P0573T PACKAGE LEAFLET: INFORMATION FORTHEUSER pharmacist ifyouare notsure. Always takethismedicineexactlyasdescribedinleafletoryourdoctorpharmacisthastoldyou.Checkwith doctoror HowtotakeLactuloseSolution 3. your doctorthatyouhaveanintolerance tosomesugars, contactyourdoctorbefore takingthis medicine. Lactulose Solutionmaycontainsmallamountsofmilksugar(lactose),galactose,epilactoseandfructose.Ifyouhavebeen toldby Lactulose Solutioncontainslactose,galactoseandfructose Lactulose Solutionhasnoornegligibleinfluenceonyourabilitytodrivesafelyusemachines. Driving andusingmachines areNo effectsonfertility tobeexpected. Lactulose Solutioncanbeusedduringpregnancy andwhenbreast-feeding ifnecessary. Talk toyourdoctororpharmacistbefore takingthismedicineifyou are pregnant, mightbecomepregnant or are breast-feeding. Pregnancy, breast-feedingandfertility Lactulose Solutioncanbetakenwithorwithoutfood.There are norestrictions onwhatyoucaneatordrink. Lactulose Solutionwithfoodanddrink Tell yourdoctororpharmacistifyouare taking,haverecently takenormighttake anyothermedicines. Other medicinesandLactuloseSolution influence thenormalreflexes forpassingstools. thetreatmentsupervise carefully. LactuloseSolutionshouldonlybegiventoinfantsandsmallerchildren ifindicatedasitcan In specialcircumstances yourdoctormayprescribe LactuloseSolutionforachild,infantorbaby. Inthesecasesyourdoctorwill Children contact yourdoctor. If youtakeLactuloseSolutionforseveral daysandthere isnoimprovement inyourconditionorifsymptomsworsen, please During thetreatment withlaxativesyoushoulddrinksufficientamountsoffluids(approx. 2litres/day, equalto6-8glasses). electrolyte balance. Chronic useofunadjusteddosages(exceeding2-3softstoolsperday)ormisusecanleadtodiarrhoeaanddisturbancethe contains alarge amountofsugar. Therefore, youmayneedtoadjustthedoseofyouranti-diabeticmedicine. If youhavediabetesandare treated forhepaticencephalopathy, yourdoseofLactuloseSolutionwillbehigher. Thishighdose • • • Talk toyourdoctororpharmacistbefore takingLactuloseSolutionifyousufferfrom anymedicalconditionsorillnesses,inparticular: Warnings andprecautions Lactulose Solution. Do nottakeLactuloseSolutionifanyoftheaboveapplytoyou.Ifyouare notsure, talktoyourdoctororpharmacistbeforetaking • • • Do nottakeLactuloseSolutionif: WhatyouneedtoknowbeforetakeLactulose Solution 2. • • It isusedtotreat: Lactulose isalaxative.Itmakesthestoolsofterandeasiertopass,bydrawing waterintothebowel.Itisnotabsorbedyourbody. WhatLactuloseSolutionisandwhatitusedfor 1. 6. Contentsofthepackandotherinformation 5. Howtostore LactuloseSolution 4. Possible sideeffects 3. HowtotakeLactuloseSolution 2. Whatyouneedtoknowbefore youtakeLactuloseSolution 1. WhatLactuloseSolutionisandwhatitusedfor What isinthisleaflet • • • • Always takethismedicineexactlyasdescribedinleafletoryourdoctor, pharmacistornurse hastoldyou. information foryou. Read allofthisleafletcarefullybeforeyoustarttakingmedicinebecauseitcontainsimportant LACTULOSE SOLUTION also knownasa'hepaticcoma'. See section4. if youhavediabetes. if youare unabletodigestmilksugar(lactoseintolerant) if yousufferfrom unexplainedtummyache you haveablockagecausedbyanythingelsebutnormalconstipation,digestiveperforation orriskofdigestiveperforation. you havearare problem called'galactosaemia' you are allergic (hypersensitive) tolactuloseoranyoftheotheringredients (listedinSection6) hepatic encephalopathy(aliverdiseasecausingconfusion,tremor, decreased levelofconsciousnessincludingcoma).This is constipation (infrequent bowelmovements,hard stools) and dry You musttalktoadoctorifyoudonotfeelbetterorworse afterseveral days. If yougetanysideeffectstalktoyourdoctor, pharmacistornurse. Thisincludesanypossiblesideeffectsnotlistedinthisleaflet. Ask yourpharmacistifyouneedmore informationoradvice. Keep thisleaflet.You mayneedtoread itagain. Pharmacode Font Size Dimensions Market orPackOwner Item Number Market TradeName Project Quality Assurance Observations: Approval Date: Pleas 3.35g/5ml e Note! Wecannotacceptre sponsibility 205 10 pt 210 x297mm-Leaflet Crescent PharmaLtd. P0573T Lactulose Oral3.35g/5ml IF Y OU accu SIGN racy toou Observations: Approval Date: T HIS PR r clien OOF Y f or an tʼs brief y errors OU ARE , th i e SIGN n t fin his al res IFYING FULL proof ponsibility mustbetake n a f Print Colours Technical Colours Non-Print 1 D Marketing Observations: Approval Date: ter approval. Whils ate

APPROVAL 25/ 05/2017 OF DESIGN A t w byou e takeextrem Keyline Black r clien ND t. TEXT. e careatalltimes toensu re Manufacturing Observations: Approval Date: 205 Proof 1 205 can helpprovide more informationonthesafetyofthismedicine. You canalsoreport sideeffectsdirectly viatheYellow Card Schemeat:www.mhra.gov.uk/yellowcard. Byreporting sideeffectsyou If yougetanysideeffects,talktoyourdoctor, pharmacistornurse. Thisincludesanypossiblesideeffectsnotlistedinthisleaflet. Reporting ofsideeffects experience anelectrolyte imbalanceduetodiarrhoea. If youusehighdoses(normallyonlyassociatedwithhepaticencephalopathy, (HE))foranextendedperiodoftime,youmay instructed are used,abdominalpainanddiarrhoeamayoccur. Insuchacasethedosageshouldbedecreased. Flatulence mayoccurduringthefirst fewdaysoftreatment. Asaruleitdisappears afterafewdays.Whendosageshigher than • Uncommon (mayaffectupto1in100 people) • • • • Common (mayaffectupto1in10 people) • common(mayaffectmoreVery than1in10 people) The followingsideeffectshavebeenreported: getsthem. Like allmedicines,thismedicinecancausesideeffects,althoughnoteverybody 4. Possiblesideeffects your doctororpharmacist. Do notstoporchangethetreatment before talkingtoyourdoctor. questionsontheuseofthismedicine,ask Ifyouhaveanyfurther If youstoptakingLactuloseSolution make upforaforgotten dose. If youforget adoseofLactuloseSolution,donotworry. Justtakethenextdoseatusualtime.Donotadoubleto If youforgettotakeLactuloseSolution abdominal pain. If youtakemore LactuloseSolutionthanyoushouldstoptakingandtalktoadoctororpharmacist.You mayhavediarrhoeaand If youtakemoreLactuloseSolutionthanshould Use inelderlypatientsandwithrenalorhepaticinsufficiency:Nospecialdosagerecommendations exist. Use inChildren:Noinformationisavailablefortreatment ofchildren (newbornto18 years ofage)withhepaticencephalopathy. doseis30-45ml3to4timesaday.Adults: Theusualstarting Hepatic encephalopathy(adultsonly) supervision. Please donotgiveLactuloseSolutiontochildren (under14 years) before consultingyourdoctorforprescription andcareful can influencethenormalreflexes forpassingstools. Use inChildren:oflaxativeschildren, becauseit infants,andbabiesshouldbeexceptionalundermedicalsupervision Infants under1year:Theusualdoseisupto5mldaily. Children 1to6years:Theusualdoseis5-10ml daily. doseis15mlChildren 7to14years:Thestarting daily. After this,thedosecanbeadjustedto10 -15ml daily. doseis15Adults andadolescents:Thestarting -45mldaily. After this,thedosecanbeadjustedto15 -30mldaily. Constipation same timeeachday, forexampleduringbreakfast. Lactulose maybetakeneitherasasingledailydoseorin2divideddoses;ifthenthisshouldatthe working.After thistimeyoumaybeabletoreduceLactulose takes2to3daysstart thedoseyoutakeaccording toyourneeds. Solution istakenforlongperiods. Swallow thedoseimmediately. Donotkeepitinyourmouthasthesugarcontentmayleadtotoothdecay, ifLactulose particularly fluids (approximately 6-8glassesthroughout theday). Take thismedicinefrom aspoonormeasuringcup.You canmixitwithfruitjuiceorwater. Itisrecommended thatyoudrinkplentyof Taking thismedicine If youwouldlikethisleafletinadifferentformatpleasecontactthelicenceholderatabove address. This leafletwaslastrevised inMay2017 Manufacturer: Crescent ManufacturingLimited,2Cunard Road,Park Royal,London,NW10 6PN,UK. Polhampton Hampshire, Lane,Overton, RG253ED,UK. Marketing AuthorisationHolder:Crescent PharmaLimited,Units3&4,QuidhamptonBusinessUnits, Marketing AuthorisationHolderandManufacturer Not allpacksizesmaybemarketed. Lactulose Solutionisaclear, colourlesstobrownish yellow, viscousliquid.Itisavailableinplasticbottlescontaining300mlor500ml. What LactuloseSolutionlookslikeandcontentsofthepack galactose, epilactoseandfructose. Lactulose Solutiondoesnotcontainanyotheringredients. However, itmaycontainsmallamountsofothersugars, suchaslactose, The activeingredient inLactuloseSolutionislactulose.Each5mlofcontains3.35g oflactulose. What LactuloseSolutioncontains 6. Contentsofthepackandotherinformation longer use.Thesemeasures willhelpprotect theenvironment. Do notthrow awayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrow awaymedicinesyouno Do notstore above25°C.Donotrefrigerate orfreeze. month. daterefers orbottle.Theexpiry datewhichisstatedonthecarton to the lastdayofthat Do notusethismedicineaftertheexpiry Keep thismedicineoutofthesightandreach ofchildren. 5. HowtostoreLactuloseSolution electrolyte imbalanceduetodiarrhoea. abdominalpain. vomiting nausea(feelingsick) flatulence(wind) diarrhoea. Taking this medicine Take this medicine from a spoon or measuring cup. You can mix it with fruit juice or water. It is recommended that you drink plenty of fluids (approximately 6-8 glasses throughout the day). Swallow the dose immediately. Do not keep it in your mouth as the sugar content may lead to tooth decay, particularly if Lactulose Solution is taken for long periods. Lactulose takes 2 to 3 days to start working. After this time you may be able to reduce the dose you take according to your needs. Lactulose may be taken either as a single daily dose or in 2 divided doses; if taken as a single daily dose then this should be at the same time each day, for example during breakfast. Read all of this leaflet carefully before you start taking this medicine because it contains important Constipation information for you. Adults and adolescents: The starting dose is 15 - 45ml daily. After this, the dose can be adjusted to 15 - 30ml daily. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Children 7 to 14 years: The starting dose is 15ml daily. After this, the dose can be adjusted to 10 - 15ml daily. • Keep this leaflet. You may need to read it again. Children 1 to 6 years: The usual dose is 5 - 10ml daily. • Ask your pharmacist if you need more information or advice. Infants under 1 year: The usual dose is up to 5ml daily. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Use in Children: Use of laxatives in children, infants, and babies should be exceptional and under medical supervision because it See section 4. • can influence the normal reflexes for passing stools. You must talk to a doctor if you do not feel better or if you feel worse after several days. Please do not give Lactulose Solution to children (under 14 years) before consulting your doctor for prescription and careful What is in this leaflet supervision. 1. What Lactulose Solution is and what it is used for Hepatic encephalopathy (adults only) 2. What you need to know before you take Lactulose Solution Adults: The usual starting dose is 30 - 45ml 3 to 4 times a day. 3. How to take Lactulose Solution Use in Children: No information is available for treatment of children (newborn to 18 years of age) with hepatic encephalopathy. 4. Possible side effects Use in elderly patients and patients with renal or hepatic insufficiency: No special dosage recommendations exist. 5. How to store Lactulose Solution If you take more Lactulose Solution than you should 6. Contents of the pack and other information If you take more Lactulose Solution than you should stop taking and talk to a doctor or pharmacist. You may have diarrhoea and 1. What Lactulose Solution is and what it is used for abdominal pain. Lactulose is a laxative. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body. If you forget to take Lactulose Solution It is used to treat: If you forget a dose of Lactulose Solution, do not worry. Just take the next dose at the usual time. Do not take a double dose to • constipation (infrequent bowel movements, hard and dry stools) make up for a forgotten dose. • hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma). This is If you stop taking Lactulose Solution also known as a 'hepatic coma'. Do not stop or change the treatment before talking to your doctor. If you have any further questions on the use of this medicine, ask 2. What you need to know before you take Lactulose Solution your doctor or pharmacist. Do not take Lactulose Solution if: 4. Possible side effects • you are allergic (hypersensitive) to lactulose or any of the other ingredients (listed in Section 6) Like all medicines, this medicine can cause side effects, although not everybody gets them. • you have a rare problem called 'galactosaemia' The following side effects have been reported: • you have a blockage caused by anything else but normal constipation, digestive perforation or risk of digestive perforation. Very common (may affect more than 1 in 10 people) • diarrhoea. Do not take Lactulose Solution if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lactulose Solution. Common (may affect up to 1 in 10 people) • flatulence (wind) Warnings and precautions • nausea (feeling sick) Talk to your doctor or pharmacist before taking Lactulose Solution if you suffer from any medical conditions or illnesses, in particular: • vomiting • if you suffer from unexplained tummy ache • abdominal pain. • if you are unable to digest milk sugar (lactose intolerant) • Uncommon (may affect up to 1 in 100 people) if you have diabetes. • electrolyte imbalance due to diarrhoea. If you have diabetes and are treated for hepatic encephalopathy, your dose of Lactulose Solution will be higher. This high dose Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days. When dosages higher than contains a large amount of sugar. Therefore, you may need to adjust the dose of your anti-diabetic medicine. instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. Chronic use of unadjusted dosages (exceeding 2-3 soft stools per day) or misuse can lead to diarrhoea and disturbance of the If you use high doses (normally only associated with hepatic encephalopathy, (HE)) for an extended period of time, you may electrolyte balance. experience an electrolyte imbalance due to diarrhoea. During the treatment with laxatives you should drink sufficient amounts of fluids (approx. 2 litres/day, equal to 6-8 glasses). Reporting of side effects If you take Lactulose Solution for several days and there is no improvement in your condition or if your symptoms worsen, please If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. contact your doctor. 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. Children In special circumstances your doctor may prescribe Lactulose Solution for a child, infant or baby. In these cases your doctor will 5. How to store Lactulose Solution supervise the treatment carefully. Lactulose Solution should only be given to infants and smaller children if indicated as it can Keep this medicine out of the sight and reach of children. influence the normal reflexes for passing stools. Do not use this medicine after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month. Other medicines and Lactulose Solution Do not store above 25°C. Do not refrigerate or freeze. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no Lactulose Solution with food and drink longer use. These measures will help protect the environment. Lactulose Solution can be taken with or without food. There are no restrictions on what you can eat or drink. 6. Contents of the pack and other information Pregnancy, breast-feeding and fertility What Lactulose Solution contains Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. The active ingredient in Lactulose Solution is lactulose. Each 5ml of Lactulose Solution contains 3.35g of lactulose. Lactulose Solution can be used during pregnancy and when breast-feeding if necessary. Lactulose Solution does not contain any other ingredients. However, it may contain small amounts of other sugars, such as lactose, No effects on fertility are to be expected. galactose, epilactose and fructose. Driving and using machines What Lactulose Solution looks like and contents of the pack Lactulose Solution has no or negligible influence on your ability to drive safely or use machines. Lactulose Solution is a clear, colourless to brownish yellow, viscous liquid. It is available in plastic bottles containing 300ml or 500ml. Not all pack sizes may be marketed. Lactulose Solution contains lactose, galactose and fructose Lactulose Solution may contain small amounts of milk sugar (lactose), galactose, epilactose and fructose. If you have been told by Marketing Authorisation Holder and Manufacturer your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Marketing Authorisation Holder: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK. 3. How to take Lactulose Solution Manufacturer: Crescent Manufacturing Limited, 2 Cunard Road, Park Royal, London, NW10 6PN, UK. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This leaflet was last revised in May 2017 If you would like this leaflet in a different format please contact the licence holder at the above address.