Dilatrend tablets

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

carvedilol

Disponibbli minn:

Cheplapharm Arzneimittel GmbH

Kodiċi ATC:

C07AG02

INN (Isem Internazzjonali):

carvedilol

Dożaġġ:

6,25mg

Għamla farmaċewtika:

tablets

Unitajiet fil-pakkett:

(30/3x10/) in blister

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2023-03-04

Fuljett ta 'informazzjoni

1
DILATREND
®
Carvedilol
ALPHA (Α) AND BETA (Β) ADRENERGIC RECEPTOR BLOCKING AGENTS
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Alpha (α) and beta (β) adrenergic receptor blocking agents.
ATC CODE: C07AG02.
1.2
TYPE OF DOSAGE FORM
Tablets.
The tablet(s) can be divided into equal doses.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: carvedilol.
_Tablets _
One 6.25 mg tablet contains 6.25 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate, yellow iron oxide [E 172].
One 12.5 mg tablet contains 12.5 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate, yellow iron oxide [E 172], red iron oxide [E 172].
One 25 mg tablet contains 25 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate.
Excipient(s) with known effect: Each tablet contains lactose
monohydrate and sucrose.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_Hypertension _
Carvedilol is indicated for the management of essential hypertension.
It can be used alone
or in combination with other anti-hypertensive agents (e.g. calcium
channel blockers,
2
diuretics).
_Coronary heart disease _
Carvedilol has demonstrated clinical efficacy in coronary heart
disease.
_Chronic heart failure _
Unless a contraindication exists, carvedilol is indicated for the
treatment of all patients
with stable and symptomatic, mild, moderate and severe chronic heart
failure (CHF) of
ischemic or non-ischemic aetiology in combination with standard
therapy (including
ACE inhibitors and diuretics with or without digitalis).
2.2
DOSAGE AND ADMINISTRATION
_Method of administration _
The tablets are to be swallowed with sufficient fluid.
_Duration of treatment _
Treatment with carvedi

Karatteristiċi tal-prodott

1
DILATREND
®
Carvedilol
ALPHA (Α) AND BETA (Β) ADRENERGIC RECEPTOR BLOCKING AGENTS
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Alpha (α) and beta (β) adrenergic receptor blocking agents.
ATC CODE: C07AG02.
1.2
TYPE OF DOSAGE FORM
Tablets.
The tablet(s) can be divided into equal doses.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: carvedilol.
_Tablets _
One 6.25 mg tablet contains 6.25 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate, yellow iron oxide [E 172].
One 12.5 mg tablet contains 12.5 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate, yellow iron oxide [E 172], red iron oxide [E 172].
One 25 mg tablet contains 25 mg carvedilol. List of excipients:
Lactose monohydrate,
Sucrose, Povidone K25, Crospovidone type A, colloidal anhydrous
silica, Magnesium
stearate.
Excipient(s) with known effect: Each tablet contains lactose
monohydrate and sucrose.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_Hypertension _
Carvedilol is indicated for the management of essential hypertension.
It can be used alone
or in combination with other anti-hypertensive agents (e.g. calcium
channel blockers,
2
diuretics).
_Coronary heart disease _
Carvedilol has demonstrated clinical efficacy in coronary heart
disease.
_Chronic heart failure _
Unless a contraindication exists, carvedilol is indicated for the
treatment of all patients
with stable and symptomatic, mild, moderate and severe chronic heart
failure (CHF) of
ischemic or non-ischemic aetiology in combination with standard
therapy (including
ACE inhibitors and diuretics with or without digitalis).
2.2
DOSAGE AND ADMINISTRATION
_Method of administration _
The tablets are to be swallowed with sufficient fluid.
_Duration of treatment _
Treatment with carvedi