RAMIPRIL SANDOZ ramipril 10mg capsule hard blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

ramipril, Quantity: 10 mg

متاح من:

Sanofi-Aventis Australia Pty Ltd

INN (الاسم الدولي):

Ramipril

الشكل الصيدلاني:

Capsule, hard

تركيب:

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

طريقة التعاطي:

Oral

الوحدات في الحزمة:

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

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Treatment of hypertension. (Data are currently not available to support the use of RAMIPRIL SANDOZ 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.

ملخص المنتج:

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

الوضع إذن:

Registered

تاريخ الترخيص:

2006-10-31

نشرة المعلومات

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

خصائص المنتج

ramipril-sandoz-ccdsv18-piv16-02sep19
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION – RAMIPRIL SANDOZ
(RAMIPRIL)
1
NAME OF THE MEDICINE
Ramipril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril Sandoz is available as 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 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.
•
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.
ramipril-sandoz-ccdsv18-piv16-02sep19
Page 2 of 29
4.2
DOSE AND METHOD OF ADMINISTRATION
Ramipril Sandoz capsules should be swallowed whole before, during or
after meals with a
generous amount of fluid.
HYPERTENSION
The recommended initial dosage for patients not receiving a diuretic
is 2.5 mg ramipril once a
day. Depending upon the patient's response, the dosage may then be
inc