Carvedi-Denk 6,25

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

carvedilol

Available from:

Artesan Pharma GmbH & Co. KG

INN (International Name):

carvedilol

Dosage:

6,25mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

_Carvedi-Denk 6.25_
Tablets – oral use
Active substance: carvedilol
Beta blocker
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 pharmacist.
– This medicine has been prescribed for
you. Do not pass it on to others. It
may harm them, even if their symp-
toms 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 CARVEDI-DENK 6.25 IS AND
WHAT IT IS USED FOR
2. BEFORE YOU TAKE CARVEDI-DENK 6.25
3. HOW TO TAKE CARVEDI-DENK 6.25
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CARVEDI-DENK 6.25
6. FURTHER INFORMATION
1.
WHAT CARVEDI-DENK 6.25 IS
AND WHAT IT IS USED FOR
Carvedi-Denk 6.25 belongs to the beta
blocker group of medicinal products (med-
icines for treating blood pressure or
increased heart rate).
Carvedi-Denk 6.25 is used for heart/cir-
culatory diseases.
Carvedi-Denk 6.25 is used for all
degrees of stable chronic heart failure
(cardiac insufficiency), of ischaemic or
nonischaemic origin (dependent or not on
circulation disorders). Use is accompanied
by treatment with diuretics and ACE
inhibitors and, if need be, digitalis (medi-
cines acting on the heart and vascular
system).
2.
BEFORE YOU TAKE
CARVEDI-DENK 6.25
DO NOT TAKE CARVEDI-DENK 6.25
– if you are hypersensitive to the active
substance carvedilol or any of the other
ingredients of Carvedi-Denk 6.25.
– if you have severely impaired cardiac
function (cardiogenic shock).
– if you have progressively worsening
heart failure (decompensated cardiac
insufficiency).
– if you have an acute pulmonary
embolism.
– if you have an unusual form of tightness
of the chest, known as Prinzmetal’s angi-
na, which is caused by constriction of
the coronary heart vessels.
– if you have particularly low blood pres-
sure (systolic blood pressure less t

Summary of Product characteristics

Page 1
INFORMATION FOR HEALTHCARE PROFESSIONALS
1.
NAME OF THE MEDICINAL PRODUCT
Carvedi-Denk 6.25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Carvedi-Denk 6.25 is a round, whitish, scored tablet.
2.2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: carvedilol
1 tablet contains 6.25 mg carvedilol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All degrees of severity of stable chronic cardiac insufficiency, of
ischaemic or non-ischaemic
origin - in addition to diuretics and ACE inhibitors and, optionally,
digitalis.
Treatment with Carvedi-Denk 6.25 should only be initiated if the
patient has been stabilised
with conventional basic treatment for cardiac insufficiency, i.e. the
dose of this pre-existing
standard treatment must have been stable for at least four weeks
before starting treatment with
Carvedi-Denk 6.25.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CHRONIC CARDIAC INSUFFICIENCY
The initial dose is 3.125 mg carvedilol twice daily for two weeks. If
this dose is tolerated, it
should be increased, at intervals each time of at least two weeks, to
2 x 6.25 mg carvedilol,
then 2 x 12.5 mg and subsequently to 2 x 25 mg carvedilol per day. The
target dose should be
the highest that the patient can tolerate. The minimum effective dose
is 6.25 mg carvedilol
twice daily. The maximum dose is usually 2 x 25 mg carvedilol per day.
It may be cautiously
attempted to increase the dose to a maximum of 2 x 50 mg carvedilol
per day only in patients
with mild to moderate chronic cardiac insufficiency whose body weight
is over 85 kg, and
with very close patient monitoring.
Page 2
The dose of Carvedi-Denk 6.25 should only be increased when the
clinical condition of the
patient is satisfactory and stable, i.e. if there are no symptoms
indicating aggravation of the
cardiac insufficiency or clinically significant undesirable effects
(particularly such effects as
result fr