Dilatrend

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Carvedilol 6.25mg

Tilgjengelig fra:

Pharmaco (NZ) Ltd

INN (International Name):

Carvedilol 6.25 mg

Dosering :

6.25 mg

Legemiddelform:

Tablet

Sammensetning:

Active: Carvedilol 6.25mg Excipient: Colloidal silicon dioxide Crospovidone Iron oxide yellow Lactose monohydrate Magnesium stearate Povidone Sucrose

Enheter i pakken:

Blister pack, Alu-PVC or Alu-polyamide-PVC, 30 tablets

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Moehs Catalana SL

Indikasjoner:

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).

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, Alu-PVC or Alu-polyamide-PVC - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Alu-PVC or Alu-polyamide-PVC - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

1996-05-08

Informasjon til brukeren

Dilatrend

-October 2018
1
_ _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DILATREND
®
CARVEDILOL
6.25 MG, 12.5 MG AND 25 MG TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using DILATREND.
This leaflet answers some common questions about DILATREND tablets.
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 DILATREND
tablets 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 DILATREND IS USED FOR
DILATREND contains the active ingredient carvedilol.
DILATREND is used to treat:

high blood pressure

angina (a type of severe chest pain)

heart failure

heart failure following a recent heart attack
DILATREND may be used in combination with other “heart” medicines.
DILATREND is a long-term
treatment.
DILATREND belongs to a group of medicines called beta blockers. These
medicines work by relaxing
tightened blood vessels and slowing the rate of heart beat. DILATREND
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 heart failure worse.
Symptoms of heart failure include shortness of breath and swelling of
the feet and/or legs due to fluid
build-up.
Dilatrend

-October 2018
2
_ _
DILATREND, 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.
DILATREND helps to stop heart failure getting worse and reduces

Preparatomtale

NEW ZEALAND DATA SHEET
CARVEDILOL - CARVEDILOL001
October 2018
Page 1 of 18
DILATREND® TABLETS
Carvedilol
1 PRODUCT NAME
Dilatrend 6.25 mg tablets
Dilatrend 12.5 mg tablets
Dilatrend 25 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 6.25 mg, 12.5 mg or 25 mg carvedilol.
Excipient(s) with known effect: Lactose, sucrose.
For full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets for oral administration.
Dilatrend 6.25 mg tablet: yellow, round biconvex tablet, with a
bilateral scoreline engraved with 'BM'
on one side and 'F1' on the other side.
Dilatrend 12.5 mg tablet: light brown, round biconvex tablet, with a
bilateral scoreline engraved with
'BM' on one side and 'H3' on the other side.
Dilatrend 25 mg tablet: white to pale yellowish beige, round biconvex
tablet, with a bilateral
scoreline engraved with 'BM' on one side and 'D5' on the other side.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
Dilatrend 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
Dilatrend is efficacious in the treatment of chronic stable angina and
unstable angina.
CHRONIC HEART FAILURE (CHF)
Unless a contraindication exists, Dilatrend 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
NEW ZEALAND DATA SHEET
CARVEDILOL - CARVEDILOL001
October 2018
Page 2 of 18
ACE inhibitors and other treatments recommended in the management of
pati