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:

PCO Manufacturing Ltd.

Kode ATC:

C09BB; C09BB02

INN (Nama Internasional):

Enalapril maleate; Lercanidipine hydrochloride

Bentuk farmasi:

Film-coated tablet

Area terapi:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Tanggal Otorisasi:

2023-02-17

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

Karakteristik produk

Health Products Regulatory Authority
17 February 2023
CRN00DCF0
Page 1 of 2
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 (equivalento to 18.88 mg lercanidipine).
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from France:_
Orange, circular, biconvex tablets of 12 mm
4 CLINICAL PARTICULARS
As per PA1404/002/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1404/002/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core: _
Lactose monohydrate
Microcrystalline cellulose
Sodium starch glycolate
Povidone K30
Sodium hydrogen carbonate
Magnesium stearate
_Film-Coating: _
Hypromellose
Titanium dioxide (E171)
Macrogol 6000
Iron oxide yellow (E172)
Talc
Iron oxide red (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
17 February 2023
CRN00DCF0
Page 2 of 2
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from light and
moisture.
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Polyamide-aluminium-PVC/aluminium blister.
Blisters containing 15 tablets.
Each pack contains 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.,
Unit 10,
Ashbourne Business Park,
Rath,
Ashbourne,
Co. Meath,
Ireland.
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/472/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17
th
February 2023
10 DATE OF REV