Ramipril TAD 2.5 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RAMIPRIL

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

C09AA05

INN (International Name):

RAMIPRIL 2.5 mg

Pharmaceutical form:

TABLET

Composition:

RAMIPRIL 2.5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2015-10-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAMIPRIL TAD 1.25 MG TABLETS
RAMIPRIL TAD 2.5 MG TABLETS
RAMIPRIL TAD 5 MG TABLETS
RAMIPRIL TAD 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 TAD is and what it is used for
2.
What you need to know before you take Ramipril TAD
3.
How to take Ramipril TAD
4.
Possible side effects
5.
How to store Ramipril TAD
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL TAD IS AND WHAT IT IS USED FOR
Ramipril TAD contains a medicine called ramipril. This belongs to a
group of medicines called ACE
inhibitors (Angiotensin Convertin Enzyme inhibitors).
Ramipril TAD 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 TAD 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 TAD
DO NOT TAKE RAMIPRIL TAD:
-
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 allerg

Summary of Product characteristics

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1
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18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ramipril TAD 1.25 mg tablets
Ramipril TAD 2.5 mg tablets
Ramipril TAD 5 mg tablets
Ramipril TAD 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
1.25 mg tablets: white to almost white, round, biconvex tablets with
bevelled edges, engraved with
mark 1.25 on one side of the tablet. Tablet diameter: 6.5 mm.
2.5 mg tablets: light brownish-yellow, capsule shaped tablets with
bevelled edges, scored on both
sides. On one side of the tablet is on one half engraved mark 2.5 and
on the other half of the tablet
mark KRK. Tablet dimensions: 8 x 5 mm. The tablet can be divided into
equal doses.
5 mg tablets: light pink with individual lighter and darker spots,
capsule shaped tablets with
bevelled edges, scored on both sides. On one side of the tablet is on
one half engraved mark 5 and
on the other half of the tablet mark KRK. Tablet dimensions: 8 x 5 mm.
The tablet can be divided
into equal doses.
10 mg tablets: white to almost white capsule shaped tablets with
bevelled edges, scored on both
sides. On one side of the tablet is on one half engraved mark 10 and
on the other half of the tablet
mark KRK. Tablet dimensions: 8 x 5 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:
-
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease or stroke,
or peripheral vascular disease) or
-
diabetes with at least one cardiovascular risk factor.
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)