Lercaril 20 mg/10 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Enalapril maleate; Lercanidipine hydrochloride

可用日期:

Recordati Ireland Limited

ATC代码:

C09BB; C09BB02

INN（国际名称）:

Enalapril maleate; Lercanidipine hydrochloride

剂量:

20 mg/10 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

授权状态:

Marketed

授权日期:

2008-08-22

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE
USER
LERCARIL 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 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) and a
calcium channel blocker
(lercanidipine), two medicines that lower blood pressure.
Lercaril is used to treat high blood pressure (hypertension) in adult
patients whose blood pressure is
not adequately controlled by enalapril 20 mg alone. Lercaril should
not be used for initial treatment of
hypertension.
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 sacubitri

产品特点

Health Products Regulatory Authority
16 July 2021
CRN00C30X
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercaril 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).
Excipients with known effect: each tablet contains 92.0 mg 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 Lercaril 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 Lercaril
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:_
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.
_Patients with hepatic impairment:_
Lercaril is contraindicated in severe hepatic dysfunction. Particular
caution is needed when initiating treatment in patients with
mild to moderat