctor before you take this medicine:


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

•    if you are on a controlled sodium diet. Each tablet contains 173 mg of sodium.


TRAILING EDGE


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 ActiFast 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 ActiFast does

2.    Check before you take Panadol ActiFast

3.    How to take Panadol ActiFast

4.    Possible side effects

5.    How to store Panadol ActiFast

6.    Further information

1. What Panadol ActiFast does

Panadol ActiFast is used for fast pain relief of headaches, including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, and period pain.

It also relieves sore throat and the feverishness, 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.



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 ActiFast at the same time as anticoagulants.



Pregnancy and breast feeding


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


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Body text size: 7.0pt Leading: 8.4pt Horizontal Scale: 100% Smallest text size: 7.0pt Microtext: N


IMPORTANT


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No 8 Inside, No 3 Outside


GSK Market is responsible for this product, its design and content. “ Ensure the artwork is thoroughly checked, all the text proof-read and approved.

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Dungarvan - Additional Artwork Information Panel

Pharmacode No.

618

Varnish Type

N/A

Generic Specification Reference No.

OTC.LT.SPEC.002


GSK Market

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

Formulation Tablet embossing Storage conditions Shelf Life


GlaxoSmithKline Artwork Information Panel

RSC A/W Version:

1

Item Number: 62000000006064

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

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

Market Trade Name: Panadol Actifast

Colour Standard Reference Number: N/A

Technical Reference No(s).: OTC.LT.002

(do NOT indude the technical reference doc[s] version no[s].}

Printing Process: Offset

Substrate: White Paper

Colours

Total: 1

K

Varnishes

Total: 0

Special Finishes

Total: 0

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.

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.


ATTENTION • ATTENTION


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LEADING EDGE


3. How to take Panadol ActiFast



Adults and children aged 12 years and over:

Swallow 2 tablets with half a tumbler of water (100 ml), every 4 hours as needed.

To obtain fast action pain relief, the dose must be 2 tablets and must be taken with half a tumbler of water (100 ml). For fastest pain relief, this should be on an empty stomach.


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.

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 ActiFast 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.


6. Further information

Active ingredient: Each tablet contains Paracetamol 500 mg.

Other ingredients: Sodium bicarbonate, starch pregelatinised, povidone, maize starch, potassium sorbate (E 202), microcrystalline cellulose, magnesium stearate, carnauba wax, titanium dioxide (E 171), polydextrose, hypromellose, glycerol triacetate, polyethylene glycol.

Packs of Panadol ActiFast contain 8 or 14 tablets.

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


The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland.


This leaflet was last revised in January 2016.

Panadol and ActiFast are registered trademarks owned by or licensed to the GSK group of companies.


GlaxoSmithKline


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

5. How to store Panadol ActiFast

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.    62000000006064


LU Q LD

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TEXT SIZE CONTAINED IN THIS ARTWORK


Body text size: 7.0pt Leading: 8.4pt Horizontal Scale: 100% Smallest text size: 7.0pt Microtext: N


IMPORTANT


Dungarvan Additional Artwork Information Panel


Reel Unwind Direction


No 8 Inside, No 3 Outside


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.


Dungarvan - Additional Artwork Information Panel

Pharmacode No.

618

Varnish Type

N/A

Generic Specification Reference No.

OTC.LT.SPEC.002


GSK Market

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

Formulation Tablet embossing Storage conditions Shelf Life


GlaxoSmithKline Artwork Information Panel

RSC A/W Version:

1

Item Number: 62000000006064

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

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

Market Trade Name: Panadol Actifast

Colour Standard Reference Number: N/A

Technical Reference No(s).: OTC.LT.002

(do NOT indude the technical reference doc[s] version no[s].}

Printing Process: Offset

Substrate: White Paper

Colours

Total: 1

K

Varnishes

Total: 0

Special Finishes

Total: 0

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.

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.


ATTENTION • ATTENTION


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