PRILACE ramipril 2.5 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ramipril, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium stearylfumarate; sodium bicarbonate; calcium sulfate dihydrate; pregelatinised maize starch

Administration route:

Oral

Units in package:

30 tablets

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. Postmyocardial infarction heart failure. Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. 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. 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 above 160 mmHg or diastolic blood pressure above 90 mmHg (or on antihypertensive treatment); total cholesterol above 5.2mmol/L: HDL cholesterol less than 0.9mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Product summary:

Visual Identification: White to off-white, oval shaped tablet, with scoreline on one side and "RP2" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-03-06

Patient Information leaflet

PRILACE - Consumer Medicine Information
Page 1 of 5
PRILACE
ramipril
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRILACE.
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 PRILACE 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 PRILACE IS USED
FOR
PRILACE contains ramipril, which
belongs to a group of medicines
called angiotensin-converting
enzyme (ACE) inhibitors.
PRILACE is used to treat:
•
high blood pressure
(hypertension)
•
some heart conditions such as
heart failure after a heart attack
•
kidney problems in some
patients.
PRILACE 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
PRILACE is used to lower high blood
pressure (hypertension). Everyone
has blood pressure. This pressure
helps circulating your blood around
your body. Your blood pressure is
different at different times of the
day and can be affected by how
busy or worried you are. You
would 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 you have hypertension is
to have your blood pressure
checked on a regular basis. If
hypertension is not treated, it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
HEART FAILURE AFTER A HEART
ATTACK
PRILACE 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 becomes
damaged. Th

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – PRILACE (RAMIPRIL)
TABLETS AND CAPSULES
1
NAME OF THE MEDICINE
Ramipril.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prilace tablets come in four strengths and contain 1.25 mg, 2.5 mg, 5
mg and 10 mg* of ramipril.
Prilace capsules contain 10 mg of ramipril.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Prilace 1.25 mg tablets are white to off-white, oval-shaped tablet
marked “RP 1” on one side.
Prilace 2.5 mg tablets are white to off-white, oval-shaped tablet
marked “RP 2” on one side and
scoreline on other side.
Prilace 5 mg tablets are white to off-white, oval-shaped tablet marked
“RP 5” on one side and
scoreline on other side.
Prilace 10 mg tablets are white to off-white, oval-shaped tablet
marked “RP 10” on one side and
scoreline on other side.
Prilace 10 mg capsules are white and blue opaque capsule with “RP
10” printed in black.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension. Data are currently not available to support
the use of ramipril in
renovascular hypertension.
Post-myocardial infarction heart failure.
Prevention of progressive renal failure in patients with persistent
proteinuria in excess of 1 g/day.
2
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.
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 >160 mmHg or diastolic blood pressure > 90
mmHg (or on antihypertensive
treatment); total cholesterol >5.2 mmol/L or HDL cholesterol <0.9
mmol/L; current smoker; known
microalbuminuria; any evidence of previous vascular disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Prilace tablets and capsules should be swallowed w