Lercanidipine HCl STADA 10 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

LERCANIDIPINEHYDROCHLORIDE HEMIHYDRAAT SAMENSTELLING overeenkomend met ; LERCANIDIPINE

Available from:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC code:

C08CA13

INN (International Name):

LERCANIDIPINEHYDROCHLORIDE HEMIHYDRATE COMPOSITION corresponding to ; LERCANIDIPINE

Pharmaceutical form:

Filmomhulde tablet

Composition:

CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Lercanidipine

Product summary:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Authorization date:

2010-01-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Lercanidipine HCI STADA 10 mg [20 mg], filmomhulde tabletten
Active substance: 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 Lercanidipin STADA is and what it is used for
2. What you need to know before you take Lercanidipin STADA
3. How to take Lercanidipin STADA
4. Possible side effects
5. How to store Lercanidipin STADA
6. Contents of the pack and other information
1. WHAT LERCANIDIPIN STADA IS AND WHAT IT IS USED FOR
Lercanidipin STADA is a selective calcium channel blocker belonging to
a group of medicines
called dihydropyridines. Selective calcium channel blockers reduce
high blood pressure. They
work by relaxing and thus widening the blood vessels.
LERCANIDIPIN STADA IS USED TO:

treat mild to moderate high blood pressure (essential hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPIN STADA
DO NOT TAKE LERCANIDIPIN STADA

if you are allergic to lercanidipine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)

if you have had allergic reactions to medicines closely related to
Lercanidipin STADA (such
as amlodipine, nicardipine, felodipine, isradipine, nifedipine or
lacidipine)

if you are pregnant or breast-feeding, or if you might become pregnant
(see section 2.
Pregnancy and breast-feeding)

if you are suffering from certain heart diseases:
-
uncontrolled cardiac failure
-
obstruction to flow of blood from the heart
-
unstable angina (angina at r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lercanidipine HCl STADA 10 mg, filmomhulde tabletten
Lercanidipine HCl STADA 20 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Lercanidipin STADA 10 mg film-coated tablets _
One tablet contains 10 mg of lercanidipine hydrochloride as
lercanidipine hydrochloride
hemihydrate. This is equivalent to 9.4 mg of lercanidipine.
Excipient with known effect:
Each film-coated tablet contains 36.55 mg lactose-monohydrate.
_Lercanidipin STADA 20 mg film-coated tablets _
One tablet contains 20 mg of lercanidipine hydrochloride as
lercanidipine hydrochloride
hemihydrate. This is equivalent to 18.8 mg of lercanidipine.
Excipient with known effect:
Each film-coated tablet contains 73.1 mg lactose-monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film_-_coated tablet
_Lercanidipin STADA 10 mg film-coated tablets _
Yellow, round, biconvex film-coated tablets of 6.5 mm with score line.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
_Lercanidipin STADA 20 mg film-coated tablets _
Pink, round, biconvex film-coated tablets of 8.1 mm with score line.
The tablets can be divided into equal doses.
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 use
The tablet should be swallowed with a sufficient amount of fluid (e.g.
one glass of water). The
recommended dosage is 10 mg once a day at least 15 minutes before
meals (preferably before
breakfast); the dose may be increased to 20 mg depending on the
individual patient's
response.
Lercanidipin STADA 20 mg film-coated tablets
The tablets can be divided into equal halves. The remaining tablet
half should be stored
protected from light. This remaining half should be taken with the
next dose.
Dose titration should be gradual, because it may take about 2