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BISOPROLOL FUMARATE 10MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL FUMARATE / BISOPROLOL FUMARATE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

1

What Bisoprolol fumarate is and what it is used for

Pharma code 517

Do not take Bisoprolol fumarate in combination with:
• Floctafenine (a medicine used for relieving pain and swelling), as
Bisoprolol fumarate belongs to a group of medicinal products called
there is an increased possibility of reduced blood pressure or shock
beta blockers. These products protect the heart against too much activity,
• Sultopride (a medicine used for the treatment of nervous system
which makes the heart more relaxed and reduces blood pressure.
disorders), as there is an increased possibility of heart rhythm
Bisoprolol fumarate is used for the treatment of:
disorders.
• High blood pressure (hypertension)
Especially tell your doctor if you are taking one of the following drugs
• Chest pain (angina pectoris).
because if Bisoprolol fumarate is used in combination with the products
What you need to know before you take Bisoprolol
mentioned below the possibility of side effects on the heart and / or
changes in the blood pressure is increased.
fumarate

2

• Medicines used to treat heart rhythm disorders and high blood pressure,
such as calcium antagonists (verapamil, diltiazem and bepridil)
• Medicines used to treat high blood pressure such as clonidine and
other blood pressure reducing medicines that work by affecting the
part of the brain that controls blood pressure, such as methyldopa,
guanfacine, moxonidine and rilmenidine
• Any other drugs used for high blood pressure treatment
• Medicines used to treat severe depression such as the so-called
MAO-A inhibitors (moclobemide).
• medicines used for the treatment of heart rhythm disorders such as
the so-called anti-arrhythmics class I (e.g. disopyramide and
quinidine) and anti-arrhythmics class III (e.g. amiodarone)
• Medicines used to treat a tight, painful feeling in the chest and high
blood pressure such as calcium antagonists (nifedipine and
amlodipine (so-called dihydropyridine derivatives))
• Medicines used for the treatment of Alzheimer's disease such as
acetyl cholinesterase inhibitors (rivastigmine, galantamine and
tacrine)
• Other beta-blockers such as atenolol or metoprolol
• Eye drops that contain beta-blockers such as timolol or betaxolol
• Medicines used for the treatment of heart weakness and certain heart
rhythm disorders such as digitalis glycosides (digoxin)
• Anesthetics, such as propofol and lidocaine. See also the section on
“Warnings and precautions”
• Medicines used in the treatment for severe depression such as
tricyclic antidepressants (amitriptyline or clomipramine)
• Medicines used to treat severe mental illness such as phenothiazines
(chlorpromazine or perphenazine)
• Medicines used for the treatment of epilepsy such as barbiturates
(phenobarbital)
Warnings and precautions
• Other blood pressure reducing medicines
Talk to your doctor or pharmacist before taking Bisoprolol fumarate
• The muscle relaxant baclofen
• If you frequently suffer from lung disorders like asthma or respiratory • Medicines used to protect the body against the consequences of
certain treatments of cancer such as amifostine
disorders. In sensitive patients, Bisoprolol fumarate can cause a
• The antimalarial drug mefloquine
narrowing of the airways; in this case your doctor will probably

Medicines used to control the immune system and symptoms of
examine your lungs before the start of the treatment and possibly also
inflammation such as corticosteroids.
prescribe a bronchodilator (or increase the dose thereof)
• Medicines used for treatment of diabetes such as insulin, metformin
• If you are planning to undergo surgery. Your heart rate and blood
and tolbutamide; Bisoprolol fumarate may enhance the glucose
pressure can change when anaesthetics are taken together with
reducing effect of these products and may hide the symptoms of a
Bisoprolol fumarate. Inform the anaesthetist that you are taking
low blood sugar level in your blood. See also “Warnings and
Bisoprolol fumarate
precautions”
• If you have to undergo an X-ray examination with a contrast medium
• Medicines used to treat migraines such as Ergotamine, as it may
(so-called iodine containing contrast mediums). Inform your doctor
increase the blood flow disorders in the arms and legs
that you are using Bisoprolol fumarate
• Medicines that cause a stimulating effect on a certain part of the
• If you suffer from diabetes, as Bisoprolol fumarate may hide the
nervous system such as beta-sympatheticomimetics (dobutamine and
symptoms of low blood sugar (hypoglycaemia). Your blood glucose
isoprenaline). Taking these medicines with Bisoprolol fumarate may
levels should be checked regularly. See also “Other medicines and
reduce the effect of both products
bisoprolol fumarate”

A certain group of pain killers (the so-called NSAIDs), such as
• If you suffer from a thyroid problem, as Bisoprolol fumarate may hide
ibuprofen, naproxen and diclofenac; these may reduce the effect of
the symptoms of an overactive thyroid
Bisoprolol fumarate.
• If you are fasting
• Drugs for treatment of Alzheimer's disease (donepezil)
• If you are treated for hypersensitivity reactions (anti-allergic

Drugs for the treatment of a disease called miasthenia gravis
treatments) or if you suffer from an allergic reaction. Bisoprolol
(neostigmin)
fumarate may potentiate the hypersensitivity to the substances you
are allergic to and increase the severity of the allergic reactions
Pregnancy, breast-feeding and fertility
• If you suffer from a heart conduction disorder (so-called 1st degree AV If you are pregnant or breastfeeding, think you may be pregnant or are
block)
planning to have a baby, ask your doctor or pharmacist for advice before
• If you suffer from a tight, painful feeling in the chest at rest (Prinzmetal taking this medicine.
Do not take Bisoprolol fumarate:
• if you are allergic to bisoprolol fumarate or any of the other
ingredients of this medicine (listed in section 6)
• If you suffer from a suddenly occurring heart weakness (acute heart
failure) or deterioration of heart failure which require heart stimulating
medicines to be administered directly into the vein
• If you are in a state of shock caused by heart dysfunction
• If you suffer from certain heart conduction disorders (2nd or 3rd
degree AV-block without a pacemaker, sinoatrial block).
• If you suffer from certain heart rhythm disorders (sick sinus syndrome
or sinoatrial block)
• If you have a slow heart rate (less than 60 beats per minute) before
the start of the treatment.
• If you have a very low blood pressure (hypotension, systolic blood
pressure of less than 100)
• If you suffer from severe forms of asthma or any other breathing
problems such as chronic respiratory disorders (COPD)
• If you suffer from severe blood circulation problems in the fingers,
toes, arms and legs, like Raynaud´s phenomenon. See also “Warnings
and precautions”
• If you have a tumour of the adrenal medulla that may cause a severe
high blood pressure (an untreated phaeochromocytoma). See also
“Warnings and precautions”
• If you suffer from a condition where there is a change in the acid/base
balance of the body (metabolic acidosis)
• If you are treated with floctafenine (a medicine used for relieving pain
and swelling) or sultopride (a medicine used for the treatment of
nervous system disorders). See also “Other medicines and bisoprolol
fumarate”.

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

angina). Bisoprolol fumarate may increase the number and the
duration of the attacks
• If you suffer from blood circulation problems in the fingers, toes, arms
Bisoprolol fumarate
and legs (Raynaud's phenomenon) or a cramp like pain in the calves
brought on by exercise or walking (intermittent claudication). The
Package leaflet: Information for the user
complaints may be worse, particularly at the beginning of the
Read all of this leaflet carefully before you start taking this medicine
treatment
because it contains important information for you.
• If you have a tumour of the adrenal medulla (phaeochromocytoma);
• Keep this leaflet. You may need to read it again.
Bisoprolol fumarate may only be used in combination with certain
• If you have any further questions, ask your doctor or pharmacist.
medicinal products (the so-called alpha-blockers)
• This medicine has been prescribed for you only. Do not pass it on to
• If you suffer (or have suffered) from a recurrent skin disorder involving
others. It may harm them, even if their signs of illness are the same as
a scaling, dry skin rash (psoriasis).
yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
At the beginning of the treatment your doctor will check you regularly
This includes any possible side effects not listed in this leaflet. See
(especially in the treatment of elderly patients).
section 4.
Consult your doctor if one of the above mentioned warnings is
What is in this leaflet
applicable to you, or has been applicable in the past.
1. What Bisoprolol fumarate is and what it is used for
Children and adolescents
2. What you need to know before you take Bisoprolol fumarate
The use of Bisoprolol fumarate is not recommended as there is
3. How to take Bisoprolol fumarate
insufficient experience with the use of this medicinal product in children
4. Possible side effects
5. How to store Bisoprolol fumarate
Other medicines and Bisoprolol fumarate
6. Contents of the pack and other information
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

Bisoprolol fumarate
5 mg and 10 mg Film-coated Tablets

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Bisoprolol fumarate can be harmful to the pregnancy and/or to the child
(increased possibility of premature birth, miscarriage, retarded growth,
low blood glucose level and reduced heart rate of the child). Therefore
this medicinal product is not recommended during pregnancy.

• Nausea, vomiting, diarrhoea, abdominal pain or constipation.
• Hypotension (low blood pressure)

Uncommon may affect up to 1 in 100 people
• Reduced heart rate, exacerbation of existing rhythm disorders such as
AV-block,
• Blood pressure reduction, for instance due to standing up quickly
from a sitting or supine position, sometimes involving dizziness
(orthostatic hypotension)
Driving and using machines
• depression
The use of Bisoprolol fumarate may sometimes result in dizziness or
• Muscle weakness and muscle cramps, joint problems
fatigue (see “Possible side effects”). If you suffer from these side effects, • Sleep disorders.
do not operate vehicles and/or machines that require your full attention. • malaise
Attention is in particular required at the beginning of the treatment, with
Rare may affect up to 1 in 1,000 people
changes in medication and with use in combination with alcohol.
• Increase in liver enzymes (AST, ALT) which can be seen in blood test
How to take Bisoprolol fumarate
• Low blood glucose level (hypoglycemia) involving feelings of hunger,
sweating, dizziness, palpitations
• Increase in a type of fat found in the blood (triglycerides)
Always take this medicine exactly as your doctor has told you. Check
• Male impotence
with your doctor or pharmacist if you are not sure.
• Inflammation of the nasal mucous membrane characterised by a
The tablets can best be taken with an ample amount of water (1 glass).
blocked up nose, sneezing (allergic rhinitis)
The recommended dose is
• Dry eyes (can be very troublesome when you are wearing contact
Adults
lenses)
Initial dose: Your doctor will start the treatment with the lowest possible
• Nightmares, Hearing disorders.
dose. Sometimes 5 mg per day (24 hours) can be sufficient.

Fainting
The usual maintenance dose is 10 mg once per day. The maximum
recommended dose is 20 mg per day.
Very rare may affect up to 1 in 10,000 people
Use in children and adolescents
• Hair loss
The use of Bisoprolol fumarate is not recommended as there is
• Inflammation of the eye or eyelid (Conjunctivitis).
insufficient experience with the use of this medicinal product in children.
Older people
Reporting of side effects
In general an adjustment of the dose is not needed. It is recommended
If you get any side effects, talk to your doctor, pharmacist or nurse. This
to start with the lowest possible dose.
includes any possible side effects not listed in this leaflet. You can also
Patients with a severely reduced kidney function
report side effects directly via the Yellow Card Scheme at:
The maximum dose is 10 mg per day (24 hours). This dose can possibly www.mhra.gov.uk/yellowcard
be distributed in 2 administrations.
By reporting side effects you can help provide more information on the
Patients with a severely reduced liver function
safety of this medicine.
The maximum dose is 10 mg per day (24 hours)
It is unknown if Bisoprolol fumarate is excreted in the breast milk.
Breast-feeding during the use of this medicinal product is therefore not
recommended.

3

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 medicine, 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:
• increased breathlessness and swelled legs which are the symptoms 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)
• Hypersensitivity reactions such as itching, redness of the skin, skin
rash and swelling (face, hands, feet), difficulty breathing (this side
effect may affect up to 1 in 1000 people)
• Fever, tiredness, painfull joints, face rash which are syptoms of a
disease called lupus syndrome (this side effect may affect up to 1 in
1000 people)
• yellow discolouration of the skin or eyes (jaundice), drak urine,
tiredness and belly pain which are signs of inflammation of the liver
(hepatitis) (this side effect may affect up to 1 in 1000 people)
• observations of things that are not present (hallucinations) (this side
effect may affect up to 1 in 1000 people)
• Worsening of a recurrent skin disorder involving scaling, dry skin rash
(psoriasis) (this side effect may affect up to 1 in 1000 people)

5

How to store Bisoprolol fumarate

Keep this medicine out of the sight and reach of children.
5 mg film-coated tablets
Bottle: Do not store above 25°C, store in the tightly closed container.
Blister strips: Do not store above 25°C, store in the original container.
10 mg film-coated tablets
Bottle: Do not store above 30°C, store in the tightly closed container in
order to protect from light and/or moisture.
Blister strips: Do not store above 30°C, store in the original container in
order to protect from light and/or moisture.
Do not use this medicine after the expiry date which is stated on the
package after “do not use after” or "exp.” The expiry date refers to the
last day of that month.
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 Bisoprolol fumarate Film-coated Tablets contain:
The active substance is bisoprolol fumarate: 5 mg or 10 mg.
The other ingredients are:
Core: microcrystalline cellulose (E460i), mannitol (E421), sodium
croscarmellose (E466), magnesium stearate (E572);
Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000.
What Bisoprolol fumarate Film-coated Tablets looks like and contents of
the pack
The 5 mg film-coated tablets are white, round, convex tablets engraved
with BISOPROLOL 5 on one side.
The 10 mg film-coated tablets are white, round, convex tablets engraved
with BISOPROLOL 10 on one side.
The tablets are packaged in blister strips or bottles of 20, 28, 30, 50, 56,
60, 84, 90, 98, 100 and 105 tablets. Not all pack sizes may be marketed.
Marketing Authorisation holder and Manufacturer:
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in March 2015.

Amongst others the following side effects can occur:
Very common may affect more than 1 in 10 people
• Tiredness, dizziness or headache (these side effects occur especially at
the beginning of the treatment and are generally mild in nature and
often disappear within 1-2 weeks)
• Cold hands and/or feet, numbness of hands and/or feet, exacerbation
of the pain in the legs and limping (intermittent claudication,
Raynaud's Phenomenon)

61149-Y
210 x 323

Expand Transcript

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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