Lercanidipine 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lercanidipine hydrochloride

Available from:

Teva UK Ltd

ATC code:

C08CA13

INN (International Name):

Lercanidipine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5017007064251

Patient Information leaflet

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 LERCANIDIPINE HYDROCHLORIDE
TABLETS ARE AND WHAT THEY ARE 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 LERCANIDIPINE HYDROCHLORIDE
TABLETS ARE AND WHAT THEY ARE USED
FOR
Lercanidipine 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.
Lercanidipine 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 LERCANIDIPINE IF YOU:
• are ALLERGIC to lercanidipine or any of the
other ingredients of this medicine (listed
in section 6).
• have HAD ALLERGIC REACTIONS to
medicines that are closely related to
Lercanidipine hydrochloride tablets (such
as amlodipine, nicardipine, felodipine,
isradipine, nifedipine or lacidipine)
• 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)
• have had a heart attack le

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lercanidipine
Hydrochloride
10 mg film-coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg lercanidipine hydrochloride,
equivalent to 9.4 mg lercanidipine.
Excipient with known effect:
Each 10 mg film-coated tablet contains 30mg Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex 6.5 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