Carvedilol Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Carvedilol 12.5mg;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Carvedilol 12.5 mg

Dosage:

12.5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Carvedilol 12.5mg   Excipient: Colloidal silicon dioxide Crospovidone Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone

Prescription type:

Prescription

Manufactured by:

Zhejiang Huahai Pharmaceutical Co Ltd

Therapeutic indications:

Carvedilol Sandoz 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).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2013-12-13

Patient Information leaflet

Carvedilol Sandoz

1
CONSUMER MEDICINE INFORMATION
CARVEDILOL SANDOZ

CARVEDILOL 6.25MG, 12.5MG AND 25MG TABLETS, UNCOATED_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Carvedilol Sandoz.
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 this
medicine 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 CARVEDILOL SANDOZ IS USED FOR
Carvedilol Sandoz is used to treat:
•
high blood pressure
•
angina (a type of severe chest pain)
•
heart failure
•
heart failure following a recent heart attack
Carvedilol Sandoz may be used in combination with other “heart”
medicines. Carvedilol Sandoz
is a long-term treatment.
Carvedilol Sandoz belongs to a group of medicines called beta
blockers. These medicines work
by relaxing tightened blood vessels and slowing the rate of heart
beat. Carvedilol Sandoz 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.
Carvedilol Sandoz, when used with other “heart” medicines, reduces
the pressure that the heart
has to pump against as well as controlling the heart rate. Over time
this will reduce the size of
an oversized heart and increase its efficiency.
Carvedilol Sandoz helps to stop heart failure getting worse and
reduces the chances of you
being admitted to hospital and/or dying from this diseas

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 17
1 PRODUCT NAME
CARVEDILOL SANDOZ, tablets, uncoated, 6.25 mg, 12.5 mg and 25 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains carvedilol 6.25 mg, 12.5 mg or 25 mg.
Excipients with known effect: Lactose
For the full list of excipients, See section 6.1
3 PHARMACEUTICAL FORM
Carvedilol Sandoz 6.25 mg: yellow, round, convex, scored uncoated
tablet, coded 'C2' on one
side.
Carvedilol Sandoz 12.5 mg: red/brown, round, convex, scored uncoated
tablet, coded 'C3' on
one side.
Carvedilol Sandoz 25 mg: white to almost white, round, convex, scored
uncoated tablet, coded
'C4' on one side.
Tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION:
Carvedilol Sandoz 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 Sandoz is efficacious in the treatment of chronic stable
angina and unstable angina.
CHRONIC HEART FAILURE (CHF):
Unless a contraindication exists, Carvedilol Sandoz 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.
NEW ZEALAND DATA SHEET
Page 2 of 17
4.2
DOSE AND METHOD OF 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,
Carve