LERCANIDIPINE TEVA PHARMA 10 Milligram Film Coated Tablet

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

LERCANIDIPINE HYDROCHLORIDE

Предлага се от:

Teva Pharma B.V.

АТС код:

C08CA13

INN (Международно Name):

LERCANIDIPINE HYDROCHLORIDE

дозиране:

10 Milligram

Лекарствена форма:

Film Coated Tablet

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Dihydropyridine derivatives

Статус Оторизация:

Authorised

Дата Оторизация:

2013-01-18

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LERCANIDIPINE TEVA PHARMA 10 MG FILM-COATED TABLETS
LERCANIDIPINE TEVA PHARMA 20 MG FILM-COATED TABLETS
Lercanidipine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Lercanidipine Teva Pharma is and what it is used for
2.
Before you take Lercanidipine Teva Pharma
3.
How to take Lercanidipine Teva Pharma
4.
Possible side effects
5.
How to store Lercanidipine Teva Pharma
6.
Further information
1.
WHAT LERCANIDIPINE TEVA PHARMA IS AND WHAT IT IS USED FOR
Lercanidipine Teva Pharma belongs to a group of medicines called
calcium channel blockers
(dihydropyridine derivatives).
Lercanidipine Teva Pharma is used to treat 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.
BEFORE YOU TAKE LERCANIDIPINE TEVA PHARMA
DO NOT TAKE LERCANIDIPINE TEVA PHARMA
-
If you are ALLERGIC (hypersensitive) to lercanidipine or to any OF THE
INGREDIENTS in
Lercanidipine Teva Pharma
-
If you have had ALLERGIC REACTIONS to medicines that are closely
related to Lercanidipine Teva
Pharma (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 a heart attack
-
If you have SEVERE LIVER OR KIDNEY PROBLEMS
-
If you are taking medicines that are inhibitors of the CYP3A4
isoenzyme: antifungal medicines
(such as ketoconazole or

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercanidipine Teva Pharma 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 10 mg of lercanidipine hydrochloride, which is
equivalent to 9.4 mg of lercanidipine.
_Excipients_
One tablet contains 30 mg of lactose monohydrate (equivalent to 28.5
mg of lactose anhydrous) and 0.27 mg of
tartrazine aluminium lake (E102).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film_-_coated tablet.
Yellow to dark yellow, round convex film
-
coated tablet debossed with the number "10" on one side and scored on
the
other.
The tablet can be divided into equal halves.
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 route
The tablet should be swallowed with sufficient liquid (_e.g._ a glass
of water).
_Dosage_
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
-
adrenoceptor 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.
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