ANGIRAM 2.5 (Ramipril Tablets BP 2.5 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

RAMIPRIL

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

RAMIPRIL

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ANGIRAM 2.5 (RAMIPRIL TABLET 2.5MG)
ANGIRAM 5 (RAMIPRIL TABLET 5MG)
ANGIRAM 10 (RAMIPRIL TABLET 10MG)
Ramipril (2.5mg, 5mg & 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What ANGIRAM is used for
2.
How ANGIRAM works
3.
Before you use ANGIRAM
4.
How to use ANGIRAM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ANGIRAM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS ANGIRAM USED FOR
The active ingredient of ANGIRAM
is Ramipril.
ANGIRAM is used for:
•
To treat high blood pressure
(hypertension)
•
To treat your heart when it
cannot pump enough blood
to the rest of your body
(congestive heart failure)
•
As treatment following
heart attack (myocardial
infarction) complicated with
heart failure
•
To reduce risk of you
having a heart attack or
stroke
•
For prevention of worsening
of kidney problems in
patients with persistent
proteinuria (presence of
excess protein in urine)
HOW ANGIRAM WORKS
ANGIRAM contains a medicine
called Ramipril. This belongs to a
group of medicines called ACE
inhibitors (Angiotensin Converting
Enzyme inhibitors).
ANGIRAM 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
BEFORE YOU USE ANGIRAM
-When you must not use it
•
If you are allergic
(hypersensitive) to
Ramipril, any other ACE
inhibitor medicine or any of
the other ingredients of
ANGIRAM. Signs of an
allergic reaction may
include: a rash, swallowing
or breathing problems,
swelling of your lips, face,
throat or tongue
•
If you have ever had a
serious allergic reaction
called ‘angioedema’. The
signs include itching, hives
(urticaria), red marks on the
hands, feet and throat,
swelling of the throat and
tongue, swelling around the
eyes and lips, difficulty
breathing and swallowing
•
If you are having dialysis or
any other type of blo

Ciri produk

D3 - PROPOSED PACKAGE INSERT
SUMMARY OF PRODUCT CHARACTERISTICS
ANGIRAM
RAMIPRIL TABLETS BP 2.5 MG, 5 MG, 10 MG
RX ONLY
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Ramipril Tablets BP 2.5 mg:_
Each uncoated tablet contains Ramipril Ph.Eur. 2.5 mg.
_Ramipril Tablets BP 5 mg:_
Each uncoated tablet contains Ramipril Ph.Eur. 5 mg.
_Ramipril Tablets BP 10 mg:_
Each uncoated tablet contains Ramipril Ph.Eur. 10 mg.
PHARMACEUTICAL FORM
_Ramipril Tablets BP 2.5 m_g: 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.
_Ramipril Tablets BP 5 mg:_ 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.
_Ramipril Tablets BP 10 mg:_ 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.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
-
Hypertension.
-
Congestive heart failure.
-
Treatment of patients who – within the first few days after an acute
myocardial infarction – have demonstrated clinical signs of
congestive
heart failure.
-
For reducing the risk of myocardial infarction, stroke, cardiovascular
death or the need for revascularization procedures in patients 55
years
or more who have clinical evidence of coronary artery disease, stroke,
or peripheral vascular disease.
NAME OF THE DRUG PRODUCT:
Ramipril Tablets BP 2.5 mg
Ramipril Tablets BP 5 mg
Ramipril Tablets BP 10 mg
(TRADE) NAME OF THE PRODUCT:
ANGIRAM 2.5
ANGIRAM 5
ANGIRAM 10
STRENGTH:
2.5 mg, 5 mg, 10 mg.
PHARMACEUTICAL DOSAGE FORM: Tablets
-
For reducing the risk of myocardial infarction, stroke, cardiovascular
death or revascularization procedures in diabetic patients 55 years or
more with one or more of the following risk factors: systolic blood
pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg (or on
antihype