Gopten

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Trandolapril

Διαθέσιμο από:

Abbott Australasia Pty Ltd

Kατηγορία:

Medicine Registered

Φύλλο οδηγιών χρήσης

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 been no
studies of its effects in children.
BEFORE YOU TAKE
GOPTEN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE GOPTEN IF YOU:
•
Are allergic (sensitive) to
trandolapril or any of the
ingredients in Gopten capsules
listed at the end of this leaflet
 Symptoms of an allergic reaction
may include skin rash, itchiness,
shortness of breath , swelling of
the face, li

Αρχείο Π.Χ.Π.

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PRODUCT INFORMATION 
GOPTEN
®

NAME OF THE MEDICINE 
Trandolapril 
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 C24 H34 N2 O5. 
CAS NUMBER 
87679-37-6 
DESCRIPTION 
Gopten is trandolapril, a
long acting, highly lipophilic, non-peptide, angiotensin
converting enzyme 
(ACE) inhibitor with a carboxyl group
but without a sulphydryl group.  Trandolapril  is a
colourless, 
crystalline substance that is soluble in
chloroform, dichloromethane and methanol.  It is slightly 
soluble in water and sparingly soluble in hydrochloric acid. 

Each Gopten capsule contains 0.5 mg, 1 mg, 2
mg or  4mg of trandolapril.  Each capsule also 
contains the following inactive
ingredients: lactose, starch-maize, povidone and sodium 
stearylfumarate in a gelatin capsule (which
contains gelatin, titanium dioxide, sodium lauryl sulfate, 
iron oxide yellow CI 77492 and erythrosine CI 45430.  The 4
mg capsule also contains iron oxide 
black CI 77499). 
PHARMACOLOGY 
MECHANISM OF ACTION 
Gopten is an orally active angiotensin converting enzyme
(ACE) inhibitor.  It is administered as a 
pro-drug (trandolapril) which is rapidly converted to
its biologically active metabolite trandolaprilat: 
a compound which binds tightly to, and dissociates slowly from, ACE.  There is evidence that 
trandolapril itself has a marked affinity for angiotensin converting enzyme, and may therefore have 
an antihypertensive effect. 
Angiotensin converting enzyme is a peptidyl-dipeptidase which
catalyses the transformation of 
angiotensin I to vasoconstrictive angiotensin II and the degradation of bradykinin to inactive 
fragments. 
By potent