RAMIPRIL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RAMIPRIL

Available from:

Accord Healthcare Limited

ATC code:

C09AA05

INN (International Name):

RAMIPRIL

Dosage:

2.5 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ramipril

Authorization status:

Not Marketed

Authorization date:

2013-03-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIPRIL 1.25 MG CAPSULES, HARD
RAMIPRIL 2.5 MG CAPSULES, HARD
RAMIPRIL 5 MG CAPSULES, HARD
RAMIPRIL 10 MG CAPSULES, HARD
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 or pharmacist.

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 or pharmacist. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ramipril capsules is and what it is used for
2. What you need to know before you take Ramipril capsules
3. How to take Ramipril capsules
4. Possible side effects
5. How to store Ramipril capsules
6. Contents of the pack and other information
1. WHAT RAMIPRIL CAPSULES IS AND WHAT IT IS ARE USED FOR
Ramipril capsules contain a medicine called ramipril. This belongs to
a group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme Inhibitors).
Ramipril capsules 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 capsules 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 CAPSULES
DO NOT TAKE RAMIPRIL CAPSULES:

If you are allergic to Ramipril, any other ACE inhibitor medicine or
any o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril 2.5 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril 2.5 mg, capsule, hard contains 2.5 mg of ramipril
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Orange / White size ‘4’ hard gelatin capsules, imprinted ‘R’
on cap & ‘2.5’ on body with black ink, containing white to
off 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 the 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 capsules is taken each day at the same
time of the day.
Ramipril capsules may be taken before, with or after meals, because
food intake does not modify its bioavailability (see
section 5.2).
Ramipril capsules has to be swallowed with liquid. It must not be
chewed or crushed.
POSOLOGY
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