BISOPROLOL FUMARATE 2.5MG TABLETS

Active substance: BISOPROLOL FUMARATE (2:1)

View full screen / Print PDF » Download PDF ⇩

Transcript
S157 Leaflet Cardicor 20121026

PACKAGE LEAFLET: INFORMATION FOR THE USER

In addition, tell your doctor if you are going to have:


desensitization therapy (for example for the prevention of hay
fever), because Cardicor may make it more likely that you
experience an allergic reaction, or such reaction may be more
severe



anaesthesia (for example for surgery), because Cardicor may
influence how your body reacts to this situation.

CARDICOR 2.5mg TABLETS
(bisoprolol fumarate)
Your medicine is marketed using the above names but will be
referred to as Cardicor Tablets throughout the following patient
information leaflet.
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 leafl et, please tell your doctor or
pharmacist.

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 Cardicor without special
advice from your doctor:


Certain medicines used to treat irregular or abnormal heartbeat
(Class I antiarrhythmic 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.

In this leaflet:
1. What Cardicor is and what it is used for
2. Before you take Cardicor
3. How to take Cardicor
4. Possible side effects
5. How to store Cardicor
6. Further information

Check with your doctor before taking the following medicines with
Cardicor; your doctor may need to check your condition more
frequently:


Certain medicines used to treat high blood pressure or angina
pectoris (dihydropyridine-type calcium antagonists such as
felodipine and amlodipine)



Certain medicines used to treat irregular or abnormal heartbeat
(Class III antiarrhythmic medicines such as amiodarone)



Beta-blockers applied locally (such as timolol eye drops for
glaucoma treatment)



Certain medicines used to treat for example Alzheimer’s
disease or glaucoma (parasympathomimetics such as tacrine or
carbachol) or medicines that are used to treat acute heart
problems (sympathomimetics such as isoprenaline and
dobutamine)



Antidiabetic medicines including insulin



Anaesthetic agents (for example during surgery)



Digitalis, 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, which can lower blood pressure as a desired or
undesired effect such as antihypertensives, certain medicines
for depression (tricyclic antidepressants such as imipramine or
amitriptyline), certain medicines used to treat epilepsy or during
anaesthesia (barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized by a loss of
contact with reality (phenothiazines 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.

1. WHAT IS CARDICOR AND WHAT IT IS USED FOR
The active substance in Cardicor 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. Cardicor is used to
treat stable chronic heart failure.
It is used in combination with other medicines suitable for this
condition (such as ACE-inhibitors, diuretics, and heart glycosides).
2. BEFORE YOU TAKE CARDICOR
Do not take Cardicor
Do not take Cardicor if one of the following conditions applies to
you:


allergy (hypersensitivity) to bisoprolol or to any of the other
ingredients (see section 6 ‘What Cardicor contains’)



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 Cardicor if you have one of the following heart
problems:

Pregnancy and breast-feeding
There is a risk that use of Cardicor 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 Cardicor during
pregnancy.



acute heart failure



worsening heart failure requiring injection of medicines into a
vein, that increase the force of contraction of the heart



slow heart rate



low blood pressure

It is not known whether bisoprolol passes into human breast milk.
Therefore, breastfeeding is not recommended during therapy with
Cardicor.



certain heart conditions causing a very slow heart rate or
irregular heartbeat

Driving and using machines



cardiogenic shock, which is an acute serious heart condition
causing low blood pressure and circulatory failure.

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.

Take special care with Cardicor
If you have any of the following conditions tell your doctor before
taking Cardicor; he or she may want to take special care (for
example give additional treatment or perform more frequent
checks):

3. HOW TO TAKE CARDICOR
Always take Cardicor exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.



diabetes



strict fasting



certain heart diseases such as disturbances in heart rhythm, or
severe chest pain at rest (Prinzmetal’s angina)



kidney or liver problems



less severe blood circulation problems in your limbs



less severe asthma or chronic lung disease



history of a scaly skin rash (psoriasis)

The blister strips are printed with abbreviation of the days of the
week in Italian. A translation of the days of the week is provided on
the blister label and in this Patient Information Leaflet:



tumour of the adrenal gland (phaeochromocytoma)

Lun = Mon

Mar = Tues

Mer = Wed

thyroid disorder.

Ven = Fri

Sab = Sat

Dom = Sun



Treatment with Cardicor 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 Cardicor is usually long-term.

Giov = Thur

Adults including the elderly:



nightmares, hallucinations

Treatment with bisoprolol must be started at a low dose and
increased gradually.



fainting.

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



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.

10 mg bisoprolol once daily for maintenance (on-going) therapy.

Tell your doctor or your pharmacist if you notice any of the side
effects listed above or any other unwanted or unexpected effects.

The maximum recommended daily dose is 10 mg bisoprolol.

5. HOW TO STORE CARDICOR

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Cardicor Tablets should not be stored above 25°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.
Children
Cardicor is not recommended for use in children.

6. FURTHER INFORMATION
If you take more Cardicor than you should

What Cardicor contains

If you have taken more Cardicor tablets than you should, tell your
doctor immediately. Your doctor will decide what measures are
necessary.



Symptoms of an overdose may include slowed heart rate, severe
difficulty in breathing, feeling dizzy, or trembling (due to decreased
blood sugar).
If you forget to take Cardicor

Active Ingredient
Each Cardicor 2.5mg Tablet contains 2.5mg of the active
ingredient, bisoprolol fumarate.



Cardicor Tablets also contain the following inactive ingredients:
calcium hydrogen phosphate anhydrous, maize starch,
microcrystalline cellulose, crospovidone, hypromellose,
magnesium stearate, colloidal anhydrous silica, titanium dioxide
(E171), macrogol 400, and dimeticone.

Do not take a double dose to make up for a forgotten dose. Take
your usual dose the next morning.

What Cardicor looks like and contents of the pack

If you stop taking Cardicor

Cardicor 2.5mg tablets are heart-shaped, biconvex, white filmcoated tablets scored on both sides.

Never stop taking Cardicor unless on your doctor’s advice.
Otherwise your condition could become much worse.

Cardicor 2.5mg Tablets are available as blister packs of 28, 30 or
100 tablets.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Product Licence holder

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cardicor 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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

The most serious side effects are related to the heart function:

This product is manufactured by Merck KGaA, 64271 Darmstadt,
Germany.



slowing of heart rate (affects more than 1 person in 10)

POM



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



dizziness when standing up



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



reduced tear flow



inflammation of the liver which can cause yellowing of the skin
or whites of the eyes



certain blood test results for liver function or fat levels differing
from normal



allergy-like reactions such as itching, flush, rash



impaired erection

PL No. 19488/0157 Cardicor 2.5mg Tablets

Leaflet revision date: 26 October 2012
Cardicor is a registered trade mark of Merck KGaA, Germany.
S157 Leaflet Cardicor 20121026

S157 Leaflet Bisoprolol 20121026

PACKAGE LEAFLET: INFORMATION FOR THE USER

In addition, tell your doctor if you are going to have:


desensitization therapy (for example for the prevention of hay
fever), because Bisoprolol Fumarate 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 may influence how your body reacts to this situation.

BISOPROLOL FUMARATE 2.5mg TABLETS
(bisoprolol fumarate)
Your medicine is marketed using the above names but will be
referred to as Bisoprolol Fumarate Tablets throughout the following
patient information leaflet.
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 leafl et, please tell your doctor or
pharmacist.

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 Fumarate
without special advice from your doctor:


Certain medicines used to treat irregular or abnormal heartbeat
(Class I antiarrhythmic 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.

In this leaflet:
1. What Bisoprolol Fumarate is and what it is used for
2. Before you take Bisoprolol Fumarate
3. How to take Bisoprolol Fumarate
4. Possible side effects
5. How to store Bisoprolol Fumarate
6. Further information

Check with your doctor before taking the following medicines with
Bisoprolol Fumarate; your doctor may need to check your condition
more frequently:


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 is used to treat stable chronic heart failure.
It is used in combination with other medicines suitable for this
condition (such as ACE-inhibitors, diuretics, and heart glycosides).
2. BEFORE YOU TAKE BISOPROLOL FUMARATE

Certain medicines used to treat high blood pressure or angina
pectoris (dihydropyridine-type calcium antagonists such as
felodipine and amlodipine)



Certain medicines used to treat irregular or abnormal heartbeat
(Class III antiarrhythmic medicines such as amiodarone)



Beta-blockers applied locally (such as timolol eye drops for
glaucoma treatment)



Certain medicines used to treat for example Alzheimer’s
disease or glaucoma (parasympathomimetics such as tacrine or
carbachol) or medicines that are used to treat acute heart
problems (sympathomimetics such as isoprenaline and
dobutamine)



Antidiabetic medicines including insulin



Anaesthetic agents (for example during surgery)



1. WHAT IS BISOPROLOL FUMARATE AND WHAT IT IS USED
FOR

Digitalis, 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, which can lower blood pressure as a desired or
undesired effect such as antihypertensives, certain medicines
for depression (tricyclic antidepressants such as imipramine or
amitriptyline), certain medicines used to treat epilepsy or during
anaesthesia (barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized by a loss of
contact with reality (phenothiazines 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.

Do not take Bisoprolol Fumarate
Do not take Bisoprolol Fumarate if one of the following conditions
applies to you:


allergy (hypersensitivity) to bisoprolol or to any of the other
ingredients (see section 6 ‘What Bisoprolol Fumarate contains’)



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 if you have one of the following
heart problems:


acute heart failure



worsening heart failure requiring injection of medicines into a
vein, that increase the force of contraction of the heart



slow heart rate



certain heart conditions causing a very slow heart rate or
irregular heartbeat



cardiogenic shock, which is an acute serious heart condition
causing low blood pressure and circulatory failure.

There is a risk that use of Bisoprolol Fumarate 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 during pregnancy.

low blood pressure



Pregnancy and breast-feeding

It is not known whether bisoprolol passes into human breast milk.
Therefore, breastfeeding is not recommended during therapy with
Bisoprolol Fumarate.
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.

Take special care with Bisoprolol Fumarate
If you have any of the following conditions tell your doctor before
taking Bisoprolol Fumarate; he or she may want to take special care
(for example give additional treatment or perform more frequent
checks):

3. HOW TO TAKE BISOPROLOL FUMARATE
Always take Bisoprolol Fumarate exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.



diabetes



strict fasting

Treatment with Bisoprolol Fumarate requires regular monitoring by
your doctor. This is particularly necessary at the start of treatment
and during dose increase.



certain heart diseases such as disturbances in heart rhythm, or
severe chest pain at rest (Prinzmetal’s angina)

Take the tablet with some water in the morning, with or without
food. Do not crush or chew the tablet.



kidney or liver problems



less severe blood circulation problems in your limbs



less severe asthma or chronic lung disease

The blister strips are printed with abbreviation of the days of the
week in Italian. A translation of the days of the week is provided on
the blister label and in this Patient Information Leaflet:



history of a scaly skin rash (psoriasis)

Lun = Mon

Mar = Tues

Mer = Wed



tumour of the adrenal gland (phaeochromocytoma)

Ven = Fri

Sab = Sat

Dom = Sun



thyroid disorder.

Treatment with Bisoprolol Fumarate is usually long-term.

Giov = Thur

Adults including the elderly:



nightmares, hallucinations

Treatment with bisoprolol must be started at a low dose and
increased gradually.



fainting.

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



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.

10 mg bisoprolol once daily for maintenance (on-going) therapy.

Tell your doctor or your pharmacist if you notice any of the side
effects listed above or any other unwanted or unexpected effects.

The maximum recommended daily dose is 10 mg bisoprolol.

5. HOW TO STORE BISOPROLOL FUMARATE

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Bisoprolol Fumarate Tablets should not be stored above 25°C.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.
Children
Bisoprolol Fumarate is not recommended for use in children.

6. FURTHER INFORMATION
If you take more Bisoprolol Fumarate than you should

What Bisoprolol Fumarate contains

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 slowed heart rate, severe
difficulty in breathing, feeling dizzy, or trembling (due to decreased
blood sugar).
If you forget to take Bisoprolol Fumarate

Active Ingredient
Each Bisoprolol Fumarate 2.5mg Tablet contains 2.5mg of the
active ingredient, bisoprolol fumarate.



Bisoprolol Fumarate Tablets also contain the following inactive
ingredients: calcium hydrogen phosphate anhydrous, maize
starch, microcrystalline cellulose, crospovidone, hypromellose,
magnesium stearate, colloidal anhydrous silica, titanium dioxide
(E171), macrogol 400, and dimeticone.

Do not take a double dose to make up for a forgotten dose. Take
your usual dose the next morning.

What Bisoprolol Fumarate looks like and contents of the pack

If you stop taking Bisoprolol Fumarate

Bisoprolol Fumarate 2.5mg tablets are heart-shaped, biconvex,
white film-coated tablets scored on both sides.

Never stop taking Bisoprolol Fumarate unless on your doctor’s
advice. Otherwise your condition could become much worse.

Bisoprolol Fumarate 2.5mg Tablets are available as blister packs of
28, 30 or 100 tablets.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Product Licence holder

4. POSSIBLE SIDE EFFECTS
Like all medicines, Bisoprolol Fumarate 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.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

The most serious side effects are related to the heart function:

This product is manufactured by Merck KGaA, 64271 Darmstadt,
Germany.



slowing of heart rate (affects more than 1 person in 10)

POM



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



dizziness when standing up



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



reduced tear flow



inflammation of the liver which can cause yellowing of the skin
or whites of the eyes



certain blood test results for liver function or fat levels differing
from normal



allergy-like reactions such as itching, flush, rash



impaired erection

PL No. 19488/0157 Bisoprolol Fumarate 2.5mg Tablets

Leaflet revision date: 26 October 2012
S157 Leaflet Bisoprolol 20121026

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.

Hide
(web4)