P703

1/02

18

Total Colours & Varnishes: 1

BLACK

Total Special Finishes: 0

1Harmony AMSArtwork Information PanelManufacturing Site Number: P7031Manufacturing Site(s): GSK_CAPE TOWN_SOUTH AFRICAProduct Market Trade Name:Beechams PowdersApproving Market(s):CFUN-UK Regulatory;United Kingdom-GBR

Print Process:FlexographyColour Standard Reference:For colour, please refer to Industry Standard Pantone values

Technical Drawing (Do NOT include version number):

CT_L613D016_DWGMaterial Spec. (Do NOT include version number):

N/AMaterial Type:White Paper SUBSTRATE

AIP_Production_V_INDD - 04_2017 - Harmony - Version 2

Body Text Size:8.0ptSmallest Text Size:7.0ptLeading:8.2ptHorizontal Scale:100%Microtext:NAdditional Info (1):N/AAdditional Info (2):N/AAdditional Info (3):N/AA

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Aspirin, CaffeinePlease read right through this leaflet before you start using this medicine.• 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 Powders do2. Check before you take Beechams Powders3. How to take Beechams Powders4. Possible side effects5. How to store Beechams Powders6. Further information

1. What Beechams Powders doBeechams Powders provide relief from cold and flu symptoms, including sore throat pain, headache, feverishness and aches and pains. It also provides relief of mild to moderate pain including migraine, neuralgia, toothache, sore throat, period pain and rheumatic pain.2. Check before you take Beechams Powders

Do not take:

• if you are allergic to aspirin or salicylates, caffeine, any other medicines known as NSAIDs or to any other ingredient (listed in Section 6).

• if you have had an allergic reaction after taking ibuprofen or aspirin.

• if you are allergic to peanut or soya. Beechams Powders contain soya protein.

• if you have had asthma or shortness of breath in response to aspirin before.

• if you suffer from high blood pressure or heart disease.

• if you have ever had a stomach ulcer, perforation or bleeding of the stomach.

• if you have blood clotting disorders (e.g. haemophilia) or have ever had gout.

• if you have liver or kidney disease.Do not give to children under 16 years of age unless your doctor tells you to.

Take special care with Beechams Powders

• There is a possible association between aspirin and Reye’s syndrome when given to children under 16 years. Reye’s syndrome is a very rare disease which affects the brain and liver and can be fatal.

• Aspirin may cause bleeding. You must tell your doctor if you experience any unusual bleeding.

• Drinking alcohol at the same time as taking aspirin increases the risk of bleeding.

• Avoid excessive intake of caffeine (e.g. coffee, tea and some canned drinks) while taking this product.

• If you think you are dehydrated (you may feel thirsty with a dry mouth).

Ask your doctor before you take this medicine:

• if you suffer from high blood pressure, asthma, allergic disease, kidney or liver problems.

• if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• if you are taking any prescribed medicines; particularly methotrexate; blood thinning drugs (anticoagulants) or blood pressure

Pharma code Ref. No. 3082

NOTE TO MARKETLocal approvers must ensure that trade mark and

copyright statements included in the brief comply with guidance provided by

Legal: Global Trade Marks.

IMPORTANTGSK LOC is responsible to

approve the change documentation, artwork briefand final artwork, ensuring

that it is accurate, consistentand complete.

GSK SDC is responsible for sitetechnical requirements and

pre-press suitability.

GSK Market is responsibleto advise SDC when changes required impact the following:

FormulationTablet embossing

Storage conditionsShelf Life

CAPE TOWNSite Additional Artwork Information PanelProduction Site:GSK_CAPE TOWN_SOUTH AFRICA

Item Code/Date Code:P7031/0218

Superceded Item Code/Date Code:P7025/1217

Page 1 of 2

Project: CO-0003909

Site Code: P7031

Document: PPC-0007126 Version: 2

Operator: KYL47024 Date/Time Created: 02.Mar.2018 11:16 GMTe-Banner

P703

1/02

18

Total Colours & Varnishes: 1

BLACK

Total Special Finishes: 0

1Harmony AMSArtwork Information PanelManufacturing Site Number: P7031Manufacturing Site(s): GSK_CAPE TOWN_SOUTH AFRICAProduct Market Trade Name:Beechams PowdersApproving Market(s):CFUN-UK Regulatory;United Kingdom-GBR

Print Process:FlexographyColour Standard Reference:For colour, please refer to Industry Standard Pantone values

Technical Drawing (Do NOT include version number):

CT_L613D016_DWGMaterial Spec. (Do NOT include version number):

N/AMaterial Type:White Paper SUBSTRATE

AIP_Production_V_INDD - 04_2017 - Harmony - Version 2

Body Text Size:8.0ptSmallest Text Size:7.0ptLeading:8.2ptHorizontal Scale:100%Microtext:NAdditional Info (1):N/AAdditional Info (2):N/AAdditional Info (3):N/AA

rtw

ork

copy

right

is th

e pr

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ty o

f the

GSK

Gro

up o

f Com

pani

es. A

ll su

pplie

rs p

rovi

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a s

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ce to

GS

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r prin

ted

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ust e

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for a

ll fo

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ed in

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with

GS

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strib

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lowering treatments (ACE inhibitors); oral hypoglycaemics (to lower blood glucose) or medicines for treating gout such as probenecid or sulfinpyrazone; ibuprofen or other painkillers known as NSAIDs (e.g. diclofenac); SSRI antidepressants (such as fluoxetine); treatments for epilepsy (such as phenytoin or valproate); beta-blockers (e.g. atenolol); acetazolamide; if you are taking any water tablets (diuretics) or steroid hormones (corticosteroids); antacids; or have an intolerance to some sugars.

If you are pregnant or breast feeding

Do not take Beechams Powders if you are pregnant or breast feeding, except on medical advice.

3. How to take Beechams PowdersMix the powder with a little water and stir before drinking.

Adults and children aged 16 years and over:One powder every 3 to 4 hours as needed.

Do not take more than 6 powders in 24 hours.

Do not use for more than 10 days for pain relief(or more than 3 days for fever). If symptoms persist see your doctor. If you take more than the recommended dose seek medical advice immediately.

4. Possible side effectsLike all medicines, Beechams Powders can cause side effects, although not everybody gets them. If you experience any of these effects then STOP taking this medicine immediately and contact your doctor or pharmacist:• Stomach ulceration or perforation: Symptoms

could include severe abdominal pain, nausea and vomiting. People with sensitive stomachs may suffer stomach irritation and may experience bleeding (you may pass blood in your stools, or vomit blood or dark particles that look like coffee grounds).

• Severe allergic reactions: Symptoms could include difficulty breathing, skin rash or swollen facial features, or tightening of the chest or asthma attacks in those sensitive to aspirin.

• Occasionally the blood does not clot well, which may result in bruising or bleeding, or yellowing of the skin and eyes may occur. Other side effects may include lethargy, weakness, shortness of breath, and generalised swelling or water retention, ringing in your ears or temporary hearing loss.

• High caffeine intake can result in nervousness and dizziness.

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.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Beechams PowdersKeep out of the sight and reach of children.Do not use this medicine after the ‘EXP’ date shown on the pack. Store below 25°C in a dry place.

6. Further informationActive ingredients Each powder contains: Aspirin 600 mg and Caffeine 50 mg. Other ingredients Lactose monohydrate, maize starch, colloidal anhydrous silica, sodium lauryl sulphate, saccharin sodium, sodium cyclamate and spice flavour.Packs of Beechams Powders contain either 10 or 20 powders.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 GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. or QP-Services UK Limited, Yatton, Somerset, U.K.This leaflet was last revised February 2018.

Pharma code Ref. No. 3082

NOTE TO MARKETLocal approvers must ensure that trade mark and

copyright statements included in the brief comply with guidance provided by

Legal: Global Trade Marks.

IMPORTANTGSK LOC is responsible to

approve the change documentation, artwork briefand final artwork, ensuring

that it is accurate, consistentand complete.

GSK SDC is responsible for sitetechnical requirements and

pre-press suitability.

GSK Market is responsibleto advise SDC when changes required impact the following:

FormulationTablet embossing

Storage conditionsShelf Life

CAPE TOWNSite Additional Artwork Information PanelProduction Site:GSK_CAPE TOWN_SOUTH AFRICA

Item Code/Date Code:P7031/0218

Superceded Item Code/Date Code:P7025/1217

Page 2 of 2

Project: CO-0003909

Site Code: P7031

Document: PPC-0007126 Version: 2

Operator: KYL47024 Date/Time Created: 02.Mar.2018 11:16 GMTe-Banner