Carvedi-Denk 25

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

carvedilol

Διαθέσιμο από:

Artesan Pharma GmbH & Co. KG

INN (Διεθνής Όνομα):

carvedilol

Δοσολογία:

25mg

Φαρμακοτεχνική μορφή:

tablets

Τρόπος διάθεσης:

Prescription

Φύλλο οδηγιών χρήσης

_Carvedi-Denk 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 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 leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. WHAT CARVEDI-DENK 25 IS AND
WHAT IT IS USED FOR
2. BEFORE YOU TAKE CARVEDI-DENK 25
3. HOW TO TAKE CARVEDI-DENK 25
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CARVEDI-DENK 25
6. FURTHER INFORMATION
1.
WHAT CARVEDI-DENK 25 IS AND
WHAT IT IS USED FOR
Carvedi-Denk 25 belongs to the beta blocker
group of medicinal products (medicines for
treating blood pressure or increased heart
rate).
Carvedi-Denk 25 is used for heart/circula-
tory diseases.
Carvedi-Denk 25 is used for
– essential high blood pressure (not organi-
cally caused),
– chronic stable angina pectoris (if the symp-
toms have been the same for months),
– all degrees of stable chronic heart failure
(cardiac insufficiency), of ischaemic or non-
ischaemic origin (dependent or not on cir-
culation disorders). Use is accompanied by
treatment with diuretics and ACE inhibitors
and, if need be, digitalis (medicines acting
on the heart and vascular system).
2.
BEFORE YOU TAKE
CARVEDI-DENK 25
DO NOT TAKE CARVEDI-DENK 25
– if you are hypersensitive to the active
substance carvedilol or any of the other
ingredients of Carvedi-Denk 25.
– if you have severely impaired cardiac
function (cardiogenic shock).
– if you have progressively worsening heart
failure (decompensated cardiac insufficien-
cy).
– if you have an acute pulmonary embolism.
– if you have an unusual form of tightness of
the chest, known as Prinzmetal’s angina,
which is caused by

Αρχείο Π.Χ.Π.

Page 1
INFORMATION FOR HEALTHCARE PROFESSIONALS
1.
NAME OF THE MEDICINAL PRODUCT
Carvedi-Denk 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Carvedi-Denk 25 is a round, whitish, scored tablet.
2.2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: carvedilol
1 tablet contains 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

essential hypertension,

chronic stable angina pectoris,

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.
NB. (concerning use in chronic cardiac insufficiency):
Treatment with Carvedi-Denk 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 25.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ESSENTIAL HYPERTENSION
_ _
The treatment should be initiated with 12.5 mg carvedilol on the first
two days. Then the
treatment is continued with 25 mg carvedilol once daily. 25 mg
carvedilol per day is generally
sufficient.
Page 2
If the effect is inadequate the dose can be increased once 14 days
have elapsed to 2 x 25 mg
carvedilol, divided over the day.
A single dose of 25 mg or a daily amount of 50 mg carvedilol should
not be exceeded.
CHRONIC STABLE ANGINA PECTORIS
The treatment should be initiated with 2 x 12.5 mg carvedilol on the
first two days. Then the
treatment should be continued with 2 x 25 mg carvedilol daily. 2 x 25
mg carvedilol divided
over the day is generally sufficient.
_ _
If the effect is inadequate the dose can be increased once
14 days have elapsed to 2 x 50 mg carvedilol, divided over the day.
_ _
CHRONIC CARDIAC INSUFFICIENCY
The initial dose is 3.125 mg carvedilol