PRILACE ramipril 10mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ramipril, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; brilliant blue FCF; allura red AC; Gelatin; phloxine B

Administration route:

Oral

Units in package:

30 capsules

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: The 10 mg capsules have a white opaque body and a blue opaque cap. The body has "RP 10" printed in black.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-03-06

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