RAMIPRIL SANDOZ ramipril 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ramipril, Quantity: 10 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium stearylfumarate; pregelatinised maize starch; sodium bicarbonate; microcrystalline cellulose; hypromellose

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. 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 an 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, oblong, biplane with facet, both sides with breaking notch. Embossment one-sided "R 10".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-11-30

Patient Information leaflet

RAMIPRIL SANDOZ
®
1
RAMIPRIL SANDOZ
®
_ramipril tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ramipril Sandoz. 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 risk of you taking Ramipril
Sandoz 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 want to read it again.
WHAT RAMIPRIL SANDOZ
IS USED FOR
This medicine 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 Sandoz 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 Sandoz 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 or 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 Sandoz 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. This may lead to further
problems, such as heart failure,
irregular heart rhythm

Summary of Product characteristics

191113-Ramipril Sandoz-pi
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
RAMIPRIL SANDOZ
® (RAMIPRIL)
1.
NAME OF THE MEDICINE
Ramipril
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril Sandoz 1.25 mg tablets contains 1.25 mg ramipril.
Ramipril Sandoz 2.5 mg tablets contains 2.5 mg ramipril.
Ramipril Sandoz 5 mg tablets contains 5 mg ramipril.
Ramipril Sandoz 10 mg tablets contains 10 mg ramipril.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Ramipril Sandoz 1.25 mg tablets are white, oblong, biplane with facet,
both sides with breaking
notch and embossed “R1.25” on one side.
Ramipril Sandoz 2.5 mg tablets are white, oblong, biplane with facet,
both sides with breaking
notch and embossed “R2.5” on one side.
Ramipril Sandoz 5 mg tablets are white, oblong, biplane with facet,
both sides with breaking
notch and embossed “R5” on one side.
Ramipril Sandoz 10 mg tablets are white, oblong, biplane with facet,
both sides with breaking
notch and embossed "R 10" on one side.
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 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 > 160 mmHg or
diastolic blood
pressure > 90 mmHg (or on antihypertensive treatment); total
cholesterol > 5.2 mmol/L;
HDL
cholesterol
<
0.9
mmol/L;
current
smoker;
known
microalbuminuria;
any
evidence of previous vascular disease.