Enalapril/Lercanidipine Krka 20mg/10mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Enalapril maleate; Lercanidipine

Fáanlegur frá:

KRKA, d.d., Novo mesto

ATC númer:

C09BB; C09BB02

INN (Alþjóðlegt nafn):

Enalapril maleate; Lercanidipine

Skammtar:

20/10 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Leyfisstaða:

Marketed

Leyfisdagur:

2013-08-09

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL/LERCANIDIPINE KRKA 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 Enalapril/Lercanidipine Krka is and what it is used for
2.
What you need to know before you take Enalapril/Lercanidipine Krka
3.
How to take Enalapril/Lercanidipine Krka
4.
Possible side effects
5.
How to store Enalapril/Lercanidipine Krka
6.
Contents of the pack and other information
1.
WHAT ENALAPRIL/LERCANIDIPINE KRKA IS AND WHAT IT IS USED FOR
Enalapril/Lercanidipine Krka is a fixed combination of an
ACE-inhibitor (enalapril) and a calcium
channel blocker (lercanidipine), two medicines that lower blood
pressure.
Enalapril/Lercanidipine Krka is used for the treatment of high blood
pressure (hypertension) in
patients whose blood pressure is not adequately controlled by
enalapril 20 mg alone.
Enalapril/Lercanidipine Krka should not be used for initial treatment
of hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL/LERCANIDIPINE KRKA
DO NOT TAKE ENALAPRIL/LERCANIDIPINE KRKA
-
if you are allergic to enalapril or lercanidipine or any of the other
ingredients of this medicine
(listed in section 6);
-
if you have ever had an allergic reaction to a type of medicines
similar to those contained in
Enalapril/Lercanidipine Krka, i.e. medicines called ACE-inhibitors or
calcium channel blockers;
-
if you have ever developed angioedema (oedema of the face, lips,
mouth, tongue or throat)
which caused

Vara einkenni

Health Products Regulatory Authority
06 April 2022
CRN00CW2V
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enalapril/Lercanidipine Krka 20mg/10mg 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).
Excipients with known effect: lactose monohydrate
Each film-coated tablet contains 307 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are yellow, round, slightly biconvex with
bevelled edges, tablet diameter 10 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 Enalapril/Lercanidipine Krka 20 mg/10 mg should not
be used for initial treatment of hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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
Enalapril/Lercanidipine Krka 20 mg/10 mg.
Individual dose titration with the components can be recommended. When
clinically appropriate, direct switch from
monotherapy to the fixed combination may be considered.
The recommended dose is one tablet once a day at least 15 minutes
before meals.
_Special populations_
_Elderly_
The dose should depend on the patient's renal function (see section
4.4, "Renal impairment").
_Renal impairment_
Enalapril/Lercanidipine Krka is contraindicated in patients with
severe renal dysfunction (creatinine clearance <30 ml/min) or in
patients undergoing haemodialysis (see sections 4.3 and 4.4).
Particular caution is needed when initiating treatment in patients
with mild to moderate (creatinine clearance: 30‑60 ml/min) renal
dysfunction.
_Hepatic impairment _
E