Ramipril Amneal 10mg Tablets

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

RAMIPRIL

Beszerezhető a:

Amneal Pharma Europe Limited

ATC-kód:

C09AA05

INN (nemzetközi neve):

RAMIPRIL

Gyógyszerészeti forma:

TABLET

Összetétel:

RAMIPRIL 10 mg

Recept típusa:

POM

Terápiás terület:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Engedélyezési státusz:

Authorised

Engedély dátuma:

2010-05-26

Betegtájékoztató

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIPRIL AMNEAL 1.25 MG TABLETS
RAMIPRIL AMNEAL 2.5 MG TABLETS
RAMIPRIL AMNEAL 5 MG TABLETS
RAMIPRIL AMNEAL 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 Amneal is and what it is used for
2.
What you need to know before you take Ramipril Amneal
3.
How to take Ramipril Amneal
4.
Possible side effects
5.
How to store Ramipril Amneal
6.
Contents of the pack and other information
1.
WHAT RAMIPRIL AMNEAL IS AND WHAT IT IS USED FOR
Ramipril Amneal contains the active substance called ramipril. This
belongs to a group of
medicines called ACE inhibitors (Angiotensin Converting Enzyme
Inhibitors).
Ramipril Amneal 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 Amneal 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 a heart attack (myocardial infarction)
complicated with heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL AMNEAL
DO NOT TAKE RAMIPRIL AMNEAL:
-
If you are allergic to ramipril, any other ACE inhibitor medicine or
any of the in

Termékjellemzők

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril Amneal 1.25 mg tablets
Ramipril Amneal 2.5 mg tablets
Ramipril Amneal 5 mg tablets
Ramipril Amneal 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg of ramipril.
Each tablet contains 2.5 mg of 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 Amneal 1.25 mg tablets: _
White to off-white colored, flat faced bevel edged round uncoated
tablet debossed with “H” and “17”
on one side and plain on other side.
_ _
_Ramipril Amneal 2.5 mg tablets: _
Light yellow to yellow colored flat faced bevel edged, round uncoated
tablet debossed with “H” and
“18” separated by score line on one side and plain on other side.
The tablet can be divided into two equal doses.
_ _
_Ramipril Amneal 5 mg tablets: _
Light pink colored mottled, flat faced bevel edged round uncoated
tablet debossed with “H” and “19”
separated by score line on one side and plain on other side.
The tablet can be divided into two equal doses.
_Ramipril Amneal 10 mg tablets: _
White to off-white colored, flat faced bevel edged round uncoated
tablet debossed with “H” and “20”
separated by 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
- 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
Page 2 of 17
o
diabetes with at least one cardiovascular risk factor (see