ACARBOSE TECNIMEDE 50 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
ACARBOSE
Available from:
Multigeneris GmbH
INN (International Name):
ACARBOSE
Dosage:
50 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization number:
PA1773/001/001
Authorization date:
2014-01-31

Package leaflet: Information for the user

<Invented name>

Acarbose

Read all of this leaflet carefully before youstart taking this medicine because it

contains important information for you.

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

-If you have further questions,ask your doctor or pharmacist.

-This medicine has been prescribed foryou only. Do not pass it on to others. It may

harmthem, even if their signs ofillness are the sameas yours.

-If you get any side effects, talk to yourdoctor or pharmacist. This includes any

possible side effects notlisted in this leaflet.

What is in this leaflet

1. What<Invented name>is and what it is used for

2. What you need to know before you take<Invented name>

3. How to take<Invented name>

4. Possible side effects

5. How to store<Invented name>

6. Contents of the pack and other information

1. What <Invented name> is and what it is used for

Acarbose isused in the treatment ofnon-insulin dependent diabetesmellitus in

patients inadequately controlled ondietalone,or ondiet and oral hypoglycaemic

agents.

This medicine has been prescribed foryou by your doctor to treat your diabetes.

Acarbose will help to control your blood sugar levels. This is because Acarbose works

by slowing down the digestion of carbohydrates(complex sugars) fromyour diet, and

this reduces the abnormally high blood sugar levels that occur after each meal.

2. What you need to knowbefore you take<Invented name>

Do not take <Invented name>

-if you are allergic toacarbose or any of the otheringredients of this medicine

(listed in section 6). If you areunsure about this ask your doctor.

-if you suffer from inflammation or ulceration of the bowel, e.g. ulcerative colitis

or Crohn's disease.

-if you have, or are susceptible to,an obstruction in your intestines.

-if you have a liver disorder.

-if you have an intestinaldisease whereby you do notdigest or absorb food

properly.

-if you have a large hernia or any other condition where increased gas in your

intestine may make it worse.

If you have a kidney disorder do not takeacarbose without consulting your doctor

first.

If you are unsure whether you might have any of these conditions, please ask your

doctor.

No modification of the normal adult dosageregimen is necessary for elderly patients.

Acarbose is not recommended forpatients under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacistbefore taking <Invented name>.

Treating hypoglycaemic episodes ("hypos").As a diabetic you may also be receiving

other treatments for your diabetes.

-If you are taking insulin orsulphonylurea drugs to control your blood sugar, you

will probably be usedtoavoidinghypoglycaemic episodes by takingsugar when

you feel that your blood sugar level is too low.

-When takingacarbose do not treat a hypoglycaemic episode with ordinary sugar

(sucrose). Instead take someglucose (also known as dextrose) tablets, syrup, or

sweets which should be available from your local pharmacist.

-If you are pregnant or breastfeeding (see section on Pregnancy, breastfeeding and

fertility below)

This medicine may affect the levels of certain proteins called enzymes in your blood.

Your doctor may wish to see you more frequently in order tomonitor the levels of

these enzymes.

Other medicines and <Invented name>

Acarbose may alter the effect of other drugsor, alternatively, somedrugs may alter

the effect of acarbose. If you are using any ofthe following drugs, speak to your

doctor or pharmacist before taking this medicine:

-Drugs known as intestinal adsorbents, e.g. charcoal.

-Drugs to help your digestion (digestive enzymepreparations e.g. amylase,

pancreatin).

-The antibiotic, neomycin.

-Colestyramine, a drug used to treat high cholesterol.

-Digoxin.

Tell your doctor or pharmacist if you are taking,have recently taken or might takeany

other medicines.

<Invented name> with food, drink and alcohol

Acarbose tablets can be swallowed with a little liquid immediately before the meal.

Pregnancy, breast-feeding and fertility

Acarbose is not recommended if you are pregnant or breastfeeding. If you are

pregnant or breast-feeding, think you may bepregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Acarbose should not affect your ability to drive or operate machinery.

<Invented name> contains: microcrystalline cellulose, pregelatinisedstarch, colloidal

anhydrous silica, and magnesiumstearate.

3. Howto take <Invented name>

To gain the maximum benefit fromAcarboseyou should adhere to the diet prescribed

for you by your doctor.This will also help in reducing any side-effects you may

experience

Always take this medicine exactly as your doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not sure.

The recommended dose is one or two tabletstaken with meals threetimes a day.

However, when you first start your treatment, your doctor may recommend that you

take your tablets once or twice a day before increasing yourdose to three times a day.

This medicine is intended for long-termuse.

Acarbose tablets should be chewed with the first mouthful offood. If you prefer not to

chew the tablets then swallowthemwhole with a little liquidimmediately before the

meal.

The scoreline is only there to help youbreak the tablet if you have difficulty

swallowing it whole and not todivide into equal doses.

If you take more <Invented name>than you should

If you do exceed the prescribed dose, or inthe event ofan overdose, you may

experience diarrhoea and other intestinal symptomssuch as flatulence (wind) and

abdominal pain.

If you take more than the prescribed dose, or in the event of an overdose, avoid the

intake of carbohydrate-containing food ordrinks and seek medical advice

immediately. If possible, takeyour tablets or the pack withyou to show the doctor.

If you forgetto take <Invented name>

If you forget to take one or more dosesof <Invented name> do not take the tablets

between meals but, instead, wait until your next scheduled dose and meal and

continue as before.

Do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

The frequency of the following effects isunknown and based on isolated reports:

However, if you get any of these reactions, seek urgent medical attention.

A decrease in the number of plateletsin the blood (associated with rash, easy

bruising or bleeding)

Allergic reactionssuchas rash, redness of the skin, skin eruptions, itching

Decrease in bowel activity (ileusassociated with severeabdominal pain, vomiting

and absence of gas or bowel motions)

Inflammation of the liver (hepatitis associatedwith jaundice-yellowingoftheskin

and eyes)

Like all medicines, this medicine can cause side effects, although not everybody gets

them. During the first few days or weeksof treatment with <Invented name> you may

experience increased flatulence (wind),rumbling in your stomach, a feeling of

fullness and possibly abdominal cramps. Itis also possible that you may pass softer

stoolsor even experience diarrhoea, particularly after a mealcontaining sugar or

sucrose-containing foods. Normally, thesesymptomswill disappear if you continue

treatment and keep to your prescribed diet

The following side effect occurred very commonly (in more than 1 in 10patients) in

clinical trials:

Flatulence (wind)

The following side effects occurredcommonly(in less than 1 in 10 patients but more

than 1 per 100 patients) in clinicaltrials:

Diarrhoea

Stomach and abdominal pain

Normally, these symptomswill disappear ifyou continuetreatment and keep toyour

prescribed diet.

The following side effects occurred uncommonly (in less than 1 in100 patients but in

more than 1 per 1000 patients) in clinicaltrials:

Nausea

Vomiting

Indigestion

Transient increase in liver enzymes

Jaundice (yellowing ofthe skin)

Do not take indigestion (antacid) preparationsfor treating symptomsofabdominal

pain, diarrhea, and flatulence as they are unlikely to have any beneficial effect. if your

symptomspersist for more than 2 or 3 days,or if they are severe, consult your doctor,

particularly in the case of diarrhoea.

These effects go away when treatment is stopped.

If you get any side effects, talk to yourdoctor or pharmacist. This includes any side

effects not listed in this leaflet.

5. Howto store <Invented name>

Keep this medicineout of the sight and reach ofchildren.

Do not use this medicine after the expiry date which is stated on the blister and carton,

after the EXP. The expiry date refers to the last day of that month.

Do not store above 30° C. Store in the original packaging to protect fromlight and

moisture.

Do not throw away any medicines via wastewater or household waste. Ask your

pharmacist how to throw away medicines you no longer use. These measures will

help protect the environment.

6. Contents of the pack and other information

What <Invented name>contains

-The active substance is acarbose. Each tablet contains 50 mgof acarbose.

-The other ingredients are microcrystalline cellulose,pregelatinised starch,

colloidal anhydrous silica,and magnesiumstearate.

What <Invented name> looks likeand contents of the pack

White, plane, round tablets, scored on one side.

The scoreline/breakline is only to facilitatebreaking for ease of swallowing and not to

divide into equal doses.

Acarbose is available as 50 mgtablets inpackages of 10, 20, 30, 40, 50, 60, 90, 120

and 270 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

MultigenerisGmbH

Marlowring 21

22525 Hamburg

Germany

Manufacturer:

West Pharma – Produções Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova

2700 - 486 Amadora

Portugal

Atlantic Pharma– Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira

2710-089 Sintra

Portugal

This medicinal product is authorised inthe Member States of the EEA under the

following names:

United Kingdom:Acarbose 50 mgTablets

Ireland: Acarbose Tecnimede 50 mg Tablets

Italy: Acarbose Tecnigen 50 mgcompresse

Poland: Symrose

This leaflet was last revised in

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AcarboseTecnimede50mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains50mgofAcarbose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

White,circular,plaintablets,scoredononeside.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AcarboseisrecommendedforthetreatmentoftypeIIdiabetesmellitusinpatientsinadequatelycontrolledondiet

alone,orondietandoralhypoglycaemicagents.

4.2Posologyandmethodofadministration

Acarbosetabletsaretakenorallyandshouldbechewedwiththefirstmouthfuloffood,orswallowedwholewitha

littleliquiddirectlybeforethemeal.Owingtothegreatindividualvariationofglucosidaseactivityintheintestinal

mucosa,thereisnofixeddosageregimen,andpatientsshouldbetreatedaccordingtoclinicalresponseandtoleranceof

intestinalsideeffects.

Adults

Therecommendedinitialdoseis50mgthreetimesaday.However,somepatientsmaybenefitfrommoregradual

initialdosetitrationtominimisegastrointestinalsideeffects.Thismaybeachievedbyinitiatingtreatmentat50mg

onceortwiceaday,withsubsequenttitrationtoathreetimesadayregimen.

Ifaftersixtoeightweeks'treatmentpatientsshowaninadequateclinicalresponse,thedosagemaybeincreasedto100

mgthreetimesaday.Afurtherincreaseindosagetoamaximumof200mgthreetimesadaymayoccasionallybe

necessary.

Patientsreceivingthemaximumdose

requirecarefulmonitoring(seeSpecialwarningsandprecautionsforuse,Section4.4).

Acarboseisintendedforcontinuouslong-termtreatment.

Elderlypatients

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Childrenandadolescentsunder18years

Theefficacyandsafetyofacarboseinchildrenandadolescentshavenotbeenestablished.Acarboseisnot

recommendedforpatientsundertheageof18years.

Renalorhepaticimpairment

Seesection4.3.

4.3Contraindications

Hypersensitivitytoacarboseoranyoftheexcipients.Acarboseisalsocontra-indicatedinpatientswithinflammatory

boweldisease,coloniculceration,partialintestinalobstructionorinpatientspredisposedtointestinalobstruction.In

addition,shouldnotbeusedinpatientswhohavechronicintestinaldiseasesassociatedwithmarkeddisordersof

digestionorabsorptionandinpatientswhosufferfromstateswhichmaydeteriorateasaresultofincreasedgas

formationintheintestine,e.g.largerhernias.

Acarboseiscontra-indicatedinpatientswithhepaticimpairment

AsAcarbosehasnotbeenstudiedinpatientswithsevererenalimpairment,itshouldnotbeusedinpatientswitha

creatinineclearance<25ml/min/1.73m².

4.4Specialwarningsandprecautionsforuse

Hypoglycaemia:Whenadministeredalone,Acarbosedoesnotcausehypoglycaemia.Itmay,however,acttopotentiate

thehypoglycaemiceffectsofinsulinandsulphonylureadrugs,andthedosagesoftheseagentsmayneedtobemodified

accordingly.Inindividualcaseshypoglycaemicshockmayoccur(i.e.clinicalsequelaeofglucoselevels<1mmol/L

suchasalteredconsciouslevels,confusionorconvulsions).

Episodesofhypoglycaemiaoccurringduringtherapymust,whereappropriate,betreatedbytheadministrationof

glucose,notsucrose.Thisisbecauseacarbosewilldelaythedigestionandabsorptionofdisaccharides,butnot

monosaccharides.

Transaminases:Patientstreatedwithacarbosemay,onrareoccasions,experienceanidiosyncraticresponsewitheither

symptomaticorasymptomatichepaticdysfunction.Inthemajorityofcasesthisdysfunctionisreversibleon

discontinuationofacarbosetherapy.Itisrecommendedthatliverenzymemonitoringisconsideredduringthefirstsix

totwelvemonthsoftreatment.Ifelevatedtransaminasesareobserved,withdrawaloftherapymaybewarranted,

particularlyiftheelevationspersist.Insuchcircumstances,patientsshouldbemonitoredatweeklyintervalsuntil

normalvaluesareestablished.

Theadministrationofantacidpreparationscontainingmagnesiumandaluminiumsalts,e.g.hydrotalcite,hasbeen

shownnottoamelioratetheacutegastrointestinalsymptomsofAcarboseinhigherdosageandshould,therefore,notbe

recommendedtopatientsforthispurpose.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Intestinaladsorbents(e.g.charcoal)anddigestiveenzymepreparationscontainingcarbohydratesplittingenzymes(e.g.

amylase,pancreatin)mayreducetheeffectofAcarboseandshouldnotthereforebetakenconcomitantly.

Theconcomitantadministrationofneomycinmayleadtoenhancedreductionsofpostprandialbloodglucoseandtoan

increaseinthefrequencyandseverityofgastro-intestinalsideeffects.Ifthesymptomsaresevere,atemporarydose

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TheconcomitantadministrationofcolestyraminemayenhancetheeffectsofAcarbose,particularlywithrespectto

reducingpostprandialinsulinlevels.SimultaneousadministrationofAcarboseandcolestyramineshould,therefore,be

avoided.IntherarecircumstancethatbothAcarboseandcolestyraminetherapyarewithdrawnsimultaneously,careis

neededasareboundphenomenonhasbeenobservedwithrespecttoinsulinlevelsinnon-diabeticsubjects.

InindividualcasesAcarbosemayaffectdigoxinbioavailability,whichmayrequiredoseadjustmentofdigoxin.

Monitoringofserumdigoxinlevelsshouldbeconsidered.

InapilotstudytoinvestigateapossibleinteractionbetweenAcarboseandnifedipine,nosignificantorreproducible

changeswereobservedintheplasmanifedipineprofiles.

4.6Fertility,pregnancyandlactation

Pregnancy

Foracarbose,noclinicaldataonexposedpregnanciesareavailable.Animalstudiesdonotindicatedirectorindirect

harmfuleffectswithrespecttopregnancy,embryonic/foetaldevelopment,parturitionorpostnataldevelopment(see

section5.3).

Acarboseisnotrecommendedduringpregnancy.

Whenthepatientplanstobecomepregnantandduringpregnancy,diabetesshouldbetreatedwithinsulintomaintain

bloodglucoselevelsasclosetonormalaspossibleinordertolowertheriskoffoetalmalformationsassociatedwith

abnormalbloodglucoselevels.

Lactation

Itisunknownwhetheracarboseisexcretedinhumanbreastmilk.Animalstudieshaveshownexcretionofacarbosein

breastmilk.Acarboseshouldnotbeusedduringbreast-feeding.

4.7Effectsonabilitytodriveandusemachines

Acarbosemonotherapydoesnotcausehypoglycaemiaandisthereforeunlikelytohaveeffectsontheabilitytodriveor

tousemachines.However,patientsshouldbealertedtotheriskofhypoglycaemiawhenacarboseisusedin

combinationwithotherantidiabeticagents.

4.8Undesirableeffects

Adversedrugreactions(ADRs)basedonplacebo-controlledstudieswithacarbosesortedbyCIOMSIIIcategoriesof

frequency(placebo-controlledstudiesinclinicaltrialdatabase:acarboseN=8,595;placeboN=7,278;status:10Feb

2006)arelistedbelow.

ADRsderivedfrompostmarketingreports(status:31Dec2005)areprintedinitalic.

SystemOrgan

Class VeryCommon

(1/10) Common

(1/100,<

1/10) Uncommon

(1/1000,<

1/100) Rare

(

1/10,000,<

1/1000) VeryRare

(<1/10,000)

Bloodandthe

lymphatic

system

disorders Thrombocytopenia

Gastrointestinal

disorders(1) Flatulence

Borborygmi

Abdominal

distension Diarrhoea

Abdominal

pain Nausea

Vomiting Ileus

Subileus

Constipation

Hepatobiliary

disorders(2) Liver

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(1)Diarrhoeaandabdominalpainmayoccuraftersucrose-containingfoodsareingested.Iftheprescribeddiabeticdiet

isnotobservedthegastrointestinaladverseeventsmaybeintensified.Thesymptomsarerelatedbothtothedoseandto

thedietarysubstrateandmaydiminishwithcontinuedtreatment.Ifseveresymptomsdevelopinspiteofadherenceto

theprescribeddiabeticdietthedosemustbetemporarilyorpermanentlyreduced.Oftenthedosereductionissufficient

foroneofthemainmeals(lunchordinner).Shoulddiarrhoeapersist,thenpatientsshouldbecloselymonitoredandthe

dosagereducedortherapywithdrawn,ifnecessary.

(2)Rarely,clinicallysignificantabnormalhepaticfunctiontests(threetimesabovetheupperlimitfornormalvalues)

havebeenobservedinpatientstreatedwiththerecommendeddailydoseof150mgto300mgofacarbosedaily.

Abnormalvaluesmaybetemporaryduringtreatment(seesection4.4).

Ifileusorsubileusissuspected,treatmentmustbestoppedimmediately.InJapan,individualcasesoffulminantliver

failurehavebeenobserved,althoughtheroleofacarboseisunclear.

IndividualcasesoffulminanthepatitiswithfataloutcomehavebeenreportedinJapan.Therelationshiptoacarboseis

unclear.

Iftheprescribeddiabeticdietisnotobservedtheintestinalsideeffectsmaybeintensified.

Ifstronglydistressingsymptomsdevelopinspiteofadherencetothediabeticdietprescribed,thedoctormustbe

consultedandthedosetemporarilyorpermanentlyreduced.

Inpatientsreceivingtherecommendeddailydoseof150to300mgAcarbose,clinicallyrelevantabnormalliver

functiontests(threetimesaboveupperlimitofnormalrange)wererarelyobserved.Abnormalvaluesmaybetransient

underongoingAcarbosetherapy.(SeeSection4.4).

4.9Overdose

WhenAcarbosetabletsaretakenwithdrinksand/ormealscontainingcarbohydratesoverdosemayleadtometeorism,

flatulenceanddiarrhoea.IfAcarbosetabletsaretakenindependentlyoffood,excessiveintestinalsymptomsneednot

beanticipated.

NospecificantidotestoAcarboseareknown.

Intakeofcarbohydrate-containingmealsorbeveragesshouldbeavoidedfor4-6hours.

Diarrhoeashouldbetreatedbystandardconservativemeasures.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Alphaglucosidaseinhibitors,ATCcode:A10BF01.

Inallspeciestested,acarboseexertsitsactivityintheintestinaltract.Theactionofacarboseisbasedonthe

competitiveinhibitionofintestinalenzymes(-glucosidases)involvedinthedegradationofdisaccharides,

oligosaccharides,andpolysaccharides.Thisleadstoadose-dependentdelayinthedigestionofthesecarbohydrates.

Glucosederivedfromthesecarbohydratesisreleasedandtakenupintothebloodmoreslowly.Inthisway,acarbose

increase Jaundice

Skinand

subcutaneous

tissuedisorders Hypersensitivityskin

reactions(Rash,

Erythema,

Exanthema,Urticaria)

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5.2Pharmacokineticproperties

Followingadministration,only1-2%oftheactiveinhibitorisabsorbed.

ThepharmacokineticsofAcarbosewereinvestigatedafteroraladministrationofthe 14

C-labelledsubstance(200mg)

tohealthyvolunteers.Onaverage,35%ofthetotalradioactivity(sumoftheinhibitorysubstanceandanydegradation

products)wasexcretedbythekidneyswithin96h.Theproportionofinhibitorysubstanceexcretedintheurinewas1.7

%oftheadministereddose.50%oftheactivitywaseliminatedwithin96hoursinthefaeces.Thecourseofthetotal

radioactivityconcentrationinplasmawascomprisedoftwopeaks.Thefirstpeak,withanaverageacarbose-equivalent

concentrationof52.2±15.7µg/lafter1.1±0.3h,isinagreementwithcorrespondingdatafortheconcentrationcourse

oftheinhibitorsubstance(49.5±26.9µg/lafter2.1±1.6h).Thesecondpeakisonaverage586.3±282.7µg/landis

reachedafter20.7±5.2h.Thesecond,higherpeakisduetotheabsorptionofbacterialdegradationproductsfrom

distalpartsoftheintestine.Incontrasttothetotalradioactivity,themaximumplasmaconcentrationsoftheinhibitory

substancearelowerbyafactorof10-20.Theplasmaeliminationhalf-livesoftheinhibitorysubstanceare3.7±2.7h

forthedistributionphaseand9.6±4.4hfortheeliminationphase.

Arelativevolumeofdistributionof0.32l/kgbody-weighthasbeencalculatedinhealthyvolunteersfromthe

concentrationcourseintheplasma.

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicity,genotoxicity,carcinogenicpotential,toxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Colloidalanhydroussilica

Magnesiumstearate

Pregelatinisedstarch

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

TransparentandcolourlessPVC/PCTFE/PVCfilm/Alfoilblisters,packedinoutercartonsisusedascontainerclosure

systemforAcarbosetablets.

Packsizes:10,20,30,40,50,60,90,120and270tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

MultigenerisGmbH

Marlowring21

22525Hamburg

Germany

8MARKETINGAUTHORISATIONNUMBER

PA1773/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29January2010

10DATEOFREVISIONOFTHETEXT

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