RAMIPRIL ACTAVIS 2.5 Milligram Capsules Hard

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

RAMIPRIL

متاح من:

Actavis Group PTC ehf

ATC رمز:

C09AA05

INN (الاسم الدولي):

RAMIPRIL

جرعة:

2.5 Milligram

الشكل الصيدلاني:

Capsules Hard

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

ACE inhibitors, plain

الوضع إذن:

Authorised

تاريخ الترخيص:

2007-12-14

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Ramipril Actavis 2.5 mg hard Capsules
Ramipril Actavis 5 mg hard Capsules
Ramipril Actavis 10 mg hard Capsules
Ramipril
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Ramipril Actavis is and what it is used for
2. What you need to know before you take Ramipril Actavis
3. How to take Ramipril Actavis
4. Possible side effects
5. How to store Rampril Actavis
6. Contents of the pack and other information
1. WHAT RAMIPRIL ACTAVIS IS AND WHAT IT IS USED FOR
Ramipril Actavis contains a medicine called ramipril. This belongs to
a group of medicines
called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril Actavis works by:
• Decreasing your body’s production of substances that could raise
your blood pressure
• Making your blood vessels relax and widen
• Making it easier for your heart to pump blood around your body.
Ramipril Actavis can be used:
• To treat high blood pressure (hypertension)
• To reduce the risk of you having a heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems
(whether or not you have
diabetes)
• To treat your heart when it cannot pump enough blood to the rest
of your body (heart failure)
• As treatment following heart attack (myocardial infarction)
complicated with heart failure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL ACTAVIS
DO NOT TAKE RAMIPRIL ACTAVIS:
• If you are allergic to ramipril, any other ACE inhibitor medicine
or any of the other ing

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril Actavis 2.5 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2.5 mg of ramipril.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Size 4, light grey capsule body and light green capsule, marked R on
cap and 2.5 on body, containing a white or almost
white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypertension.
Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
-
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease or stroke, or peripheral
vascular disease) or
-
diabetes with at least one cardiovascular risk factor (see section
5.1).
Treatment of renal disease.
-
Incipient glomerular diabetic nephropathy as defined by presence of
microalbuminuria.
-
Manifest glomerular diabetic nephropathy as defined by
macroproteinuria in patients with at least one
cardiovascular risk factor (see section 5.1),
-
Manifest glomerular non diabetic nephropathy as defined by
macroproteinuria
3 g/day (see section 5.1).
Treatment of symptomatic heart failure.
Secondary prevention after acute myocardial infarction: reduction of
mortality from the acute phase of
myocardial
infarction in patients with clinical signs of heart failure when
started > 48 hours following acute
myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Oral use.
It is recommended that Ramipril is taken each day at the same time of
the day. Ramipril can be taken before, with or
after meals, because food intake does not modify its bioavailability
(see section 5.2). Ramipril has to be swallowed
with liquid. It must not be chewed or crushed.
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