Zanidip 20mg, film-coated tablet

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

Lercanidipine

MAH:

ABBOTT LABORATORIES (M) SDN. BHD.

INN:

Lercanidipine

units_in_package:

28Tablet Tablets; 100 Tablet Tablets

manufactured_by:

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.

PIL

_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 angi

SPC

1. TRADE NAME OF THE MEDICINAL PRODUCT
ZANIDIP 20 mg Film -Coated Tablet
2. ACTIVE INGREDIENT COMPOSITION
Lercanidipine 18.8mg (equivalent to 20mg lercanidipine hydrochloride). For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet. Pink, circular, biconvex tablets, scored on one side.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
ZANI DIP 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 2 0mg depending on the individual patient’s response. Dose titration should be gradual, as it
may take about 2 weeks before the maximal antihypertensive effect is apparent. Some individuals, not
adequately controlled on a single antihypertensive agent, may b enefit 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 platea u 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 requi red, 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