Novamtel 5mg80mg Tablets

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

AMLODIPINE BESYLATE; TELMISARTAN

Tersedia dari:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Internasional):

AMLODIPINE BESYLATE; TELMISARTAN

Unit dalam paket:

1x10 Tablets; 3x10 Tablets; 6x10 Tablets; 10x10 Tablets; 50x10 Tablets; 100x10 Tablets

Diproduksi oleh:

NOVUGEN PHARMA SDN. BHD.

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NOVAMTEL TABLETS
Amlodipine/Telmisartan (5mg/40mg, 10/40mg, 5mg/80mg, 10mg/80mg)
1
WHAT IS IN THIS LEAFLET
1.
What NOVAMTEL is used for
2.
How NOVAMTEL works
3.
Before you use NOVAMTEL
4.
How to use NOVAMTEL
5.
While you are using NOVAMTEL
6.
Side effects
7.
Storage
and
Disposal
of
NOVAMTEL
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT NOVAMTEL IS USED FOR
NOVAMTEL
is
a
prescription
medicine that contains amlodipine and
telmisartan.
NOVAMTEL tablets may be used to
treat
high
blood
pressure
(hypertension):
•
in
adult
patients
whose
blood
pressure is not controlled enough
with
amlodipine
or
telmisartan
alone.
•
in
adult
patients
who
already
receive amlodipine and telmisartan
from separate tablets and who wish
to take instead the same doses in
one tablet for convenience.
•
as the first medicine to lower your
high blood pressure if your doctor
decides you are likely to need more
than one medicine.
High blood pressure, if not treated, can
damage
blood
vessels
in
several
organs, which puts patients at risk of
serious
events
such
as
heart
attack,
heart
or
kidney
failure,
stroke,
or
blindness.
There
are
usually
no
symptoms
of
high
blood
pressure
before
damage
occurs.
Thus,
it
is
important to regularly measure blood
pressure to verify if it is within the
normal range.
HOW NOVAMTEL WORKS
NOVAMTEL
tablets
contain
two
active
substances
called
amlodipine
and
telmisartan.
Both
of
these
substances help to control your high
blood pressure:
−
Telmisartan belongs to a group of
substances
called
“angiotensin-II
receptor antagonists”.
Angiotensin
II
is
a
substance
produced in the body which causes
blood
vessels
to
narrow,
thus
increasing
blood
pressure.
Telmisartan works by blocking the
effect of angiotensin II.
−
Amlodipine belongs to a group of
substances called “calcium channel
blockers”.
Amlodipine
stops
calcium
from
moving
into
the
blood vessel wall which stops the
blood vessels from tighteni

Karakteristik produk

NOVAMTEL 5MG/40MG TABLETS
NOVAMTEL 5MG/80MG TABLETS
NOVAMTEL 10MG/40MG TABLETS
NOVAMTEL 10MG/80MG TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Novamtel 5mg/40mg Tablets
Novamtel 5mg/80mg Tablets
Novamtel 10mg/40mg Tablets
Novamtel 10mg/80mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NOVAMTEL
5MG/40MG
TABLETS:
Each
tablet
contains
6.93mg
of
Amlodipine
Besylate
equivalent to Amlodipine 5mg and Telmisartan 40mg.
NOVAMTEL
5MG/80MG
TABLETS:
Each
tablet
contains
6.93mg
of
Amlodipine
Besylate
equivalent to Amlodipine 5mg and Telmisartan 80mg.
NOVAMTEL 10MG/40MG TABLETS:
Each tablet contains 13.87mg of Amlodipine Besylate
equivalent to Amlodipine 10mg and Telmisartan 40mg.
NOVAMTEL 10MG/80MG TABLETS:
Each tablet contains 13.87mg of Amlodipine Besylate
equivalent to Amlodipine 10mg and Telmisartan 80mg.
3.
PHARMACEUTICAL FORM
Tablet.
NOVAMTEL 5MG/40MG TABLETS:
White-blue, oval biconvex bilayer tablets, possibly with
blue specks in the white layer. The blue layer is debossed with 'C 54'
and white layer
is plain.
NOVAMTEL 5MG/80MG TABLETS:
White-blue, oval biconvex bilayer tablets, possibly with
blue specks in the white layer. The blue layer is debossed with 'C 52'
and white layer
is plain.
NOVAMTEL 10MG/40MG TABLETS:
White-blue, oval biconvex bilayer tablets, possibly with
blue specks in the white layer. The blue layer is debossed with 'C 53'
and white layer
is plain.
NOVAMTEL 10MG/80MG TABLETS:
White-blue, oval biconvex bilayer tablets, possibly with
blue specks in the white layer. The blue layer is debossed with 'C 51'
and white layer
is plain.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Replacement Therapy
Patients receiving telmisartan and amlodipine from separate tablets
may instead receive
Novamtel containing the same component doses.
Add on therapy
Novamtel is indicated in patients whose blood pressure is not
adequately controlled on
telmisartan or amlodipine monotherapy.
Initial therapy
Novamtel may also be used as initial therapy in patients who are
likel