Lerkanidipin Orifarm 20 mg Filmdragerad tablett

Nchi: Uswidi

Lugha: Kiswidi

Chanzo: Läkemedelsverket (Medical Products Agency)

Viambatanisho vya kazi:

lerkanidipinhydroklorid, vattenfri

Inapatikana kutoka:

Orifarm AB

ATC kanuni:

C08CA13

INN (Jina la Kimataifa):

lercanidipine hydrochloride, anhydrous

Kipimo:

20 mg

Dawa fomu:

Filmdragerad tablett

Tungo:

laktosmonohydrat Hjälpämne; lerkanidipinhydroklorid, vattenfri 20 mg Aktiv substans

Dawa ya aina:

Receptbelagt

Bidhaa muhtasari:

Förpacknings: Blister, 100 tabletter

Idhini hali ya:

Avregistrerad

Idhini ya tarehe:

2016-11-23

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LERKANIDIPIN ACTAVIS 10 MG FILM-COATED TABLETS
LERKANIDIPIN ACTAVIS 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
/.../
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 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.
/.../
has been prescribed to you to treat your high blood pressure, also
known as hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE /.../
DO NOT TAKE /.../
-
if you are allergic to lercanidipine or any of the other ingredients
of this medicine ( listed in
section 6).
-
if you are suffering from certain heart diseases:
-
uncontrolled cardiac failure
-
an obstruction to flow of blood from the heart
-
unstable angina (angina at rest or progressively increasing)
-
if you have had heart attack less than one month ago
-
if you have severe liver problem
-
if you have severe kidney problems

Tabia za bidhaa

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Lerkanidipin Actavis 10 mg film-coated tablet
Lerkanidipin Actavis 20 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg lercanidipine hydrochloride,
equivalent to 9.4 mg lercanidipine.
One film-coated tablet contains 20 mg lercanidipine hydrochloride,
equivalent to 18.8 mg
lercanidipine.
Excipient with known effect:
/.../ 10 mg film-coated tablet: Lactose monohydrate 30 mg
Excipient with known effect:
/.../ 20 mg film-coated tablet: Lactose monohydrate 60 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
/.../ 10 mg film-coated tablet: Yellow, round, biconvex 6.5 mm
film-coated tablets, scored on one side,
marked 'L' on the other side.
/.../ 20 mg film-coated tablet: Pink, round, biconvex 8.5 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
/.../ 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 lercandipine to therapy with a beta-adrenoceptor blocking
drug (atenolol), a diuretic
(hydrochlorothiazide) or an angiotensin converting enzyme inhibitor
(captopril or enalapril).
2
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