Ramipril 2.5mg/5ml Oral Solution

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ramipril

Beschikbaar vanaf:

Rosemont Pharmaceuticals Ltd

ATC-code:

C09AA; C09AA05

INN (Algemene Internationale Benaming):

Ramipril

Dosering:

2.5 mg/5ml

farmaceutische vorm:

Oral solution

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

ACE inhibitors, plain; ramipril

Autorisatie-status:

Marketed

Autorisatie datum:

2011-11-18

Bijsluiter

VERSION: MAY 2017
PAGE 27
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Oral Solution is and what it is used for
2.
What you need to know before you take Ramipril Oral Solution
3.
How to take Ramipril Oral Solution
4.
Possible side effects
5.
How to store Ramipril Oral Solution
6.
Contents of the pack and other information
1. WHAT RAMIPRIL ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Ramipril 2.5mg/5ml Oral Solution (called
Ramipril in
this leaflet). Ramipril belongs to a group of medicines called ACE
inhibitors
(Angiotensin Converting Enzyme inhibitors).
Ramipril 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 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 ORAL SOLUTION
RAMIPRIL 2.5MG/5ML ORAL SOLUTION
Ramipril
VERSION: MAY 2017
PAGE 28
DO NOT TAKE RAMIPRIL ORAL SOLUTION:
•
If you are allergic (hypersensitive) to ramipril,

Productkenmerken

Health Products Regulatory Authority
28 September 2018
CRN008L47
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril 2.5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of solution contains 2.5mg Ramipril.
Excipients with known effect:
Ethyl Hydroxybenzoate 3mg/5ml
Butyl Hydroxybenzoate 0.25mg/5ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution
A clear colourless solution.
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.
Health Products Regulatory Authority
28 September 2018
CRN008L47
Page 2 of 22
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
DIURETIC-TREATED PATIENTS
Hypotension may occur following initiation of therapy with Ramipril;
this is more
likely in patients who are being treated concurrently with diuretics.
Caution is
therefore recommended since these patients may be volume and/or salt
depleted.
If possible, the diuretic should be discontinued 2 to 3 days before
beginning therapy
with Ramipril (see section