Zanipress 20mg/20mg film-coated Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Malta Medicines Authority

Viambatanisho vya kazi:

ENALAPRIL MALEATE, LERCANIDIPINE HYDROCHLORIDE

Inapatikana kutoka:

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

ATC kanuni:

C09BB02

INN (Jina la Kimataifa):

ENALAPRIL MALEATE 20 mg LERCANIDIPINE HYDROCHLORIDE 20 mg

Dawa fomu:

FILM-COATED TABLET

Tungo:

ENALAPRIL MALEATE 20 mg LERCANIDIPINE HYDROCHLORIDE 20 mg

Dawa ya aina:

POM

Eneo la matibabu:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Idhini hali ya:

Authorised

Idhini ya tarehe:

2014-05-15

Taarifa za kipeperushi

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ZANIPRESS_ 20 MG/20 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 maleate) and a
calcium channel blocker
(lercanidipine hydrochloride), two medicines that lower blood
pressure.
_Zanipress_
is used to treat high blood pressure (hypertension) in adult patients
who are currently taking
enalapril and lercanidipine as separate tablets.
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 you have taken or are currently taking sacubitril

Tabia za bidhaa

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_Zanipress_
20 mg/20 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
20 mg lercanidipine hydrochloride (equivalent to 18.88 mg
lercanidipine).
Excipient with known effects:
each tablet contains 204 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, circular, biconvex, tablets of 12 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension as substitution therapy in adult
patients whose blood
pressure is adequately controlled
with enalapril 20 mg lercanidipine 20 mg and given
concurrently as separate tablets.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet once a day at least 15 minutes
before a meal.
_ _
_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.
_Paediatric population: _
There is no relevant use of
_Zanipress_
in the paediatric population in the indication of
hypertension.
Method of administration
_Precautions to be taken before handling or administering the
medicinal product_
:
-
Treatment should be preferably administered in the morning at least 15
minutes before
breakfast.
-
This product should not be administered with grapefruit juice (see
section 4.3 and 4.5).
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4.3
CONTRAINDICATIONS
•
Hypersensitivity to any ACE-inh