LERCANIDIPINE SANDOZ lercanidipine hydrochloride 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lercanidipine hydrochloride

Available from:

Mylan Health Pty Ltd

INN (International Name):

Lercanidipine hydrochloride

Authorization status:

Registered

Patient Information leaflet

LERCANIDIPINE
SANDOZ
_Lercanidipine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
Lercanidipine Sandoz. 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 SANDOZ.
If you are helping someone else take
Lercanidipine Sandoz, 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
Sandoz 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
SANDOZ IS USED FOR
The name of your medicine is
Lercanidipine Sandoz, which is also
known as lercanidipine.
Lercanidipine Sandoz belongs to a
group of medicines called calcium
channel blockers (of the
dihydropyridine group).
Lercanidipine Sandoz 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 Sandoz
helps lower your blood pressure.
Lercanidipine Sandoz cannot be
obtained

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LERCANIDIPINE SANDOZ
_Lercanidipine hydrochloride tablets _
1
NAME OF THE MEDICINE
Lercanidipine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lercanidipine hydrochloride is a microcrystalline, odourless, citrine
powder.
Each
Lercanidipine
Sandoz
10 mg
tablet contains
9.4 mg of lercanidipine (present as lercanidipine
hydrochloride 10 mg) as the active ingredient.
Each Lercanidipine Sandoz 20 mg tablet contains 18.8 mg of
lercanidipine (present as lercanidipine
hydrochloride 20 mg) as the active ingredient.
Excipients with known effect: Lercanidipine Sandoz also contains
lactose, see
SECTION 4.4 - SPECIAL
WARNINGS
AND PRECAUTIONS FOR USE
.
For the full list of excipients, see
SECTION 6.1 - LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Lercanidipine Sandoz 10 mg tablet is available as a yellow, round,
scored, film-coated tablet.
Lercanidipine Sandoz 20 mg tablet is available as a pink, circular,
biconvex, film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lercanidipine Sandoz is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 10 mg once daily, at least 15 minutes before a
meal. The dose may be increased to
20 mg once daily depending on the individual response. Dose titration
should be gradual, as it may take about
2 weeks for the maximal antihypertensive effect to be apparent.
Titration may proceed more rapidly, however,
if clinically warranted, provided the patient is assessed frequently.
Since it is unlikely that increasing the dose
beyond 20 mg will further improve the efficacy, and may be associated
with side effects, doses above 20 mg
are not recommended. Some individuals not adequately controlled on a
single antihypertensive agent may
benefit from the addition of lercanidipine at the same doses used in
monotherapy to the existing regimen with
a beta-blocker, a diuretic or an ACE inhibitor.
Use in elderly, children, hepatic and renal impairment: see
SECTION 4.4 - SPECIAL WARNINGS AND PRECAUTIO