Ramipril Krka 2.5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ramipril

Available from:

KRKA, d.d., Novo mesto

ATC code:

C09AA; C09AA05

INN (International Name):

Ramipril

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; ramipril

Authorization status:

Marketed

Authorization date:

2010-11-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMIPRIL KRKA 1.25 MG TABLETS
RAMIPRIL KRKA 2.5 MG TABLETS
RAMIPRIL KRKA 5 MG TABLETS
RAMIPRIL KRKA 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 Ramipril Krka is and what it is used for
2.
What you need to know before you take Ramipril Krka
3.
How to take Ramipril Krka
4.
Possible side effects
5.
How to store Ramipril Krka
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL KRKA IS AND WHAT IT IS USED FOR
Ramipril Krka contains a medicine called ramipril. This belongs to a
group of medicines called ACE
inhibitors.
Ramipril Krka 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 Krka 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 KRKA
DO NOT TAKE RAMIPRIL KRKA:
-
if you are allergic to ramipril, any other ACE inhibitor medicine, or
any of the other ingredients
of Ramipril Krka listed in section 6.
Signs of an allergic reaction may include a ras

Summary of Product characteristics

Health Products Regulatory Authority
10 October 2019
CRN009D7D
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril Krka 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg ramipril.
Excipient with known effect:
Lactose: 150.86 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow oblong flat tablets, dimensions 10.0 x 5.00 mm.
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
_Adults_
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with Ramipril
Krka; 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 Krka (see section 4.4).
Health Products Regulatory Authority
10 October 2019
CRN009D7D
Page 2 of 15
In hypertensive patients in who