TRITACE ramipril 10mg capsule hard blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ramipril, Quantity: 10 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: indigo carmine; pregelatinised maize starch; titanium dioxide; erythrosine; Gelatin; iron oxide black

Administration route:

Oral

Units in package:

28 capsules, 14 capsules, 7 capsules (sample), 30 capsules, 10 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. (Data are currently not available to support the use of Tritace in renovascular hypertension.) Post myocardial infarction 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.

Product summary:

Visual Identification: Hard gelatin capsules, size 4, blue opaque/white opaque, containing a white powder mixture.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-07-18

Patient Information leaflet

TRITACE
®
(TRY-TASE)
_Ramipril (RAM-(m)e-pril)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tritace.
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 Tritace 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 TRITACE IS USED
FOR
Tritace belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
Tritace is used to treat:
•
high blood pressure
(hypertension)
•
some heart conditions such as
heart failure after a heart attack
•
kidney problems in some patients
Tritace 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
Tritace 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
Tritace 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,

Summary of Product characteristics

tritace-ccdsv18-piv24-02sep19
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION – TRITACE
® (RAMIPRIL)
1
NAME OF THE MEDICINE
Ramipril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tritace is available as tablets containing 1.25 mg, 2.5 mg, 5.0 mg and
10 mg ramipril and a
capsule containing 10 mg ramipril.
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°C and 112°C.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The 1.25 mg tablets are white to almost white, oblong shaped tablets
with score lines on both
sides. Tablets are embossed 1.25/HMN on one side and 1.25/Hoechst logo
on the other.
The 2.5 mg tablets are yellowish to yellow, oblong shaped tablets with
score lines on both
sides. Tablets are embossed 2.5/HMR on one side and 2.5/Hoechst logo
on the other.
The 5.0 mg tablets are pale red, oblong shaped tablets with score
lines on both sides. Tablets
are embossed 5/HMP on one side and 5/Hoechst logo on the other.
The 10 mg tablets are white to almost white, oblong shaped tablets
with score lines on both
sides. Tablets are embossed with HMO/HMO on one side only.
The 10 mg capsules are two component, one half of opaque blue, the
other of opaque white.
4
CLINICAL PARTICULARS
4.1
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.
tritace-ccdsv18-piv24-02sep19
Page 2 of 29
•
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