Rennie Dual Action chewable tablets, Rennie Extra tablets – patient leaflet, side effects, dosage

1. WHAT RENNIE DUAL ACTIONTABLETS ARE ANDWHATTHEY ARE USEDFOR

RennieDualActionTablets providerelieffromheartburn and acid indigestion.

RennieDualActionTablets workintwodifferentways:

1. 1. Alginicacidformsaprotectivebarrierinthestomachtostopacidescapingupwards,soothingthatburningpainin yourchest 2. Calciumcarbonateandmagnesiumcarbonateproviderapidneutralisationofexcessacidinthestomach

2. WHATYOUNEEDTOKNOWBEFOREYOUTAKE RENNIE DUAL ACTIONTABLETS

Do nottake Rennie Dual ActionTablets:

• Ifyouhaveseverekidneydiseaseorsufferfromkidneystones.
• Ifyouhavehighcalciumorlowphosphatelevelsintheblood.
• Ifyouareallergictoanyoftheingredients.

Warningsand precautions:

Aswithotherantacidproducts,taking these tablets can maskthesymptomsofother,moreserious,underlying medicalconditions.Ifsymptoms persistafterfourteendaysconsultyourdoctor.

PleaseconsultyourdoctororpharmacistbeforetakingRennieDualActionTabletsifyouhaveanykidneyproblems,havebeendiagnosedwith sarcoidosis(inflammationdiseasethataffects multipleorgans inthebody),orsufferfrom severeorchronicgastro-intestinalsymptomsor diseases.

Other medicines and RennieDual ActionTablets:

• Pleasetellyourdoctororpharmacistifyouaretakingorhaverecentlytakenanyothermedicines,includingmedicinesobtainedwithout aprescription.

• Iftakingantibiotics(tetracyclines,quinolones),cardiacglycosides(digoxin,digitoxin),bisphosphonates(used for thetreatmentof osteoporosis),dolutegravir(ananti-retroviralmedicineusedforthetreatmentofHIVinfection),levothyroxine(athyroidhormone), eltrombopag (a medicine usedtoincreasethenumberofplatelets)orotherprescribedmedicines(e.g.fluorides,phosphate,ironcontaining products)speak toyourdoctorbeforetakingRennieDualActionTabletsbecauseitcanaffecthow these medicines work.Tomaximisethe benefitofallmedicinesbeingused,takeRennieDualActionTablets1to 2hoursaftertakinganyothermedicines. • Ifyouaretakinganythiazidediuretics(e.g.bendroflumethiazide),whichareusedtoincreaseurineproduction,thenyoushould tell your doctorbeforetakingthe productbecauseheorshemaywanttomonitorthecalciumlevelsinyourblood. RennieDual ActionTablets with food and drink

Aswithallcalciumcontainingantacidproductsintakewithlargeamountsofmilkordairyproducts shouldberefrained. Pregnancy and breast-feeding:Askyourdoctor or pharmacist foradvicebeforetakinganymedicine.RennieDualActionTabletscan beused duringpregnancyiftakenasinstructed.RennieDualActionTabletscanbeusedwhile breast-feedingiftakenasinstructed (seeSection3). AsRennieDualActionTabletsprovidea substantial amountofcalciuminadditiontodietarycalciumintakepregnantwomenshouldstrictly limittheiruseofRennieDualActionTabletstothemaximumrecommendeddailydoseandavoidconcomitant,excessiveintakeofmilk (1litre containsupto1.2gelementalcalcium)anddairyproducts.

Rennie Dual ActionTablets contains sodium, glucose andsucrose:

Thisproductcontains 14 mg of sodium (main componentofcooking/tablesalt)ineach tablet.Thisisequivalent to 0.7 %of the recommended maximumdailydietaryintakeofsodiumforanadult.

Thisproductalsocontains230mgsucroseand about555.2 mgglucose(includingfrom dextrates)pertablet,whichshould be takeninto accountinpatientswith diabetesmellitus.

Ifyouhavebeentoldbyyour doctorthatyouhaveanintoleranceto somesugars, contactyourdoctorbefore taking this medicinal product. Moreover glucoseandsucrosemaybeharmfultotheteeth.

3. HOWTOTAKE RENNIE DUAL ACTIONTABLETS

AlwaystakeRennie DualActionTabletsexactlyasyourdoctorhastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure. Adults and children over 12 only:2tabletstobe chewed, preferably1hourafter meals andbeforebedtime. Forheartburnanextra2tablets maybetakenbetweenthesetimes.Donottakemorethan12tabletsin24hours.

Rennie Dual ActionTabletscanbe usedduringpregnancyandbreastfeeding iftakenasinstructedabove.

Ifsymptomspersistafter14daysconsultyourdoctorinordertoexcludea moreseriousdisease.Prolonged use should beavoided.Donotgiveto childrenundertheageof12.

If you take more Rennie Dual ActionTablets than you should:Drinkplentyof water andconsultyourdoctororpharmacist.Symptomsof anoverdoseinclude nauseaand vomiting,constipation,tiredness, increasedurineproduction,increased thirst, dehydrationandabnormal muscularweakness.

Ifyouhave anyquestionsontheuse ofthis product,askyourdoctororpharmacist.

If you forget to take Rennie Dual ActionTablets: Do not take adouble dose to make up for aforgottendose.

4. POSSIBLE SIDE EFFECTS

Likeallmedicines,this medicine can causesideeffects, although not everybodygetsthem.

Sideeffectsareunlikelyattherecommended dose.

Rarelyallergicreactionstoingredients havebeenreported,e.grashes, itching, difficultyinbreathing and swellingoftheface, mouth or throat andanaphylacticshock.Ifyouexperiencethese reactionsstoptreatmentimmediatelyandseekmedicaladvice. Longtermuseofhighdosescancausehighbloodlevelsofcalciumandmagnesium,especiallyinpeoplewithkidneyconditions.Thiscancause nauseaand vomiting,upsetstomach,diarrhoea,tiredness, muscularweakness, confusion, increasedurineproduction,increased thirstand dehydration.

TakingRennie Dual ActionTabletswithmilkor dairy products overalong periodof timemaycausemilkalkalisyndrome, whichcancausehigh bloodlevels ofcalcium.Specificsymptomsofmilkalkalisyndromemayincludeimpaired sense of taste,headache,kidneyproblems,fatigueand lumps undertheskin.

Reporting ofside effects: Ifyougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossiblesideeffects notlisted inthisleaflet.Youcanalsoreportsideeffects directly viatheYellowCard Scheme at:www.mhra.gov.uk/yellowcardorsearch forMHRAYellow Card inthe Google PlayorAppleAppStore.By reportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyof this medicine.

5. HOWTOSTORE RENNIE DUALACTIONTABLETS

Keep this medicine out of the sightand reachofchildren.

Donot usethis medicine aftertheexpiry date which is stated onthecarton andfoilafter“EXP”.Theexpirydatereferstothe lastday ofthat month.

Donotstoreabove30°C.Storeintheoriginalpackageinordertoprotectfrom moisture.

Donotthrowawayanymedicines viawastewater or household waste.Askyourpharmacisthow tothrow awaymedicinesyounolonger use. Thesemeasureswillhelpprotecttheenvironment.

6. CONTENTS OFTHE PACK ANDOTHERINFORMATION

WhatRennie Dual ActionTablets contain:

Theactivesubstancesarecalciumcarbonate(625mg),magnesiumcarbonate(73.5mg)andalginicacid(150mg). Theotheringredients are:sodium hydrogencarbonate,sucrose,glucosemonohydrate,povidone, talc,magnesiumstearate,dextrates, saccharinsodium,lemoncreamflavour(containslemonoil,limeoil,orangeoil,l-menthole,vanilline,maltodextrin,gumarabic,ascorbicacid, butylhydroxyanisol),peppermintflavour(containspeppermintoil, maltodextrin,gumarabic,silicondioxide).

WhatRennie Dual ActionTablets looklike and contents of the pack:

Rennie Dual ActionTablets areoffwhite,speckledcircularchewabletablets,flatonbothsideswith abevelled edge. Theyare suppliedinfoilstrips inacartonwiththisleaflet.

Thetabletsareavailable inpack-sizesof12,18,24,30,36and48.

Notallpacksizesmay be marketed.

Marketing Authorisation Holder Manufacturer

Bayer plc Delpharm Gaillard

400SouthOakWay 33 ruedel’Industrie

ReadingRG2 6AD 74240Gaillard

UK France

This leaflet was last revised inAugust2020.

PACKAGELEAFLET: INFORMATION FORTHEUSER

Chewable Tablets

135 mm

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PIL 135 x 197 Rennie Chew Tablets Dual Action Leaflet

UK

12/24 Pack

APPROVAL PANEL

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Country Approval:

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BAY416297