Document: Laxogol powder for oral solution in sachet PL change

• Laxogol powder for oral solution, sachet PL
• Laxogol powder for oral solution, sachet OTC PL
• Laxogol powder for oral solution in sachet PL

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Packageleaflet:Information fortheuser

Laxogol

Powder fororal solution, sachet

Readall ofthisleaflet carefullybefore you start takingthismedicine because itcontainsimportantinformationforyou.

Alwaystakethismedicineexactlyas describedinthisleafletor asyour doctoror pharmacisthas toldyou.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is in thisleaflet:

Laxogol isa laxative usedforthe treatmentof longtime constipation. Itis notrecommendedfor childrenbelow12 yearsof age. Macrogol 3350 makes yourfaeces softerand easierto pass, givingyou relieffromconstipation. The electrolytes (salts) helpto maintainyourbody’s normallevels ofsodium, potassiumand waterwhile you are beingtreatedforconstipation.

Donottake Laxogol

• if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6)

• if you have a perforated gut (bowel) wall

• if you have a blockage in your intestine (gut obstruction, ileus)

• if you have severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon

Ifany ofthese applies to you, pleasetalk to yourdoctoror pharmacistforfurtheradvice.

Othermedicinesand Laxogol

Somemedicines, e.g. anti-epileptics,maynot workas effectivelyduringuse withLaxogol.Tellyourdoctoror pharmacistifyou are taking, haverecentlytaken ormighttake anyothermedicines.

Laxogolwithfood anddrink

Laxogol can betaken at anytime with or withoutfood ordrink

Pregnancy and breast-feeding

Ifyou are pregnantor breast-feeding, think youmaybe pregnantor are planningto have a baby, ask yourdoctoror pharmacistforadvice before takingthis medicine.

Driving andusingmachines

Laxogol has no effecton theabilityto driveorusemachinery.

Laxogolcontainspotassium,sodiumandsorbitol(lemon limeflavour)

Laxogolcontains 0.63 mmol(25 mg)of potassiumper sachet.Thisshould betaken intoconsiderationif you take more than one sachetdailyand you have reduced kidneyfunction, or if youare on acontrolledpotassiumdiet.

Laxogolcontains 8.1 mmol(187 mg)of sodiumper sachet.Thisshouldbe takeninto considerationif you are ona controlledsodiumdiet.

The lemonlimeflavourin Laxogolcontainssorbitol(E420).Ifyouhavebeen toldby yourdoctorthatyouhavean intoleranceto somesugars,contactyourdoctorbeforetakingthis medicinalproduct.

Adults,children(aged 12years andabove)andtheelderly:

Theusualdosefor constipationis one sachet taken oneto three times daily.

Howto mix

Open thesachet andpour the contents intoa glass. Add about125 mlor a quarterpintof waterto theglass. Stirwell until the powderhas dissolved and then drinkit.

Durationof treatment

This course of treatmentforconstipationshould notnormally lastlongerthan 2 weeks.

Ifyoutakemore Laxogolthanyoushould

This can cause severe painand swellingin yourabdomen (stomach), or vomiting(sickness)or diarrhoea.Ifthis happens,contactyourdoctororpharmacist.

Ifyouforgetto take Laxogol

Ifyou forgetto take a dose,take itassoon asyou rememberand then continueon as before. Do nottake a doubledoseto make up fora forgottendose.

IfyoustoptakingLaxogol

To getthe mostbenefitfromLaxogol,always finish thecourse of treatmentaccordingto thedirectionsinthis package leaflet.This willmake sure thatyourconstipationis cleared,otherwise thesymptoms you are sufferingfrom maypersist.

Youmustcontacta doctorifyoursymptoms worsen ordo not improve after14days.

Ifyouhaveanyfurtherquestions ontheuseof thisproduct,ask yourdoctororpharmacist.

Like all medicines,this medicine can cause sideeffects, although not everybodygets them.

Ifyou experience anyofthefollowingsideeffects, stoptakingLaxogol andseeyourdoctorimmediately:

• signs of an allergy, such as a rash, itching, shortness of breath or difficulty in breathing.

• signs of a change in your body’s fluid or electrolyte levels (salts levels), such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache

Thefollowingside effects are also possible:

• abdominal (stomach) pain

• mild diarrhoea (when starting to take Laxogol, this usually stops if you reduce the number of sachets you take)

• nausea (feeling sick)

• vomiting

• swelling of your abdomen (feeling bloated)

• stomach rumbling

• flatulence (wind)

• soreness of the anus (bottom)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

Keepthis medicine outof thesightand reachof children.

Do notusethis medicine aftertheexpiry datewhich isstatedon thecartonandsachet.Theexpiry daterefers to the lastdayof thatmonth.

Do not storeabove 25 °C.

Do not use thismedicineifyou noticethatanyof the sachets isdamaged.

ReconstitutedLaxogol solutioncanbe covered andstoredin the refrigerator(2°Cto 8°C), and shouldbe used within24 hours. After 24 hours,anyunused solutionshouldbe discarded.

Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrowawaymedicinesyou nolongeruse.Thesemeasureswillhelpprotecttheenvironment.

WhatLaxogolcontains

The active substances are:Each sachetcontains:

macrogol3350 (polyethylene glycol3350) 13.125 g

sodiumchloride 0.3507 g

sodiumhydrogencarbonate 0.1785 g

potassiumchloride 0.0466 g

The otheringredients arecolloidalanhydrous silica, saccharinsodium, orange flavour(Orange flavourcontains:flavouringsubstancesand flavouringpreparations, maltodextrin, acacia gum, alpha-tocopherol)andlemon limeflavour(Lemon lime flavourcontains:flavouringpreparations, maltodextrin, mannitol, gluconolactone,sorbitol (E420),acacia gum, colloidalanhydrous silica).

WhatLaxogol lookslike andcontents ofthepack

Laxogolisa whitepowder.

Each sachetcontains13.8 gof powderand is packedin cartonscontaining2, 6, 8, 10, 20, 30, 50, 60(2x30)and 100 (2x50)sachets.

Notallofthesepacksizesare marketed.

MarketingAuthorisationHolder andManufacturer

MarketingAuthorisationHolder

<Tobe completed nationally>

Manufacturer

Klocke Pharma-Service GmbHStrassburgerStrasse 77

77767 AppenweierGermany

HermesPharmaGes.m.b.H.Allgäu36

9400 WolfsbergAustria

Thisleaflet waslastrevised in

2015-01-30 SE takes over as RMS.