APO-RAMIPRIL ramipril 5 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ramipril, Quantity: 5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ramipril

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium stearylfumarate; hypromellose; pregelatinised maize starch; iron oxide yellow

Administration route:

Oral

Units in package:

30

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 on 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: Light yellow to yellow mottled oblong tablets with R and 19 on either side of the score line on one side and score line on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-12-22

Patient Information leaflet

APO-RAMIPRIL
_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 ramipril. 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 using 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
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
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.
Untreated high blood pressure 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, which 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, i

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- RAMIPRIL (RAMIPRIL) TABLETS
1
NAME OF THE MEDICINE
Ramipril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg or 10 mg ramipril as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-
RAMIPRIL TABLETS
2.5 MG TABLET
Pink to red mottled, oblong tablet with R and 18 on either side of
score line on one side and
score line on the other side.
5 MG TABLET
Light yellow to yellow mottled, oblong tablet with R and 19 on either
side of score line on one
side and score line on the other side.
10 MG TABLET
Light yellow to yellow mottled, oblong tablet with R and 10 on either
side of score line on one
side and score line on the other side.
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.
•
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Ramipril tablets are intended for oral administration.
2
Ramipril tablets should be swallowed whole before, during or after
meals with a generous
amount of fluid. Where a 1.25mg dose is required, this can be
administered as