RAMIPRIL WINTHROP 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

INN (International Name):

Ramipril

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. (Data are currently not available to support the use of RAMIPRIL WINTHROP 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 > 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 Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-10-31

Patient Information leaflet

RAMIPRIL WINTHROP
®
_Ramipril_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ramipril Winthrop.
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 Ramipril
Winthrop 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 RAMIPRIL
WINTHROP IS USED FOR
Ramipril Winthrop belongs to a
group of medicines called
angiotensin converting enzyme
(ACE) inhibitors.
Ramipril Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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

Summary of Product characteristics

ramipril-winthrop-ccdsv18-piv13-02sep19
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION – RAMIPRIL WINTHROP
®
(RAMIPRIL)
1
NAME OF THE MEDICINE
Ramipril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril Winthrop 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.
ramipril-winthrop-ccdsv18-piv13-02sep19
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 myocar