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BISOPROLOL FUMARATE 5MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL FUMARATE

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TEVA UK Ref:

231-30-61149-X LEA BISOPROLOL A/S TABS TUK

Version:

1

06 March 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

7(!4)3).4()3,%!&,%4
1. What Bisoprolol fumarate is and what it is used for
2. What you need to know before you take Bisoprolol fumarate
3. How to take Bisoprolol fumarate
4. Possible side effects
5. How to store Bisoprolol fumarate
6. Contents of the pack and other information

1

WHAT BISOPROLOL FUMARATE IS AND WHAT IT IS USED FOR

At the beginning of the treatment your doctor will check you regularly
(especially in the treatment of elderly patients).
Consult your doctor if one of the above mentioned warnings is
applicable to you, or has been applicable in the past.
Children and adolescents
The use of Bisoprolol fumarate is not recommended as there is
insufficient experience with the use of this medicinal product in children.

Bisoprolol fumarate belongs to a group of medicinal products called beta Other medicines and bisoprolol fumarate
Tell your doctor or pharmacist if you are taking, have recently taken or
blockers. These products protect the heart against too much activity,
might take any other medicines.
which makes the heart beat more calmly and lowers blood pressure.
Bisoprolol fumarate is used for the treatment of:
s (IGHBLOODPRESSUREHYPERTENSION
s #HESTPAINANGINAPECTORIS 
Pharma code 517

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BISOPROLOL FUMARATE

Do not take Bisoprolol fumarate in combination with:
s &LOCTAFENINEAMEDICINEUSEDFORRELIEVINGPAINANDSWELLING ASTHERE
is an increased possibility of reduced blood pressure or shock
s 3ULTOPRIDEAMEDICINEUSEDFORTHETREATMENTOFNERVOUSSYSTEM
disorders), as there is an increased possibility of heart rhythm
disorders.

Do not take Bisoprolol fumarate:
Especially tell your doctor if you are taking one of the following drugs
s IFYOUAREALLERGICTOBISOPROLOLFUMARATEORANYOFTHEOTHER
because if Bisoprolol fumarate is used in combination with the products
ingredients of this medicine (listed in section 6)
s )FYOUSUFFERFROMASUDDENLYOCCURRINGHEARTWEAKNESSACUTEHEART mentioned below the possibility of side effects on the heart and / or
changes in the blood pressure is increased.
failure) or deterioration of heart failure which require heart
stimulating medicines to be administered directly into the vein
s -EDICINESUSEDTOTREATHEARTRHYTHMDISORDERSANDHIGHBLOOD
s )FYOUAREINASTATEOFSHOCKCAUSEDBYHEARTDYSFUNCTION
pressure, such as calcium antagonists (verapamil, diltiazem and
s )FYOUSUFFERFROMCERTAINHEARTCONDUCTIONDISORDERSNDORRD
bepridil)
DEGREE!6 BLOCKWITHOUTAPACEMAKER SINOATRIALBLOCK
s -EDICINESUSEDTOTREATHIGHBLOODPRESSURESUCHASCLONIDINEAND
s )FYOUSUFFERFROMCERTAINHEARTRHYTHMDISORDERSSICKSINUS
other blood pressure reducing medicines that work by affecting the
syndrome or sinoatrial block)
part of the brain that controls blood pressure, such as methyldopa,
s )FYOUHAVEASLOWHEARTRATELESSTHANBEATSPERMINUTE BEFORE
guanfacine, moxonidine and rilmenidine
the start of the treatment
s )FYOUHAVEAVERYLOWBLOODPRESSUREHYPOTENSION SYSTOLICBLOOD s !NYOTHERDRUGSUSEDFORHIGHBLOODPRESSURETREATMENT
s -EDICINESUSEDTOTREATSEVEREDEPRESSIONSUCHASTHESO CALLED
pressure of less than 100)
-!/ !INHIBITORSMOCLOBEMIDE
s )FYOUSUFFERFROMSEVEREFORMSOFASTHMAORANYOTHERBREATHING
s -EDICINESUSEDFORTHETREATMENTOFHEARTRHYTHMDISORDERSSUCHAS
PROBLEMSSUCHASCHRONICRESPIRATORYDISORDERS#/0$
the so-called anti-arrhythmics class I (e.g. disopyramide and
s )FYOUSUFFERFROMSEVEREBLOODCIRCULATIONPROBLEMSINTHEFINGERS
quinidine) and anti-arrhythmics class III (e.g. amiodarone)
toes, arms and legs, like Raynaud´s phenomenon. See also
s -EDICINESUSEDTOTREATATIGHT PAINFULFEELINGINTHECHESTANDHIGH
h7ARNINGSANDPRECAUTIONSv
s )FYOUHAVEATUMOUROFTHEADRENALMEDULLATHATMAYCAUSEASEVERE blood pressure such as calcium antagonists (nifedipine and
amlodipine (so-called dihydropyridine derivatives))
high blood pressure (an untreated phaeochromocytoma). See also
s -EDICINESUSEDFORTHETREATMENTOF!LZHEIMERgSDISEASESUCHASACETYL
h7ARNINGSANDPRECAUTIONSv
cholinesterase inhibitors (rivastigmine, galantamine and tacrine)
s )FYOUSUFFERFROMACONDITIONWHERETHEREISACHANGEINTHE
s /THERBETA BLOCKERSSUCHASATENOLOLORMETOPROLOL
acid/base balance of the body (metabolic acidosis)
s )FYOUAREALLERGICHYPERSENSITIVE TO"ISOPROLOLFUMARATEORTOANY s %YEDROPSTHATCONTAINBETA BLOCKERSSUCHASTIMOLOLORBETAXOLOL
s -EDICINESUSEDFORTHETREATMENTOFHEARTWEAKNESSANDCERTAINHEART
of the other ingredients in the tablet
rhythm disorders such as digitalis glycosides (digoxin)
s )FYOUARETREATEDWITHFLOCTAFENINEAMEDICINEUSEDFOR
s !NAESTHETICS SUCHASPROPOFOLANDLIDOCAINE3EEALSOTHESECTIONON
relieving pain and swelling) or sultopride (a medicine used for the
h7ARNINGSANDPRECAUTIONSv
TREATMENTOFNERVOUSSYSTEMDISORDERS 3EEALSOh/THERMEDICINES
s -EDICINESUSEDINTHETREATMENTFORSEVEREDEPRESSIONSUCHASTRICYCLIC
and bisoprolol fumarate”.
antidepressants (amitriptyline or clomipramine)
s -EDICINESUSEDTOTREATSEVEREMENTALILLNESSSUCHASPHENOTHIAZINES
Warnings and precautions
(chlorpromazine or perphenazine)
Talk to your doctor or pharmacist before taking Bisoprolol fumarate:
s )FYOUFREQUENTLYSUFFERFROMLUNGDISORDERSLIKEASTHMAORRESPIRATORY s -EDICINESUSEDFORTHETREATMENTOFEPILEPSYSUCHASBARBITURATES
(phenobarbital)
disorders. In sensitive patients, Bisoprolol fumarate can cause a
s /THERBLOODPRESSUREREDUCINGMEDICINES
NARROWINGOFTHEAIRWAYSINTHISCASEYOURDOCTORWILLPROBABLY
s 4HEMUSCLERELAXANTBACLOFEN
examine your lungs before the start of the treatment and possibly
s -EDICINESUSEDTOPROTECTTHEBODYAGAINSTTHECONSEQUENCESOF
also prescribe a bronchodilator (or increase the dose thereof).
certain treatments of cancer such as amifostine
s )FYOUAREPLANNINGTOUNDERGOSURGERY9OURHEARTRATEANDBLOOD
s 4HEANTIMALARIALDRUGMEFLOQUINE
pressure can change when anaesthetics are taken together with
s -EDICINESUSEDTOCONTROLTHEIMMUNESYSTEMANDSYMPTOMSOF
Bisoprolol fumarate. Inform the anaesthetist that you are taking
inflammation such as corticosteroids
Bisoprolol fumarate.
s )FYOUHAVETOUNDERGOAN8 RAYEXAMINATIONWITHACONTRASTMEDIUM s -EDICINESUSEDFORTREATMENTOFDIABETESSUCHASINSULIN METFORMIN
ANDTOLBUTAMIDE"ISOPROLOLFUMARATEMAYENHANCETHEGLUCOSE
(so-called iodine containing contrast mediums). Inform your doctor
reducing effect of these products and may hide the symptoms of a low
that you are using Bisoprolol fumarate.
BLOODSUGARLEVELINYOURBLOOD3EEALSOh7ARNINGSANDPRECAUTIONSv
s )FYOUSUFFERFROMDIABETES AS"ISOPROLOLFUMARATEMAYHIDETHE
s -EDICINESUSEDTOTREATMIGRAINESSUCHAS%RGOTAMINE ASITMAY
symptoms of low blood sugar (hypoglycaemia). Your blood glucose
increase the blood flow disorders in the arms and legs
LEVELSSHOULDBECHECKEDREGULARLY3EEALSOh/THERMEDICINESAND
s -EDICINESTHATCAUSEASTIMULATINGEFFECTONACERTAINPARTOFTHE
bisoprolol fumarate”.
nervous system such as beta-sympatheticomimetics (dobutamine and
s )FYOUSUFFERFROMATHYROIDPROBLEM AS"ISOPROLOLFUMARATEMAYHIDE
isoprenaline). Taking these medicines with Bisoprolol fumarate may
the symptoms of an overactive thyroid
reduce the effect of both products.
s )FYOUAREFASTING
s !CERTAINGROUPOFPAINKILLERSTHESO CALLED.3!)$S SUCHAS
s )FYOUARETREATEDFORHYPERSENSITIVITYREACTIONSANTI ALLERGIC
IBUPROFEN NAPROXENANDDICLOFENACTHESEMAYREDUCETHEEFFECTOF
treatments) or if you suffer from an allergic reaction. Bisoprolol
Bisoprolol fumarate
fumarate may potentiate the hypersensitivity to the substances you
s $RUGSFORTREATMENTOF!LZHEIMERSDISEASEDONEPEZIL
are allergic to and increase the severity of the allergic reactions.
s $RUGSFORTHETREATMENTOFADISEASECALLEDMYASTHENIAGRAVISNEOSTIGMIN 

Top of page cut-off to middle of registration mark: 44 mm.

s )FYOUSUFFERFROMAHEARTCONDUCTIONDISORDERSO CALLEDSTDEGREE!6
block)
s )FYOUSUFFERFROMATIGHT PAINFULFEELINGINTHECHESTATREST0RINZMETAL
angina). Bisoprolol fumarate may increase the number and the
duration of the attacks.
0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2
s )FYOUSUFFERFROMBLOODCIRCULATIONPROBLEMSINTHEFINGERS TOES ARMS
and legs (Raynaud's phenomenon) or a cramp like pain in the calves
Read all of this leaflet carefully before you start taking this medicine
brought on by exercise or walking (intermittent claudication). The
because it contains important information for you.
complaints may be worse, particularly at the beginning of the
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
treatment.
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTORORPHARMACIST
s )FYOUHAVEATUMOUROFTHEADRENALMEDULLAPHAEOCHROMOCYTOMA 
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY$ONOTPASSITONTO
Bisoprolol fumarate may only be used in combination with certain
others. It may harm them, even if their signs of illness are the same as
medicinal products (the so-called alpha-blockers)
yours.
s )FYOUSUFFERORHAVESUFFERED FROMARECURRENTSKINDISORDERINVOLVING
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTORORPHARMACIST4HIS
a scaling, dry skin rash (psoriasis).
includes any possible side effects not listed in this leaflet. See section 4.

BISOPROLOL FUMARATE
5 mg AND 10 mg
FILM-COATED TABLETS

TEVA UK Ref:

Version:

231-30-61149-X LEA BISOPROLOL A/S TABS TUK

1

06 March 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or
Amongst others the following side effects can occur:
are planning to have a baby, ask your doctor or pharmacist before taking s Common side effects (may affect more than 1 in 10 people)
this medicine.
(tiredness), dizziness or headache (these side effects occur especially
at the beginning of the treatment and are generally mild in nature and
Bisoprolol fumarate can be harmful to the pregnancy and/or to the child
often disappear within 1-2 weeks)
(increased possibility of premature birth, miscarriage, retarded growth,
s #OLDHANDSANDORFEET NUMBNESSOFHANDSANDORFEET EXACERBATION
low blood glucose level and reduced heart rate of the child). Therefore
of the pain in the legs and limping (intermittent claudication,
this medicinal product is not recommended during pregnancy.
Raynaud's Phenomenon)
It is unknown if Bisoprolol fumarate is excreted in the breast milk.
s .AUSEA VOMITING DIARRHOEA ABDOMINALPAINORCONSTIPATION
Breast-feeding during the use of this medicinal product is therefore not
s (YPOTENSIONLOWBLOODPRESSURE
recommended.
s 5NCOMMONSIDEEFFECTSMAYAFFECTUPTOINPEOPLE REDUCED
HEARTRATE EXACERBATIONOFEXISTINGRHYTHMDISORDERSSUCHAS!6 BLOCK
Driving and using machines
blood pressure reduction, for instance due to standing up quickly from
The use of Bisoprolol fumarate may sometimes result in dizziness or
a sitting or supine position, sometimes involving dizziness (orthostatic
fatigue (see “Possible side effects”). If you suffer from these side effects,
hypotension)
do not operate vehicles and/or machines that require your full attention. s DEPRESSION
Attention is in particular required at the beginning of the treatment, with s -USCLEWEAKNESSANDMUSCLECRAMPS JOINTPROBLEMS
changes in medication and with use in combination with alcohol.
s 3LEEPDISORDERS
s MALAISE

3

HOW TO TAKE BISOPROLOL FUMARATE

Always take Bisoprolol fumarate exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The tablets can best be taken with an ample amount of water (1 glass).
The recommended dose is:
Adults
Initial dose: Your doctor will start the treatment with the lowest possible
dose. Sometimes 5 mg per day (24 hours) can be sufficient.
The usual maintenance dose is 10 mg once per day. The maximum
recommended dose is 20 mg per day.
Children and adolescents
The use of Bisoprolol fumarate is not recommended as there is
insufficient experience with the use of this medicinal product in children.
Elderly patients
In general an adjustment of the dose is not needed. It is recommended
to start with the lowest possible dose.
Patients with a severely reduced kidney function
The maximum dose is 10 mg per day (24 hours). This dose can possibly
be distributed in 2 administrations.
Patients with a severely reduced liver function
The maximum dose is 10 mg per day (24 hours).
If you take more Bisoprolol fumarate than you should
If you have taken too much Bisoprolol fumarate, contact your doctor or
pharmacist immediately. Symptoms that may occur when taking a dose
that is too high are, reduced heart rate, reduced blood pressure,
shortness of breath, insufficient action of the heart and a low blood
glucose level (involving feelings of hunger, sweating, dizziness and
palpitations). In severe cases the doctor will possibly flush out your
stomach (gastric lavage).
If you forget to take Bisoprolol fumarate
If you have missed a dose, then take this dose as quickly as possible.
However, if it is almost time for the next dose, skip the missed dose and
continue on your normal dosing schedule. Never take a double dose of
Bisoprolol fumarate to make up for a forgotten dose.
If you stop taking Bisoprolol fumarate
If you suddenly stop the use of Bisoprolol fumarate an exacerbation of a
disorder of the heart may occur or your blood pressure may become
high again. Therefore, it is better not to suddenly discontinue the use of
this medicinal product. Your doctor will gradually reduce the dose.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side effects, although not
everybody gets them.
If you feel one of the following, stop taking bisoprolol and go to your
doctor or the nearest hospital straight away:
s INCREASEDBREATHLESSNESSANDSWELLEDLEGSWHICHARETHESYMPTOMS
of a reduced action of the heart (heart failure) (this side effect may
affect up to 1 in 100 people) - Shortness of breath and wheezing due
to narrowing of the airways in patients with asthma or disorders of
the airways (bronchospasm) (this side effect may affect up to 1 in 100
people)
s (YPERSENSITIVITYREACTIONSSUCHASITCHING REDNESSOFTHESKIN SKIN
rash and swelling (face, hands, feet), difficulty breathing (this side
effect may affect up to 1 in 1000 people)
s &EVER TIREDNESS PAINFULJOINTS FACERASHWHICHARESYMPTOMSOFA
disease called lupus syndrome (this side effect may affect up to 1 in
1000 people)
s YELLOWDISCOLOURATIONOFTHESKINOREYESJAUNDICE DRAKURINE
tiredness and belly pain which are signs of inflammation of the liver
(hepatitis) (this side effect may affect up to 1 in 1000 people)
s OBSERVATIONSOFTHINGSTHATARENOTPRESENTHALLUCINATIONS THISSIDE
effect may affect up to 1 in 1000 people)
s 7ORSENINGOFARECURRENTSKINDISORDERINVOLVINGSCALING DRYSKIN
rash (psoriasis) (this side effect may affect up to 1 in 1000 people).

Rare side effects: (may affect up to 1 in 1,000 people)
s )NCREASEINLIVERENZYMES!34 !,4 WHICHCANBESEENINBLOODTEST
s ,OWBLOODGLUCOSELEVELHYPOGLYCEMIA INVOLVINGFEELINGSOFHUNGER
sweating, dizziness, palpitations
s )NCREASEINATYPEOFFATFOUNDINTHEBLOODTRIGLYCERIDES
s -ALEIMPOTENCE
s )NFLAMMATIONOFTHENASALMUCOUSMEMBRANECHARACTERISEDBYA
blocked up nose, sneezing (allergic rhinitis)
s $RYEYESCANBEVERYTROUBLESOMEWHENYOUAREWEARINGCONTACT
lenses)
s .IGHTMARES (EARINGDISORDERS
s &AINTING
Very rare side effects: (may affect up to 1 in 10,000 people)
s (AIRLOSS
s )NFLAMMATIONOFTHEEYEOREYELID#ONJUNCTIVITIS 
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 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.

5

HOW TO STORE BISOPROLOL FUMARATE

Keep out of the reach and sight of children
5 mg film-coated tablets
"OTTLE$ONOTSTOREABOVEª# STOREINTHETIGHTLYCLOSEDCONTAINER
"LISTERSTRIPS$ONOTSTOREABOVEª# STOREINTHEORIGINALCONTAINER
10 mg film-coated tablets
"OTTLE$ONOTSTOREABOVEª# STOREINTHETIGHTLYCLOSEDCONTAINERIN
order to protect from light and/or moisture.
"LISTERSTRIPS$ONOTSTOREABOVEª# STOREINTHEORIGINALCONTAINERIN
order to protect from light and/or moisture.
$ONOTUSE"ISOPROLOLFUMARATE&ILM COATED4ABLETSAFTERTHEEXPIRYDATE
which is stated on the package after “do not use after” or “exp.” The
expiry date refers to the last day of that month.
$ONOTTHROWAWAYANYMEDICINESVIAWASTEWATERORHOUSEHOLDWASTE
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Bisoprolol fumarate Film-coated Tablets contain:
The active ingredient is bisoprolol fumarate: 5 mg or 10 mg.
The other ingredients are:
Core: microcrystalline cellulose (E460i), mannitol (E421), sodium
CROSCARMELLOSE% MAGNESIUMSTEARATE% 
Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000.
What Bisoprolol fumarate Film-coated Tablets look like and contents of
the pack
The 5 mg film-coated tablets are white, round, convex tablets engraved
WITH")3/02/,/,ONONESIDE
The 10 mg film-coated tablets are white, round, convex tablets engraved
WITH")3/02/,/,ONONESIDE
4HETABLETSAREPACKAGEDINBLISTERSTRIPSORBOTTLESOF    
60, 84, 90, 98, 100 and 105 tablets. Not all pack sizes may be marketed.
Marketing Authorisation holder and company responsible for
manufacture:4%6!5+,IMITED %ASTBOURNE ".!'
This leaflet was last revised in 03/2014.

 8
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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