Zanidip 20mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lercanidipine hydrochloride

Available from:

Recordati Industria Chimica e Farmaceutica SpA

ATC code:

C08CA; C08CA13

INN (International Name):

Lercanidipine hydrochloride

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dihydropyridine derivatives; lercanidipine

Authorization status:

Marketed

Authorization date:

2005-08-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANIDIP_ _10 MG FILM-COATED TABLETS
ZANIDIP 20 MG FILM-COATED TABLETS
lercanidipine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again
-
If you have any further questions, ask your doctor or pharmacist
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zanidip is and what it is used for
2.
What you need to know before you take Zanidip
3.
How to take Zanidip
4.
Possible side effects
5.
How to store Zanidip
6.
Contents of the pack and other information
1._ _WHAT ZANIDIP IS AND WHAT IT IS USED FOR_ _
Zanidip, lercanidipine hydrochloride, belongs to a group of medicines
called Calcium Channel
Blockers (dihydropyridine derivatives) that lower blood pressure.
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).
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZANIDIP _ _
DO NOT TAKE ZANIDIP
•
If you are allergic to lercanidipine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
•
If you are suffering from certain heart diseases:
o
obstruction to flow of blood from the heart
o
untreated heart failure
o
unstable angina (chest discomfort occurring at rest or progressively
increasing)
o
wit
hin one month of a heart attack.
• If you have severe liver problems.
• If you have severe kidney problems or you are undergoing dialysis.
• If you are taking medicines that are inhibitors of the hepatic
metabolism, such as:
o
antifungal medicines (such as ketoconazole or itraconazole)
o
macrolide antibiotics (such as erythromycin. tr

Summary of Product characteristics

Health Products Regulatory Authority
01 July 2021
CRN00C0ZG
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZANIDIP 20mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg lercanidipine hydrochloride equivalent to
18.8 mg lercanidipine.
Excipient(s) with known effect:
One film-coated tablet contains 60 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, circular, biconvex tablets of 8.5 mm, scored on one side. The
tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZANIDIP is indicated in adults for the treatment of mild tomoderate
essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 10 mg orally once a day at least 15 minutes
before meals; the dose may be increased to 20 mg
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
20-30 mg, it is unlikely that efficacy will be improved
by higher doses; whereas side effects may increase.
_Elderly patients: _
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.
_Paediatric population:_ the safety and efficacy of ZANIDIP in
children aged up to 18 years have not been established.
No data are available.
_Patients with renal or hepatic impairment: _
special care should be exercised when treatment is commenced in
patients with mild
to moderate