BUSCOPAN 10 Milligram Coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
HYOSCINE BUTYLBROMIDE
Available from:
Boehringer Ingelheim Limited
ATC code:
A03BB01
INN (International Name):
HYOSCINE BUTYLBROMIDE
Dosage:
10 Milligram
Pharmaceutical form:
Coated Tablets
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Belladonna alkaloids, semisynthetic, quaternary ammonium compounds
Authorization status:
Authorised
Authorization number:
PA0007/016/001
Authorization date:
1979-04-01

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking Buscopan 10mg Coated Tablets,

because it contains important information

for you.

Keep this leaflet. You may need to use it

again.

Ask your pharmacist if you need more

information or advice.

You must stop taking and talk to your

pharmacist or doctor if you do not feel

better after two weeks of treatment, or if

you feel worse.

If you get any side effects, talk to your

pharmacist or doctor. This includes any

possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

1. What Buscopan 10mg Coated Tablets are

and what they are used for

2. What you need to know before you take

Buscopan 10mg Coated Tablets

3. How to take Buscopan 10mg Coated Tablets

4. Possible side effects

5. How to store Buscopan 10mg Coated Tablets

6. Contents of the pack and further

information

1.What Buscopan 10mg Coated Tablets are

and what they are used for

Buscopan 10mg Coated Tablets are tablets

that contain ‘hyoscine butylbromide’. They

belong to a group of medicines called

‘anti-spasmodics’.

This medicine is used to relieve abdominal

cramps which cause pain and discomfort

associated with your digestive tract, and in

Irritable Bowel Syndrome (IBS). It works by

relaxing the cramping muscles of your

stomach and bowel.

What are abdominal cramps?

Abdominal cramps (or spasms) are due to the

sudden, irregular tightening up of muscles in

the wall of your stomach or bowel.

What is Irritable Bowel Syndrome (IBS)?

Irritable Bowel Syndrome or IBS is a group of

symptoms that can include abdominal pain,

cramps, spasms, bloating, and a change in

bowel habit (diarrhoea or constipation).

These symptoms may come and go over

a period of time and you may not have all

these symptoms. You can use Buscopan 10mg

Coated Tablets to help relieve the pain of the

cramping spasm but it is important to see

a doctor to then have a diagnosis of IBS

confirmed.

While the precise cause of abdominal cramps

and IBS is unknown, the muscles of the

stomach and bowel appear to be very

sensitive to things like:

Stress, eating and drinking habits

Food allergies or intolerances

Stimulants such as coffee

Hormonal factors

These things can trigger painful abdominal

cramps or spasms if you have a sensitive

bowel. You may also feel bloated, with excess

wind and abdominal discomfort.

2.What you need to know before you take

Buscopan 10mg Coated Tablets

DonottakeBuscopan10mgCoatedTabletsif:

You are allergic to hyoscine butylbromide

or any of the other ingredients of Buscopan

You are intolerant to or cannot digest some

sugars (as the tablet coating contains

a small amount of sucrose)

You have glaucoma (an eye problem)

You have megacolon (a very enlarged bowel)

You have something called ‘myasthenia

gravis’ (a very rare muscle weakness problem)

You are pregnant, likely to get pregnant, or

are breast-feeding

Do not take this medicine if any of the above

applies to you. If you are not sure, talk to your

pharmacist or doctor before taking this

medicine.

Warnings and precautions

Talk to your pharmacist or doctor straight

away if you have unexplained abdominal pain

which persists or worsens or occurs with:

fever

feeling sick or being sick

changes in your bowel movements

blood in your stools

abdominal tenderness

feeling faint due to low blood pressure

Talk to your pharmacist or doctor before

taking Buscopan 10mg Coated Tablets if any

of the following applies to you. This is in case

your abdominal pain is something else:

If this is the first time you have had

symptoms of Irritable Bowel Syndrome

You are 40 years or over and it is some time

since your last attack of abdominal cramps or

IBS or the symptoms are different this time

You have recently passed blood in your stools

You have severe constipation

You are feeling sick or being sick

You have lost your appetite or lost weight

You have difficulty or pain passing water

(urine)

You have a fever

You have recently travelled abroad (in case

you have picked up a stomach bug)

You have a very fast heart rate or other

heart problems

You have been treated by a doctor for

a severe sweating problem

You have abnormal vaginal bleeding or

discharge

If any of the above applies to you (or you are

not sure), talk to your pharmacist or doctor

before taking this medicine even if you have

diagnosed IBS. This is in case your abdominal

pain is something else.

Children

This medicine is not recommended for

children under 12 years of age.

OthermedicinesandBuscopan10mgCoated

Tablets

Tell your pharmacist or doctor if you are taking,

have recently taken or might take any other

medicines, including medicines obtained

without a prescription. This includes herbal

medicines. This is because Buscopan 10mg

Coated Tablets can affect the way some other

medicines work; also some other medicines

can affect the way Buscopan 10mg Coated

Tablets work.

In particular, tell your pharmacist or doctor if

you are taking any of the following medicines:

Antihistamines - to treat hayfever and other

allergies

Tetracyclic or tricyclic medicines - to treat

depression and some types of pain

Antipsychotic medicines such as

butyrophenones or phenothiazines - to treat

severe mental illness such as schizophrenia

Dopamine antagonists such as

10mg Coated Tablets

hyoscine butylbromide ABCD

437219/IE/1

File information

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PITCH CODE

2 mm

5 mm

1 mm

Beta 2 adrenergic medicines such as

salbutamol inhalers - for asthma

Quinidine or disopyramide – to control your

heart beat

Amantadine – for Parkinson’s disease and flu

Anticholinergic medicines such as tiotropium,

ipratropium or atropine-like medicines –

usually inhaled to treat breathing problems

If any of the above applies to you (or you are

not sure), talk to your pharmacist or doctor

before taking this medicine.

Pregnancy and breast-feeding

Do not take Buscopan 10mg Coated Tablets if

you are pregnant, think you may be pregnant, are

planning to have a baby or are breast-feeding.

Driving and using machines

Some people may have temporary blurring of

vision while taking this medicine. If this happens

to you, wait until your vision returns to normal

before driving or using any tools or machines.

Buscopan 10mg Coated Tablets contain

sucrose

If you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking this medicine.

3.How to take Buscopan 10mg Coated

Tablets

Always take this medicine exactly as your

pharmacist or doctor has told you. Check

with them if you are not sure.

Do not take Buscopan 10mg Coated Tablets

continuously for more than 2 weeks.

Stop taking and talk to your pharmacist or

doctor if you do not feel better after 2 weeks

Also stop taking and talk to your pharmacist

or doctor if:

you get new symptoms

your symptoms get worse

Abdominal cramps

Adults and children 12 years or over:

2 tablets four times a day

Irritable Bowel Syndrome

Adults and children 12 years or over:

Start by taking 1 tablet up to three times a day

You can increase your dose to a maximum

of 2 tablets four times a day, if needed

Swallow the tablet whole with water

Do not crush or chew the tablet

Buscopan 10mg Coated Tablets are not

recommended for children under 12 years.

If you take more Buscopan 10mg Coated

Tablets than you should

If you take more than you should, talk to

a doctor or go to a hospital straight away.

Take the medicine pack with you.

If you have any further questions on the use of

this medicine, ask your pharmacist or doctor.

4.Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them. The following side effects may happen

with this medicine:

Serious side effects

Stop taking this medicine and tell your

doctor straight away if you notice any of the

following. You may need urgent medical

treatment:

Uncommon: may affect up to 1 in 100 people

Skin reactions that cause itching (such as

urticaria and pruritis)

Increased heart rate (tachycardia)

Rare: may affect up to 1 in 1,000 people

Problems emptying the bladder

Not known: these are so rare it is not known

how many people may be affected

Anaphylactic reaction and shock - a severe

type of allergic reaction. An itchy rash may

spread all over your body, as well as

swelling. You may have difficulty in

Difficult or laboured breathing (dyspnoea)

Allergic reactions (hypersensitivity) such as

skin rash and patchy red skin (erythema)

A painful red eye with loss of vision - you

may have an eye problem called ‘glaucoma’

Stop taking this medicine and tell your doctor

straight away if you notice any of the serious

side effects above.

Other side effects

Tell your doctor or pharmacist if the following

side effects get troublesome or seem serious

to you. These are usually mild and do not

normally require medical treatment:

Uncommon: may affect up to 1 in 100 people

Dry mouth

Constipation

Outbreaks of sweat and dryness of skin

(dyshidrosis)

Reporting of side effects

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 national

reporting system (see details below):

HPRA Pharmacovigilance

Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

By reporting side effects you can help provide

more information on the safety of this medicine.

5.How to store Buscopan 10mg Coated

Tablets

Keep this medicine out of the sight and

reach of children.

Do not use this medicine after the expiry

date which is stated on the foil and carton

label. The expiry date (EXP) refers to the

last day of that month.

Store below 30°C.

Store in the original package in order to

protect from light.

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.Contentsofthepackandotherinformation

WhatBuscopan10mgCoatedTabletscontains

The active substance is hyoscine butylbromide

Each tablet contains 10mg of hyoscine

butylbromide

The other ingredients are calcium hydrogen

phosphate anhydrous, maize starch, starch

soluble, silica colloidal anydrous, tartaric

acid, stearic/palmitic acid, sucrose, talc,

acacia, titanium dioxide (E171), macrogol

6000, carnauba wax, beeswax white and

povidone.

What Buscopan 10mg Coated Tablets looks

like and contents of the pack

The tablets are round, white, biconvex

sugar-coated tablets.

Buscopan 10mg Coated Tablets are available

in blister packs of 20 and 40 tablets.

Marketing Authorisation Holder and

Manufacturer

The Marketing Authorisation is held by:

Boehringer Ingelheim Limited,

Ellesfield Avenue, Bracknell, Berkshire,

RG12 8YS, United Kingdom.

and the tablets are manufactured by:

Istituto De Angeli S.r.l.

Loc. Prulli, 103/C

50066 Reggello (FI) Italy

This leaflet was revised in July 2016.

© Boehringer Ingelheim Limited 2016

Consumer Healthcare

437219/IE/1

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Buscopan10mgCoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains10mghyoscinebutylbromide.

Excipient(s)withknowneffect:Sucrose(41.2mgpertablet)

Forthefulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Coatedtablet

Round,white,biconvexsugar-coatedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Buscopan10mgCoatedTabletsareindicatedforthereliefofspasmofthegastrointestinaltractandforthe

symptomaticreliefofIrritableBowelSyndrome.

4.2Posologyandmethodofadministration

Posology

Reliefofspasmofgastrointestinaltract

Adultsandchildrenover12years:Twotablets(20mg)fourtimesdaily.

ForthesymptomaticreliefofIrritableBowelSyndrome

Adultsandchildrenover12years:Therecommendedstartingdoseis1tabletuptothreetimesdaily,thiscanbe

increasedupto2tabletsfourtimesdailyifnecessary.

Ifsymptomsdonotimproveoriftheyworsenafter2weeksoftreatmentadoctorshouldbeconsulted.

Buscopan10mgCoatedTabletsshouldnotbetakenonacontinuousdailybasisorforextendedperiodswithout

investigatingthecauseofabdominalpain.

Nospecificinformationontheuseofthisproductintheelderlyisavailable.Clinicaltrialshaveincludedpatientsover

65yearsandnoadversereactionsspecifictothisagegrouphavebeenreported.

Paediatricpopulation

Buscopan10mgCoatedTabletsarenotrecommendedforuseinchildrenunder12yearsofage.

Methodofadministration

Oraluse.

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4.3Contraindications

Buscopan10mgCoatedTabletsarecontraindicatedinpatientswith:

myastheniagravis

megacolon

narrowangleglaucoma.

Hypersensitivitytotheactivesubstanceortoanyoftheexcipientslistedinsection6.1

4.4Specialwarningsandprecautionsforuse

Incasesevere,unexplainedabdominalpainpersistsorworsens,oroccurstogetherwithsymptomslikefever,nausea,

vomiting,changesinbowelmovements,abdominaltenderness,decreasedbloodpressure,faintingorbloodinstool,

medicaladviceshouldbesoughtimmediately.

Buscopan10mgCoatedTabletsshouldbeusedwithcautioninconditionscharacterisedbytachycardiasuchas

thyrotoxicosis,cardiacinsufficiencyorfailureandincardiacsurgerywhereitmayfurtheracceleratetheheartrate.

Duetotheriskofanticholinergiccomplications,cautionshouldbeusedinpatientssusceptibletointestinalorurinary

outletobstruction.

Becauseofthepossibilitythatanticholinergicsmayreducesweating,Buscopan10mgCoatedTabletsshouldbe

administeredwithcautiontopatientswithpyrexia.

ElevationofintraocularpressuremaybeproducedbytheadministrationofanticholinergicagentssuchasBuscopan

10mgCoatedTabletsinpatientswithundiagnosedandthereforeuntreatednarrowangleglaucoma.Therefore,patients

shouldseekurgentophthalmologicaladviceincasetheyshoulddevelopapainful,redeyewithlossofvisionwhilstor

aftertakingBuscopan10mgCoatedTablets.

Asthetabletcoatcontainssucrose(41.2mg),patientswithrarehereditaryproblemsoffructoseintolerance,glucose-

galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakeBuscopan10mgCoatedTablets.

BeforetakingBuscopan10mgCoatedTabletsadoctorshouldbeconsultedifanyofthefollowingapply:

ifthisisthefirsttimethepatienthassymptomsofIrritableBowelSyndrome

thepatientis40yearsoroveranditissometimesincethelastepisodeofIBS/abdominalcrampsorthe

symptomsaredifferentthistime

thepatienthasrecentlypassedbloodfromthebowel

thepatientisfeelingsickorvomiting

thepatienthaslosthis/herappetiteorlostweight

thepatientlookspaleandisfeelingtired

thepatientissufferingfromsevereconstipation

thepatienthasafever

thepatienthasrecentlytravelledabroad

thepatienthasabnormalvaginalbleedingordischarge

thepatienthasdifficultyorpainpassingurine

Ifsymptomsdonotimproveoriftheyworsenafter2weeksoftreatmentadoctorshouldbeconsulted.

Paediatricpopulation

Buscopan10mgCoatedTabletsarenotrecommendedforuseinchildrenunder12yearsofage.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theanticholinergiceffectofdrugssuchastri-andtetracyclicantidepressants,antihistamines,quinidine,amantadine,

antipsychotics(e.g.phenothiazines,butyrophenones),disopyramideandotheranticholinergics(e.g.tiotropium,

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Concomitanttreatmentwithdopamineantagonistssuchasmetoclopramidemayresultindiminutionoftheeffectsof

bothdrugsonthegastrointestinaltract.

Thetachycardiceffectsofbeta-adrenergicagentsmaybeenhancedbyBuscopan10mgCoatedTablets.

4.6Fertility,pregnancyandlactation

Pregnancy

Thereislimiteddatafromtheuseofhyoscinebutylbromideinpregnantwomen.

Animalstudiesdonotindicatedirectorindirectharmfuleffectswithrespectto

reproductivetoxicity(seesection5.3).

Breastfeeding

Thereisinsufficientinformationontheexcretionofhyoscinebutylbromideanditsmetabolitesinhumanmilk.

Asaprecautionarymeasure,itispreferabletoavoidtheuseofBuscopan10mg

CoatedTabletsduringpregnancyandlactation.

Fertility

Nostudiesontheeffectsonhumanfertilityhavebeenconducted.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.Becauseofvisual

accommodationdisturbancespatientsshouldnotdriveoroperatemachineryifaffected.

4.8Undesirableeffects

Manyofthelistedundesirableeffectscanbeassignedtotheanticholinergicpropertiesofhyoscinebutylbromide.

AnticholinergicsideeffectsofBuscopan10mgCoatedTabletsaregenerallymildandself-limited.

Adverseeventshavebeenrankedunderheadingsoffrequencyusingthefollowingconvention:

Verycommon(1/10)

Common(1/100,<1/10)

Uncommon(1/1000,<1/100)

Rare(1/10000,<1/1000)

Veryrare(<1/10000)

Notknown(cannotbeestimatedfromavailabledata)

Immunesystemdisorders

Uncommon:skinreactions(e.g.urticaria,pruritus)

Notknown*:anaphylacticshock,anaphylacticreactions,dyspnoea,rash,erythemaandotherhypersensitivity.

Cardiacdisorders

Uncommon:tachycardia

Gastrointestinaldisorders

Uncommon:drymouth,constipation

Eyedisorders

Notknown:Visualaccommodationdisturbances

Skinandsubcutaneoustissuedisorders

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Renalandurinarydisorders

Rare:urinaryretention

*Thisadversereactionhasbeenobservedinpost-marketingexperience.With95%certainty,thefrequencycategoryis

notgreaterthanuncommon(3/1,368),butmightbelower.Aprecisefrequencyestimationisnotpossibleastheadverse

drugreactiondidnotoccurinaclinicaltrialdatabaseof1,368patients.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL–Dublin2;Tel:+35316764971;

Fax:+35316762517.

Website: www.hpra.ie ;e-mail: medsafety@hpra.ie .

4.9Overdose

Symptoms

Serioussignsofpoisoningfollowingacuteoverdosagehavenotbeenobservedinman.Inthecaseofoverdosage,

anticholinergicsymptomssuchasurinaryretention,drymouth,reddeningoftheskin,tachycardia,inhibitionof

gastrointestinalmotilityandtransientvisualdisturbancesmayoccur,andCheynes-Stokesrespirationhasbeenreported.

Therapy

Inthecaseoforalpoisoning,gastriclavagewithmedicinalcharcoalshouldbefollowedbymagnesiumsulphate

(15%).SymptomsofBuscopan10mgCoatedTabletsoverdosagerespondtoparasympathomimetics.Forpatientswith

glaucoma,pilocarpineshouldbegivenlocally.

Cardiovascularcomplicationsshouldbetreatedaccordingtousualtherapeuticprinciples.Incaseofrespiratory

paralysis,intubationandartificialrespirationshouldbeconsidered.Catheterisationmayberequiredforurinary

retention.

Inaddition,appropriatesupportivemeasuresshouldbeusedasrequired.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Belladonnaalkaloids,semisyntheticquaternaryammoniumcompounds

ATCcode:A03BB01

Hyoscinebutylbromideexertsaspasmolyticactiononthesmoothmuscleofthegastrointestinal,biliaryandgenito-

urinarytracts.Asaquaternaryammoniumderivative,hyoscinebutylbromidedoesnotenterthecentralnervous

system.Therefore,anticholinergicsideeffectsatthecentralnervoussystemdonotoccur.Peripheralanticholinergic

actionresultsfromaganglion-blockingactionwithinthevisceralwallaswellasfromananti-muscarinicactivity.

5.2Pharmacokineticproperties

Absorption

Asaquaternaryammoniumcompound,hyoscinebutylbromideishighlypolarandhenceonlypartiallyabsorbed

followingoral(8%)orrectal(3%)administration.Afteroraladministrationofsingledosesofhyoscinebutylbromidein

therangeof20to400mg,meanpeakplasmaconcentrationsbetween0.11ng/mLand2.04ng/mLwerefoundat

approximately2hours.Inthesamedoserange,theobservedmeanAUC

0-tz -valuesvariedfrom0.37to10.7ngh/mL.

Themedianabsolutebioavailabilitiesofdifferentdosageforms,i.e.coatedtablets,suppositoriesandoralsolution,

containing100mgofhyoscinebutylbromideeachwerefoundtobelessthan1%.

Distribution

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distributedonmusclecellsoftheabdominalandpelvicareaaswellasintheintramuralgangliaoftheabdominal

organs.Plasmaproteinbinding(albumin)ofhyoscinebutylbromideisapproximately4.4%.Animalstudies

demonstratethathyoscinebutylbromidedoesnotpasstheblood-brainbarrier,butnoclinicaldatatothiseffectis

available.Hyoscinebutylbromide(1mM)hasbeenobservedtointeractwiththecholinetransport(1.4nM)in

epithelialcellsofhumanplacentainvitro.

Biotransformationandelimination

Followingoraladministrationofsingledosesintherangeof100to400mg,theterminaleliminationhalf-livesranged

from6.2to10.6hours.Themainmetabolicpathwayisthehydrolyticcleavageoftheesterbond.Orallyadministered

hyoscinebutylbromideisexcretedinthefaecesandintheurine.Studiesinmanshowthat2to5%ofradioactivedoses

iseliminatedrenallyafteroral,and0.7to1.6%afterrectaladministration.Approximately90%ofrecovered

radioactivitycanbefoundinthefaecesafteroraladministration.Theurinaryexcretionofhyoscinebutylbromideisless

than0.1%ofthedose.Themeanapparentoralclearancesafteroraldosesof100to400mgrangefrom881to1420

L/min,whereasthecorrespondingvolumesofdistributionforthesamerangevaryfrom6.13to11.3x10 5

L,probably

duetoverylowsystemicavailability.Themetabolitesexcretedviatherenalroutebindpoorlytothemuscarinic

receptorsandarethereforenotconsideredtocontributetotheeffectofthehyoscinebutylbromide.

5.3Preclinicalsafetydata

Hyoscinebutylbromidewasneitherembryotoxicnorteratogenicatoraldosesofupto200mg/kginthediet(rat)or200

mg/kgbygavageor50mg/kgs.c.(rabbit).Fertilitywasnotimpairedatdosesofupto200mg/kgp.o..

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CalciumHydrogenPhosphate,anhydrous

MaizeStarch

Starch,soluble

Silica,ColloidalAnhydrous

Tartaricacid

Stearic/Palmiticacid

Sucrose

Talc

Acacia

TitaniumDioxide(E171)

Macrogol6000

CarnaubaWax

Beeswax,White

Povidone

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

PVC-aluminiumblisterpacksof20and40tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BoehringerIngelheimLimited

EllesfieldAvenue

Bracknell

BerkshireRG128YS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0007/016/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1April1979

Dateoflastrenewal:1April2009

10DATEOFREVISIONOFTHETEXT

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