Dicarz

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Carvedilol 12.5mg

Доступно од:

Viatris Limited

INN (Међународно име):

Carvedilol 12.5 mg

Дозирање:

12.5 mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Carvedilol 12.5mg Excipient: Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-22-18096 Povidone

Јединице у пакету:

Blister pack, PVC/aluminium blister strip - 90 tablets, 90 tablets

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Moehs Catalana SL

Терапеутске индикације:

Hypertension Dicarz is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents (e.g. calcium channel blockers, diuretics).

Резиме производа:

Package - Contents - Shelf Life: Blister pack, PVC/aluminium blister strip - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/aluminium blister strip - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle, PP cap with permaseal liner - 90 tablets - 12 months from date of manufacture stored at or below 25°C

Датум одобрења:

2004-04-29

Информативни летак

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DICARZ
_CARVEDILOL FILM-COATED TABLETS _
_6.25 MG, 12.5 MG & 25 MG _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dicarz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Dicarz
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT DICARZ IS USED
FOR
Dicarz is used to treat:
•
high blood pressure.
•
angina (a type of severe
chest pain).
•
heart failure.
•
heart failure following a
recent heart attack.
It may be used in combination with
other heart medications.
Dicarz contains the active ingredient
carvedilol_._ It belongs to a group of
medicines called beta blockers.
These medicines work by relaxing
tightened blood vessels and slowing
the rate of your heart beat.
Dicarz is different from conventional
beta blockers as it has additional
effects of being an alpha blocker
and an antioxidant.
This means your heart does not
have to pump as hard to move the
blood around the body. When you
place extra demands on your heart,
such as during exercise, the heart
may cope better so you may not get
short of breath as easily.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this medicine
for people under the age of 18
years.
BEFORE YOU TAKE
DICARZ
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE DICARZ IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
carvedilol.
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing

Карактеристике производа

Page 1 of 15
NEW ZEALAND DATA SHEET
DICARZ
_CARVEDILOL FILM-COATED TABLETS _
_3.125 MG, 6.25 MG, 12.5 MG AND 25 MG _
_ _
PRESENTATION
DICARZ 3.125 mg: White, oval shaped, film-coated tablet, plain on both
sides.
DICARZ 6.25 mg: White, oval shaped, film-coated tablet with a
breakline on both sides, imprinted
“6.25” on one side.
DICARZ 12.5 mg: White, oval shaped, film-coated tablet, with a
breakline on both sides, imprinted
“12.5” on one side.
DICARZ 25 mg: White, oval shaped, film-coated tablet, with a breakline
on both sides, imprinted
“25” on one side.
INDICATIONS
HYPERTENSION
DICARZ is indicated for the management of essential hypertension. It
can be used alone or in
combination with other antihypertensive agents (e.g. calcium channel
blockers, diuretics).
TREATMENT OF ANGINA PECTORIS
DICARZ is efficacious in the treatment of chronic stable angina and
unstable angina.
CHRONIC HEART FAILURE (CHF)
Unless a contraindication exists, DICARZ is indicated for the
treatment of all patients with stable and
symptomatic mild, moderate and severe chronic heart failure of
ischaemic or non-ischaemic
aetiology in combination with standard therapy (including ACE
inhibitors and diuretics with or without
digitalis).
LEFT VENTRICULAR DYSFUNCTION FOLLOWING ACUTE MYOCARDIAL INFARCTION
Long term treatment following myocardial infarction complicated by
left ventricular dysfunction (LVEF
≤
40% or wall motion index
≤
1.3), including well controlled heart failure, in combination with ACE
inhibitors and other treatments recommended in the management of
patients after myocardial
infarction.
DOSAGE AND ADMINISTRATION
_METHOD OF ADMINISTRATION _
The tablets are to be swallowed with sufficient fluid. It is not
necessary to take the dose in relation to
meals, however, for chronic heart failure patients, DICARZ should be
taken with food to slow the
rate of absorption and reduce the incidence of orthostatic effects.
Page 2 of 15
_DURATION OF TREATMENT _
Treatment with DICARZ is a long-term therapy. As with all
β
-blockers, tre