Ramipril Teva Pharma 1.25mg Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Ramipril

Dostupné s:

Teva Pharma B.V.

ATC kód:

C09AA; C09AA05

INN (Mezinárodní Name):

Ramipril

Dávkování:

1.25 milligram(s)

Léková forma:

Tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

ACE inhibitors, plain; ramipril

Stav Autorizace:

Marketed

Datum autorizace:

2013-05-31

Informace pro uživatele

_RAMIPRIL TEVA PHARMA 1.25 MG TABLETS_
_RAMIPRIL TEVA PHARMA 2.5 MG TABLETS_
_RAMIPRIL TEVA PHARMA 5 MG TABLETS_
_RAMIPRIL TEVA PHARMA 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.
1. What Ramipril Teva Pharma is and what it is
used for
2. What you need to know before you take
Ramipril Teva Pharma
3. How to take Ramipril Teva Pharma
4. Possible side effects
5. How to store Ramipril Teva Pharma
6. Contents of the pack and other information
WHAT RAMIPRIL TEVA PHARMA IS AND
WHAT IT IS USED FOR
Ramipril Teva Pharma contains a medicine
called ramipril. This belongs to a group of
medicines called ACE inhibitors (Angiotensin
Converting Enzyme Inhibitors).
Ramipril Teva Pharma 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 Teva Pharma 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.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RAMIPRIL TEVA PHARMA
DO NOT TAKE RAMIPRIL TEVA PHARMA
-
If you are allergic to ramipril, any other ACE
inhibitor medicine or any of the other
ingredients of

Charakteristika produktu

Health Products Regulatory Authority
21 October 2021
CRN00C9KG
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril Teva Pharma 1.25mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ramipril 1.25 mg
Excipient with known effect:
Each tablet contains 79.4 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, oblong, biplane tablets, 8.0 mm x 4.00 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of hypertension.

Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
o
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease or stroke, or peripheral
vascular disease) or
o
diabetes with at least one cardiovascular risk factor (see section
5.1).

Treatment of renal disease:
o
Incipient glomerular diabetic nephropathy as defined by the presence
of microalbuminuria,
o
Manifest glomerular diabetic nephropathy as defined by
macroproteinuria in patients with at least one
cardiovascular risk factor (see section 5.1),
o
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
Health Products Regulatory Authority
21 October 2021
CRN00C9KG
Page 2 of 15
Hypotension may occur following initiation of therapy with Ramipril
Tablets; 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 Tablets