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BISOPROLOL 5 MG FILM-COATED TABLET

Active substance(s): BISOPROLOL FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Bisoprolol 2.5 mg
Film-coated Tablet
Bisoprolol 5 mg
Film-coated Tablet
Bisoprolol 10 mg
Film-coated Tablet
Bisoprolol fumarate

• certain pain killers (for instance acetyl salicylic
acid, diclofenac, indomethacin, ibuprofen,
naproxen)
• medicines for asthma or medicines used for a
blocked nose
• medicines used for certain eye disorders such
as glaucoma (increased pressure in the eye) or
used to widen the pupil of the eye
• certain medicines to treat clinical shock (e. g.
adrenaline, dobutamine, noradrenaline)
• mefloquine, a medicine for malaria
• all these drugs as well as bisoprolol may
influence the blood pressure and/or heart
function.
• rifampicin for the treatment of infections
• medicines to treat severe headaches or
migraines (ergotamine derivatives).

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines,.

- 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 signs of illness are the same as
yours.
- If you get any side effects talk to your doctor
orpharmacist. This includes any possible side
effects not listed in this leaflet.

Pregnancy and breast-feeding:

What is in this leaflet.
1. What Bisoprolol Tablets are and what they are
used for.
2. What you need to know before you take
Bisoprolol Tablets.
3. How to take Bisoprolol Tablets.
4. Possible side effects.
5. How to store Bisoprolol Tablets.
6. Contents of the pack and other information

1. What Bisoprolol Tablets are
and what they are used for
The active ingredient in this medicine is
Bisoprolol fumarate. Bisoprolol Tablets belongs to
group of medicines called beta-blockers.
Beta-blockers protect the heart against too much
activity.
Bisoprolol 2.5 mg, 5 mg and 10 mg Tablets are
used in combination with other medicines to treat
stable heart failure. Heart failure occurs when the
heart muscle is too weak to pump blood around
the circulation adequately. This results in
breathlessness and swelling. Bisoprolol slows
down the heart rate and makes the heart more
efficient at pumping blood around the body.
Bisoprolol 5 mg and 10 mg tablets are also used
to treat high blood pressure (Hypertension) and
angina pectoris (Chest pain caused by blockages
in the arteries that supply the heart muscle)

2. What you need to know before
you take Bisoprolol Tablets
Do not take Bisoprolol Tablets if you:
- are allergic to Bisoprolol fumarate or any of the
other ingredients of this medicine (listed in
section 6).
- have severe asthma or sever chronic lung disease.
- have severe blood circulation problem in your
limbs (such as Raynaud’s syndrome), which
may cause your fingers and toes to tingle or
turn pale or blue.
- have untreated phaeochromocytoma, a rare
tumour of the adrenal gland (medulla).
- have metabolic acidosis, a condition when there
is too much acid in the blood.
- have heart failure that suddenly becomes worse
and / or that may require hospital treatment
- have a slow heart rate
- have very low blood pressure
- have a slow or irregular heart rate (less than 60
beats per minute). Ask your doctor if you are not
sure
Warnings and precautions:
Talk to your doctor before you start to take this
medicine if you:
• have asthma or chronic lung disease
• have diabetes. Bisoprolol can hide the
symptoms of low blood sugar
• are fasting from solid food
• are treated for hypersensitivity (allergic)
reactions. Bisoprolol may make your allergy
worse or more difficult to treat.
• have any heart problems
• have any liver or kidney problems
• have any problems with the circulation in your
limbs
• are going to be given a general anaesthetic
during an operation – tell your doctor that you
are taking bisoprolol
• are taking verapamil or diltiazem, medicines
used to treat heart conditions. Concomitant use
is not recommended, see also “taking other
medicines”
• have (or have had) psoriasis (a recurring skin
rash)
• have phaeochromocytoma (a rare tumour of the
adrenal gland). Your doctor will need to treat
this before prescribing bisoprolol for you
• have a thyroid problem. The tablets can hide
symptoms of an overactive thyroid.
Other medicines and Bisoprolol Tablets:
Tell your doctor if you are already taking or using
any of the following as they may interact with
your medicine:
• medicines for controlling the blood pressure or
medicines for heart problems (such as
amiodarone, amlodipine, clonidine, digitalis
glycosides, diltiazem, disopyramide, felodipine,
flecainide, lidocaine, methyldopa, moxonidine, ,
propafenone, quinidine, rilmenidine, verapamil)
• medicines for depression e.g. imipramine,
amitriptyline, moclobemide
• medicines to treat mental illness e.g.
phenothiazines such as levomepromazine
• medicines used for anaesthesia during an
operation (see also “Take special care with
Bisoprolol Tablets”)
• medicines used to treat epilepsy e.g. phenytoin
and barbiturates such as phenobarbital

There is a risk that Bisoprolol Tablets can harm
the baby if it is used during pregnancy. If you are
pregnant, think you may be pregnant or are
planning to become pregnant ask your doctor for
advice before taking this medicine. He or she will
determine whether you can take Bisoprolol
Tablets during pregnancy. It is not known whether
Bisoprolol fumarate passes in to breast milk.
Therefore, breastfeeding is not recommended
during treatment with Bisoprolol Tablets.
Driving and using machine:
The ability to drive or operate machinery may be
affected, depending on how well you tolerate the
medicine. Be especially careful at the beginning
of the treatment, when the dose is increased or
when the medication is changed, and when
combined with alcohol.

3. How to take Bisoprolol Tablets
Always take this medicine exactly as your doctor
has told you. Check with your doctor or your
pharmacist if you are not sure. Treatment with
Bisoprolol Tablets requires regular medical check
up. This is particularly important in the initiation of
therapy and during dose increase. Bisoprolol
Tablets should be taken in the morning, with or
without food. Swallow the tablet/s whole with
some water and do not chew or crush them. The
tablet can be divided into equal doses. Treatment
with Bisoprolol Tablets is usually prolonged.
Adult:
Chest pain and high blood pressure:
Your doctor will start the treatment with lowest
possible dose (5 mg). Your doctor will monitor
you closely at the start of treatment. Your doctor
will increase your dose to obtain the best
possible dosage for you.
The maximum recommended dose is 20 mg once
per day.
Patient with kidney disease:
Patient with severe kidney disease should not
exceed 10 mg of bisoprolol once daily. Please
consult your doctor before starting to use this
medicine.
Patient with liver disease:
Patient with severe liver disease should not exceed
10 mg of bisoprolol once daily. Please consult your
doctor before starting to use this medicine.
Heart failure:
Before you start using Bisoprolol Tablets, you
should already be taking other medicines for heart
failure including any ACE inhibitor, a diuretic and
(as an added option) a cardiac glycoside.
Treatment with Bisoprolol Tablets 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:
- 1.25 mg bisoprolol fumarate once daily for a
week
- 2.5 mg bisoprolol fumarate once daily for a
week
- 3.75 mg bisoprolol fumarate once daily for a
week
- 5 mg bisoprolol fumarate once daily for four
weeks
- 7.5 mg bisoprolol fumarate once daily for four
weeks
- 10 mg bisoprolol fumarate once daily for
maintenance (on-going) therapy.
The maximum recommended daily dose of
bisoprolol fumarate is 10 mg.
Depending on how well you tolerate the medicine,
the doctor may also extend the time between dose
increases. If your condition gets worse or if you no
longer tolerate the drug, it may be necessary to
lower the dose again or to stop treatment. For
some patients a maintenance dose lower than 10
mg bisoprolol fumarate may be sufficient. Your
doctor will tell you what to do. If you have to stop
the treatment entirely, your doctor will usually
advice you to reduce the dose gradually, as
otherwise your condition may become worse.
Use in children:
Bisoprolol Tablets is not recommended for use in
children.
Elderly patient:
In general adjustment of the dose is not needed.
It is recommended to start with lowest possible
dose.
If you notice that the bisoprolol dose is too strong
or does not work well enough, please consult
your doctor or pharmacist.
If you take more Bisoprolol Tablets than you
should:
If you take too much medicine, or if a child has
swallowed the medicine by mistake ask your
doctor or hospital for assessing risk and advice.
Take this leaflet and any tablets you still have
with you. You may feel slow heartbeat, severe
breathing difficulties, dizziness or tremor (due to
decreased blood sugar).

If you forget to take Bisoprolol Tablets:
If you forget to take a dose, take it as soon as
you remember it unless it is nearly time for your
next dose. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Bisoprolol Tablets:
Do not stop treatment suddenly or change the
recommended dose without talking to your doctor
first. If you need to stop treatment, it must be
done gradually to avoid side effects.
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.
The following side effects are important and will
require immediate action if you experience them.
You should stop taking Bisoprolol Tablets and see
your doctor immediately if the following
symptoms occur:
Common side effects (affecting fewer than 1
in 10 people):
• worsening of heart failure causing increased
breathlessness and / or retention of fluid.
Frequency not stated:
• worsening of symptoms of blockage of the main
blood vessels to the legs, especially at the start
of treatment.
The following side-effects have also been
reported:
Very common side effects (affecting more
than 1 in 10 people):
• slow heart beat.
Common side effects (affecting fewer than 1
in 10 people):
• cold hands and/or feet
• numbness of hands and/or feet
• low blood pressure
• feeling sick, vomiting, diarrhoea, constipation
• tiredness*
• feeling weak
• dizziness*
• headache*.
Uncommon side effects (affecting fewer than
1 in 100 people):
• worsening of irregular heart beat
• sleep disorders
• depression
• breathing problems in patients with asthma or
chronic lung disease
• muscle weakness, muscle cramps.
Rare side effects (affecting fewer than 1 in
1,000 people):
• changes in blood test results
• reduced tear flow (can be a problem if you wear
contact lenses)
• hearing disorders
• blocked, runny nose
• inflammation of the liver (hepatitis) causing
abdominal pain, loss of appetite and sometimes
jaundice with yellowing of the whites of the eyes
and skin and dark urine
• hypersensitivity reactions such as itching,
redness and skin rash
• reduced sexual performance
• nightmares
• hallucinations (imagining things)
• fainting.
Very rare side effects (affecting fewer than 1
in 10,000 people):
• inflammation of the eye (conjunctivitis)
• aggravation of the skin condition psoriasis or
the appearance of a similar dry, scaly rash
• hair loss.
* if treated for high blood pressure or angina then
these symptoms occur especially at the
beginning of treatment, or if your dosage
changes. They are generally mild and often
disappear within 1 to 2 weeks.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the the national
reporting system (see contact details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Bisoprolol
Tablets
- Keep out of the sight and reach of children.
- Do not use this medicine after the expiry date
which is stated on the blister and carton after
EXP. The expiry date refers to the last day of
that month.
- Do not store above 30°C. 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 Tablets contains:
The active substance is bisoprolol fumarate.
Each tablet contains either 2.5mg, 5mg or 10mg
Bisoprolol fumarate.

The other ingredients are Cellulose
microcrystalline, Sodium starch glycolate
(Type-A), Povidone K-30, Silica colloidal
anhydrous, Magnesium stearate(E572),
Hypromellose E-15(E464), Macrogol 400(E553),
Titanium dioxide (E171), Talc.
What Bisoprolol Tablets looks like and
contents of the pack:
For Bisoprolol 2.5 mg Tablets: White to off white,
round, biconvex, film coated tablets, debossed
‘b1’ on one side and break line on other side
For Bisoprolol 5 mg Tablets: White to off white,
round, biconvex, film coated tablets, debossed
‘b2’ on one side and break line on other side
For Bisoprolol 10 mg Tablets: White to off white,
round, biconvex, film coated tablets, debossed
‘b3’ on one side and break line on other side
Pack sizes of 20, 28, 30, 50, 56, 60, 90 and 100
tablets per pack are registered for all strengths.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Accord Healthcare Limited,
Sage house,
319 Pinner road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
This leaflet was last revised in: 03/ 2015

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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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