Lecalpin 10 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Lercanidipine hydrochloride

Tilgjengelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

C08CA; C08CA13

INN (International Name):

Lercanidipine hydrochloride

Dosering :

10 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Dihydropyridine derivatives; lercanidipine

Autorisasjon status:

Marketed

Autorisasjon dato:

2009-09-11

Informasjon til brukeren

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 (dihydropyridine
derivatives) that lower blood pressure.
Lecalpin is used to treat your 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 LECALPIN
DO NOT TAKE LECALPIN
-
if you are allergic (hypersensitive) to lercanidipine or any of the
other ingredients of this
medicine ( listed in section 6).
-
if you are suffering from certain heart diseases:
-
untreated heart failure
-
an obstruction to flow of blood from the heart
-
unstable angina (chest discomfort occurring at rest or progressively
increasing)
-
within one month of heart attack
-
if you have severe liver problems
-
if you have severe kidney problems or are undergoing dialysis
-
If you are taking medicines that are inhibitors of the hepatic
metabolism, such as:
-
antifungal medicines (such as ketoconazole or intraconazole)
-
macrolide antibiotics (such as erythromycin, troleandomycin or
clarithromycin)
-
an

Preparatomtale

Health Products Regulatory Authority
18 October 2022
CRN00D4ZT
Page 1 of 10
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.
Yellow colored, round shaped, biconvex, coated tablets debossed with
"LT1" on one side and breakline on the other side. The
diameter of tablet is approximately 6.5mm.
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 in adults 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 lercanidipine
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 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 Leca