LERCANIDIPINE AN lercanidipine hydrochloride 10 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

lercanidipine hydrochloride, Quantity: 10 mg

Boleh didapati daripada:

Southern XP IP Pty Ltd

INN (Nama Antarabangsa):

Lercanidipine hydrochloride

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: polyvinyl alcohol; iron oxide yellow; purified talc; magnesium stearate; macrogol 3350; lactose monohydrate; sodium starch glycollate; microcrystalline cellulose; povidone; titanium dioxide

Laluan pentadbiran:

Oral

Unit dalam pakej:

28's, 30's, 7's (sample)

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Treatment of hypertension.

Ringkasan produk:

Visual Identification: round biconvex yellow coated tablets, scored on one side, marked "L" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2011-07-14

Risalah maklumat

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C: Products/Lercanidipine AN/CMI 29June16
Page
1 of 3
LERCANIDIPINE AN
_Lercanidipine hydrochloride _
_ _
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some of the
common questions about
LERCANIDIPINE AN. It does not
contain all the available information. It
does not replace seeking advice from
your doctor or pharmacist.
PLEASE READ THIS LEAFLET BEFORE YOU
START TAKING LERCANIDIPINE AN.
If you are helping someone else take
LERCANIDIPINE AN, please read
this leaflet before you give the first
dose.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking LERCANIDIPINE AN
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
What LERCANIDIPINE
AN is used for
The name of your medicine is
LERCANIDIPINE AN, which is also
known as lercanidipine.
LERCANIDIPINE AN belongs to a
group of medicines called calcium
channel blockers (of the
dihydropyridine group).
LERCANIDIPINE AN lowers high
blood pressure, which doctors call
hypertension. It works by relaxing
some of the blood vessels in the body
and reducing resistance to the flow of
blood through the blood vessels.
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood pressure
may be different at different times of
the day, depending on how busy or
worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays higher
than is needed, even when you are
calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension is
to have your blood pressure checked
on a regular basis. If high blood
pressure is not treated it can lead to
serious health problems. You may feel
fine and have no symptoms, but
eventually hypertension can cause
stroke, heart disease and ki

Ciri produk

C:Products/Lercan AN/PI June16
Page 1 of 11
PRODUCT INFORMATION
LERCANIDIPINE AN TABLETS 10 MG AND 20 MG
NAME OF THE MEDICINE
PROPRIETARY NAME:
LERCANIDIPINE AN Tablets 10 mg and 20 mg
NON PROPRIETARY NAME:
Lercanidipine hydrochloride tablets 10 mg and 20 mg
CHEMICAL
NAME:
3,5-pyridinedicarboxylic
acid,
1,4-
dihydro-2,
6-dimethyl-4-(3-
nitrophenyl)-2- [(3,3-diphenylpropyl)methylamino]- 1,1-dimethylethyl
methyl ester
hydrochloride.
The chemical structure of lercanidipine hydrochloride is:
.HCl
Molecular formula: C
36
H
41
N
3
O
6
.HCl
MW: 648.2 (free base: 611.7).
CAS: 132866-11-6
DESCRIPTION
Lercanidipine hydrochloride is a microcrystalline, odourless, citrine
powder, readily
soluble in chloroform and methanol, practically insoluble in water.
Octanol: water
partition coefficient (LogP): 6.4.
Lercanidipine is a dihydropyridine derivative. It is a racemate due to
the presence of a
chiral carbon atom at position 4 of the 1,4-dihydropyridine ring.
_ACTIVE _
Lercanidipine hydrochloride
_ _
_ _
_EXCIPENTS _
Lactose, microcrystalline cellulose, sodium starch glycollate,
povidone,
magnesium stearate and the film coating ingredients Opadry II Yellow
85F32553,
which contains polyvinyl alcohol, titanium dioxide, Macrogol 3350,
purified talc and
iron oxide yellow (10 mg) or Opadry II Pink 85F34564, which contains
polyvinyl
alcohol, titanium dioxide, Macrogol 3350, purified talc and iron oxide
red (20 mg).
C:Products/Lercan AN/PI June16
Page 2 of 11
PHARMACOLOGY
_PHARMACODYNAMIC _
_PROPERTIES._
Lercanidipine
is
a
calcium
antagonist
of
the
dihydropyridine group and selectively inhibits the transmembrane
influx of calcium
into cardiac and vascular smooth muscle, with a greater effect on
vascular smooth
muscle than on cardiac smooth muscle. The antihypertensive action is
due to a direct
relaxant effect on vascular smooth muscle which lowers total
peripheral resistance
and hence blood pressure. Lercanidipine has a prolonged
antihypertensive activity
because of its high membrane partition coefficient. It is devoid of
negative inot