Ramipril 2.5 mg capsules, hard

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ramipril

Tersedia dari:

Accord Healthcare Ireland Ltd.

Kode ATC:

C09AA; C09AA05

INN (Nama Internasional):

Ramipril

Dosis:

2.5 milligram(s)

Bentuk farmasi:

Capsule, hard

Area terapi:

ACE inhibitors, plain; ramipril

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2013-03-15

Selebaran informasi

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

Karakteristik produk

Health Products Regulatory Authority
13 January 2022
CRN009MQF
Page 1 of 14
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 (Capsule)
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
Adults
Diuretic- Treated Patients
Health Products Regulatory Authority
13 January 20