Lercanidipine HCl 20 mg Teva, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LERCANIDIPINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; LERCANIDIPINE

Beschikbaar vanaf:

Teva Nederland B.V.

ATC-code:

C08CA13

INN (Algemene Internationale Benaming):

LERCANIDIPINEHYDROCHLORIDE COMPOSITION corresponding to ; LERCANIDIPINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lercanidipine

Product samenvatting:

Hulpstoffen: ALLURAROOD AC ALUMINIUM LAK (E 129); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-07-20

Bijsluiter

Lercanidipine hydrochloride 10 & 20 mg Film-coated Tablets
UK/H/4385/001-002/DC
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lercanidipine HCl 10 mg Teva, filmomhulde tabletten
Lercanidipine HCl 20 mg Teva, filmomhulde tabletten
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 of the 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
belongs to a group of medicines called
calcium channel blockers
(dihydropyridine derivatives).
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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
-
If you are ALLERGIC (hypersensitive) to lercanidipine or to 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 (such as amlodipine, nicardipine, felodipine,
isradipine, nifedipine or lacidipine)
-
If you are suffering from CERTAIN HEART DISEASES:
-
untreated heart failure
-
obstruction to flow of blo

Productkenmerken

Lercanidipine hydrochloride 10 & 20 mg Film-coated Tablets
UK/H/4385/001-002/DC
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lercanidipine HCl 10 mg Teva, filmomhulde tabletten
Lercanidipine HCl 20 mg Teva, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg strength: One tablet contains 10 mg of lercanidipine
hydrochloride, which is equivalent to
9.4 mg of lercanidipine.
20 mg strength: One tablet contains 20 mg of lercanidipine
hydrochloride, which is equivalent to
18.8 mg of lercanidipine.
_Excipients with known effects _
10 mg strength: 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).
20 mg strength: One tablet contains 60 mg of lactose monohydrate
(equivalent to 57 mg of lactose
anhydrous) and 0.711 mg of allura red AC aluminium lake (E129).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film_-_coated tablet.
10 mg strength: Yellow to dark yellow, round convex film-coated tablet
debossed with the number
"10" on one side and scored on the other.
20 mg strength: Light pink to pink, round convex film-coated tablet
debossed with the number "20" on
one side and scored on the other
The tablet 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
_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 to therapy with a beta-adrenoceptor blocking
agent (atenolol), a diuretic
(hydrochlorothiazide) or an angiotensin-converting