CARDICOR 3.75 Milligram Film Coated Tablet

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

BISOPROLOL HEMIFUMARATE

Boleh didapati daripada:

Merck Serono Limited

Kod ATC:

C07AB07

INN (Nama Antarabangsa):

BISOPROLOL HEMIFUMARATE

Dos:

3.75 Milligram

Borang farmaseutikal:

Film Coated Tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Beta blocking agents, selective

Status kebenaran:

Transfer Pending

Tarikh kebenaran:

2000-03-20

Risalah maklumat

PLACEHOLDER
MC-2314-2016/TW1205731
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
• chronic lung disease or less severe asthma
• 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.
If you have chronic lung disease or less
severe asthma please inform your doctor
immediately if you start to experience new
difficulties in breathing, cough, wheezing
after exercise, etc. when using Cardicor.
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.
Do not take the following medicines with
Cardicor without special advice from your
doctor:
• certain
medicines
used
to
treat
irr

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardicor 3.75 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.75 mg bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Off-white, heart-shaped, scored and film-coated tablets.
The scored tablets can be divided into two equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in addition to ACE inhibitors,
and diuretics, and optionally cardiac glycosides (for additional
information see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker in case of intolerance to
ACE inhibitors), a beta-blocker, diuretics, and when appropriate
cardiac glycosides. Patients should be stable (without
acute failure) when bisoprolol treatment is initiated.
It is recommended that the treating physician should be experienced in
the management of chronic heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may
occur during the titration period and thereafter.
Posology
_Titration phase_
The treatment of stable chronic heart failure with bisoprolol requires
a titration phase
The treatment with bisoprolol is to be started with a gradual
uptitration according to the following steps:
1.25 mg once daily for 1 week, if well tolerated increase to
2.5 mg once daily for a further week, if well tolerated increase to
3.75 mg once daily for a further week, if well tolerated increase to
5 mg once daily for the 4 following weeks, if well tolerated increase
to
7.5 mg once daily for the 4 following weeks, if well tolerated
increase to
10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and
symptoms of worsening heart failure is recommended
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