ZANIDIP 10MG FILM COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LERCANIDIPINE HYDROCHLORIDE

Boleh didapati daripada:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

LERCANIDIPINE HYDROCHLORIDE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

RECORDATI CHIMICA E FARMACEUTICA S.P.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ZANIDIP FILM-COATED TABLETS
Lercanidipine hydrochloride (10mg, 20mg)
Page no.
WHAT IS IN THIS LEAFLET
1. What Zanidip is used for
2. How Zanidip works
3. Before you use Zanidip
4. How to use Zanidip
5. While you are using it
6. Side effects
7. Storage and disposal of Zanidip
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT ZANIDIP
IS USED FOR
Zanidip is used to treat high blood
pressure also known as hypertension
in adults over the age of 18 years (it
is not recommended for children
under 18 years old)
HOW ZANIDIP WORKS
Zanidip belongs to a group of
medicines called Calcium Channel
Blockers (dihydropyridine
derivatives).
BEFORE YOU USE ZANIDIP
_- When you must not use it_
•
If you are allergic to
lercanidipine hydrochloride
or any of the ingredients
listed at the end of this
leaflet
•
You have had allergic
reactions to drugs closely
related to Zanidip tablets
(such as amlodipine,
nicardipine, felodipine,
isradipine, nifedipine or
lacidipine)
•
If you are suffering from
certain heart diseases:
o
Untreated heart failure
o
Obstruction to flow of
blood from the heart
o
Unstable angina (angina
at rest or progressively
increasing)
o
Within one month of
heart attack
•
You have severe liver or
kidney problems
•
You are taking drugs that are
inhibitors of CYP3A4
isoenzyme:
o
Antifungal medicines
(such as ketoconazole or
itraconazole)
o
Macrolide antibiotics
(such as erythromycin or
troleandomycin)
o
Antivirals (such as
ritonavir)
•
You are taking another drug
called ciclosporin or
cyclosporin (used after
transplants to prevent organ
rejection).
•
With grapefruit or grapefruit
juice.
Do not use if you are pregnant or
breastfeeding (see Pregnancy and
Breastfeeding section for more
information).
_- Before you start to use it_
Take special care with Zanidip and
tell your doctor if:
•
You have certain other heart
conditions which have not
been treated by insertion of a
pacemaker or have pre-
existing angina
•

Ciri produk

1. TRADE NAME OF THE MEDICINAL PRODUCT
ZANIDIP 10 mg film-coated tablets
2. ACTIVE INGREDIENT COMPOSITION
Lercanidipine 9.4 mg (equivalent to 10mg lercanidipine hydrochloride).
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet. Yellow, circular, biconvex tablets, scored on one
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZANIDIP is indicated in adults for the treatment of mild to moderate
essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 10mg orally once a day at least 15 minutes
before meals; the dose may be
increased to 20mg depending on the individual patient’s response.
Dose titration should be gradual, because
it may take about 2 weeks before the maximal antihypertensive effect
is apparent. Some individuals, not
adequately controlled on a single antihypertensive agent, may benefit
from the addition of ZANIDIP to
therapy
with
a
beta-adrenoceptor
blocking
drug
(atenolol),
a
diuretic
(hydrochlorothiazide)
or
an
angiotensin converting enzyme inhibitor (captopril or enalapril).
Since the dose-response curve is steep with a plateau at doses between
20-30mg, it is unlikely that efficacy
will be improved by higher doses; whereas side effects may increase.
_USE IN ELDERLY:_
although the pharmacokinetic data and clinical experience suggest that
no adjustment of the
daily dosage is required, special care should be exercised when
initiating treatment in the elderly.
_USE IN CHILDREN:_
Not recommended since there is no clinical experience in patients
under the age of 18years
_USE IN RENAL/HEPATIC DYSFUNCTION:_
special care should be exercised when treatment is commenced in
patients with mild to moderate renal or hepatic dysfunction. Caution
is necessary when increasing the daily
dose to 20mg. The antihypertensive effect may be enhanced in patients
with hepatic impairment and
consequently an adjustment of the dosage should be considered. ZANIDIP
is not recommended for use in
patients with severe hepatic or renal impairment (GFR<30ml