BISOPROLOL 2.5 MG FILM-COATED TABLET

Active substance: 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

• 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).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without prescription.

Read all of this leaflet carefully before you
start taking this medicine.

Pregnancy and breast-feeding:

- 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

There is a risk that Bisoprolol Tablets can harm the
baby if it is used during pregnancy. If you are
pregnant or plan to become pregnant you should
tell your doctor. 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.

In this leaflet:

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.

1. What Bisoprolol Tablets are and what they are
used for.
2. Before you take Bisoprolol Tablets.
3. How to take Bisoprolol Tablets.
4. Possible side effects.
5. How to store Bisoprolol Tablets.
6. Further 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. Before you take Bisoprolol
Tablets
Do not take Bisoprolol Tablets if you:
- are allergic (Hypersensitive) to Bisoprolol
fumarate or any of the other ingredients of
Bisoprolol Tablets.
- 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
Take special care with Bisoprolol Tablets. Tell 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.
Taking other medicines: 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
• certain pain killers (for instance acetyl salicylic
acid, diclofenac, indomethacin, ibuprofen,
naproxen)

3. How to take Bisoprolol Tablets
Always take Bisoprolol Tablets exactly as your
doctor has told you. You should 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.
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.
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 question on the use of
this product, ask your doctor or pharmacist.

Like all medicines, Bisoprolol Tablets 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.
side-effects

have

also

been

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.
If any of the side effects get serious or if any side
effect is noticed which is not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Bisoprolol
Tablets
- Keep out of the reach and sight of children.
- Do not use Bisoprolol Tablets 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.
- Store below 30ºC.
- Medicinal products should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information
What Bisoprolol Tablets contain:
The active ingredient is bisoprolol fumarate. Each
tablet contains 2.5 mg, 5 mg or 10 mg 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.

looks

like

and

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
Manufacturer:

4. Possible side effects

The following
reported:

What Bisoprolol Tablets
contents of the pack:

Holder

Accord Healthcare Limited,
Sage house,
319 Pinner road,
North Harrow
HA1 4HF,
Middlesex,
United Kingdom
This leaflet was last approved in: 03/2012.

and

Expand view ⇕

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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