Duride

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Hent Indlægsseddel (PIL)
12-06-2024
Hent Produktets egenskaber (SPC)
12-06-2024

Aktiv bestanddel:

Isosorbide mononitrate

Tilgængelig fra:

Alphapharm Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

                                DURIDE
 
_contains the active ingredient isosorbide mononitrate_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Duride.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Duride against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT DURIDE IS USED
FOR
Duride is used to prevent angina.
Angina is a pain or uncomfortable
feeling in the chest, often spreading
to the arms or neck and sometimes to
the shoulders and back. This may be
caused by too little blood and oxygen
getting to the heart. The pain of
angina is usually brought on by
exercise or stress.
Duride belongs to a group of
medicines called nitrates. These
medicines work by relaxing blood
vessels, letting more blood and
oxygen reach the heart.
Your doctor may have prescribed
Duride for another reason. Ask your
doctor if you have any questions
about why Duride has been
prescribed for you.
Duride is not recommended for use
in children, as there is not enough
information available on its effects in
children.
Duride is available only with a
doctor's prescription.
There is no evidence that Duride is
addictive.
BEFORE YOU TAKE
DURIDE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DURIDE IF YOU ARE
TAKING MEDICINES USED TO TREAT
IMPOTENCE, NAMELY; SILDENAFIL
(VIAGRA), TADALAFIL (CIALIS) AND
VARDENAFIL (LEVITRA).
DO NOT TAKE DURIDE IF YOU ARE
ALLERGIC TO NITRATES, NITRITES OR THE
FOODS THAT CONTAIN THEM.
DO NOT TAKE DURIDE IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
ISOSORBIDE MONONITRATE OR ANY
OTHER NITRATE MEDICINE, OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips or
                                
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Produktets egenskaber

                                DURIDE
 
_Isosorbide mononitrate_ 
 
PRODUCT INFORMATION 
 
 
NAME OF THE MEDICINE 
 
The active ingredient in Duride is isosorbide mononitrate (sustained
release).   
 
The chemical name of isosorbide mononitrate is 1,4:3,6-dianhydro-
D
-glucitol 5-nitrate.  Its structural formula is: 
 
 
O
O
H
H
ONO
2
H
OH
H
 
C
6
H
9
NO
6 
 
 
Molecular weight: 191.14 
 
CAS Registry No: 16051-77-7 
 
 
DESCRIPTION
 
 
Isosorbide mononitrate is a white
crystalline powder and is freely soluble in water.  Duride
sustained release 
tablets contain the active drug embedded in a porous inert matrix
consisting of hard paraffin, synthetic paraffin, 
heavy kaolin, magnesium stearate, colloidal anhydrous silica and
microcrystalline cellulose. The tablets also 
contain Opadry Yellow OY-LS-22814. 
 
 
PHARMACOLOGY
 
 
Isosorbide mononitrate is an active metabolite of isosorbide
dinitrate.  It has qualitatively similar effects. 
Isosorbide mononitrate reduces the workload of the
heart by producing venous and arterial dilatation. It lowers 
intramural pressure by reducing the end diastolic
pressure and volume.  This leads to an improvement in the 
subendocardial blood flow.   When isosorbide mononitrate
is administered, the net effect is therefore a reduced 
workload for the heart and an improvement in the oxygen supply/demand
balance of the myocardium. 
 
Nitrates are highly effective in the prophylaxis of symptomatic and
asymptomatic myocardial ischaemia. Nitrates 
dilate coronary arteries in pre- and poststenotic vessels and also
in eccentric lesions.  Vascular relaxation is 
thought to be initiated naturally by endothelium derived relaxing
factor (EDRF).  EDRF has both the clinical and 
biological characteristics of nitric oxide.  In muscle cells,
organic nitrates are metabolised to nitric oxide via a 
sulfhydryl dependent mechanism.  Organic nitrates are therefore
thought to act as a physiological substitute for 
EDRF. 
 
 
PHARMACOKINET
                                
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