VASODIP COMBO 10

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ENALAPRIL MALEATE; LERCANIDIPINE HYDROCHLORIDE

Available from:

DEXCEL LTD, ISRAEL

ATC code:

C09AA02

Pharmaceutical form:

TABLETS

Composition:

LERCANIDIPINE HYDROCHLORIDE 10 MG; ENALAPRIL MALEATE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DEXCEL LTD, ISRAEL

Therapeutic group:

ENALAPRIL

Therapeutic area:

ENALAPRIL

Therapeutic indications:

Treatment of essential hypertension in patients whose blood pressure cannot be adequately controlled under Lercanidipine monotherapy.

Authorization date:

2014-06-30

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
® COMBO 10, 20, TABLETS
Each tablet contains Lercanidipine hydrochloride 10 mg and Enalapril
maleate 10 mg or 20 mg
respectively.
Inactive ingredients and allergens in the medicine
–
see section 6 “Additional information” and
in section 2 “Important information about some of the ingredients of
the medicine”.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
ask the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it to others.
It may harm them, even if
it seems that their medical condition is similar to yours.
VASODIP COMBO is not intended for primary treatment of hypertension.
1. WHAT IS THE MEDICINE INTENDED FOR?

VASODIP COMBO 10 is used for the treatment of hypertension in patients
whose blood
pressure is not adequately controlled by treatment with Lercanidipine
alone.

VASODIP COMBO 20 is used for the treatment of hypertension in patients
whose blood
pressure is not adequately controlled by treatment with Enalapril
alone.
THERAPEUTIC GROUP:

Enalapril belongs to the group of angiotensin-converting enzyme (ACE)
inhibitors.

Lercanidipine belongs to the group calcium channel blockers.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredients (Enalapril
maleate or
Lercanidipine hydrochloride) or to any of the other ingredients this
medicine
contains (see section 6).

You have ever had an allergic reaction to a type of medicine similar
to those
contained in VASODIP COMBO, i.e. medicines called ACE inhibitors or
calcium
channel blockers.

You have ever had swelling of your face, lips, mouth, tongue or throat
which
caused difficulty in swallowing or breathing (angioedema) after taking
an ACE
inhibitor medicine or due to an unknown r

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vasodip Combo 10
Vasodip Combo 20
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vasodip Combo 10:_ _
Each tablet contains 10 mg lercanidipine hydrochloride (equivalent to
9.44 mg lercanidipine)
and 10 mg enalapril maleate (equivalent to 7.64 mg enalapril).
Vasodip Combo 20:_ _
Each tablet contains 10 mg lercanidipine hydrochloride (equivalent to
9.44 mg lercanidipine)
and 20 mg enalapril maleate (equivalent to 15.29 mg enalapril).
Excipients with known effect:
_ _
Vasodip Combo 10: each tablet contains about 97 mg of lactose.
Vasodip Combo 20: each tablet contains about 87 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Vasodip Combo 10:
White, biconvex, round film-coated tablets.
Vasodip Combo 20:
Yellow, biconvex, round film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vasodip Combo 10: Treatment of essential hypertension in patients
whose blood pressure is
not adequately controlled by lercanidipine monotherapy.
Vasodip Combo 20:_ _Treatment of essential hypertension in patients
whose blood pressure is
not adequately controlled by enalapril monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fixed combination Vasodip Combo should not be used for initial
treatment of hypertension.
The combination Vasodip Combo 10 can be given to patients whose blood
pressure cannot
be controlled adequately by treatment with 10 mg lercanidipine alone.
The combination of Vasodip Combo 20 can be given to patients whose
blood pressure
cannot be controlled adequately by treatment with 20 mg enalapril
alone.
2
Individual dose titration with the components can be recommended. When
clinically
appropriate, direct change from monotherapy to the fixed combination
may be considered.
_POSOLOGY _
The recommended dose is 1 tablet taken once daily at least 15 minutes
before a meal._ _
_ELDERLY PATIENTS: _The dose should depend on the patient's renal
function (see "Use in renal
impairment").
_CHILDREN AND A