CARDILOC 1.25

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

BISOPROLOL HEMIFUMARATE

Dostupno od:

UNIPHARM LTD, ISRAEL

ATC koda:

C07AB07

Farmaceutski oblik:

FILM COATED TABLETS

Sastav:

BISOPROLOL HEMIFUMARATE 1.25 MG

Administracija rute:

PER OS

Tip recepta:

Required

Proizveden od:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Terapijska grupa:

BISOPROLOL

Područje terapije:

BISOPROLOL

Terapijske indikacije:

Treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function (ejection fraction < 35%, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides

Datum autorizacije:

2017-08-31

Uputa o lijeku

PATIENT
PACKAGE
INSERT
IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
CARDILOC 1.25/2.5/5/10
Tablets
COMPOSITION:
Each tablet of CARDILOC 1.25 contains:
Bisoprolol Fumarate 1.25 mg
Each tablet of CARDILOC 2.5 contains:
Bisoprolol Fumarate 2.5 mg
Each tablet of CARDILOC 5 contains:
Bisoprolol Fumarate 5 mg
Each tablet of CARDILOC 10 contains:
Bisoprolol Fumarate 10 mg
For inactive ingredients and allergens – see
section 6: “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the
treatment of your ailment. Do not pass it on
to others. It may harm them, even if it seems
to you that their medical condition is similar.
This medicine is not intended for children.
1. WHAT IS THE MEDICINE INTENDED
FOR?
CARDILOC 1.25/CARDILOC 2.5: For the
treatment of heart failure.
CARDILOC 5/CARDILOC 10: For the treatment
of heart failure. For the treatment of
hypertension. For the treatment of angina
pectoris.
THERAPEUTIC GROUP: The medicine belongs
to the beta blocker group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
• If you have a known sensitivity to
bisoprolol or to any of the ingredients
of the medicine )see section 6 “Further
Information”(.
• In patients suffering from heart
failure requiring intravenous therapy
with substances that increase heart
contraction .
• If you had cardiogenic shock, which is a
serious heart condition that causes low
blood pressure and circulatory failure.
• In cases of severe disturbances in
conduction in the heart )second or third
degree AV block( in patients who have a
slow heart rate.
• In patients suffering from low blood
pressure.
• In patients suffering from severe asthma.
• In different heart conditions which cause
a very slow heart rate or abnormal
heartbeat )sick sinus

Svojstava lijeka

0912A
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ע עבקנ הז ולע טמרופ
ע עבקנ הז ולע טמרופ
ע עבקנ הז ולע טמרופ
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ודי לע רשואו קדבנ ונכותו תואירבה דרשמ
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ודי לע רשואו קדבנ ונכותו תואירבה דרשמ
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
_Cardiloc 1.25, _film-coated tablet
_Cardiloc 2.5, _film-coated tablet
_Cardiloc 5, _film-coated tablet
_Cardiloc 10, _film-coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Bisoprolol fumarate
_Cardiloc 1.25 _
One film-coated tablet contains 1.25 mg bisoprolol fumarate.
_Cardiloc 2.5 _
One film-coated tablet contains 2.5 mg bisoprolol fumarate. _ _
_Cardiloc 5 _
One film-coated tablet contains 5 mg bisoprolol fumarate.
_Cardiloc 10 _
One film-coated tablet contains 10 mg bisoprolol fumarate.
For a full list of excipients see section 6.1.
3. DOSAGE FORM
Film-coated tablets
_Cardiloc 1.25_ are orange, circular, biconvex, film-coated tablets.
_Cardiloc 2.5_ are white, circular, biconvex, film-coated tablets with
breakline on one side.
_Cardiloc 5 _are white, circular, biconvex, film-coated tablets with
breakline on one side.
_Cardiloc 10 _are white, circular, biconvex, film-coated tablets with
breakline on one side.
Tablets with a breakline can be divided in halves.
4. CLINICAL DATA
4.1 THERAPEUTIC INDICATIONS
CARDILOC 1.25, 2.5, 5, 10:
Treatment of stable chronic,
moderate to severe heart failure with impaired systolic
ventricular function (ejection fraction < 35 %, determined by
echocardiography) in
addition to ACE inhibitors, and diuretics, and optionally cardiac
glycosides (for
additional information see section 5.1).
CARDILOC 5, 10:
Management of angina pectoris, hypertention.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HYPERTENSION, ANGINA PECTORIS:
Treatment should princi