VASCALACE 1.25 ramipril 1.25mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

29-11-2017

Active ingredient:

ramipril, Quantity: 1.25 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: croscarmellose sodium; sodium bicarbonate; pregelatinised maize starch; sodium stearylfumarate; lactose monohydrate

Administration route:

Oral

Units in package:

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? Treatment of hypertension. Data are currently not available to support the use of Ramipril in renovascular hypertension. ,? Post MI heart failure ,? Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. ,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. ,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularization procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160mmHg or diastolic blood pressure >90mmHg (or on antihypertensive treatment); total cholesterol >5.2mmol/L; HDL cholesterol <0.9mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Product summary:

Visual Identification: White to off-white coloured, flat faced bevel edged round uncoated tablet debossed with 'H' &'17' on one side and plain on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2011-10-06

Patient Information leaflet

VASCALACE
CONSUMER MEDICINE INFORMATION
Ver 1.0
Page 1 of 6
VASCALACE
Ramipril
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VASCALACE.
It does not contain all the available
information about this medicine.
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
VASCALACE 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 VASCALACE IS USED
FOR
VASCALACE belongs to a group of
medicines
called
angiotensin
converting enzyme (ACE) inhibitors.
VASCALACE is used to treat:
•
high blood pressure (hypertension)
•
some
heart
conditions
such
as
heart failure after a heart attack
•
kidney problems in some patients
VASCALACE is also used to reduce
the risk of cardiovascular problems
and complications in patients aged
55 years or more with heart or blood
vessel disease, or diabetes.
HYPERTENSION
VASCALACE is used to lower high
blood
pressure
(hypertension).
Everyone has blood pressure. This
pressure
helps
get
your
blood
all
around
your
body.
Your
blood
pressure may be different at different
times
of
the
day
and
can
be
influenced by how busy or worried
you
are.
You
have
hypertension
when
your
blood
pressure
stays
higher than is needed, even when
you are calm and relaxed.
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,
including stroke, heart disease and
kidney failure.
HEART FAILURE AFTER A HEART ATTACK
VASCALACE may be used after a
heart attack. A heart attack occurs
when one of the major blood vessels
supplying
blood
to
your
heart
becomes blocked. This means that
your heart muscle cannot receive the
oxygen
it
needs
and
become

Read the complete document

Summary of Product characteristics

Product Information:
VASCALACE
Ver 1.0
Page 1 of 24
PRODUCT INFORMATION
VASCALACE
NAME OF THE MEDICINE
The name of the medicine is ramipril.
CHEMICAL NAME:
(2
_S_
,3a
_S_
,6a
_S_
)-1-[(2
_S_
)-2-[[(1
_S_
)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]
propanoyl]octahydrocyclopenta[
_b_
]pyrrole-2-carboxylic acid
MOLECULAR FORMULA:
C
23
H
32
N
2
O
5
MOLECULAR WEIGHT:
416.5
CAS REGISTRY NUMBER:
[87333-19-5]
DESCRIPTION
Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid
derivative. It is a white, crystalline
substance sparingly soluble in water and soluble in polar organic
solvents and buffered aqueous
solutions. Ramipril melts between 105°C and 112°C. Ramipril has 5
chiral centres. It has S-
configuration in all 5 asymmetric carbon atoms. Ramipril pKa values
are 2.98 & 4.56.
VASCALACE is available as tablets containing 1.25 mg, 2.5 mg, 5 mg &
10 mg of ramipril.
VASCALACE
tablets
contains
following
inactive
ingredients:
pregelatinised
maize
starch,
lactose, sodium bicarbonate, croscarmellose sodium and sodium stearyl
fumarate. The 2.5 mg
tablet also contains iron oxide yellow CI77492. The 5mg tablet also
contains iron oxide red
CI77491.
VASCALACE CAPS is available as capsules containing 1.25, 2.5, 5 & 10
mg ramipril.
VASCALACE CAPS contain the following inactive ingredients: Colloidal
anhydrous silica,
pregelatinised maize starch. The capsules are made of gelatin, sodium
lauryl sulphate and are
coloured with titanium dioxide, iron oxide yellow (1.25 mg & 2.5 mg
capsules), brilliant scarlet
4R (2.5 mg, 5 mg & 10 mg capsules) and patent blue V (5 mg & 10 mg
capsules).
Product Information:
VASCALACE
Ver 1.0
Page 2 of 24
PHARMACOLOGY
MECHANISM OF ACTION
Ramipril is a prodrug which, after absorption from the
gastrointestinal tract, is hydrolysed in the
liver to form the active moiety, ramiprilat. Ramipril and ramiprilat
inhibit angiotensin-converting
enzyme (ACE) which is identical to KININASE II. This converting enzyme
(ACE) is a peptidyl
dipeptidase that catalyses the conversion of angiotensin I to the
vasoconst

Read the complete document