ARX-LERCANIDIPINE lercanidipine hydrochloride 20 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

lercanidipine hydrochloride, Quantity: 20 mg

Boleh didapati daripada:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Antarabangsa):

Lercanidipine hydrochloride

Borang farmaseutikal:

Tablet, film coated

Komposisi:

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

Laluan pentadbiran:

Oral

Unit dalam pakej:

28 tablets, 7 tablets (sample), 30 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Treatment of hypertension.

Ringkasan produk:

Visual Identification: round biconvex pink 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; Container Closure: Child resistant closure

Status kebenaran:

Licence status A

Tarikh kebenaran:

2011-07-14

Risalah maklumat

LERCANIDIPINE APOTEX TABLETS
1
LERCANIDIPINE APOTEX
TABLETS
_Contains the active ingredient lercanidipine (as 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
Lercanidipine APOTEX. It contains
the active ingredient lercanidipine (as
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 usually no symptoms of

Ciri produk

1
AUSTRALIAN PRODUCT INFORMATION
LERCANIDIPINE APOTEX (LERCANIDIPINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Lercanidipine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg lercanidipine hydrochloride as the
active ingredient.
EXCIPIENTS WITH KNOWN EFFECT: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
10 mg: round biconvex yellow film coated tablets, scored on one side,
marked “L” on the other
side.
20 mg: round biconvex pink film coated tablets, scored on one side,
marked “L” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lercanidipine is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lercanidipine tablets are intended for oral administration.
DOSAGE
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 two 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 THE ELDERLY, CHILDREN, HEPATIC AND RENAL IMPAIRMENT
See Section 4.4 Special Warnings and Precautions for Use.
4.3
CONTRAINDICATIONS
▪
Hypersensitivity to any dihydropyridine or any ingredient in this
medicine (see Section
6.1 List of Excipients)
▪
Left ventricular outflow tract obstruction
▪
Untreated congestive cardiac failure
2
▪
Unstable angina pectoris or recent (within 1 month) my