Ramipril Aurobindo 1.25mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RAMIPRIL

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

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:

2012-12-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIPRIL AUROBINDO 1.25 MG TABLETS
RAMIPRIL AUROBINDO 2.5 MG TABLETS
RAMIPRIL AUROBINDO 5 MG TABLETS
RAMIPRIL AUROBINDO 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 Aurobindo is and what it is used for
2.
What you need to know before you take Ramipril Aurobindo
3.
How to take Ramipril Aurobindo
4.
Possible side effects
5.
How to store Ramipril Aurobindo
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL AUROBINDO IS AND WHAT IT IS USED FOR
Ramipril Aurobindo contains the active substance called ramipril. This
belongs to a group of
medicines called ACE inhibitors (Angiotensin Converting Enzyme
Inhibitors).
Ramipril Aurobindo 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 Aurobindo 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 AUROBINDO
DO NOT TAKE RAMIPRIL AUROBINDO
•
If you are allergic to ramipril, any other ACE inhi

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ramipril Aurobindo 1.25 mg tablets
Ramipril Aurobindo 2.5 mg tablets
Ramipril Aurobindo 5 mg tablets
Ramipril Aurobindo 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg ramipril.
Each tablet contains 2.5 mg ramipril.
Each tablet contains 5 mg ramipril.
Each tablet contains 10 mg ramipril.
_Excipients with known effect: _
Each tablet contains 12.1 mg lactose monohydrate.
Each tablet contains 10.8 mg lactose monohydrate.
Each tablet contains 21.7 mg lactose monohydrate.
Each tablet contains 43.4 mg lactose monohydrate.
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Tablet
_Ramipril Aurobindo 1.25 mg tablets: _
White to Off-white coloured, flat faced bevel edged round [diameter
5.0] uncoated tablet
debossed with “H” and “17” on one side and plain on other side
_ _
_Ramipril Aurobindo 2.5 mg tablets: _
Light yellow to yellow coloured, flat faced bevel edged round
[diameter 5.0] uncoated tablet
debossed with “H” and “18” separated by scoreline on one side
and plain on other side. The
tablet can be divided into two equal doses.
_ _
_Ramipril Aurobindo 5 mg tablets: _
Light pink coloured mottled, flat faced bevel edged round [diameter
6.0] uncoated tablet
debossed with “H” and “19” separated by scoreline on one side
and plain on other side. The
tablet can be divided into two equal doses.
_Ramipril Aurobindo 10 mg tablets: _
White to Off-white colored, flat faced bevel edged round [diameter
8.0] uncoated tablet
debossed with “H” and “20” separated by scoreline on one side
and plain on other side. The
tablet can be divided into two equal doses.
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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 vascu