BLOOMS THE CHEMIST LERCANIDIPINE lercanidipine hydrochloride 20 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lercanidipine hydrochloride

Available from:

Apotex Pty Ltd

INN (International Name):

Lercanidipine hydrochloride

Authorization status:

Registered

Patient Information leaflet

BLOOMS THE CHEMIST
LERCANIDIPINE TABLETS
_Contains the active ingredient, lercanidipine (as lercanidipine
hydrochloride)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some of the
common questions about
lercanidipine. It does not contain all
the available information. It does not
replace seeking advice from your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking lercanidipine
against the benefits this medicine is
expected to have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Blooms The Chemist Lercanidipine.
It contains the active ingredient,
lercanidipine (as lercanidipine
hydrochloride).
Lercanidipine belongs to a group of
medicines called dihydropyridine
calcium channel blockers.
Lercanidipine helps lower high blood
pressure, otherwise known as
hypertension.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
This medicine 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. If your
blood pressure stays higher than is
needed, even when you are calm and
relaxed, you have hypertension (high
blood pressure).
There are us

Summary of Product characteristics

Product Information – Australia
BLOOMS THE CHEMIST Lercanidipine Tablets
Page 1
BLOOMS THE CHEMIST LERCANIDIPINE TABLETS
NAME OF THE MEDICINE
Lercanidipine Hydrochloride.
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.
Structural Formula:
HCl
Molecular Formula:
C
36
H
42
ClN
3
O
6
Molecular Weight:
648.2 (free base: 611.7)
CAS Registry Number:
132866-11-6
DESCRIPTION
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.
Lercanidipine hydrochloride is a yellow amorphous powder, readily
soluble in chloroform and methanol,
practically insoluble in water. Octanol:water partition coefficient
(LogP): 6.4.
Each tablet contains 10 mg or 20 mg lercanidipine hydrochloride as the
active ingredient.
In addition, each tablet contains the following inactive ingredients:
Cellulose – microcrystalline , lactose
monohydrate, croscarmellose sodium, butylated hydroxytoluene,
magnesium stearate, hypromellose,
macrogol 8000, titanium dioxide, purified talc, yellow iron oxide (10
mg only) and red iron oxide (20 mg
only).
`
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
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 inotropic effects and its vascular
selectivity is due to its voltage dependent calcium
antagonist activity. Since the vasodilatation induced by lercanidipine
hydrochloride is gradual in onset,
acute hypotension with reflex tachy