Ramipril Teva Pharma 10mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ramipril

Available from:

Teva Pharma B.V.

ATC code:

C09AA; C09AA05

INN (International Name):

Ramipril

Dosage:

10 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:

2013-05-31

Patient Information leaflet

Ramipril, tablets, DK/H/2130/001-004, 17.02.2021
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_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.
WHAT IS IN THIS LEAFLET
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
1.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL TEVA PHARMA
DO NOT

Summary of Product characteristics

Health Products Regulatory Authority
09 October 2023
CRN00D3MV
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril Teva Pharma 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ramipril 10 mg.
Excipient with known effect:
Each tablet contains 193.2 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
10 mg: white to off-white, round, biconvex tablets with break score on
one side and a diameter of 9.0 mm.
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:
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
09 October 2023
CRN00D3MV
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