Lercanidipine Clonmel 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lercanidipine hydrochloride

Available from:

Clonmel Healthcare Ltd

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:

2010-03-19

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
LERCANIDIPINE CLONMEL 10MG FILM-COATED TABLETS
LERCANIDIPINE CLONMEL 20MG FILM-COATED TABLETS
ACTIVE SUBSTANCE: 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 Lercanidipine Clonmel is and what it is used for
2.
What you need to know before you take Lercanidipine Clonmel
3.
How to take Lercanidipine Clonmel
4.
Possible side effects
5.
How to store Lercanidipine Clonmel
6.
Contents of the pack and other information
1. WHAT LERCANIDIPINE CLONMEL IS AND WHAT IT IS USED FOR
Lercanidipine Clonmel is a selective calcium channel blocker belonging
to a group of medicines
called dihydropyridines. Selective calcium channel blockers reduce
high blood pressure. They work
by relaxing and thus widening the blood vessels.
LERCANIDIPINE CLONMEL IS USED TO:

treat mild to moderate high blood pressure (essential hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPINE CLONMEL
DO NOT TAKE LERCANIDIPINE CLONMEL

if you are allergic to lercanidipine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)

if you have had allergic reactions to medicines closely related to
Lercanidipine Clonmel (such as
amlodipine, nicardipine, felodipine, isradipine, nifedipine or
lacidipine)

if you are pregnant or breast-feeding or if you might become pregnant
(see section 2. Pregnancy
and breast-feeding)

if you are suffering from certain heart diseases:

uncontrolled cardiac failure

Summary of Product characteristics

Health Products Regulatory Authority
31 July 2020
CRN009W4V
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercanidipine Clonmel 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 20 mg of lercanidipine hydrochloride as
lercanidipine hydrochloride hemihydrate. This is equivalent to
18.8 mg of lercanidipine.
Excipient with known effect:
Each film-coated tablet contains 73.1 mg lactose-monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film_-_coated tablet
Pink, round, biconvex film-coated tablets of 8.1 mm with score line.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lercanidipine is indicated for the treatment of mild to moderate
essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Oral use
The tablet should be swallowed with a sufficient amount of fluid (e.g.
one glass of water). The recommended dosage is 10 mg
once a day at least 15 minutes before meals (preferably before
breakfast); the dose may be increased to 20 mg depending on
the individual patient's response.
The tablets can be divided into equal halves. The remaining tablet
half should be stored protected from light. This remaining
half should be taken with the next dose.
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 lercanidipine
to therapy with a beta-blocking agent (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.
_Older people_
Although the pharmacokinetic data and clinical experience suggest that
no adjustment of the daily dosage