APO-RAMIPRIL ramipril 10mg capsule blister pack

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

Composition:

Excipient Ingredients: lactose monohydrate; titanium dioxide; Gelatin; erythrosine; magnesium stearate; iron oxide black; indigo carmine; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

10, 7, 30, 28, 14

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 > 160 mm Hg or diastolic blood pressure > 90 mm Hg (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: blue cap & white body imprinted with APO 10 in black ink; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2011-09-27

Patient Information leaflet

APO-RAMIPRIL
1
APO-RAMIPRIL
_contains the active ingredient ramipril _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 risks of you taking this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Ramipril. It contains the active
ingredient, ramipril.
Ramipril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
Ramipril 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 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.
HIGH BLOOD PRESSURE
(HYPERTENSION)
Ramipril 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 high
blood pressure when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
There are usually no symptoms of
high blood pressure. The only way of
knowing that you have high blood
pressure 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 may be used after a heart
attack. A heart attack o

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- RAMIPRIL (RAMIPRIL) CAPSULES
1
NAME OF THE MEDICINE
Ramipril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Ramipril Capsules
Each capsule contains 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate, gelatin (sulfites)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-Ramipril Capsules
The 1.25 mg capsules have a yellow cap and white body; they are
imprinted with _“APO 1.25”_
in black ink.
The 2.5 mg capsules have an orange cap and white body; they are
imprinted with _“APO 2.5”_
in black ink.
The 5 mg capsules have a red cap and white body; they are imprinted
with _“APO 5”_ in black
ink.
The 10 mg capsules have a blue cap and white body; they are imprinted
with _“APO 10”_ in black
ink
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
1g/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 mm Hg or diastolic blood pressure > 90
mm Hg (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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Ramipril is intended for oral administration.
Capsules should be swallowed whole before, during or after meals with
a generous