Lercanidipine 20mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Lercanidipine hydrochloride

Dostupné z:

Mawdsley-Brooks & Company Ltd

ATC kód:

C08CA13

INN (Medzinárodný Name):

Lercanidipine hydrochloride

Dávkovanie:

20mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02060200

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LERCANIDIPINE HYDROCHLORIDE 10 MG
FILM-COATED TABLETS
LERCANIDIPINE HYDROCHLORIDE 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.
IN THIS LEAFLET:
1. What Lercanidipine Hydrochloride is and what
it is used for
2. What you need to know before you take
Lercanidipine Hydrochloride
3. How to take Lercanidipine Hydrochloride
4. Possible side effects
5. How to store Lercanidipine Hydrochloride
6. Contents of the pack and other information
1. WHAT LERCANIDIPINE HYDROCHLORIDE IS AND WHAT
IT IS USED FOR
Lercanidipine Hydrochloride 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.
This medicine has been prescribed to you to treat
your high blood pressure, also known
as hypertension.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LERCANIDIPINE HYDROCHLORIDE
DO NOT TAKE LERCANIDIPINE HYDROCHLORIDE
• if you are allergic to lercanidipine or to any of the
ingredients in this medicine (listed in section 6)
• if you have had allergic reactions to medicines
that are closely related to lercanidipine (such as
amlodipine, nicardipine,

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lercanidipine
Hydrochloride
20 mg film-coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg lercanidipine hydrochloride,
equivalent to 18.8 mg lercanidipine.
Excipient with known effect:
Each 20 mg film-coated tablet contains 60 mg Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
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
Lercanidipine Hydrochloride 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-
adrenoreceptor blocking drug, a diuretic (hydrochlorothiazide) or an
angiotensin converting enzyme inhibitor.
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 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 _
Lercanidipine is not recommended for use in children and adolescents
below
the age of 18 years as there is no clinical experience.
_Renal or hepatic insufficiency _
Special care should be exercised when treatment is commenced