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BISOPROLOL FUMARATE 5MG TABLETS

Active substance(s): BISOPROLOL FUMARATE / BISOPROLOL FUMARATE (2:1)

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PIL Bisoprolol Fumarate Niche UK v16.qxt 25/06/2014 10:29 Page 1

Package Leaflet: Information for the User

Bisoprolol Fumarate 2.5mg, 5mg & 10mg
Tablets
Bisoprolol fumarate
Read all of this leaflet carefully before you start taking this medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
■ If you get any side effects tell your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See Section 4.
What is in this leaflet:
1. What Bisoprolol Fumarate Tablets are
and what they are used for
2. What you need to know before you
take Bisoprolol Fumarate Tablets
3. How to take Bisoprolol Fumarate
Tablets
4. Possible side effects
5. How to store Bisoprolol Fumarate
Tablets
6. Contents of the pack and other
information

1. What Bisoprolol Fumarate Tablets
are and what they are used for
The active substance in Bisoprolol Fumarate
is bisoprolol. Bisoprolol belongs to a group of
medicines called beta-blockers. These
medicines work by affecting the body’s
response to some nerve impulses, especially
in the heart. As a result, bisoprolol slows
down the heart rate and makes the heart
more efficient at pumping blood around the
body.
Heart failure occurs when the heart muscle is
weak and unable to pump enough blood to
supply the body’s needs. Bisoprolol Fumarate
Tablets are used to treat stable chronic heart
failure. They are used in combination with
other medicines suitable for this condition
(such as ACE-inhibitors, diuretics and heart
glycosides).

2. What you need to know before you
take Bisoprolol Fumarate Tablets
Do not take Bisoprolol Fumarate Tablets
Do not take Bisoprolol Fumarate Tablets if one
of the following conditions applies to you:
■ If you are allergic to bisoprolol fumarate or
any of the other ingredients of this
medicine (listed in section 6)
■ severe asthma or severe chronic lung
disease
■ severe blood circulation problems in your
limbs (such as Raynaud’s syndrome), which
may cause your fingers and toes to tingle
or turn pale or blue
■ untreated phaeochromocytoma, which is a
rare tumour of the adrenal gland
■ metabolic acidosis, which is a condition
when there is too much acid in the blood.
Do not take Bisoprolol Fumarate Tablets if you
have one of the following heart problems:
■ heart failure that suddenly becomes worse
and/or that may require hospital treatment
■ slow or irregular heart rate
■ very low blood pressure
Warnings and precautions
Talk to your doctor or pharmacist before
taking Bisoprolol Fumarate Tablets. If you
have any of the following conditions, he or
she may want to take special care (for
example, give additional treatment or
perform more frequent checks):
■ diabetes (bisoprolol can hide the symptoms
of low blood sugar)
■ strict fasting
■ certain heart diseases such as disturbances
in heart rhythm, or severe chest pain at
rest (Prinzmetal’s angina)
■ kidney or liver problems
■ blood circulation problems in your limbs
■ asthma or chronic lung disease
■ history of a scaly rash (psoriasis)
■ tumour of the adrenal gland
(phaeochromocytoma)
■ thyroid disorder (bisoprolol can hide
symptoms of an overactive thyroid)
In addition, tell your doctor if you are going to
have:
■ desensitization therapy (for example for the
prevention of hay fever), because
Bisoprolol Fumarate Tablets may make it
more likely that you experience an allergic
reaction, or such reaction may be more
severe
■ anaesthesia (for example for surgery),
because Bisoprolol Fumarate Tablets may
influence how your body reacts to this
situation.
Other medicines and Bisoprolol
Fumarate Tablets
Please tell your doctor or pharmacist if you
are taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.
Do not take the following medicines with
Bisoprolol Fumarate Tablets without special
advice from your doctor:
■ Certain medicines used to treat irregular or
abnormal heartbeat (medicines such as

quinidine, disopyramide, lidocaine,
phenytoin; flecainide, propafenone)
■ Certain medicines used to treat high blood
pressure, angina pectoris or irregular
heartbeat (calcium antagonists such as
verapamil and diltiazem)
■ Certain medicines used to treat high blood
pressure such as clonidine, methyldopa,
moxonodine, rilmenidine. However, do
not stop taking these medicines
without checking with your doctor first.
Check with your doctor before taking the
following medicines with Bisoprolol Fumarate
Tablets; your doctor may need to check your
condition more frequently:
■ Certain medicines used to treat high blood
pressure or angina pectoris (felodipine and
amlodipine)
■ Certain medicines used to treat irregular or
abnormal heartbeat (medicines such as
amiodarone)
■ Timolol eye drops (and related medicines)
for glaucoma treatment
■ Certain medicines used to treat for
example Alzheimer’s disease or glaucoma
(such as tacrine or carbachol) or medicines
that are used to treat acute heart problems
(such as isoprenaline and dobutamine)
■ Antidiabetic medicines including insulin
■ Anaesthetic agents (for example during
surgery)
■ Digoxin, used to treat heart failure
■ Non-steroidal anti-inflammatory medicines
(NSAIDs) used to treat arthritis, pain or
inflammation (for example ibuprofen or
diclofenac)
■ Any medicine, that can lower blood
pressure such as antihypertensives, certain
medicines for depression (such as
imipramine or amitriptyline), certain
medicines used to treat epilepsy or during
anaesthesia (such as phenobarbital), or
certain medicines to treat mental illness
(such as levomepromazine)
■ Mefloquine, used for prevention or
treatment of malaria
■ Depression treatment medicines called
monoamine oxidase inhibitors (except
MAO-B inhibitors) such as moclobemide
■ Some medicines for migraine (ergotamine
derivatives).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.
There is a risk that use of Bisoprolol Fumarate
Tablets during pregnancy may harm the baby.
If you are pregnant or planning to become
pregnant, tell your doctor. He or she will
decide whether you can take Bisoprolol
Fumarate Tablets during pregnancy.
It is not known whether bisoprolol passes into
human breast milk. Therefore, breastfeeding
is not recommended during therapy with
Bisoprolol Fumarate Tablets.
Driving and using machines
Your ability to drive or use machinery may be
affected depending on how well you tolerate
the medicine. Please be especially cautious
at the start of treatment, when the dose is
increased or the medication is changed, as
well as in combination with alcohol.
Bisoprolol Fumarate Tablets contain
lactose
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 Bisoprolol Fumarate
Tablets
Always take Bisoprolol Fumarate Tablets
exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not
sure.
Treatment with Bisoprolol Fumarate Tablets
requires regular monitoring by your doctor.
This is particularly necessary at the start of
treatment and during dose increase.
Take the tablet with some water in the
morning, with or without food. Do not crush
or chew the tablet.
Treatment with Bisoprolol Fumarate Tablets is
usually long-term.
Adults including older people:
Treatment with bisoprolol must be
started at a low dose and increased
gradually. Your doctor will decide
how to increase the dose, and this
will normally be done in the
following way:

PIL Bisoprolol Fumarate Niche UK v16.qxt 25/06/2014 10:29 Page 2

1.25mg bisoprolol once daily for one week
2.5mg bisoprolol once daily for one week
■ 3.75mg bisoprolol once daily for one week
■ 5mg bisoprolol once daily for four weeks
■ 7.5mg bisoprolol once daily for four weeks
■ 10mg bisoprolol once daily for
maintenance (on-going) therapy.
The maximum recommended daily dose is
10mg bisoprolol.
Depending on how well you tolerate the
medicine, your doctor may also decide to
lengthen the time between dose increases. If
your condition gets worse or you no longer
tolerate the drug, it may be necessary to
reduce the dose again or to interrupt
treatment. In some patients a maintenance
dose lower than 10mg bisoprolol fumarate
may be sufficient. Your doctor will tell you
what to do.
If you have to stop treatment entirely, your
doctor will usually advise you to reduce the
dose gradually, as otherwise your condition
may become worse.



Use in Children
Bisoprolol Fumarate Tablets are not
recommended for use in children.
If you take more Bisoprolol Fumarate
Tablets than you should
If you have taken more Bisoprolol Fumarate
Tablets than you should, tell your doctor
immediately. Your doctor will decide what
measures are necessary.
Symptoms of an overdose may include
dizziness, light-headedness, fatigue,
breathlessness and/or wheezing. Also, there
may be reduced heart rate, reduced blood
pressure, insufficient action of the heart and a
low blood glucose level (which may involve
feelings of hunger, sweating and palpitations).
If you forget to take Bisoprolol Fumarate
Tablets
Do not take a double dose to make up for a
forgotten dose. Take your usual dose the next
morning.
If you stop taking Bisoprolol Fumarate
Tablets
Never stop taking Bisoprolol Fumarate Tablets
unless on your doctor’s advice. Otherwise
your condition could become much worse.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

4. Possible Side Effects
Like all medicines, Bisoprolol Fumarate
Tablets can cause side effects, although not
everybody gets them.
To prevent serious reactions, speak to a
doctor immediately if a side effect is severe,
occurred suddenly or gets worse rapidly.
The most serious side effects are related to
the heart function:
■ slowing of heart rate (affects more than 1
person in 10)
■ worsening of heart failure (affects less than
1 person in 10)
■ slow or irregular heartbeat (affects less
than 1 person in 100)
If you feel dizzy or weak, or have breathing
difficulties please contact your doctor as
soon as possible.
Further side effects are listed below
according to how frequently they may occur:
Common (affects less than 1 person in
10):
■ tiredness, feeling weak, dizziness,
headache
■ feeling of coldness or numbness in hands
or feet
■ low blood pressure
■ stomach or intestine problems such as
nausea, vomiting, diarrhoea, or
constipation.
Uncommon (affects less than 1 person in
100):
■ sleep disturbances
■ depression
■ breathing problems in patients with asthma
or chronic lung disease
■ muscle weakness, muscle cramps.
Rare (affects less than 1 person in 1,000):
■ hearing problems
■ allergic runny nose
■ dry eyes from reduced tear flow (can be
troublesome if you use contact lenses)
■ inflammation of the liver which can cause
yellowing of the skin or whites of the eyes
■ allergy-like reactions such as itching, flush,
rash
■ reduced sexual performance (potency
disorder)
■ nightmares, hallucinations
■ fainting
Very rare (affects less than 1 person in
10,000):
■ irritation and redness of the eye
(conjunctivitis)
■ hair loss
■ appearance or worsening of scaly skin rash
(psoriasis); psoriasis-like rash.

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
Tablets
Keep out of the sight and reach of children.
Do not use Bisoprolol Fumarate Tablets after
the expiry date which is printed on the carton
and blister. The expiry date refers to the last
day of that month.
Do not store Bisoprolol Fumarate Tablets
above 30˚C.
Do not use Bisoprolol Fumarate Tablets if you
notice your tablets become discoloured or
show any other signs of deterioration, and
return to your pharmacist for advice.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away any medicines
you no longer use. These measures will help
to protect the environment.

6. Contents of the pack and other
information
What Bisoprolol Fumarate Tablets
contain
■ The active substance is bisoprolol
fumarate.
Each 2.5mg tablet contains 2.5mg
bisoprolol fumarate.
Each 5mg tablet contains 5mg bisoprolol
fumarate.
Each 10mg tablet contains 10mg bisoprolol
fumarate.
■ The other ingredients are lactose
monohydrate, cellulose microcrystalline
(E460), magnesium stearate (E572) and
crospovidone (E1202).
Each 5mg tablet also contains a yellow
colour (which contains lactose
monohydrate and iron oxide yellow [E172]).
Each 10mg tablet also contains a beige
colour (which contains lactose
monohydrate and iron oxide red and
yellow [E172]).
What Bisoprolol Fumarate Tablets look
like and contents of the pack
The 2.5mg tablets are white, oblong,
uncoated, breakline on both top and bottom
sides, “BI” and “2.5” debossed on either side
of the breakline on the top.
The 5mg tablets are pale yellow mottled,
round and convex, uncoated, “BI” and “5”
debossed on either side of a break-line on the
top side, plain on the bottom side.
The 10mg tablets are beige mottled, round
and convex, uncoated, “BI” and “10”
debossed on either side of a breakline on the
top side, plain on the bottom side.
The tablets are packed in blisters comprising
of uPVC/PVdC aluminium foil, contained
within a printed cardboard carton.
Each carton will contain either 10, 14, 20, 28,
30, 50, 56, 60, 90 or 100 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder:
Niche Generics Limited, 1 The Cam Centre,
Wilbury Way, Hitchin, Herts, SG4 0TW, United
Kingdom.
Manufacturer:
Niche Generics Limited, Unit 5, 151 Baldoyle
Industrial Estate, Dublin 13, Ireland.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Netherlands: Bisoprololfumaraat
2.5mg/5mg/10mg Mylan, tabletten
UK: Bisoprolol Fumarate 2.5mg/5mg/10mg
Tablets
Ireland: Bisoprolol Fumarate
2.5mg/5mg/10mg Tablets
This leaflet was last revised in: 04/2014

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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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