Lercaril 20 mg/20 mg Film-coated Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Enalapril maleate; Lercanidipine hydrochloride

Tersedia dari:

Recordati Ireland Limited

Kode ATC:

C09BB; C09BB02

INN (Nama Internasional):

Enalapril maleate; Lercanidipine hydrochloride

Dosis:

20 mg/20 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Status otorisasi:

Marketed

Tanggal Otorisasi:

2014-07-11

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
LERCARIL 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 Lercaril is and what it is used for
2.
What you need to know before you take Lercaril
3.
How to take Lercaril
4.
Possible side effects
5.
How to store Lercaril
6.
Contents of the pack and other information
1.
WHAT LERCARIL IS AND WHAT IT IS USED FOR
Lercaril is a fixed combination of an ACE-inhibitor (enalapril
maleate) and a calcium channel blocker
(lercanidipine hydrochloride), two medicines that lower blood
pressure.
Lercaril 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 LERCARIL
DO NOT TAKE LERCARIL:
•
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
Lercaril, 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/valsartan, a
medicine used to treat a type of

Karakteristik produk

Health Products Regulatory Authority
16 July 2021
CRN00C30X
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercaril 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).
Excipients 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:_
Lercaril 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: _
Lercaril 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 Lercaril 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).
4.3 CONTRAINDICATIONS
Healt