Lercanidipine Teva 10 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lercanidipine hydrochloride

Available from:

Teva Pharma B.V.

ATC code:

C08CA; C08CA13

INN (International Name):

Lercanidipine hydrochloride

Dosage:

10 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:

2010-07-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LERCANIDIPINE TEVA 10 MG FILM-COATED TABLETS
LERCANIDIPINE TEVA 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 Lercanidipine Teva is and what it is used for
2.
What you need to know before you take Lercanidipine Teva
3.
How to take Lercanidipine Teva
4.
Possible side effects
5.
How to store Lercanidipine Teva
6.
Contents of the pack and other information
1. WHAT LERCANIDIPINE TEVA IS AND WHAT IT IS USED FOR
Lercanidipine
Teva
belongs
to
a
group
of
medicines
called
calcium
channel
blockers
(dihydropyridine derivatives). Lercanidipine Teva is used to treat
mild to moderate
HIGH BLOOD
PRESSURE
also known as hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPINE TEVA
DO NOT TAKE LERCANIDIPINE TEVA:
•
if you are
ALLERGIC
(hypersensitive) to lercanidipine hydrochloride or to
ANY OF THE OTHER
INGREDIENTS
of this medicine (listed in section 6)
2
•
if you have had
ALLERGIC REACTIONS
to medicinal products closely related to Lercanidipine
Teva (such as amlodipine, nicardipine, felodipine, isradipine,
nifedipine or lacidipine)
•
if you are suffering from
CERTAIN HEART DISEASES
:
-
untreated heart failure
-
obstruction to flow of blood from the heart
-
unstable angina (angina at rest or progressively increasing)
-
within one month of heart attack
•
if you have
SEVERE LIVER OR KIDNEY PROBLEMS
•
if you are taking
MEDICINAL PRODUCTS
that are inhibitors of CYP3A4 isoenzyme:
-
antifu

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2019
CRN009CMX
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercanidipine Teva 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg lercanidipine hydrochloride,
equivalent to 9.4 mg lercanidipine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round shaped biconvex, film-coated tablet of 6.5 mm diameter,
with score line on one side and plain on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lercanidipine Teva is indicated for the treatment of mild to moderate,
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 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 adverse reactions may increase.
_USE IN OLDER PEOPLE:_
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 older
people.
Lercanidipine Teva is not recommended for use in children below 18
years due to a lack of data on safety and efficacy.
_USE IN RENAL OR HEPATIC IMPAIRMENT:_
Special care should be exercised when treatment is comm