Lercanidipine Mylan 10 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Lercanidipine hydrochloride

זמין מ:

McDermott Laboratories Ltd., T/A Gerard Laboratories

קוד ATC:

C08CA; C08CA13

INN (שם בינלאומי):

Lercanidipine hydrochloride

כמות:

10 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Dihydropyridine derivatives; lercanidipine

מצב אישור:

Not marketed

תאריך אישור:

2011-06-03

עלון מידע

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LERCANIDIPINE MYLAN 10MG FILM-COATED TABLETS
LERCANIDIPINE MYLAN 20MG 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 Mylan is and what it is used for
2.
What you need to know before you take Lercanidipine Mylan
3.
How to take Lercanidipine Mylan
4.
Possible side effects
5.
How to store Lercanidipine Mylan
6.
Contents of the pack and other information
1.
WHAT LERCANIDIPINE MYLAN IS AND WHAT IT IS USED FOR
Lercanidipine Mylan contains the active ingredient lercanidipine.
Lercanidipine belongs to a group of medicines called calcium channel
blockers (dihydropyridine
derivatives) which are used to treat high blood pressure
(hypertension). Lercanidipine works by
opening up the blood vessels and increasing the flow of blood through
them, helping to reduce
pressure.
Lercanidipine Mylan is used to treat high blood pressure in adults
over the age of 18 years (it is not
recommended for children up to 18 years old).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPINE MYLAN
DO NOT TAKE LERCANIDIPINE MYLAN:

if you are allergic to lercanipidine hydrochloride or any other
ingredients of this medicine
(listed in section 6).

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

if you have

מאפייני מוצר

Health Products Regulatory Authority
31 March 2021
CRN00C31D
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercanidipine Mylan 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of lercanidipine hydrochloride,
which is equivalent to 9.4 mg of lercanidipine.
Excipient with known effect: each film-coated tablet contains 25.0 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film_-_coated tablet.
Yellowish brown, round, biconvex film-coated tablet debossed with
“LR over 1” on one side of the tablet and with a deep score
line 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 Mylan 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 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
Mylan to therapy with a beta-adrenoreceptor 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 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 elderly.
_Paediatric population_
The safety and efficacy of Lercanidip