Lipercosyl 40 mg/5 mg hard capsules

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Atorvastatin; Perindopril arginine

متاح من:

Les Laboratoires Servier

INN (الاسم الدولي):

Atorvastatin; Perindopril arginine

جرعة:

40 mg/5 milligram(s)

الشكل الصيدلاني:

Capsule, hard

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

الوضع إذن:

Not marketed

تاريخ الترخيص:

2018-01-26

نشرة المعلومات

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIPERCOSYL 10 MG/5 MG HARD CAPSULES
LIPERCOSYL 20 MG/5 MG HARD CAPSULES LIPERCOSYL 40 MG/5 MG HARD CAPSULES LIPERCOSYL 10 MG/10 MG HARD CAPSULES LIPERCOSYL 20 MG/10 MG HARD CAPSULES
LIPERCOSYL 40 MG/10 MG HARD CAPSULES
atorvastatin / perindopril arginine
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 Lipercosyl is and what it is used for
2.
What you need to know before you take Lipercosyl
3.
How to take Lipercosyl
4.
Possible side effects
5.
How to store Lipercosyl
6.
Contents of the pack and other information
1.
WHAT LIPERCOSYL IS AND WHAT IT IS USED FOR
Lipercosyl contains two active ingredients, atorvastatin and
perindopril arginine in one capsule.
Atorvastatin belongs to a group of medicines known as statins, which
are lipid (fat) regulating medicines.
Atorvastatin is used to lower lipids known as cholesterol and
triglycerides in the blood when a low fat diet and
life style changes on their own have failed. If you are at an
increased risk of heart disease, atorvastatin can also
be used to reduce such risk even if your cholesterol levels are
normal.
Perindopril arginine is an angiotensin converting enzyme (ACE)
inhibitor. In patients with high blood pressure,
it works by widening the blood vessels, which makes it easier for your
heart to pump blood through them.
Lipercosyl is intended for adult patients already on treatment with
atorvastatin and perindopril arginine as
single tablets as part of cardiovascular risk management. Instead

خصائص المنتج

Health Products Regulatory Authority
20 January 2022
CRN00CLXY
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipercosyl 40 mg/5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 43.28 mg atorvastatin calcium trihydrate
equivalent to 40 mg atorvastatin, 5 mg perindopril
arginine equivalent to 3.395 mg perindopril.
Excipient with known effect: sucrose (72.6 mg for Lipercosyl 40/5 mg).
For the full list of excipients, see section6.1.
3 PHARMACEUTICAL FORM
Capsules, hard
Size 2 hard gelatin capsule, with black imprint “40 5” on blue
body and black imprint
on blue cap, containing white to
slightly white spherical pellets.
Size 2 hard gelatin capsules are approximately 18 mm in length.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipercosyl is indicated as substitution therapy as part of
cardiovascular risk management (see section 5.1), in adult patients
adequately controlled with atorvastatin and perindopril given
concurrently at the same dose level but as separate products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual posology is one capsule once daily.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, titration should be done with the
individual components.
The patients should continue a standard cholesterol-lowering diet
during treatment with Lipercosyl.
_Co-administration with other medicines _
In patients taking tipranavir, ritonavir, telaprevir or ciclosporine
concomitantly with Lipercosyl, the dose of atorvastatin in
Lipercosyl should not exceed 10 mg/day (see sections 4.4 and 4.5).
In patients taking hepatitis C antiviral agents containing boceprevir,
elbasvir/grazoprevir or letermovir for cytomegalovirus
infection prophylaxis concomitantly with Lipercosyl, the dose of
atorvastatin in Lipercosyl should not exceed 20 mg/day (see
sections 4.4 and 4.5). Use of Lipercosyl is not recommended in
patients taking letermovir co-administered with ciclosporin (see
se