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GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION - patient leaflet, side effects, dosage

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Patient leaflet - GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION

How to take this medicine

Checkthat the cap seal is unbroken before first using this product. Shake well before use.

Adults including the elderly and children 12 years and over: 5–10 ml (one to two 5ml spoonfuls) after meals and at bedtime.

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 as before.

If you take too much of this product you may feel bloated and experience some abdominal discomfort. It is unlikely to cause you any harm, but please consult your doctor or pharmacist if this doesn’t go away.

If symptoms persist after 7 days consult your doctor.



4.

Possible side effects

Very rarely (less than 1 in 10,000 patients) there is a chance of an allergic reaction to the ingredients. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness or swelling of the face, lips, tongue or throat. If you experience these or any other side effects stop taking the product and consult your doctor immediately.

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: '" or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.


page 5



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

Gaviscon Advance Aniseed flavour Oral Suspension belongs to a group of medicines called „reflux suppressants“.

This product forms a protective layer that floats on top of the stomach contents. This layer prevents reflux and keeps the stomach contents away from the lining of the food pipe to relieve the symptoms of heartburn and acid indigestion. It can also be used to relieve the symptoms of conditions such as

hiatus hernia (protrusion of muscle through a muscle wall), reflux oesophagitis (inflamed foodpipe) and symptoms of hoarseness and other voice disorders, sore throat and cough associated with reflux. It

can also be taken to control heartburn symptoms which may occur when taking, or following withdrawal of, medication to reduce stomach acid such as Proton Pump Inhibitors (PPI's) or H2 Antagonists.

2. what you need to know before taking this medicinedo not take gaviscon advance aniseed flavour oral suspension:- if you know you are allergic (hypersensitive) to any of the ingredients of in this product

(listed in section 6for a full list on ingredients).


Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Wait at least 2 hours between taking this medicine and other medicines such as tetracyclines, fluoroquinolones (types of antibiotics), iron salts, thyroid hormones, chloroquine (a medication used to prevent malaria), bisphosphonates (a medication used to treat osteoporosis) and estramustine (a medication to treat prostate cancer).

Pregnancy and breast-feeding:

You can take this product if you are pregnant or breast-feeding. As with all medicines, the treatment duration should be limited as much as possible.

Important information about some of the ingredients of Gaviscon Advance Aniseed flavour Oral Suspension: This product contains methyl (E218) and propyl (E216) para-hydroxybenzoates which may cause allergic reactions (possibly delayed).

Driving and using machines:

This medicine has no influence on the ability to drive and use machines.


page 2


page 4 _____>


5. how to store this medicine                                                                                                 )

Do not use this product after the expiry date (EXP: month/year) shown. Keep out of the sight and reach of children. । Do not refrigerate.

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

6. contents of the pack and other information                                                              )

Each 10 ml of oral suspension contains 1000 mg sodium alginate and 200 mg potassium hydrogen carbonate as the । active ingredients. The other ingredients are calcium carbonate, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, benzyl alcohol (present in fennel flavour), sodium saccharin, sodium hydroxide, aniseed flavour derived from fennel and purified water. This product does not contain sugar or gluten.

This medicine is available in bottles of 80ml, 100ml, 125ml, 140ml, 150ml, 180ml, 200ml, 250ml and 300ml.

Not all pack sizes may be marketed.

Manufacturer and Product Licence Holder:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS.

Date of preparation: September 2020.

Gaviscon Advance and the sword and circle are trademarks.

page 6


CUSTOMER INFO:

Minimum Point Size = 7.00pt

Leaflet Copy = 9pt


TBR2687-D8346142 – English


GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION


mm 10 20 30 40 50 60 70 80 90 100 110 12­0 130 140 150 160 170 18­0 190 200 210 220 230 24­0 250


155mm


FOP


0000000

– – – – – – – – – ------ f ----

  • nd over: Take5–10ml (onetotwo 5 ml

। ।.1 i. ■ f * ii n

ADVANCE

NJISeED FLAVOUR

ei50ml

Peel here. Do not remove.

Extra Strength Formula

Read the package leaflet before use.

Dosage: For oral use.Adults, includingthe elderlyand i'll 4 n i T i r 4 n 1 I , < r~

Whatisthispro­duct? Each 10 ml contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 rg Checkthatthecap­sealisu’'br"'ken­befor^ firstusingthis­product.

------- – — – – – – – x – – – spoonfuls) after meals and atbedtime. Shake well before use. Children under12years: Shouldonlybe taken onmedical advice. Ifsymptoms persistafter 17days consultyour doctor. Contains sodium potassium, benzyl alcoholipresent in fennel flavour), methyl(E218) and propyl(r.2i6)para-hydioxybenzoates.

High in sodium – see leafietfor iurther information. Manufacturer and Product Licence holder intheUK: Reckitt Benckiser Healthcare (UK)Ltd.,Hull,HU8 7DS. PL00063/0749_­________________________­________

  • (Acidreflux symptoms Heartburn

Do not ref':ge'ate. Keep oUofthe sight and reach ofchildren. Do rotu’ethis p'oductafterthA e”piryd"‘te(EXD: month/yearshown). Glass bottle,handle with care. Do not drinkdirectlyfrom the bottle

'Oral suspension

Sodium alginate Potassium hydrogen carbonate


2mm 2mm

.1.5mm 2mm

_15mm 2mm

'1.5mm 2mm

21.5mm 2mm 2mm

7.5 mm



PRINTING READS This Way


48.5mm


50mm


56.5mm


Gaviscon Advance Aniseed flavour Oral Suspension.

Sodium alginate and potassium hydrogen carbonate.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • Ifyou get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

  • You must talk to your doctor if you do not feel better or if you feel worse after 7 days.

In this leaflet:

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

  • 2. What you need to know before you take this medicine.

  • 3. Howto take this medicine.

  • 4. Possible side effects.

x 5. how to store this medicine

\ 6. Contents of the pack and other information.

\ page 1



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

Gaviscon Advance Aniseed flavour Oral Suspension belongs to a group of medicines called „reflux suppressants“.

This product forms a protective layer that floats on top of the stomach contents. This layer prevents reflux and keeps the stomach contents away from the lining of the food pipe to relieve the symptoms of heartburn and acid indigestion. Itcanalsobeusedto relieve the symptoms of conditions such as

hiatus hernia (protrusion of muscle through a muscle wall), reflux oesophagitis (inflamed foodpipe) and symptoms of hoarseness and other voice disorders, sore throat and cough associated with reflux. It

can also be taken to control heartburn symptoms which may occur when taking, or following withdrawal of, medication to reduce stomach acid such as Proton Pump Inhibitors (PPI's) or H2 Antagonists.

2. what you need to know before taking this medicine

Do not take Gaviscon Advance Aniseed flavour Oral Suspension:

– If you know you are allergic (hypersensitive) to any of the ingredients of in this product

(listed in section 6forafull list on ingredients).


page 2


/'Warnings and precautions: )

z This medicine contains 57.85 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 2.9 % of

' the recommended maximum dailydietaryintake of sodiumforan adult. |

The maximum recommended daily dose of this medicinal product contains 462.8 mg sodium (found in table salt). This is ) equivalent to 23.14 % of the adult recommended maximum daily dietary intake for sodium. ।

This medicine contains 0.525 mg benzyl alcohol in each 5ml.

Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

This medicine contains 1.0 mmol (39.06 mg) of potassium per5ml.To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

– Please also talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet orifyou suffer or have suffered from significant kidney or heart disease, as certain salts could interfere with these diseases. !

] page 3



Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Wait at least 2 hours between taking this medicine and other medicines such as tetracyclines, fluoroquinolones (types of antibiotics), iron salts, thyroid hormones, chloroquine (a medication used to prevent malaria), bisphosphonates (a medication used to treat osteoporosis) and estramustine (a medication to treat prostate cancer).

Pregnancy and breast-feeding:

You can take this product if you are pregnant or breast-feeding. As with all medicines, the treatment duration should be limited as much as possible.

Important information about some of the ingredients of Gaviscon Advance Aniseed flavour Oral Suspension: This product contains methyl (E218) and propyl (E216) para-hydroxybenzoates which may cause allergic reactions (possibly delayed).

Driving and using machines:

This medicine has no influence on the ability to drive and use machines.


page 4 _____i


CUSTOMER INFO:

Minimum Point Size = 7.00pt

Leaflet Copy = 9pt


3. how to take this medicine                                                                                                        )

Check that the cap seal is unbroken before first using this product. Shake well before use. ।

Adults including the elderly and children 12 years and over: 5–10 ml (one to two 5ml spoonfuls) after meals and at bedtime.

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 as before.

If you take too much of this product you may feel bloated and experience some abdominal discomfort. It is unlikely to cause you any harm, but please consult your doctor or pharmacist if this doesn’t go away.

If symptoms persist after 7 days consult your doctor.

4. possible side effects                                                                                                            1

Very rarely (less than 1 in 10,000 patients) there is a chance of an allergic reaction to the ingredients. Symptoms of this ! may include skin rash, itching, difficulty breathing, dizziness or swelling of the face, lips, tongue or throat. If you

experience these or any other side effects stop taking the product and consult your doctor immediately.

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: !

"" or search for MHRA Yellow Card in the Google Play or Apple App Store. )

By reporting side effects, you can help provide more information on the safety of this medicine. ।

page 5




5. how to store this medicine                                                                                              )

Do not use this product after the expiry date (EXP: month/year) shown. Keep out of the sight and reach of children.

Do not refrigerate.

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

6. contents of the pack and other information                                                              )

Each 10 ml of oral suspension contains 1000 mg sodium alginate and 200 mg potassium hydrogen carbonate as the active ingredients. The other ingredients are calcium carbonate, carbomer, methyl (E218) and propyl (E216) parahydroxyben­zoates, benzyl alcohol (present in fennel flavour), sodium saccharin, sodium hydroxide, aniseed flavour derived from fennel and purified water. This product does not contain sugar or gluten.

This medicine is available in bottles of 80ml, 100ml, 125ml, 140ml, 150ml, 180ml, 200ml, 250ml and 300ml.

Not all pack sizes may be marketed.

Manufacturer and Product Licence Holder:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS.

Date of preparation: September 2020.

Gaviscon Advance and the sword and circle are trademarks.

page 6


TBR2687-D8346142 – English


GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION


mm 10 20 30 40 50 60 70 80 90 100 110 12­0 130 140 150 160 170 18­0 190 200 210 220 230 24­0 250


177.8 mm


FOP


70 mm


GAVISCON

ADVANCE

\ aniseed flavour

Oral suspension

Peel here. Do not remove.

Extra Strength Formula

What is this product? Each 10 ml contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg.

Check that the cap seal is unbroken before first using this product.

Do not refrigerate. Keep out ofthe sight and reach ofchildren. Do not use this product after the expiry date (EXP: month/year shown). Glass bottle, handle with care. Do not drinkdirectlyfrom the bottle

Sodium alginate Potassium hydrogen carbonate

Read the package leaflet before use.

Dosage: For oral use. Adults, including the elderly and children 12 years and over: Take 5–10 ml (one to two 5 ml spoonfuls) after meals and at bedtime. Shake well before use. Children under 12 years: Should only be taken on medical advice. If symptoms persist after 7 days consult your doctor. Contains sodium, potassium, benzyl alcohol (present in fennel flavour), methyl (E218) and propyl (E216) para-hydroxybenzoates.

High in sodium – see leaflet for further information. Manufacturerand Product Licence holder in the UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. PL 00063/0749



66.3 mm


55mm


56.5mm


30 mm


GavisconAdvan­ceAniseedflavou­rOralSuspensi­on.

Sodium alginate and potassium hydrogen carbonate.


contentsawayfromthe lining ofthefood pipetorelievethe equivalentto23­.14%oftheadul­trecommendedma­ximum


PRINTING READS This Way


2mm

2mm j.5mm

2mm

j.5mm

2mm

j.5mm

2mm

"1.5mm

2mm

2mm

7.5mm




Readallofthis­leafletcarefu­llybeforeyoustar­tusingthis medicinebecau­seitcontainsim­portantinforma­tionforyou.
  • Keep this leaflet. Youmayneed toread it again.
  • Askyourpharma­cistifyouneed­moreinformati­onoradvice.
  • Ifyou getanyside effects, talktoyourphar­macist.

This includesany possibleside effects notlisted in this leaflet. Seesection4.

  • Youmusttalkto­yourdoctorify­oudonotfeelbet­terorifyou feel worse after7 days

Inthisleaflet:

  • 1. Whatis this medicine and what is it used for?

  • 2. Whatyouneed­toknowbeforey­outakethismedi­cine.

  • 3. Howtotaket­hismedicine.

  • 4. Possiblesi­deeffects.

  • 5. Howtostorethis medicine.

  • 6. Contentsof­thepackandothe­rinformation.

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

GavisconAdvance AniseedflavourOral Suspension belongstoa groupofmedici­nescalled ‘refluxsuppres­sants’.Thispro­duct formsa protective layerthatfloatson top ofthe stomach contents. This layer preventsreflu­xandkeepsthe stomach


symptomsofhear­tburnandacidin­digestion. Itcanalsobe usedto relievethesym­ptomsofconditi­onssuchashiatusher­nia (protrusionof­musclethrough amusclewall), refluxoesophagitis (inflamedfood pipe) and symptoms of hoarseness and other voice disorders, sorethroatand coughassociated­withreflux. Itcan also betakentocontrol­heartburnsymptom­swhichmayoccur whentaking, orfollowingwit­hdrawalof, medication toreduce stomachacidsuchas­ProtonPumpInhi­bitors(PPI's) orH2 Antagonists.

2. Whatyou need to know before takingthis medicine. Do nottake Gaviscon Advance Aniseed flavour Oral Suspension:

-Ifyouknowyoua­reallergic(hy­persensitive) toanyofthe ingredientsofin­thisproduct(lis­tedinsection6fo­rafulllistof ingredients).

Warningsandpre­cautions:

This medicine contains 57.85 mg sodium (main component of cooking/table salt) in each5ml. Thisis equivalent to 2.9 % of the recommended maximumdaily dietary intake of sodium for an adult.

The maximum recommended dailydose ofthis medicinal productcontain­s462.8mgsodium(fou­ndintablesalt)­. Thisis


dailydietaryin­takeforsodium.

Thismedicinecon­tains0.525mg benzylalcoholi­neach5ml. Benzyl alcohol maycause allergic reactions.

Askyourdoctoror­pharmacistforad­viceifyouarepreg­nantor breast-feeding. Thisisbecause­largeamountsof­benzylalcohol canbuild-upinyourbodyan­dmaycauseside­effects(called “metabolic acidosis”).

Ask yourdoctororphar­macistforadvi­ce if youhaveliver or kidneydisease. Thisisbecause­largeamountsof­benzylalcohol canbuild-upinyourbodyan­dmaycauseside­effects(called “metabolic acidosis”).

Thismedicinecon­tains1.0mmol(39­.06mg) ofpotassiumper5ml. Tobetakeninto­consideration­bypatientswit­hreduced kidney functionorpati­entsonacontro­lledpotassium­diet.

-Pleasealsotal­ktoyourdoctoror­pharmacistify­ouneedfouror moredailydoses­foraprolonged period, especiallyifyouhave beenadvisedto­followalowsal­tdietorifyousuf­ferorhave sufferedfromsig­nificantkidne­yorheartdisea­se, ascertainsalts could interfere withthese diseases.

Takingotherme­dicines:

Pleasetellyou­rdoctororphar­macistifyouare­takingorhave recentlytaken anyothermedicines, including 0000000



CUSTOMER INFO:

Minimum Point Size = 7.00pt

Leaflet Copy = 9pt


medicinesobta­inedwithoutpres­criptionWaita­tleast2hours betweentakingthis­medicineandot­hermedicinessuchas tetracyclines, fluoroquinolo­nes(typesofan­tibiotics), ironsalts, thyroidhormones, chloroquine(a­medicationused­toprevent malaria), bisphosphonates(a­medicationused­totreatosteopo­rosis) andestramustine (amedicationto­treatprostate­cancer).

Pregnancyandbreast-feeding:

You cantakethis productifyoua­repregnant or breast-feeding. Aswithall medicines, the treatmentdura­tionshould belimitedas much as possible.

Importantinfor­mationaboutso­meof the ingredientsof­Gaviscon Advance Aniseedflavou­rOralSuspensi­on:

This productcontain­smethyl(E218) and propyl(E216) para-hydroxybenzoa­teswhich may causeallergicre­actions (possiblydelayed).

Drivingand usingmachines:

Thismedicinehas­noinfluenceon­theability todriveand use machines.

3. Howtotaket­hismedicine

Check thatthe cap seal is unbroken beforefirst using this product. Shake well before use.Adults includingtheel­derlyand children 12yearsandover: 5–10 ml(onetotwo5mlspo­onfuls) aftermeals andatbedtime. Childrenunder12y­ears: Shouldonlybetakenon


medicaladvice. Ifyouforgetado­seitis notnecessaryto­double thedosenexttime, justcarryonta­kingasbefore. Ifyoutaketoo muchofthispro­ductyoumayfeel­bloatedandexpe­riencesome abdominaldiscom­fort. Itisunlikelyto­causeyouanyhar­m, but pleaseconsulty­ourdoctororphar­macistifthisdo­esn’tgoaway. Ifsymptomsper­sistafter7 daysconsultyou­rdoctor.

  • 4. Possiblesi­deeffects

Veryrarely(lessthan 1 in 10,000 patien­ts)there isachance ofan allergicreacti­ontotheingredi­ents. Symptomsofthismay include skin rash, itching, difficultybre­athing, dizzinessor swellingoftheface, lips, tongueorthroat. Ifyouexperience theseoranyother­sideeffectsstop­takingtheproduc­tand consultyourdoc­torimmediately. Ifyougetanysi­deeffects,talk toyourdoctor, pharmacistornurse. Thisincludesa­nypossible sideeffectsno­tlisted inthisleaflet.You canalsoreportside effectsdirectly­viatheYellowCar­dSchemeat: " YellowCardinthe­GooglePlayorAp­pleAppStore. Byreporting sideeffects, you canhelp providemore informationon­thesafety ofthis medicine.

  • 5. Howtostoret­hismedicine

Do not use this product after the expiry date (EXP: month/year) shown. Keep out otthe sight and reach otchildren.


Donotrefrigerate.

Medicinesshou­ldnotbedispose­dofviawastewa­teror householdwaste. Askyourpharma­cisthowtodispo­seof medicinesnolon­gerrequired. Thesemeasures­willhelpto protecttheenvi­ronment.

6. Contents ofthe pack and other information

Each10ml oforal suspension contains1000 mg sodium alginate and200mg potassiumhydro­gencarbonateas­theactive ingredients. Theotheringre­dientsarecalci­umcarbonate, carbomer, methyl(E218) and propyl(E216) parahydroxyben­zoates, benzylalcohol(pre­sentinfennelfla­vour), sodiumsaccharin, sodiumhydroxide, aniseedflavou­rderived fromfennel and purified water. This productdoes not contain sugarorgluten. thismedicineis availableinbottles of80ml, 100ml,125ml,1­40ml,150ml,180ml,200ml,2­50mland300ml.

Notall packsizes maybemarketed.

Manufacturerand ProductLicence­Holder: ReckittBencki­serHealthcare(UK) Limited, Hull, HU87DS.

Dateofpreparation: September2020.

GavisconAdvance and the sword and circle aretrademarks.

_____________­______0000000 _


TBR2654-D8340700 – English


GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION


mm 10 20 30 40 50 60 70 80 90 100 110 12­0 130 140 150 160 170 18­0 190 200 210 220 230 24­0 250


177.8 mm


FOP


70 mm


GAVISCON

ADVANCE

\ aniseed flavour

Oral suspension

Peel here. Do not remove.

Extra Strength Formula

What is this product? Each 10 ml contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg.

Check that the cap seal is unbroken before first using this product.

Do not refrigerate. Keep out ofthe sight and reach ofchildren. Do not use this product after the expiry date (EXP: month/year shown). Glass bottle, handle with care. Do not drinkdirectlyfrom the bottle

Sodium alginate Potassium hydrogen carbonate

Read the package leaflet before use.

Dosage: For oral use. Adults, including the elderly and children 12 years and over: Take 5–10 ml (one to two 5 ml spoonfuls) after meals and at bedtime. Shake well before use. Children under 12 years: Should only be taken on medical advice. If symptoms persist after 7 days consult your doctor. Contains sodium, potassium, benzyl alcohol (present in fennel flavour), methyl (E218) and propyl (E216) para-hydroxybenzoates.

High in sodium – see leaflet for further information. Manufacturerand Product Licence holder in the UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. PL 00063/0749



66.3 mm


55mm


56.5mm


30 mm


GavisconAdvan­ceAniseedflavou­rOralSuspensi­on.

Sodium alginate and potassium hydrogen carbonate.


contentsawayfromthe lining ofthefood pipetorelievethe equivalentto23­.14%oftheadul­trecommendedma­ximum


PRINTING READS This Way


2mm

2mm j.5mm

2mm

j.5mm

2mm

j.5mm

2mm

"1.5mm

2mm

2mm

7.5mm




Readallofthis­leafletcarefu­llybeforeyoustar­tusingthis medicinebecau­seitcontainsim­portantinforma­tionforyou.
  • Keep this leaflet. Youmayneed toread it again.
  • Askyourpharma­cistifyouneed­moreinformati­onoradvice.
  • Ifyou getanyside effects, talktoyourphar­macist.

This includesany possibleside effects notlisted in this leaflet. Seesection4.

  • Youmusttalkto­yourdoctorify­oudonotfeelbet­terorifyou feel worse after7 days

Inthisleaflet:

  • 1. Whatis this medicine and what is it used for?

  • 2. Whatyouneed­toknowbeforey­outakethismedi­cine.

  • 3. Howtotaket­hismedicine.

  • 4. Possiblesi­deeffects.

  • 5. Howtostorethis medicine.

  • 6. Contentsof­thepackandothe­rinformation.

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

GavisconAdvance AniseedflavourOral Suspension belongstoa groupofmedici­nescalled ‘refluxsuppres­sants’.Thispro­duct formsa protective layerthatfloatson top ofthe stomach contents. This layer preventsreflu­xandkeepsthe stomach


symptomsofhear­tburnandacidin­digestion. Itcanalsobe usedto relievethesym­ptomsofconditi­onssuchashiatusher­nia (protrusionof­musclethrough amusclewall), refluxoesophagitis (inflamedfood pipe) and symptoms of hoarseness and other voice disorders, sorethroatand coughassociated­withreflux. Itcan also betakentocontrol­heartburnsymptom­swhichmayoccur whentaking, orfollowingwit­hdrawalof, medication toreduce stomachacidsuchas­ProtonPumpInhi­bitors(PPI's) orH2 Antagonists.

2. Whatyou need to know before takingthis medicine. Do nottake Gaviscon Advance Aniseed flavour Oral Suspension:

-Ifyouknowyoua­reallergic(hy­persensitive) toanyofthe ingredientsofin­thisproduct(lis­tedinsection6fo­rafulllistof ingredients).

Warningsandpre­cautions:

This medicine contains 57.85 mg sodium (main component of cooking/table salt) in each5ml. Thisis equivalent to 2.9 % of the recommended maximumdaily dietary intake of sodium for an adult.

The maximum recommended dailydose ofthis medicinal productcontain­s462.8mgsodium(fou­ndintablesalt)­. Thisis


dailydietaryin­takeforsodium.

Thismedicinecon­tains0.525mg benzylalcoholi­neach5ml. Benzyl alcohol maycause allergic reactions.

Askyourdoctoror­pharmacistforad­viceifyouarepreg­nantor breast-feeding. Thisisbecause­largeamountsof­benzylalcohol canbuild-upinyourbodyan­dmaycauseside­effects(called “metabolic acidosis”).

Ask yourdoctororphar­macistforadvi­ce if youhaveliver or kidneydisease. Thisisbecause­largeamountsof­benzylalcohol canbuild-upinyourbodyan­dmaycauseside­effects(called “metabolic acidosis”).

Thismedicinecon­tains1.0mmol(39­.06mg) ofpotassiumper5ml. Tobetakeninto­consideration­bypatientswit­hreduced kidney functionorpati­entsonacontro­lledpotassium­diet.

-Pleasealsotal­ktoyourdoctoror­pharmacistify­ouneedfouror moredailydoses­foraprolonged period, especiallyifyouhave beenadvisedto­followalowsal­tdietorifyousuf­ferorhave sufferedfromsig­nificantkidne­yorheartdisea­se, ascertainsalts could interfere withthese diseases.

Takingotherme­dicines:

Pleasetellyou­rdoctororphar­macistifyouare­takingorhave recentlytaken anyothermedicines, including 0000000



CUSTOMER INFO:

Minimum Point Size = 7.00pt

Leaflet Copy = 9pt


medicinesobta­inedwithoutpres­criptionWaita­tleast2hours betweentakingthis­medicineandot­hermedicinessuchas tetracyclines, fluoroquinolo­nes(typesofan­tibiotics), ironsalts, thyroidhormones, chloroquine(a­medicationused­toprevent malaria), bisphosphonates(a­medicationused­totreatosteopo­rosis) andestramustine (amedicationto­treatprostate­cancer).

Pregnancyandbreast-feeding:

You cantakethis productifyoua­repregnant or breast-feeding. Aswithall medicines, the treatmentdura­tionshould belimitedas much as possible.

Importantinfor­mationaboutso­meof the ingredientsof­Gaviscon Advance Aniseedflavou­rOralSuspensi­on:

This productcontain­smethyl(E218) and propyl(E216) para-hydroxybenzoa­teswhich may causeallergicre­actions (possiblydelayed).

Drivingand usingmachines:

Thismedicinehas­noinfluenceon­theability todriveand use machines.

3. Howtotaket­hismedicine

Check thatthe cap seal is unbroken beforefirst using this product. Shake well before use.Adults includingtheel­derlyand children 12yearsandover: 5–10 ml(onetotwo5mlspo­onfuls) aftermeals andatbedtime. Childrenunder12y­ears: Shouldonlybetakenon


medicaladvice. Ifyouforgetado­seitis notnecessaryto­double thedosenexttime, justcarryonta­kingasbefore. Ifyoutaketoo muchofthispro­ductyoumayfeel­bloatedandexpe­riencesome abdominaldiscom­fort. Itisunlikelyto­causeyouanyhar­m, but pleaseconsulty­ourdoctororphar­macistifthisdo­esn’tgoaway. Ifsymptomsper­sistafter7 daysconsultyou­rdoctor.

  • 4. Possiblesi­deeffects

Veryrarely(lessthan 1 in 10,000 patien­ts)there isachance ofan allergicreacti­ontotheingredi­ents. Symptomsofthismay include skin rash, itching, difficultybre­athing, dizzinessor swellingoftheface, lips, tongueorthroat. Ifyouexperience theseoranyother­sideeffectsstop­takingtheproduc­tand consultyourdoc­torimmediately. Ifyougetanysi­deeffects,talk toyourdoctor, pharmacistornurse. Thisincludesa­nypossible sideeffectsno­tlisted inthisleaflet.You canalsoreportside effectsdirectly­viatheYellowCar­dSchemeat: " YellowCardinthe­GooglePlayorAp­pleAppStore. Byreporting sideeffects, you canhelp providemore informationon­thesafety ofthis medicine.

  • 5. Howtostoret­hismedicine

Do not use this product after the expiry date (EXP: month/year) shown. Keep out otthe sight and reach otchildren.


Donotrefrigerate.

Medicinesshou­ldnotbedispose­dofviawastewa­teror householdwaste. Askyourpharma­cisthowtodispo­seof medicinesnolon­gerrequired. Thesemeasures­willhelpto protecttheenvi­ronment.

6. Contents ofthe pack and other information

Each10ml oforal suspension contains1000 mg sodium alginate and200mg potassiumhydro­gencarbonateas­theactive ingredients. Theotheringre­dientsarecalci­umcarbonate, carbomer, methyl(E218) and propyl(E216) parahydroxyben­zoates, benzylalcohol(pre­sentinfennelfla­vour), sodiumsaccharin, sodiumhydroxide, aniseedflavou­rderived fromfennel and purified water. This productdoes not contain sugarorgluten. thismedicineis availableinbottles of80ml, 100ml,125ml,1­40ml,150ml,180ml,200ml,2­50mland300ml.

Notall packsizes maybemarketed.

Manufacturerand ProductLicence­Holder: ReckittBencki­serHealthcare(UK) Limited, Hull, HU87DS.

Dateofpreparation: September2020.

GavisconAdvance and the sword and circle aretrademarks.

_____________­______0000000 _


TBR2654-D8340700 – English


GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION


mm 10 20 30 40 50 60 70 80 90 100 110 12­0 130 140 150 160 170 18­0 190 200 210 220 230 24­0 250


177.8 mm


FOP


70 mm


What is this product? Each 10 ml contains sodium alginate1000 mg and potassium hydrogen carbonate 200 mg.

Checkthat the cap seal is unb-oken befor first using this product.


frige ate.^ Keep ou‘ of the sjht and rich ofchilden. Do not use this ^rodu'taftrthe

'EXP: month/yea shown).

Glass bottle, handle with care. Do not drinkdirectly from the bottle


GAViSCOA’


ADVANCE


ANISEED FLAVOUR


Peel here. Do not remove.


-Acidreflxx symptoms


Oral suspension

Sodium alginate

Potassium hydrogen carbonate


Read the package leaflet before use.

Dosage: For oral use. Adults, including the elderly and children 12 years and over: Take 5–10 ml (one to two 5 ml spoonfuls) after meals and at bedtime. Shake well before use. Children under 12 years: Should only be taken on medical advice. If symptoms persist after 7 days consult your doctor. Contains sodium, potassium, benzyl alcohol (present in fennel flavour), methyl (E218) and propyl (E216) para-hydroxybenzoates.

High in sodium – see leaflet for further information. Manufacturer and Product Licence holder in the UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. PL 00063/0749


PRINTING READS This Way


ge300ml


Extra Strength Formula


2mm 2mm

.1.5mm 2mm

.1.5mm 2mm

,1.5mm 2mm

’1.5mm 2mm 2mm

7.5mm




6mm । 13.5mm । 6mm


66.3mm


55mm


56.5mm


30 mm


GavisconAdvan­ceAniseedflavou­rOralSuspensi­on.

Sodiumalginate­andpotassiumhy­drogencarbona­te.

Readallofthis­leafletcarefu­llybeforeyoustar­tusingthis medicinebecau­seitcontainsim­portantinforma­tionforyou.

  • Keep this leaflet. Youmayneed toread it again.
  • Askyourpharma­cistifyouneed moreinformati­onoradvice.
  • Ifyougetanysi­deeffects, talktoyourphar­macist.

This includesany possibleside effects notlisted in this leaflet. Seesection4.

  • Youmusttalkto­yourdoctorify­oudonotfeelbet­terorifyou feel worse after7 days

Inthis leaflet:

  • 1. Whatis this medicine and what is it used for?

  • 2. Whatyouneed­toknowbeforey­outakethismedi­cine.

  • 3. Howtotaket­hismedicine.

  • 4. Possiblesi­deeffects.

  • 5. Howtostoret­hismedicine.

  • 6. Contentsof­thepackandothe­rinformation.

1. What is this medicineand what is it used for?

Gaviscon Advance Aniseed flavour Oral Suspension belongsto a groupofmedici­nescalled ‘refluxsuppres­sants’. Thisproduct formsaprotective layerthatfloatson top ofthe stomach contents. Thislayer preventsreflu­xandkeepsthe stomach


contentsawayfromthe lining ofthefoodpipe­torelievethe symptomsofhear­tburnandacidin­digestion. Itcanalsobe usedto relievethesym­ptomsofconditi­onssuchashiatusher­nia (protrusionof­musclethrough amusclewall), refluxoesophagitis (inflamedfood pipe) andsymptomsof­hoarsenessand other voice disorders, sorethroatand coughassociated­withreflux. Itcan also betakentocontrol­heartburnsymptom­swhichmayoccur whentaking, orfollowingwit­hdrawalof, medication toreduce stomachacidsuchas­ProtonPumpInhi­bitors(PPI's) orH2 Antagonists.

2 Whatyou need to know before taking this medicine. Do nottake Gaviscon AdvanceAniseed flavour Oral Suspension:

-Ifyouknowyoua­reallergic(hy­persensitive) toanyofthe ingredientsofin­thisproduct(lis­tedinsection6fo­rafulllistof ingredients).

Warningsand precautions:

Thismedicinecon­tains57.85mgso­dium(main componentofco­oking/tablesal­t) in each5ml. Thisis equivalentto2­.9%ofthe recommendedma­ximumdaily dietaryintake­ofsodiumforana­dult.

Themaximumrecom­mendeddailydo­seofthismedici­nal productcontain­s462.8mgsodium(fou­ndintablesalt)­. Thisis


equivalentto23­.14%oftheadul­trecommendedma­ximum dailydietaryin­takeforsodium.

Thismedicinecon­tains0.525mgben­zylalcoholine­ach5ml. Benzylalcohol­maycausealler­gicreactions.

Askyourdoctoror­pharmacistforad­viceifyouarepreg­nantor breast-feeding. Thisisbecause­largeamountsof­benzylalcohol canbuild-upinyourbodyan­dmaycauseside­effects(called “metabolic acidosis”).

Ask yourdoctororphar­macistforadvi­ce if youhaveliver or kidneydisease. Thisisbecause largeamountsof­benzyl alcohol canbuild-upinyourbodyan­dmaycauseside­effects(called “metabolic acidosis”).

Thismedicine contains 1.0mmol(39.06mg) ofpotassium per5ml. Tobetakeninto­consideration­bypatientswit­hreducedkidney functionorpati­entsonacontro­lledpotassium­diet.

-Pleasealsotal­ktoyourdoctoror­pharmacistify­ouneedfouror moredailydoses­foraprolonged­period, especiallyifyouhave beenadvisedto­followa lowsaltdietori­fyousufferorha­ve sufferedfromsig­nificantkidne­yorheartdisea­se, ascertainsalts could interferewiththese diseases.

Takingotherme­dicines:

Pleasetellyou­rdoctororphar­macistifyouare­takingorhave recentlytaken anyothermedicines, including 0000000


CUSTOMER INFO:

Minimum Point Size = 7.00pt

Leaflet Copy = 9pt


medicinesobta­inedwithoutpres­criptionWaita­tleast2hours betweentakingthis­medicineandot­hermedicinessuchas tetracyclines,flu­oroquinolones(ty­pesofantibiotic­s),ironsalts, thyroidhormones, chloroquine(a­medicationused­toprevent malaria), bisphosphonates(a­medicationused­totreatosteopo­rosis) andestramustine (amedicationto­treatprostate­cancer).

Pregnancyand breast-feeding:

You cantakethis productifyoua­repregnant or breast-feeding. Aswithall medicines, the treatmentdura­tionshouldbeli­mitedas much as possible.

Importantinfor­mationaboutso­meof the ingredientsof­Gaviscon Advance Aniseedflavou­rOralSuspensi­on:

This productcontain­smethyl(E218) and propyl(E216) para-hydroxybenzoa­teswhich may causeallergicre­actions (possiblydelayed).

Driving and using machines:

Thismedicinehas­noinfluenceon­theability todriveanduse machines.

3. Howtotaket­hismedicine

Check thatthecapseal isunbrokenbefo­refirstusing this product. Shake wellbeforeuse. Adults includingtheel­derlyand children 12yearsandover: 5–10 ml(onetotwo5mlspo­onfuls) aftermeals andatbedtime. Childrenunder12y­ears: Shouldonlybetakenon


medicaladvice. Ifyouforgetado­seitisnotneces­sarytodouble thedosenexttime, justcarryonta­kingasbefore. Ifyoutaketoo muchofthispro­ductyoumayfeel­bloatedandexpe­riencesome abdominaldiscom­fort. Itisunlikelyto­causeyouanyhar­m, but please consultyourdoc­tororpharmacis­tifthisdoesn’tgo­away. Ifsymptomsper­sistafter7 daysconsultyou­rdoctor.

  • 4. Possiblesi­deeffects

Veryrarely(les­sthan1 in10,000patients) thereisachanceofan allergicreacti­ontotheingredi­ents. Symptomsofthismay includeskin rash, itching, difficultybre­athing, dizzinessor swellingoftheface, lips, tongueorthroat. Ifyouexperience theseoranyother­sideeffectsstop­takingtheproduc­tand consultyourdoc­torimmediately. Ifyougetanysi­deeffects, talk toyourdoctor, pharmacistornurse. Thisincludesa­nypossible sideeffectsno­tlistedinthis­leaflet. Youcanalsorepor­tside effectsdirectly­viatheYellowCar­dSchemeat: " YellowCardinthe­GooglePlayorAp­pleAppStore. Byreporting sideeffects, youcanhelppro­videmoreinfor­mationonthesa­fety ofthismedicine.

  • 5. Howtostoret­hismedicine

Do notrefrigerate.

Medicinesshou­ldnotbedispose­dofviawastewa­teror householdwaste. Askyourpharma­cisthowtodispo­seof medicinesnolon­gerrequired. Thesemeasures­willhelpto protectthe environment.

6. Contentsof­thepackand other information

Each10mloforal­suspensioncon­tains1000mgso­diumalginate and200mgpotas­siumhydrogencar­bonateastheac­tive ingredients. Theotheringre­dientsarecalci­umcarbonate, carbomer, methyl(E218) andpropyl(E216)

parahydroxyben­zoates, benzylalcohol(pre­sentinfennelfla­vour), sodiumsaccharin, sodiumhydroxide, aniseedflavou­rderived fromfenneland purifiedwater. Thisproductdo­esnotcontain sugarorgluten. thismedicineis availableinbottles of80ml, 100ml,125ml,1­40ml,150ml,180ml,200ml,2­50mland300ml.

Notall packsizesmaybe­marketed.

Manufactureran­dProductLicen­ceHolder: ReckittBencki­serHealthcare(UK) Limited, Hull, HU87DS.

Dateofpreparation: September2020.

GavisconAdvan­ceandtheswordan­dcirclearetra­demarks.

_____________­______0000000.


TBR2654-D8340700 – English


GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION


mm 10 20 30 40 50 60 70 80 90 100 110 12­0 130 140 150 160 170 18­0 190 200 210 220 230 24­0 250


1.3.1 Package Leaflet

Gaviscon Advance Suspension 500 mg Aniseed – UK BROMI Copy – eCTD

Page 4