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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enalapril maleate; Lercanidipine

Available from:

KRKA, d.d., Novo mesto

ATC code:

C09BB; C09BB02

INN (International Name):

Enalapril maleate; Lercanidipine

Dosage:

10/10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Authorization status:

Marketed

Authorization date:

2013-08-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL/LERCANIDIPINE KRKA 10 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
lercanidipine 10 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
ca

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2022
CRN00CVD5
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enalapril/Lercanidipine Krka 10mg/10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg enalapril maleate (equivalent
to 7.64 mg enalapril) and 10 mg lercanidipine
hydrochloride (equivalent to 9.44 mg lercanidipine).
Excipients with known effect: lactose monohydrate
Each film-coated tablet contains 317 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are white, 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 lercanidipine 10 mg
alone.
Fixed combination Enalapril/Lercanidipine Krka 10 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
lercanidipine 10 mg alone could either be titrated up to
lercanidipine 20 mg monotherapy or switched to fixed combination
Enalapril/Lercanidipine Krka 10 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