RAMIPRIL CH ramipril 2.5mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ramipril, Quantity: 2.5 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: pregelatinised maize starch; meglumine; titanium dioxide; quinoline yellow; sorbitan monolaurate; allura red AC; potable water; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

Blister Strip Pack of 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Data are currently not available to support the use of RAMIPRIL CH capsules 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 revascularisation 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: Size '4' capsule with orange cap, imprinted with 'RAMI' in black ink and orange body imprinted with '2.5' in black ink, containing white to off-white powder.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-06-30

Patient Information leaflet

_Ramipril CH – Consumer Medicine Information _
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_Page 1 _
RAMIPRIL CH CAPSULES
_Ramipril _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ramipril CH.
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
Ramipril CH against the benefits
it is expected to 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 RAMIPRIL CH IS
USED FOR
Ramipril CH belongs to a group
of medicines called angiotensin
converting enzyme (ACE)
inhibitors.
Ramipril CH is used to treat:
• high blood pressure
(hypertension)
• some heart conditions such as
heart failure after a heart attack
• kidney problems in some
patients
Ramipril CH 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
Ramipril CH 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
Ramipril CH 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
oxyg

Summary of Product characteristics

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_Ramipril CH capsules Product Information _
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_Amneal Pharma Australia Pty Ltd _
Doc ID: 93.CH.P.3.0
Page 1 of 24
RAMIPRIL CH
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_(RAMIPRIL CAPSULES) _
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PRODUCT INFORMATION
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NAME OF THE MEDICINE
The name of the medicine is Ramipril
CHEMICAL NAME:
(2
_S_
,3a
_S_
,6a
_S_
)-1-[(
_S_
)-2-[[(
_S_
)-l-(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
soluble
in
polar
organic
solvents
and
buffered
aqueous
solutions. Ramipril
melts
between 105
o
C and 112
o
C. Ramipril has five chiral centres. It has S-configuration in all
five
asymmetric carbon atoms.
Ramipril-CH capsules contain meglumine, pregelatinised starch. The
capsules are Capsugel
Part No G41CSRR0331-ARTG 12044 (1.25 mg only); Capsugel Part No.
G41CSRR0332-
ARTG 12047 (2.5 mg only); Capsugel Part No. G41CSRR0333-ARTG 12048 (5
mg only)
and Capsugel Part No. G41OSRR0334-ARTG 12045 (10 mg only).
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
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_Ramipril CH capsules Product Information _
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_Amneal Pharma Australia Pty Ltd _
Doc ID: 93.CH.P.3.0
Page 2 of 24
(ACE) which is identical to KININASE II. This converting enzyme (ACE)
is a peptidyl dipeptidase
that catalyses the conversion of angiotensin I to the vasoconstrictor
substance, angiotensin II.
Angiotensin II also stimulates aldosterone secretion by the adrenal
cortex, thus inhibition of ACE
results in decreased plasma angiotensin II, which leads to decreased
vasopressor activity and to
decreased aldosterone secretion. The latter decrease may result in a
small increase in serum potassium.
KININASE II is one of the enzymes responsible for