Ramipril Aristo 1.25mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RAMIPRIL

Available from:

Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany

ATC code:

C09AA05

INN (International Name):

RAMIPRIL 1.25 mg

Pharmaceutical form:

TABLET

Composition:

RAMIPRIL 1.25 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2012-12-05

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIPRIL ARISTO 1.25 MG TABLETS
RAMIPRIL ARISTO 2.5 MG TABLETS
RAMIPRIL ARISTO 5 MG TABLETS
RAMIPRIL ARISTO 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 Aristo is and what it is used for
2.
What you need to know before you take Ramipril Aristo
3.
How to take Ramipril Aristo
4.
Possible side effects
5.
How to store Ramipril Aristo
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL ARISTO IS AND WHAT IT IS USED FOR
Ramipril Aristo contains the active substance ramipril. This belongs
to a group of medicines called
ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril Aristo works by
-
Decreasing your body’s production of substances that could raise
your blood pressure
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Making your blood vessels relax and widen
-
Making it easier for your heart to pump blood around your body.
Ramipril Aristo can be used
-
To treat high blood pressure (hypertension)
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To reduce the risk of you having a heart attack or stroke
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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 a heart attack (myocardial infarction)
complicated with heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL ARISTO
DO NOT TAKE RAMIPRIL ARISTO
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If you are allergic to ramipril or any of the other ingredients of
this medicine (listed in
section 6).
-
I

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril Aristo 1.25 mg tablets
Ramipril Aristo 2.5 mg tablets
Ramipril Aristo 5 mg tablets
Ramipril Aristo 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril Aristo 1.25 mg tablets
Each tablet contains 1.25 mg of ramipril.
Excipients with known effect:
Each tablet contains 12.1 mg lactose monohydrate.
Ramipril Aristo 2.5 mg tablets
Each tablet contains 2.5 mg of ramipril.
Excipients with known effect:
Each tablet contains 10.8 mg lactose monohydrate.
Ramipril Aristo 5 mg tablets
Each tablet contains 5 mg ramipril.
Excipients with known effect:
Each tablet contains 21.7 mg lactose monohydrate.
Ramipril Aristo 10 mg tablets
Each tablet contains 10 mg ramipril.
Excipients with known effect:
Each tablet contains 43.4 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Ramipril Aristo 1.25 mg tablets
White to off-white colored, biconvex, bevel edged, round uncoated
tablet without engraving, plain on
both sides.
_ _
Ramipril Aristo 2.5 mg tablets
Light yellow to yellow colored, biconvex, bevel edged, round uncoated
tablet, without engraving, with
a score line on one side and plain on other side.
The tablet can be divided into two equal doses.
_ _
Ramipril Aristo 5 mg tablets
Pink colored, mottled, bevel edged, round biconvex uncoated tablet,
without engraving, with a score
line on one side.
The tablet can be divided into two equal doses.
Ramipril Aristo 10 mg tablets
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White to off-white colored, flat faced bevel edged round uncoated
tablet without engraving, with score
line on one side and plain on other side.
The tablet can be divided into two equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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Treatment of hypertension.
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Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
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manifest atherothrombotic cardiovascular disease (history of coronary
heart disease or stroke,
or peripheral vascular disease) or