TRITACE 2.5MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

RAMIPRIL

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

RAMIPRIL

Units in package:

28Tablet Tablets

Manufactured by:

Sanofi S.r.I.

Patient Information leaflet

TRITACE
® TABLETS
Ramipril
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START
TAKING
THIS
MEDICINE.
- 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. Do not pass it on to others. It
may
harm
them,
even
if
their
symptoms are the same as yours.
-
If
any
of
the
side
effects
gets
serious,
or
if
you
notice
any
side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What is Tritace used for
2.
How Tritace works
3.
Before you take Tritace
4.
How to take Tritace
5.
While you are using Tritace
6.
Side effects
7.
Storage and disposal of Tritace
8.
Product description
1.
WHAT
IS
TRITACE
USED
FOR
Tritace is used
–
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 the 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).
2. HOW TRITACE WORKS
Tritace
contains
a
medicine
called
ramipril. This belongs to a group of
medicines
called
ACE
inhibitors
(Angiotensin
Converting
Enzyme
inhibitors).
Tritace 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
3.
BEFORE
YOU
TAKE
TRITACE
WHEN YOU MUST NOT TAKE IT

If
you
are
allergic
(hypersensitive) to ramipril, any
other ACE inhibitor medicine or
any of the other ingredients of
Tritace.
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),

Summary of Product characteristics

1
This package insert is continually updated: please read ca refully before using a new pack
Active ingredient: Ramipril
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tritace 2.5mg tablets: One tablet contains 2,5 mg ramipril.
Tritace 5 mg tablets: One tablet contains 5 mg ramipril.
Tritace 10 mg tablets: One tablet contains 10 mg ramipril.
For a full list of excipients see List of Excipients .
PHARMACEUTICAL FORM
Tritace® 2.5: Yellowish to yellow oblong tablets with score -line,
Upper stamp: 2.5 and company logo, Lower stamp: HMR and 2.5
Tritace® 5: Pale red oblong tablets with score -line,
Upper stamp: 5 and company logo , Lower stamp: HMP and 5
Tritace® 10: White to almost white oblong tablets with score -line,
Upper stamp: HMO/HMO , Lower stamp: anonym ous
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.
– For reducing the risk of myocardial infarction, stroke, cardiovascular death or
revascularisation procedures in diabetic patients 55 years or more with one or more of the
following risk factors: systolic blood pressure > 160 mmHg or diastolic blood pressure > 90
mmHg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/L; HDL cholesterol <
0.9 mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular
disease.
– Prevention of progressive renal failure in patients with persistent proteinuria.
Posology and method of administration
Oral use.
It is recommended that Tritace is taken each day at the same time of the day.