BISOPROLOL FUMARATE 5 MG TABLETS

Active substance: BISOPROLOL FUMARATE (2:1)

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bisoprolol Fumarate 2.5mg, 5mg and 10mg Tablets
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 your 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.
In this leaflet:
1. What bisoprolol is and what it is used for
2. Before you take bisoprolol
3. How to take bisoprolol
4. Possible side effects
5. How to store bisoprolol
6. Further information
1. WHAT BISOPROLOL IS AND WHAT IT IS
USED FOR
The active substance in Bisoprolol Fumarate 2.5mg,
5mg and 10mg Tablets is bisoprolol.
Bisoprolol belongs to a group of medicines called
beta-blockers.
Bisoprolol is used to treat stable heart failure.
Bisoprolol is given as an additional treatment to other
medications for heart failure.
Heart failure occurs when the heart muscle is weak
and unable to pump enough blood around the
circulation. This results in breathlessness and
swelling. Bisoprolol slows down the heart rate and
makes the heart more efficient at pumping blood
around the body.
2. BEFORE YOU TAKE BISOPROLOL
Do not take bisoprolol
Do not take bisoprolol if you:
• are allergic (hypersensitivity) to bisoprolol or to any of
the other ingredients (see section 6 ‘What Bisoprolol
Fumarate 2.5mg, 5mg and 10mg Tablets contain’)
• have severe asthma or severe chronic lung disease
• have severe blood circulation problems in your
limbs (such as Raynaud’s syndrome), that may
cause your fingers and toes to tingle or turn pale
or blue
• have untreated phaeochromocytoma, a rare
tumour of the adrenal gland
• 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 or irregular heart rate: ask your doctor
if you are not sure
• have very low blood pressure
Take special care with bisoprolol:
If you have any of the following conditions tell your
doctor before taking bisoprolol; 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
• any heart disease
• kidney or liver problems
• any blood circulation problems in your limbs
• asthma or chronic lung disease
• psoriasis, now or in the past
• tumour of the adrenal gland
(phaeochromocytoma)
• thyroid disorder (bisoprolol can hide the 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 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 may influence how your body reacts to
this situation.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Do not take the following medicines with
bisoprolol without special advice from your
doctor:
• 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, phenytoin, 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”)
• Medicines used to treat epilepsy e.g. barbiturates
such as phenobarbital
• 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 the above medicines as well as bisoprolol may
affect blood pressure and/or heart function.
It is also especially important to speak with your doctor
if you are taking:
• Insulin or other products for diabetes. The ability to
lower blood glucose may be enhanced. Symptoms
of low blood glucose level can be masked.
Taking bisoprolol with food and drink
Take the tablet with some water in the morning, with
or without food. Do not crush or chew the tablet.
Pregnancy and breast-feeding
There is a risk that use of bisoprolol 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
during pregnancy. It is not known whether bisoprolol
passes into human breast milk. Therefore,
breastfeeding is not recommended during therapy
with bisoprolol.
Driving and using machines
Your ability to drive or use machinery may be
affected depending on how well you tolerate this
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.
Important information about some of the
ingredients of Bisoprolol Fumarate Tablets
Bisoprolol Fumarate Tablets contain milk sugar
(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
Before you start using Bisoprolol Fumarate 2.5mg,
5mg and 10mg Tablets, you should already be
taking other medicines for heart failure including an
ACE-inhibitor, a diuretic and (as an added option)
a cardiac glycoside.
Always take bisoprolol exactly as your doctor has told
you. Check with your doctor or pharmacist if you are
not sure.
Treatment with bisoprolol 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 is usually long-term.
Adults including the elderly:
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:
• 1.25 mg bisoprolol once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
• 7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily for maintenance
(on-going) therapy.

The maximum recommended daily dose is 10 mg
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 10 mg bisoprolol 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.

5. HOW TO STORE BISOPROLOL
Keep out of the reach and sight of children.
Do not use bisoprolol after the expiry date which is
stated on the blister and the carton after EXP. The
expiry date refers to the last date of that month.
Do not store above 30ºC.
Medicines 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

Children
Bisoprolol is not recommended for use in children.

What Bisoprolol Fumarate 2.5mg, 5mg and 10mg
Tablets contain

If you take more bisoprolol than you should
Contact your doctor or local emergency ward
immediately. Take this leaflet and any tablets you still
have with you. Your doctor will decide what measures
are necessary. Symptoms of an overdose may include:
• dizziness, light-headedness, fatigue
• breathing difficulties
• slowed heart rate, low blood pressure
• feelings of hunger, sweating and palpitations
(caused by low blood sugar).

The active substance is bisoprolol fumarate:
Each 2.5mg tablet contains 2.5mg of bisoprolol fumarate.
Each 5mg tablet contains 5mg of bisoprolol fumarate.
Each 10mg tablet contains 10mg of bisoprolol fumarate.

If you forget to take bisoprolol
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
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
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, bisoprolol 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 and see your
doctor immediately if the following symptoms
occur:
Common effects (affects less than 1 person in 10):
• 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 other ingredients are:
microcrystalline cellulose, lactose monohydrate,
magnesium stearate, crospovidone.
Bisoprolol Fumarate 5 mg Tablets additionally contain:
Yellow PB 22812 (Iron oxide yellow (E172), lactose
monohydrate).
Bisoprolol Fumarate 10 mg Tablets additionally contain:
Biege PB 27215 (Iron oxide yellow (E172), Iron oxide
red (E172), lactose monohydrate).
What Bisoprolol Fumarate 2.5mg, 5mg and 10mg
Tablets look like and contents of the pack
Bisoprolol Fumarate 2.5 mg Tablets: White, oblong
uncoated, break-line on both top and bottom sides,
“BI” and “2.5” debossed on either side of the break-line
on the top. The tablet can be divided into equal halves.
Bisoprolol Fumarate 5 mg Tablets: pale yellow
mottled, normal convex tablet embossed with BI,
break-line and 5 on one side and plain on the
reverse. The tablet can be divided into equal halves.
Bisoprolol Fumarate 10 mg Tablets: mottled,
beige, round normal convex tablet embossed with BI,
break-line and 10 on one side and plain on the
reverse. The tablet can be divided into equal halves.
Each pack contains 28, 30, or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Zentiva,
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer: Niche Generics Limited, Unit 5,
151 Baldoyle Industrial Estate, Dublin 13, Ireland.
This leaflet was last revised in August 2011.

Further side effects are listed below according to how
frequently they may occur:
Very Common (affects more than 1 person in 10):
• Slow heart beat
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
• nausea, vomiting, diarrhoea, or constipation.
Uncommon (affects less than 1 person in 100):
• sleep disturbances
• depression
• dizziness
• breathing problems in patients with asthma or
chronic lung disease
• muscle weakness, muscle cramps
• irregular heart beat.
Rare (affects less than 1 person in 1,000):
• hearing problems
• allergic runny nose
• reduced tear flow (important if you use contact
lenses)
• inflammation of the liver which can cause
yellowing of the skin or whites of the eyes
• changes in blood test results
• allergy-like reactions such as itching, flush, rash
• reduced sexual potency
• nightmares, hallucinations
• fainting.
Very rare (affects less than 1 person in 10,000):
• irritation and redness of the eye (conjunctivitis)
• hair loss
• cause or worsen a skin rash similar to psoriasis.
Tell your doctor or your pharmacist if you notice any
of the side effects listed above or any other unwanted
or unexpected effects.
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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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