CARDICOR 10.0MG FILM-COATED TABLETS

Active substance: BISOPROLOL FUMARATE

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Package leaflet: Information for the user

Cardicor ®
Cardicor ®
Cardicor ®
Cardicor ®
Cardicor ®
Cardicor ®

Merck KGaA
Packaging Artwork Center Darmstadt
MS-TGD-SC Artwork Development
Frankfurter Straße 250
D-64293 Darmstadt
COORDINATOR
Name:

Elena Cruz-Parron

Tel.:

+41 (0)21 821 76 80

E-mail:

elena.cruz-parron@external.merckgroup.com

1.25 mg film-coated tablets
2.5 mg film-coated tablets
3.75 mg film-coated tablets
5 mg film-coated tablets
7.5 mg film-coated tablets
10 mg film-coated tablets

Bisoprolol fumarate

IDENTIFICATION OF THE COMPONENT
ERP component code:

1235481-A

Local product name:

Cardicor

Strength (s):

2,5 mg, 3,75 mg, 5 mg, 7,5 mg, 10 mg

TECHNICAL DATA
Packaging site:

Merck Mollet

Technical layout ref:

175 x 594 mm folded to 175 x 297 mm

COLOURS
Printed colour(s)
Black (+15% halftone value)
Technical information(s)
Keyline
FONT SIZE
Regul. text min. font size:

11 pt

BARCODE
Bar code type:

Laetus

Alpha numeric content:

773

Spotmark:

n/a

VARIABLE DATA
Online printed prefixes

n/a

Prefixes in English

Original Prefixes

Date Format

1.

Expiry date

n/a

n/a

2.

Batch No

n/a

n/a

3.

Mfg date

n/a

n/a

AGENCY

Ostring 13 • 65205 Wiesbaden-Nordenstadt
Telefon: 06122 506714 • Fax: 06122 506767
E-Mail: merck_packaging@data-graphis.de

TRACEABILITY (VERSIONS)
Vx

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet.

Date

Designer

01

25.04.2013

Miriam Müller

02

30.04.2013

Simone Hettmann

03

21.05.2013

Sina Ungeheuer

04

23.05.2013

Sina Ungeheuer

05

27.05.2013

Sina Ungeheuer

06

04.06.2013

Simone Hettmann

What is in this leaflet:
1. What Cardicor is and what it is used for
2. What you need to know before you take Cardicor
3. How to take Cardicor
4. Possible side effects
5. How to store Cardicor
6. Contents of the pack and other information
1. What Cardicor is 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. What you need to know 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:
• 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
• 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.
Warnings and precautions
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):
• 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)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.
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.
Children and adolescents
Cardicor is not recommended for use in children or
adolescents
Other medicines and Cardicor
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

1235481_A_L6.indd 1

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.
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.
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.
It is not known whether bisoprolol passes into
human breast milk. Therefore, breastfeeding is not
recommended during therapy with Cardicor.
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.
3. How to take Cardicor
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
Treatment with Cardicor requires regular monitoring
by your doctor. This is particularly necessary at the
start of treatment, during dose increase and when
you stop treatment.
Take the tablet with some water in the morning, with
or without food. Do not crush or chew the tablet. The
scored tablets can be divided into two equal doses.
Treatment with Cardicor 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 (ongoing) 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.
1235481-A/TW 566572
Your doctor will tell you what to do.

04.06.13 10:22

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.

If you take more Cardicor than you should
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).

Merck KGaA
Packaging Artwork Center Darmstadt
MS-TGD-SC Artwork Development
Frankfurter Straße 250
D-64293 Darmstadt
COORDINATOR
Name:

Elena Cruz-Parron

Tel.:

+41 (0)21 821 76 80

E-mail:

elena.cruz-parron@external.merckgroup.com

IDENTIFICATION OF THE COMPONENT
ERP component code:

1235481-A

Local product name:

Cardicor

Strength (s):

2,5 mg, 3,75 mg, 5 mg, 7,5 mg, 10 mg

TECHNICAL DATA
Packaging site:

Merck Mollet

Technical layout ref:

175 x 594 mm folded to 175 x 297 mm

COLOURS

If you forget to take Cardicor
Do not take a double dose to make up for a forgotten
dose. Take your usual dose the next morning.
If you stop taking Cardicor
Never stop taking Cardicor unless on your doctor’s
advice. Otherwise your condition could become
much worse.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Printed colour(s)
Black (+15% halftone value)
Technical information(s)
Keyline
FONT SIZE
Regul. text min. font size:

11 pt

BARCODE
Bar code type:

Laetus

Alpha numeric content:

773

Spotmark:

n/a

VARIABLE DATA
Online printed prefixes

n/a

Prefixes in English

Original Prefixes

Date Format

1.

Expiry date

n/a

n/a

2.

Batch No

n/a

n/a

3.

Mfg date

n/a

n/a

AGENCY

Ostring 13 • 65205 Wiesbaden-Nordenstadt
Telefon: 06122 506714 • Fax: 06122 506767
E-Mail: merck_packaging@data-graphis.de

TRACEABILITY (VERSIONS)
Vx

Date

Designer

01

25.04.2013

Miriam Müller

02

30.04.2013

Simone Hettmann

03

21.05.2013

Sina Ungeheuer

04

23.05.2013

Sina Ungeheuer

05

27.05.2013

Sina Ungeheuer

06

04.06.2013

Simone Hettmann

4. Possible side effects
Like all medicines, this medicine 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
• 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
• 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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
5. How to store Cardicor
• Keep this medicine out of the sight and reach of
children
• Do not use this medicine 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.
Cardicor 1.25, 2.5 mg, 3.75 mg film-coated tablets:
• Do not store above 25°C.
Cardicor 5, 7.5 mg, 10 mg film-coated tablets:
• Do not store above 30°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away of medicines you no longer use. These
measures will help protect the environment.

Film coating: dimethicone; macrogol 400; titanium
dioxide (E171); hypromellose.
Cardicor 3.75 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 3.75 mg.
• The other ingredients are: Tablet core: Silica, colloidal
anhydrous; magnesium stearate; crospovidone;
maize starch; microcrystalline cellulose; calcium
hydrogen phosphate (anhydrous).
Film coating: Iron oxide yellow (E172); dimethicone;
macrogol 400; titanium dioxide (E171); hypromellose.
Cardicor 5 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 5 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium
stearate; crospovidone; maize starch; microcrystalline
cellulose; calcium hydrogen phosphate (anhydrous).
Film coating: Iron oxide yellow (E172); dimethicone;
macrogol 400; titanium dioxide (E171); hypromellose.
Cardicor 7.5 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 7.5 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium
stearate; crospovidone; maize starch; microcrystalline
cellulose; calcium hydrogen phosphate (anhydrous).
Film coating: Iron oxide yellow (E172); dimethicone;
macrogol 400; titanium dioxide (E171); hypromellose.
Cardicor 10 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 10 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium
stearate; crospovidone; maize starch; microcrystalline
cellulose; calcium hydrogen phosphate (anhydrous).
Film coating: Iron oxide red (E172); Iron oxide
yellow (E172); dimethicone; macrogol 400; titanium
dioxide (E171); hypromellose.
What Cardicor looks like and contents of the pack
Cardicor 1.25 mg film-coated tablets are white and
round.
Cardicor 2.5 mg film-coated tablets are white and
heart-shaped with a break-line on both sides.
Cardicor 3.75 mg film-coated tablets are off-white
and heart-shaped with a break-line on both sides.
Cardicor 5 mg film-coated tablets are yellowish-white
and heart-shaped with a break-line on both sides.
Cardicor 7.5 mg film-coated tablets are pale yellow
and heart-shaped with a break-line on both sides.
Cardicor 10 mg film-coated tablets are pale orange
– light orange and heart-shaped with a break-line
on both sides.
Each pack contains 20, 28, 30, 50, 56, 60, 90, or 100
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Serono Ltd
Bedfont Cross, Stanwell Road, Feltham, Middlesex,
TW14 8NX, UK
Manufacturer
1.25 mg tablets:
Merck KGaA, Frankfurter Strasse 250, 64293
Darmstadt, Germany
2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg tablets:
Merck S.L., Poligono Merck, 08100 Mollet del Vallès
(Barcelona), Spain
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria: Concor COR, Belgium: Emconcor Minor,
Finland: Emconcor CHF, France: Cardensiel, Germany:
Concor COR, Ireland: Cardicor, Italy: Sequacor,
Luxemburg:Concor Cor, Netherlands: Emcor Deco,
Portugal: Concor IC, Spain: EMCONCOR COR, Sweden:
Emconcor CHF, United Kingdom: Cardicor
This leaflet was last revised in April 2013

6. Contents of the pack and other information
What Cardicor contains
Cardicor 1.25 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 1.25 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium
stearate; crospovidone; pregelatinised maize
starch; maize starch; microcrystalline cellulose;
calcium hydrogen phosphate (anhydrous).
Film coating: dimethicone; talc; macrogol 400;
titanium dioxide (E171); hypromellose.
Cardicor 2.5 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 2.5 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium
stearate; crospovidone; maize starch; microcrystalline
cellulose; calcium hydrogen phosphate (anhydrous).

1235481_A_L6.indd 2

1235481-A/TW 566572

04.06.13 10:22

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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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