Zanipress 20mg/10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE

Available from:

Recordati Ireland Limited Raheens East, Ringaskiddy Co. Cork, Ireland

ATC code:

C09BB02

INN (International Name):

ENALAPRIL MALEATE 20 mg LERCANIDIPINE HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ENALAPRIL MALEATE 20 mg LERCANIDIPINE HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2009-03-27

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ZANIPRESS_ 20 MG/10 MG FILM-COATED TABLETS
ENALAPRIL MALEATE/LERCANIDIPINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
_Zanipress_
is and what it is used for
2.
What you need to know before you take
_Zanipress_
3.
How to take
_Zanipress_
4.
Possible side effects
5.
How to store
_Zanipress_
6.
Contents of the pack and other information
1.
WHAT _ZANIPRESS_ IS AND WHAT IT IS USED FOR
_Zanipress_
is a fixed combination of an ACE-inhibitor (enalapril) and a calcium
channel blocker
(lercanidipine), two medicines that lower blood pressure.
_Zanipress_
is used to treat high blood pressure (hypertension) in adult patients
whose blood pressure is
not adequately controlled by enalapril 20 mg alone.
_Zanipress_
should not be used for initial treatment
of hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ZANIPRESS_
DO NOT TAKE _ZANIPRESS_:
•
If you are allergic (hypersensitive) to enalapril maleate or
lercanidipine hydrochloride or to any
other ingredients of this medicine (listed in section 6).
•
If you have ever had an allergic reaction to a type of medicine
similar to those contained in
_Zanipress_
, i.e. medicines called ACE-inhibitors or calcium channel blockers.
•
If you have ever had swelling of your face, lips, mouth, tongue or
throat which caused difficulty in
swallowing or breathing (angioedema) after taking a type of medicine
called ACE-inhibitors, or
when the reason why was not known or it was inherited.
•
If

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_Zanipress_
20 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg enalapril maleate (equivalent
to 15.29 mg enalapril)
and 10 mg lercanidipine hydrochloride (equivalent to 9.44 mg
lercanidipine).
Excipient with known effect:
each tablet contains 92.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, circular, biconvex tablets of 8.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in patients whose blood pressure
is not adequately
controlled by enalapril 20 mg alone.
Fixed combination
_Zanipress_
20 mg/10 mg should not be used for initial treatment of
hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients whose blood pressure is not adequately controlled by
treatment with enalapril 20 mg
alone could either be titrated up to the higher dose of enalapril
monotherapy or switched to
_Zanipress_
20mg/10mg.
Individual
dose
titration
with
the
components
can
be
recommended.
When
clinically
appropriate, direct switch from monotherapy to the fixed combination
may be considered.
Posology
The recommended dose is one tablet once a day at least 15 minutes
before meals.
_Elderly:_
The dose should depend on the patient's renal function (see "Use in
renal impairment").
_ _
_Renal impairment:_
_Zanipress_
is contraindicated in patients with severe renal dysfunction
(creatinine clearance
<30 ml/min) or in patients undergoing haemodialysis (see section 4.3
and 4.4). Particular
caution
is
needed
when
initiating
treatment
in
patients
with
mild
to
moderate
renal
dysfunction.
_Hepatic impairment: _
_Zanipress_
is contraindicated in severe hepatic dysfunction. Particular caution
is needed when
initiating treatment in patients with mild to moderate hepatic
dysfunction.
_ _
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_Paediatric population_
There is no relevant use of
_Zanipress_
in the paediatric popu