Carvedi-Denk 6,25 tablets

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Unduh Selebaran informasi (PIL)
06-02-2023
Unduh Karakteristik produk (SPC)
30-10-2018

Bahan aktif:

carvedilol

Tersedia dari:

Artesan Pharma GmbH & Co. KG

Kode ATC:

C07AG02

INN (Nama Internasional):

carvedilol

Dosis:

6,25mg

Bentuk farmasi:

tablets

Unit dalam paket:

(30/3x10/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2018-08-08

Selebaran informasi

                                _Carvedi-Denk 6.25_
Tablet – oral use
Beta blocker
Active substance: carvedilol
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAK-
ING 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 doc-
tor or 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. See section 4.
What is in this leaflet
1. WHAT CARVEDI-DENK 6.25 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW 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. CONTENTS OF THE PACK AND OTHER 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 medic-
inal products (medicines for treating high blood pressure or in-
creased heart rate).
Carvedi-Denk 6.25 is used for heart/circulatory diseases.
Carvedi-Denk 6.25 is used for
• all degrees of stable chronic heart failure (cardiac insufficien
-
cy), of ischaemic or nonischaemic origin (dependent or not on
circulation disorders). Use is accompanied by treatment with di-
uretics and ACE inhibitors and, if need be, digitalis (medicines
acting on the heart and vascular system)
Patients with heart failure should have been clinically stable on
standard heart failure therapy (e.g. diuretics, digitalis, ACE in-
hibitors) for approximately 4 weeks before starting treatment
with Carvedi-Denk 6.25.
2.
What you need to know before you take
Carvedi-Denk 6.25
Do not take Carvedi-Denk, if you
• are allergic to carvedilol or any of the other ingredients of this
medicine (listed in section 6)
• have severely impaired cardiac function (cardiogenic shock)
•
have progressivel
                                
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Karakteristik produk

                                1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carvedi-Denk 6.25
Carvedi-Denk 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: carvedilol
_Carvedi-Denk 6.25: _
Each tablet contains 6.25 mg carvedilol.
_Carvedi-Denk 25: _
Each tablet contains 25 mg carvedilol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Round, whitish, half-scored tablets.
_ _
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is a non-selective beta and alpha1 receptor
antagonist.
Carvedi-Denk is used in adults.
_Carvedi-Denk 6.25: _
-
Chronic heart failure:
In the absence of contraindications, Carvedi-Denk 6.25 mg is indicated
in all patients with
stable, symptomatic, chronic heart failure of ischaemic or
non-ischaemic origin of any intensity,
combined with standard therapy (such as ACE inhibitors and diuretics
with or without digitalis).
_Carvedi-Denk 25: _
-
Essential hypertension
-
Chronic stable angina pectoris
-
Chronic heart failure:
In the absence of contraindications, Carvedi-Denk 25 mg is indicated
in all patients with stable,
symptomatic, chronic heart failure of ischaemic or non-ischaemic
origin of any intensity,
combined with standard therapy (such as ACE inhibitors and diuretics
with or without digitalis).
2
_Note (on use in chronic heart failure): _
Treatment with carvedilol may be commenced only if the patient's
condition has been stabilised on
conventional, basic heart failure therapy, i.e. the dosage of this
existing, standard therapy must have
remained stable for at least four weeks prior to starting treatment
with carvedilol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Essential hypertension _
Treatment should begin with 12.5 mg carvedilol once daily on the first
two days. Treatment can then
be continued with 25 mg carvedilol once daily. As a rule, 25 mg
carvedilol once daily is sufficient.
If the effect is inadequate, the dose can be slowly increased at
intervals of no less t
                                
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