VASODIP 10

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LERCANIDIPINE HYDROCHLORIDE

Available from:

DEXCEL LTD, ISRAEL

ATC code:

C08CA13

Pharmaceutical form:

TABLETS

Composition:

LERCANIDIPINE HYDROCHLORIDE 10.0 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DEXCEL LTD, ISRAEL

Therapeutic group:

LERCANIDIPINE

Therapeutic area:

LERCANIDIPINE

Therapeutic indications:

Mild to moderate essential hypertension.

Authorization date:

2020-09-30

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS)-1986
This medicine can be sold with a physician's prescription only
VASODIP
® 10, TABLETS
Each tablet contains Lercanidipine hydrochloride 10 mg
Inactive ingredients and allergens in the medicine - see section 6
“Additional
information” and in section 2 “Important information about some of
the
ingredients of this medicine”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains concise information about the medicine. If you have any
further
questions, ask the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems that their medical condition is the same
as yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of mild to moderate high blood pressure.
THERAPEUTIC GROUP: calcium channel blockers of the dihydropyridine
derivative.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredient
(Lercanidipine
hydrochloride) or to any of the other ingredients this medicine
contains
(see section 6).

You suffer from certain heart diseases:
o
obstruction of the blood flow from the heart
o
untreated heart failure
o
unstable angina (angina at rest or progressively increasing)
o
within one month of a heart attack

You suffer from severe liver problems

You suffer from severe kidney problems

You are concomitantly taking medicines that are inhibitors of hepatic
metabolism, such as:
o
antifungal medicines (such as ketoconazole or itraconazole)
o
antibiotics of the macrolide group (such as erythromycin,
troleandomycin or clarithromycin)
o
antiviral medicines (such as ritonavir)

You are taking another medicine called ciclosporin (used after
transplants to prevent organ rejection)

You consume grapefruits or grapefruit juice.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE THE TREATMENT WITH VASODIP, TELL THE DOCTOR IF:

You suffer from a heart

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
VASODIP
®
10
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg lercanidipine hydrochloride (equivalent to
9.4 mg lercanidipine).
Excipient with known effect:
Each tablet contains about 29 mg Lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets. Yellow, circular, biconvex, film-coated tablets, scored on
one side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vasodip 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 Vasodip to therapy with a beta-adrenoceptor blocking drug
(atenolol), a diuretic (hydrochlorothiazide) or an
angiotensin converting enzyme inhibitor (captopril or enalapril).
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 patients:_ 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: _The safety and efficacy of Vasodip in
children aged up to 18 years have not been
established.
No data are available.
_Patients with renal or hepatic impairment: _special care should be
exercised when treatment is commenced in
patients with mild to moderate renal or hepatic dysfunction. Although
the usually recommended dose
schedule may be tolerated by these subgroups, an incre