LERCANIDIPINE GH 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:

Southern Cross Pharma Pty Ltd

INN (International Name):

Lercanidipine hydrochloride

Patient Information leaflet

LERCANIDIPINE GH CMI v0.3
C:Products/Lercan/CMI GH June 2016
29/06/16
Page 1 of 6
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CONSUMER MEDICINE INFORMATION
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LERCANIDIPINE GH
_LERCANIDIPINE HYDROCHLORIDE TABLETS _
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WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Lercanidipine
GH. 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 GH.
If you are helping someone else take Lercanidipine GH, 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 GH
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 GH IS USED FOR
The name of your medicine is Lercanidipine GH, which is also known as
lercanidipine. Lercanidipine GH
belongs to a group of medicines called calcium channel blockers (of
the dihydropyridine group).
Lercanidipine GH 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 kidney failure. Lercanidipine GH helps

Summary of Product characteristics

LERCANIDIPINE GH PI v0.5 24 June 2016
Page 1 of 10
PRODUCT INFORMATION
LERCANIDIPINE GH
LERCANIDIPINE HYDROCHLORIDE TABLETS
NAME OF THE MEDICINE
The products Lercanidipine GH contain lercanidipine hydrochloride as
the active ingredient.
The chemical structure of lercanidipine hydrochloride is:
.HCl
The chemical name of lercanidipine hydrochloride is
3,5-pyridinedicarboxylic acid, 1,4- dihydro-2, 6-
dimethyl-4-(3-nitrophenyl)-2- [(3,3-diphenylpropyl)methylamino]-
1,1-dimethylethyl methyl ester
hydrochloride.
Molecular formula: C
36
H
41
N
3
O
6
.HCl. Molecular Weight: 648.2 (free base: 611.7). CAS number:
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.
The excipients contained in each of the two strengths of Lercanidipine
GH include lactose, microcrystalline
cellulose, sodium starch glycollate, povidone, magnesium stearate. The
film coating ingredients are: 10 mg
contains polyvinyl alcohol, titanium dioxide, macrogol 3350,
talc–purified and iron oxide yellow CI77492;
20 mg contains polyvinyl alcohol, titanium dioxide, Macrogol 3350,
talc–purified, iron oxide yellow CI77492
and iron oxide red CI77491.
LERCANIDIPINE GH PI v0.5 24 June 2016
Page 2 of 10
PHARMACOLOGY
PHARMACODYNAMICS
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 coefficien