Auro-Carvedilol 3.125

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Carvedilol 3.125mg

Available from:

Aurobindo Pharma NZ Limited

INN (International Name):

Carvedilol 3.125 mg

Dosage:

3.125 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Carvedilol 3.125mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Polysorbate 80 Povidone Purified water   Sucrose Titanium dioxide

Units in package:

Blister pack, PVC/PE/PVdC/Al, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aurobindo Pharma Limited

Therapeutic indications:

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).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVdC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE with CR/RS closure sealed with induction wad - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE with CR/RS closure sealed with induction wad - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE with CR/RS closure sealed with induction wad - 1000 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2010-10-18

Patient Information leaflet

AURO-CARVEDILOL
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 5
AURO-CARVEDILOL 3.125, 6.25, 12.5 & 25
Carvedilol
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
AURO-
CARVEDILOL.
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 AURO-CARVEDILOL
against the benefits expected 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
AURO-CARVEDILOL
USED FOR
AURO-CARVEDILOL contains the
active ingredient carvedilol.
AURO-CARVEDILOL is used to
treat:
 high blood pressure
 angina (a type of severe chest pain)
 heart failure
 heart failure following a recent
heart attack
AURO-CARVEDILOL may be used
in combination with other “heart”
medicines. AURO-CARVEDILOL is
a long-term treatment.
AURO-CARVEDILOL belongs to a
group of medicines called beta
blockers. These medicines work by
relaxing tightened blood vessels and
slowing the rate of heart rate. AURO-
CARVEDILOL is different from
conventional beta blockers as it has
additional effects of being an alpha
blocker (which also relaxes and
widens your blood vessels) and an
antioxidant.
Heart failure occurs when the heart
can no longer pump blood strongly
enough for the body's needs. Often the
heart gets bigger to try to improve the
blood flow but this can make the heart
failure worse.
Symptoms of heart failure include
shortness of breath and swelling of
the feet and/or legs due to fluid build-
up.
AURO-CARVEDILOL, when used
with other “heart” medicines, reduces
the pressure that the heart has to pump
against as well as cont

Summary of Product characteristics

Data Sheet:
AURO-CARVEDILOL (carvedilol 3.125, 6.25, 12.5 & 25 mg tablets)
Ver 1.1
Page 1 of 16
DATA SHEET
AURO-CARVEDILOL 3.125
AURO-CARVEDILOL 6.25
AURO-CARVEDILOL 12.5
AURO-CARVEDILOL 25
_THIS PRODUCT MAY NOT BE INTERCHANGEABLE WITH SIMILAR PRODUCTS ON THE NEW ZEALAND MARKET._
PRESENTATION
AURO-CARVEDILOL 3.125 CARVEDILOL 3.125MG TABLETS
White to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the
other side.
AURO-CARVEDILOL 6.25 CARVEDILOL 6.25MG TABLETS
White to off-white, oval shaped, film-coated tablets debossed with ‘F 57’ on one side and deep
break line on the other side.
AURO-CARVEDILOL 12.5 CARVEDILOL 12.5MG TABLETS
White to off-white, oval shaped, film-coated tablets debossed with ‘F 58’ on one side and deep
break line on the other side.
AURO-CARVEDILOL 25 CARVEDILOL 25MG TABLETS
White to off-white, oval shaped, film-coated tablets debossed with ‘F 59’ on one side and deep
break line on the other side.
EXCIPIENTS
Each tablet contains the following excipients: lactose, silica, colloidal anhydrous, crospovidone
(Type A), povidone, Sucrose, crospovidone (Type B), magnesium stearate, macrogol, polysorbate
80, titanium dioxide & hypromellose.
INDICATIONS
HYPERTENSION
Carvedilol 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
Carvedilol is efficacious in the treatment of chronic stable angina and unstable angina.
CHRONIC HEART FAILURE (CHF)
Unless a contraindication exists, Carvedilol is indicated for the treatment of all patients with stable
and symptomatic mild, moderate and severe chronic heart failure of ischaemic or non-ischaemic
aetiologyin combination with standard therapy