Dilatrend tablets
Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
Patient Information leaflet
(PIL)
04-03-2023
Summary of Product characteristics
(SPC)
04-03-2023
Active ingredient:
carvedilol
Available from:
Cheplapharm Arzneimittel GmbH
ATC code:
C07AG02
INN (International Name):
carvedilol
Dosage:
12,5mg
Pharmaceutical form:
tablets
Units in package:
(30/3x10/) in blister
Prescription type:
Prescription
Authorization status:
Registered
Authorization date:
2023-03-04
Patient Information leaflet
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
Read the complete document
Summary of Product characteristics
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
Read the complete document
