Reckitt Benckiser 0002-pl00063-0613-spc-variation

Gaviscon Advance Mint Chewable

60

CHEWABLE TABLETS

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. See leaflet for further information.

Gaviscon

ADVANCE MINT CHEWABLE TABLETS Sodium alginate Potassium bicarbonate

Manufacturer and Product Licence Holder in UK: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS. UK.

UK Distributors: Forum Health Products Ltd.

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Gaviscon and (J) are trade marie. PL 00063^0613.

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2. TTefore taking Gaviscon Advance Mint Chewable

Tablets

Do not take Gaviscon Advance Mint Chewable Tablets if you

•    are allergic to any of the ingredients listed in Section 6

•    have a condition called phenylketonuria (as this product is sweetened with aspartame, a source of phenylalanine which is harmful to patients with phenylketonuria).

Please consult your doctor before taking Gaviscon

Advance Mint Chewable Tablets if you

•    are on a potassium, sodium or calcium restricted diet, as each two tablet dose contains small amounts of sodium (4.6mmol), potassium (2.0mmol) and calcium (2.0mmol)

suffer from heart disease or kidney disease

• are taking diuretics fwater tablets'I For high blooc pressure as the salt content of these tablets car affect the above diseases and the effect of diuretics Pregnancy and breastfeeding You can take this product if you are pregnant or breastfeeding.

3. How to take Gaviscon Advance Mint Chewable Tablets

For oral use only.

Adults including the elderly and children 12 years and over

Take 1-2tablets after meals and at bedtime, or as directerj Chew thoroughly before swallowing.    i

___________________________PB48680!

jEAVISCOM ADVAINfCElMINTCHEWABLETABLETS

i Sodium alginate and potassium bicarbonate

iPATIENT INFORMATION LEAFLET

'PLEASE READ THIS LEAFLET CAREFULLY BEFORE

YOU TAKE THIS MEDICINE. IF YOU ARE NOT SURE

ABOUT ANYTHING ASK YOUR PHARMACIST OR

DOCTOR.

1. What is this medicine and what is it used for?

jGaviscon Advance Mint Chewable Tablets belong to a group of medicines called'reflux suppressants', which jform a protective layer on top of the stomach contents to prevent stomach acid escaping from the stomach where it works into the food pipe causing pain and discomfort.

GavTscon Advance MinfChewableTablets are usetffor the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy, and in patients with symptoms related to oesophagitis. It can be used to relieve the symptoms of conditions such as hiatus hernia (protrusion of muscle through a muscle wall), symptoms of hoarseness and other voice disorders, sore throat and cough associated with reflux. It can be taken to control heartburn symptoms which may occur while taking, or following withdrawal of medication to reduce stomach acid such as Proton Pump Inhibitor (PPI's) or H2 Antagonists.    _RR

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1. TTefore talcing Gaviscon Advance Mint Chewable Tablets

Do not take Gaviscon Advance Mint Chewable Tablets if you

•    are allergic to any of the ingredients listed in Section 6

•    have a condition called phenylketonuria (as this product is sweetened with aspartame, a source of phenylalanine which is harmful to patients with phenylketonuria).

Please consult your doctor before taking Gaviscon Advance Mint Chewable Tablets if you

•    are on a potassium, sodium or calcium restricted diet, as each two tablet dose contains small amounts of sodium (4.6mmol), potassium (2.0mmol) and calcium (2.0mmol)

• suffer from heart disease or kidney disease

• are taking diuretics (water tablets'!Tor high blood pressure as the salt content of these tablets can affect the above diseases and the effect of diuretics, Pregnancy and breastfeeding You can take this product if you are pregnant or breastfeeding.

3. How to take Gaviscon Advance Mint Chewable Tablets

For oral use only.

Adults including the elderly and children 12 years and over

Take 1-2tablets after meals and at bedtime, or as directec Chew thoroughly before swallowing.

__________________________-RB4868C

(Children under 12 years

(Should only be taken on medical advice.

After taking this product

(• If you forget a dose, do not double the dose next time, ' just skip it and carry on as before, j* If you take too much, you may feel bloated. It is unlikely ( to cause you harm, but please consult your doctor or i pharmacist.

(• As with all medicines, treatment should be as short as i possible.

(• If symptoms persist for longer than 7 days, consult ¹ your doctor.

(4. Possible side effects

Sid.e_effe.cls_arevery rarejlesslhan 1_in lOJDQOusers) _ _

and include rash, difficulty breathing, dizziness due to an allergic reaction to the ingredients.

If you experience these or any other effects not listed, stop taking the tablets and consult your doctor immediately.

If you get any side effects, talkto 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

"http://www.mhra.gov.uk/yellowcard". By reporting side effects, you can help provide more information on the safety of this medicine.

____________________________RB4BB81

5.    "How to store Gaviscon Advance Mint GRewable Tablets

KEEP OUT OFTHE REACH AND SIGHT OF CHILDREN. Store in the orginal package. Do not store above 30°C. Do not use after the expiry date shown after 'EXP' on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

Each tablet contains 500mg sodium alginate and lOOmg potassium bicarbonate.as the active ingredients. The other .ingredients are mannitol (_E42J), cajcjum

carbonate, macrogol 20j(M, copovidone, magnesium! stearate, aspartame (951), acesulfame potassium andi mint flavour.    (

Manufacturer and Product License Holder: ReckittJ Benckiser Healthcare (UK) Ltd, Damson Lane, Hull UK; HU87DS.    (

Gaviscon and ® are trademarks.

Leaflet last revised May 2014.    ¹

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TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3A?, England. T: +44 (0) 1482 828100

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

STUDIO USE ONLY Lee Hardey    vi

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ARTWORK APPROVAL

Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________

UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

Tel. Alan Smith: +44 (0)1482 710304

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Component Code (2D if applicable):    0284409

S^Pap^J,ioⁿ„ⁱ:^CalPaCka9i"⁹    D0018525

Bulk Code (if applicable):    N/a

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CAD Cam Ref: 6-ert-D0018525-57.5x19.5x109.5mm Printer: Nampak Healthcare (Previously Storey Evans) Substrate:    Carton Board - White

Edgemark Position:    N/a

Pharmacode No/NE: 11000111(454)

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COLOURS TO MATCH RECOGNISED STANDARDS

BARCODE 11MEO

Barcode Type:    EAN 13

Barcode Number:    5000158067745

Magnification:    90°/o

BWR:    10 microns

Truncated by (smallest Bar): 7.6 mm Encoded Data:_N/A_

All other aspects of the bar code to conform to the current GS1 Operating Manual or other agreed commercial standard.

TBR787-D0018525

TRIDENT

Connaught Bouse, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

• •

STUDIO USE ONLY Lee Hardey    vi.o

Sm*Art check results: G=3; 0=0; R=0; - LH -14/10/10 13:44:17

GAVISCON ADVANCE MINT CHEWABLE TABLETS

ARTWORK APPROVAL

Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________

CUSTOMER INFO: Minimum Point Size = 6.3 pt

UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

Tel. Alan Smith: +44 (0)1482 710304

NOT APPROVED FOR COLOUR

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Artwork Type: Commercial Print

Component Code (2D if applicable):    0284409

S^Pap^J,ioⁿ„ⁱ:^CalPaCka9i"⁹    D0018525

Bulk Code (if applicable):    N/a

xxxx

CAD Cam Ref: 6-ert-D0018525-57.5x19.5x109.5mm Printer: Nampak Healthcare (Previously Storey Evans) Substrate:    Carton Board - White

Edgemark Position:    N/a

Pharmacode No/NE: 11000111(454)

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Print and Technical Colours

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COLOURS TO MATCH RECOGNISED STANDARDS

BARCODE 11MEO

Barcode Type:    EAN 13

Barcode Number:    5000158067745

Magnification:    90°/o

BWR:    10 microns

Truncated by (smallest Bar): 7.6 mm Encoded Data:_N/A_

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Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100

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GAVISCON ADVANCE MINT CHEWABLE TABLETS

STUDIO USE ONLY Lee Hardey    vi.o

Sm*Art check results: G=3; 0=0; R=0; - LH -14/10/10 13:44:17

ARTWORK APPROVAL

Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________

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CUSTOMER INFO: Minimum Point Size = 6.3 pt

UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

Tel. Alan Smith: +44 (0)1482 710304

NOT APPROVED FOR COLOUR

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GAVISCON

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PL 00063/0613.

GAVISCON ADVANCE MINT CHEWABLE TABLETS

CUSTOMER INFO: Minimum Point Size = 6.3 pt

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Artwork Type: Commercial Print

Component Code (2D if applicable):    0284410

Parent Technical Packaging

Specification:

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CAD Cam Ref: G-crt-D0064707-57.5 x 39 x 109.5mm Printer: Nampak Healthcare (Previously Storey Evans) Substrate:    Carton Board - White

Edgemark Position:    NA

Pharmacode No/NE: 11000110(453)

Print and Technical Colours

COLOURS TO MATCH RECOGNISED STANDARDS

BARCODE INFO

Barcode Type:    EAN 13

Barcode Number:    5000158067752

Magnification:    90%

BWR:    10 microns

Truncated by (smallest Bar): 4.1 mm Encoded Data:_N/A_

All other aspects of the bar code to conform to the current GS1 Operating Manual or other agreed commercial standard.

G2S

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

STUDIO USE ONLY Lee Hardey    vi.o

Sm*Art check results: G=3; 0=0; R=0; - LH -14/10/1015:00:37

ARTWORK APPROVAL

Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________

DIVIDER MO C1RC01VISTAMCES SHOOED THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION PROM TRIDENT.

Tel. Alan Smith: +44 (0)1482 710304

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GAVISCON ADVANCE MINT CHEWABLE TABLETS

CUSTOMER INFO: Minimum Point Size = 6.3 pt

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Artwork Type: Commercial Print

Component Code (2D if applicable):    0284410

Parent Technical Packaging

Specification:

Na

CAD Cam Ref: G-crt-D0064707-57.5 x 39 x 109.5mm Printer: Nampak Healthcare (Previously Storey Evans) Substrate:    Carton Board - White

Edgemark Position:    NA

Pharmacode No/NE: 11000110(453)

Print and Technical Colours

COLOURS TO MATCH RECOGNISED STANDARDS

BARCODE INFO

Barcode Type:    EAN 13

Barcode Number:    5000158067752

Magnification:    90%

BWR:    10 microns

Truncated by (smallest Bar): 4.1 mm Encoded Data:_N/A_

All other aspects of the bar code to conform to the current GS1 Operating Manual or other agreed commercial standard.

G2S

TRIDENT

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

STUDIO USE ONLY Lee Hardey    vi.o

Sm»Art check results: G=3; 0=0; R=0; - LH -14/10/1015:00:37

ARTWORK APPROVAL

Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________

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PATIENT INFORMATION LEAFLET ! GAVISCCjIN ADVANCE MINT CHEWABLE TABLETS |    i    Sodium lalginate    i

i    | Potassium bicarbonate |

[Please read this leaflet carefully before you take this medicine. If you are not sufe about anything d$k your pharmacist or doctor.

fVhat are Gaviscon Advance Mint Chewable Tablets?

Gaviscon Advance Mint Chewable [Tablets belong to a group of medicines called ‘reflux suppressants’, which form a protective layer bn top of the stomach contents to prevent stomach acid' escaping from [the stomach where it works into the food pipe causing pain and discomfort.

Mhat are Gaviscon Advance Mint Chewable Tablets used for?

Gaviscon Advance Mint Chewable [Tablets are used for! the treatment of symptoms ofj gastro-oesophageaj reflux such as acid[ regurgitation, heartburn and indigestion, which may occur, for example, following fneals or during pregnancy, and in patients with symptoms related to oesophagitis. [    [    [

it can also he used to relieve the symptoms of conditions such as hiatus hernia (protrusion of muscle'through a muscle wall), symptoms of hoarseness and other voice disorders, sore throat and cough associated with [reflux. It can he ta^en to control heartbjum symptoms Which may occur while taking, or following withdrawal of medication to reduce stomalch acid such as Proton Pump Inhibitors! (PPI’s) or H2 Antagonists.    [    [    [

Before using daviscon Advance Mint Chewable Tablets:

'Do not take this product if:    [    [

i* You know yoji are allergic to any) of the ingredients ^s very rarely [ difficulty in breathing and skin rashes have occurred'(see further ' information for a full list of ingredients).    !

[Take special c^re before treatment with Gaviscon Advance Mint phewable Tablets:

This medicine contains sodium (4.5 mmol per two-tablet dose), potassium (2.0 (nmol per two-tablef dose) and calcium [(2.0 mmol per )wo-tahlet dose}.

[• If you have been advised to follow a diet restricted in any of these i salts please consult your doctor tjefore taking this product.

[• Please also talk to your doctor regarding these salt contents if you [ suffer or have suffered from significant kidney or heart disease, as ' certain salts cjould interfere with these diseases. [

[If you have phenylketonuria, note that this product is sweetened with aspartame, a source of phenylalanine.    [

These tablets do[hot contain sugar of gluten.

Gaviscon Advance Mint Chewable tablets are available in pack sizes of [ !l2’s & 24’s.    [

Manufacturer atid PL Holder:

keckitt BenckisCr Healthcare (UK) Limited, Dansom Lahe, Hull,

[HU8 7DS.

fclaviscon and (J) are trade marks.

Text revised: Mgy 2014

1.3.2 Mock-up

Gaviscon Advance Chewable National Tablets 0019964

'Taking other njedicines    ~[    [

please tell your doctor or pharmacist if you are taking or'have recently taken any other medicines, including medicines obtained without [prescription. [    [    [

[Pregnancy and[ breast-feeding: [

[You can take thils product if you are pregnant or breast- feeding. As with 'all medicines, tt)e treatment duration! should be limited aji much as possible.

flow to take Gaviscon Advance Mint Chewable Tablets:

'For oral administration. Chew thoroughly before swallowing.

[Adults and children over 12 years! When symptoms occur take one to [two tablets after meals and at bedtime.    i

[Children under 12 years: Should only be taken on medical advice.

[If you forget a dose it is not necessary to double the dose next time, just [carry on taking (is before.    [    [

[If you take too much of this product you may feel bloated. It is unlikely [to cause you any harm, but please consult your doctor or[ pharmacist.

[After taking Gaviscon Advance Mint Chewable Tablets:

[If symptoms persist after 7 days consult your doctor.    i

Possible side effects    [    [

[Very rarely (less than 1 in 10,000 patients treated), there is chance of an [allergic reaction! to the ingredients. Symptoms of this maiy include skin rash, difficulty ih breathing, dizziness, or swelling of the[face, lips, tongue or throat[ If you experience these or any other side-effects stop faking the product and consult your doctor or pharmacist.

if you get any side effects, talk to yo[ur doctor, pharmacist or nurse. This fncludes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: i"http://www.mhfa.gov.uk/yellowcar<jl". By reporting sid^ effects, you [can help provide more information on the safety of this medicine.

'Storing your medicine:    [    [    [

t)o not use after[ the expiry date (EXf* month/year) showfi on the pack. ' [KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

[Do not store above 30°C. Store in th]e original package. [    [

[Further information

[Gaviscon Advance Mint Chewable ’tablets are off-white to cream,    i

'circular, flat with bevelled edges tablets with the odour a[nd flavour of [ peppermint. Eacjh tablet contains sodium alginate 500 mg and potassium [ bicarbonate 100'mg as the active ingredients.    '    '

The other ingredients are mannitol (E421), calcium carbonate, macrogol! 20,000, magnesium stearate, aspartajne (E951), mint flavour, acesulfam^ potassium, copovidone.    '    '    '

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RB49358

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