LECALPIN

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

LERCANIDIPINE HCI

Saatavilla:

Actavis Group PTC ehf

ATC-koodi:

C08CA13

INN (Kansainvälinen yleisnimi):

LERCANIDIPINE HCI

Annos:

10 Milligram

Lääkemuoto:

Film Coated Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

lercanidipine

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2009-09-11

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LECALPIN 10 MG FILM-COATED TABLETS
LECALPIN 20 MG FILM-COATED TABLETS
Lercanidipine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Lecalpin is and what it is used for
2.
What you need to know before you take Lecalpin
3.
How to take Lecalpin
4.
Possible side effects
5.
How to store Lecalpin
6.
Contents of the pack and other information
1.
WHAT LECALPIN IS AND WHAT IT IS USED FOR
Lecalpin belongs to a group of medicines called calcium channel
blockers that block the entry of
calcium into the muscle cells of the heart and the blood vessels that
carry blood away from the heart
(the arteries). It is the entry of calcium into these cells that
causes the heart to contract and arteries to
narrow. By blocking the entry of calcium, calcium channel blockers
decrease contraction of the heart
and dilate (widen) the arteries, and the blood pressure is reduced.
Lecalpin has been prescribed to you to treat your high blood pressure,
also known as hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LECALPIN
DO NOT TAKE LECALPIN
-
if you are allergic to lercanidipine or any of the other ingredients
of this medicine ( listed in
section 6).
-
if you have had allergic reactions to medicines that are closely
related to Lecalpin tablets (such
as amlodipine, nicardipine, felodipine, isradipine, nifedipine or
lacidipine)
-
if you are suffering from certain heart diseases:
-
uncontrolled cardiac failure
-
an obstruction to flow of blood from the heart
-
unstab

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lecalpin 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.
Excipient with known effect:
Lecalpin 10 mg film
-
coated tablet: Lactose monohydrate 30 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film
-
coated tablet
Lecalpin 10 mg film-coated tablet: Yellow, round, biconvex 6.5 mm film
-
coated tablets, scored on one side, marked 'L'
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
Lecalpin is indicated for the treatment of mild to moderate essential
hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Route of administration: For oral use.
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
lercandipine to therapy with a beta
-
adrenoreceptor blocking drug, a diuretic (hydrochlorothiazide) or an
angiotensin
converting enzyme inhibitor.
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_
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.
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