Ramilo 10 mg Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ramipril

Beschikbaar vanaf:

Rowex Ltd

ATC-code:

C09AA; C09AA05

INN (Algemene Internationale Benaming):

Ramipril

Dosering:

10 milligram(s)

farmaceutische vorm:

Tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

ACE inhibitors, plain; ramipril

Autorisatie-status:

Marketed

Autorisatie datum:

2004-09-10

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMILO 1.25 MG TABLETS
RAMILO 2.5 MG TABLETS
RAMILO 5 MG TABLETS
RAMILO 10 MG TABLETS
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 Ramilo is and what it is used for
2.
What you need to know before you take Ramilo
3.
How to take Ramilo
4.
Possible side effects
5.
How to store Ramilo
6.
Contents of the pack and other information
1
WHAT RAMILO IS AND WHAT IT IS USED FOR
Ramilo contains a medicine called ramipril. This belongs to a group of
medicines called ACE
inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramilo 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.
Ramilo 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 RAMILO
DO NOT TAKE RAMILO:
-
if you are allergic to ramipril, any other ACE inhibitor medicine or
any of the other ingredients of
this medicine (listed in section 6). signs of an allergic reaction may
include a rash, swallowing or
breathing problems, swelling of your lips, fa

Productkenmerken

Health Products Regulatory Authority
18 September 2019
CRN008VRK
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramilo 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ramipril.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, oblong, biplane with facet, both sides with breaking notch.
Marking one-sided ‘R 10’.
The tablet can be divided into equal doses.
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
Posology
It is recommended that Ramilo is taken each day at the same time of
the day.
Ramilo can be taken before, with or after meals, because food intake
does not modify its bioavailability (see section 5.2).
Ramilo has to be swallowed with liquid. It must not be chewed or
crushed.
Health Products Regulatory Authority
18 September 2019
CRN008VRK
Page 2 of 17
_Adults _
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with Ramilo;
this is more likel