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Beechams All-In-One

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Document: leaflet MAH BRAND_PL 44673-0007 change

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TABLETS

Paracetamol, Phenylephrine, Guaifenesin


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

This medicine is available without prescription, but you still need to use Beechams All in One 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 Beechams All in One Tablets do

2.    Check before you take Beechams All in One Tablets

3.    How to take Beechams All in One Tablets

4.    Possible side effects

5.    How to store Beechams All in One Tablets

6.    Further information

1. What Beechams All in One Tablets do

Beechams All in One Tablets are used for the short term relief of the symptoms of colds, chills and flu with chesty coughs. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh, sore throat and a chesty, productive cough.

This medicine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Guaifenesin is an expectorant which loosens phlegm and relieves a chesty cough. Phenylephrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily.


2. Check before you take Beechams All in One Tablets

□ Do not take Beechams All in One Tablets:

•    if you have ever had an allergic reaction to paracetamol, guaifenesin, phenylephrine hydrochloride or to any of the other ingredients (listed in Section 6)

•    if you have kidney or liver problems (including alcoholic liver disease), overactive thyroid, diabetes, high blood pressure or heart disease

•    if you have phaeochromocytoma or glaucoma

•    if you are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression

•    if you are taking beta blockers (e.g. atenolol).

Do not take anything else containing paracetamol while taking this medicine.

Do not take with any other flu, cold, decongestant products or cough

suppressants.


Take special care with Beechams All in One Tablets

This product may cause dizziness. If affected do not drive or operate machinery.

Ask your doctor before you take this medicine:

if you have been told by your doctor you have an intolerance to some sugars if you have a blood vessel disease such as Raynaud's Phenomenon if you have an enlarged prostate if you have asthma or chronic cough if you have heart or circulation disease.


If you are taking other medicines


Talk to your doctor or pharmacist before taking Beechams All in One Tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or ergotamine or methylsergide (for migraine) or colestyramine (to lower blood cholesterol)

or drugs to lower blood pressure; appetite suppressants or stimulants; drugs to

_11000010003110


Pharma code Ref. No. 1407


Alcala - Additional Artwork Information Panel

Component Name

PROSP BAIO 16 Y 24

Dimensions

150x 200 mm

Folded dimensions

N/A

Varnish Type

N/A

Reel Unwind Reference No

N/A

Glossines / Matte printed side

N/A


GlaxoSmithKline Artwork Information Panel

Item Number:

11000010003110

Manufacturing Site: GSK-ESP-Alcala-ESALC

Market or Pack Owner:

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

Market Trade Name: Beechams All In One

Colour Standard Reference Number: N/A

Technical Reference No(s).:

L607D008_02

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

Printing Process:

Offset

Substrate:

White Paper

Colours


Total: 1


TEXT SIZE CONTAINED IN THIS ARTWORK

Body text size: 7.Opt Leading: 8.4pt Horizontal Scale: 100% Smallest text size: 7.Opt Microtext: N

Varnishes


Total: 0


Special Finishes


Total: 0


IMPORTANT

ICOMP UK 1508


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

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

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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treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin) or if you take blood thinning drugs (anticoagulants e.g. warfarin).

Pregnancy and breast feeding

Talk to your doctor before taking this product if you are pregnant or breast feeding.

3.    How to take Beechams All in One Tablets

For oral use. Adults and children 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 take more than the recommended dose.

•    Do not take for more than 5 days without asking your doctor.

•    Do not give to children under 12 years.

If you take too many tablets

Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If your symptoms persist, see your doctor.

4.    Possible side effects

Like all medicines, Beechams All in One Tablets can have side effects, but not everybody gets them. A small number of people have had side effects.

Stop taking this 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 or aspirin. Unexplained bruising or bleeding.

Reoccuring fevers or infections.

Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

•    Visual disturbances. This is rare but is more likely in those with glaucoma.

•    Unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat.

•    Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland.

The following side effects may also occur. Tell your doctor if you get them.

•    Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea or sickness.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.qov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Beechams All in One Tablets

Keep out of the sight and reach 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 ingredient Each tablet contains Paracetamol 250 mg, Guaifenesin 100 mg

and Phenylephrine Hydrochloride 5 mg,

Other ingredients Lactose, microcrystalline cellulose, maize starch, stearic acid, colloidal anhydrous silica, purified talc, povidone, potassium sorbate (E 202), hypromellose, titanium dioxide (E 171), and polyethylene glycol.

Packs of Beechams All in One Tablets contain 8, 12, 16 or 24 tablets.

Not all pack sizes may be marketed.

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

The manufacturer is SmithKIine Beecham SA, Ctra de Ajalvir, Km 2500,

28806 Alcala de Henares, Madrid, Spain.

This leaflet was last revised in November 2015.

Beechams is a registered trademark of the GSK group of companies.

GlaxoSmithKline

11000010003110

llllllllll

Pharma code Ref. No. 1407

Alcala - Additional Artwork Information Panel

Component Name

PR0SP BAI0 16 Y 24

Dimensions

150x200 mm

Folded dimensions

N/A

Varnish Type

N/A

Reel Unwind Reference No

N/A

Glossines / Matte printed side

N/A

GlaxoSmithKline Artwork Information Panel

Item Number:

11000010003110

Manufacturing Site: GSK-ESP-Alcala-ESALC

Market or Pack Owner:

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

Market Trade Name:

Beechams All In One

Colour Standard Reference Number: N/A

Technical Reference No(s).:

L607D008_02

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

Printing Process:

Offset

Substrate:

Total: 1


O)

c


White Paper

Colours

TEXT SIZE CONTAINED IN THIS ARTWORK

Varnishes


Total: 0


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

Special Finishes


Total: 0


IMPORTANT


o


KOMPUK1508


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

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

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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