Ramipril Actavis 5 mg Hard Capsules

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Ramipril

Dostupno od:

Accord Healthcare Ireland Ltd.

ATC koda:

C09AA; C09AA05

INN (International ime):

Ramipril

Doziranje:

5 milligram(s)

Farmaceutski oblik:

Capsule, hard

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

ACE inhibitors, plain; ramipril

Status autorizacije:

Marketed

Datum autorizacije:

2005-07-01

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Ramipril 2.5 mg hard Capsules
Ramipril 5 mg hard Capsules
Ramipril 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 is and what it is used for
2. What you need to know before you take Ramipril
3. How to take Ramipril
4. Possible side effects
5. How to store Ramipril
6. Contents of the pack and other information
1. WHAT RAMIPRIL IS AND WHAT IT IS USED FOR
Ramipril contains a medicine called ramipril. This 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
DO NOT TAKE RAMIPRIL:
• 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, swal

Svojstava lijeka

Health Products Regulatory Authority
24 February 2020
CRN009JZ4
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril Actavis 5 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 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 green capsule cap, marked R on cap
and 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.
Posology
_Adults_
Diuretic-Treated patients
Health Products Regulatory Authority
24 February 2020
CRN009JZ4
Page 2 of 15
Hypotension may