Lercaril 20 mg/10 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Enalapril maleate; Lercanidipine hydrochloride

Dostępny od:

PCO Manufacturing Ltd.

Kod ATC:

C09BB; C09BB02

INN (International Nazwa):

Enalapril maleate; Lercanidipine hydrochloride

Forma farmaceutyczna:

Film-coated tablet

Dziedzina terapeutyczna:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Data autoryzacji:

2022-04-14

Ulotka dla pacjenta

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 sacubit

Charakterystyka produktu

Health Products Regulatory Authority
14 April 2022
CRN00CVGD
Page 1 of 2
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).
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 Romania:_
Yellow, circular, biconvex tablets of 8.5 mm
4 CLINICAL PARTICULARS
As per PA1404/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1404/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core: _
Lactose monohydrate
Cellulose microcrystalline
Sodium starch glycolate Type A
Povidone K30
Sodium hydrogen carbonate
Magnesium stearate
_Film-Coating: _
Hypromellose 5 cP
Titanium dioxide (E171)
Talc
Macrogol 6000
Quinoline yellow aluminium lake (E104)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
14 April 2022
CRN00CVGD
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
Blisters containing 14 tablets.
Each pack contains 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused 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
PPA0465/472/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
April 2022
10 DATE OF REVISION OF THE TEXT
April 2022