Carvedilol tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

carvedilol

Disponibil de la:

Arpimed LLC

Codul ATC:

C07AG02

INN (nume internaţional):

carvedilol

Dozare:

25mg

Forma farmaceutică:

tablets

Unități în pachet:

(40/1x40/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2017-12-26

Caracteristicilor produsului

SUMMARY PRODUCT CHARACTERISTIC (SPC)
CARVEDILOL
TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
1.1
TRADE NAME – Carvedilol
1.2
INTERNATIONAL NON-PROPERTY NAME – Carvedilol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE INGREDIENT:_ Carvedilol
Each 6.25 mg tablet contains 6.25 mg carvedilol.
Each 12.5 mg tablet contains 12.5 mg carvedilol.
Each 25 mg tablet contains 25 mg carvedilol.
_For a full list of excipients, see section 6.1._
_ _
3.
PHARMACEUTICAL FORM
6.25 mg tablet: light greenish flat scored tablets, odorless
12.5 mg tablet: white flat scored tablets, odorless
25 mg tablet: light pink flat scored tablets, odorless
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_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, diuretics).
_ANGINA PECTORIS _
Carvedilol is indicated in the management of chronic stable angina.
_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 etiology in combination with standard therapy
(including ACE
inhibitors and diuretics with or without digitalis).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration _
The tablets should be taken with the adequate supply of fluid. It is
recommended that heart
failure patients take their carvedilol medication with food to allow
the absorption to be slower
and the risk of orthostatic hypotension to be reduced.
_Duration of treatment _
Treatment with carvedilol is a long-term therapy. As with all
β-blockers, treatment should not
be stopped abruptly but rather gradually reduced at weekly intervals.
This is particularly
important in the case of patients with concomitant coronary heart
disease.
_CHRONIC HEART FAILURE _
For CHF patients Carvedilol should be given with food. Symptomatic
chronic heart failure.
Initiation o