Gopten

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Trandolapril 0.5mg

Dostupné z:

Viatris Limited

INN (Medzinárodný Name):

Trandolapril 0.5 mg

Dávkovanie:

0.5 mg

Forma lieku:

Capsule

Zloženie:

Active: Trandolapril 0.5mg Excipient: Erythrosine Gelatin Iron oxide yellow Lactose monohydrate Maize starch Povidone Sodium laurilsulfate Sodium stearyl fumarate Titanium dioxide

Počet v balení:

Blister pack, PVC/PVDC/Al sample pack, 7 capsules

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

AbbVie Ireland NL B.V.

Terapeutické indikácie:

All grades of essential hypertension. Trandolapril may be used alone or in combination with other antihypertensive agents.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al sample pack - 7 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al sample pack - 15 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al - 28 capsules - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 28 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 30 capsules - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

1991-08-27

Príbalový leták

Gopten (trandolapril) Capsules  
Version 07 

30 November 2009 
1 of 4 

GOPTEN 

trandolapril 

CONSUMER MEDICINE INFORMATION  

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about Gopten. 

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 Gopten 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 GOPTEN IS USED FOR 

Gopten is used to treat high blood 
pressure (hypertension) and also to 
treat some heart  conditions. 

There are usually no symptoms of 
hypertension.  The only way of 
knowing that you  have hypertension 
is to have your blood pressure 
checked on a regular basis.  If high 
blood pressure is not treated it can 
lead to serious health problems.  You 
may feel fine and have no symptoms, 
but eventually hypertension can lead 
to serious health problems, including 
stroke, heart disease and kidney 
failure.  Gopten helps to lower your 
blood pressure. 

Gopten belongs to a group of 
medicines called Angiotensin 
Converting Enzyme (ACE) inhibitors.  
It works by relaxing your blood 
vessels, making it easier for blood to 
move around your body.  This helps 
lower blood pressure and increase the 
supply of blood and oxygen to the 
heart. 
Your doctor may prescribe Gopten for 
another reason.  Ask your doctor if 
you have any questions about why 
Gopten has been prescribed for you. 

Gopten is only available with a 
doctor’s prescription. 

Gopten is not addictive. 

Gopten is not recommended for use in 
children as there have be

Súhrn charakteristických

DATA SHEET 
GOPTEN
®

NAME OF THE MEDICINE 
Gopten (trandolapril) capsules 0.5 mg, 1 mg, 2 mg 
CHEMICAL STRUCTURE 
The chemical name is [2S-(1(R*(R*));2a, 3aa,
7ab)]-1-[2-[(1-(ethoxy-carbonyl)-3-phenylpropyl) 
amino]-1-oxopropyl] octahydro-1H-indole-2-carboxylic acid. 

It has a molecular weight of 430.54 and the molecular formula is C
24
 H
34
 N
2
 O
5
. 
CAS NUMBER 
87679-37-6 
DESCRIPTION 
Trandolapril capsules 0.5* mg: Size 4 gelatin capsules with a red
opaque body and a yellow 
opaque cap, filled with a practically white granulate. 
Trandolapril capsules 1.0 mg: Size 4 gelatin capsules with a red
opaque body and an orange 
opaque cap, filled with a practically white granulate. 
Trandolapril capsules 2.0 mg: Size 4 red opaque gelatin capsules,
filled with a practically white 
granulate. 
PHARMACOLOGY 
PHARMACODYNAMICS 
Gopten capsules contain the pro-drug trandolapril, which after oral
administration is converted to 
the active angiotensin converting enzyme inhibitor trandolaprilat.
 Trandolapril contains a carboxyl 
group but is without a sulphydryl group.  Trandolaprilat is a highly
specific ACE inhibitor with a long 
duration of action. 
Gopten has a sustained effect on blood pressure.  Comparing the fall
in blood pressure at the 
steady state trough level of trandolaprilat (ie at 24 hours,
immediately before the next dose) with 
that at the steady state peak level, the trough/peak
ratio is almost 100% for a 24-hour period and 
approximately 70-80% for a 48-hour period after a dose.  Thus,
at steady state, the 
antihypertensive effect of Gopten is maintained for up to 48
hours after a dose.   Gopten is 
however, administered as a single daily dose to achieve and maintain
effective steady state levels. 
In patients with left ventricular dysfunction after myocardial
infarction, a multicentre, placebo-
controlled clinical trial has been performed.  1,749 patients with
left ventricular dysfunction were 
randomised to receive placebo o