Lercaril 10 mg/10 mg film-coated tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Lercanidipine hydrochloride; Enalapril maleate

Mevcut itibaren:

IMED Healthcare Ltd.

ATC kodu:

C09BB; C09BB02

INN (International Adı):

Lercanidipine hydrochloride; Enalapril maleate

Farmasötik formu:

Film-coated tablet

Terapötik alanı:

ACE inhibitors and calcium channel blockers; enalapril and lercanidipine

Yetkilendirme tarihi:

2022-11-18

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
LERCARIL 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 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 lercanidipine 10 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 sacubi

Ürün özellikleri

Health Products Regulatory Authority
18 November 2022
CRN00D6ZZ
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lercaril 10 mg/10 mg 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
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Spain_
White, circular, biconvex tablets of 8.5 mm.
4 CLINICAL PARTICULARS
As per PA1404/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1404/002/001
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
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
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
Health Products Regulatory Authority
18 November 2022
CRN00D6ZZ
Page 2 of 2
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 28 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd,
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/198/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
November 2022
10 DATE