Lipertance 10mg/5mg/5mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin; Perindopril arginine; Amlodipine

Available from:

Les Laboratoires Servier

ATC code:

C10BX; C10BX11

INN (International Name):

Atorvastatin; Perindopril arginine; Amlodipine

Dosage:

10 mg/5 mg/5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

Box of 30, 90 (3 tablet containers of 30) or 100 film-coated tablets.

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

les laboratoires servier industrie

Therapeutic group:

: Lipid modifying agents, HMG CoA reductase inhibitors, other combinations

Therapeutic area:

HMG CoA reductase inhibitors, other combinations; ZZZ atorvastatin, amlodipine and perindopril

Therapeutic indications:

Triveram is indicated for the treatment of essential hypertension and/or stable coronary artery disease, in association with primary hypercholesterolaemia or mixed hyperlipidaemia, as substitution therapy in adult patients adequately controlled with atorvastatin, perindopril and amlodipine given concurrently at the same dose level as in the combination.

Authorization status:

Not marketed

Authorization date:

2015-10-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIPERTANCE 10MG/5MG/5MG FILM-COATED TABLETS
LIPERTANCE 20MG/5MG/5MG FILM-COATED TABLETS
LIPERTANCE 20MG/10MG/5MG FILM-COATED TABLETS
LIPERTANCE 20MG/10MG/10MG FILM-COATED TABLETS
LIPERTANCE 40MG/10MG/10MG FILM-COATED TABLETS
atorvastatin / perindopril arginine / amlodipine
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 Lipertance is and what it is used for
2.
What you need to know before you take Lipertance
3.
How to take Lipertance
4.
Possible side effects
5.
How to store Lipertance
6.
Contents of the pack and other information
1.
WHAT LIPERTANCE IS AND WHAT IT IS USED FOR
Lipertance contains three active ingredients, atorvastatin,
perindopril arginine and amlodipine in one tablet.
Atorvastatin belongs to a group of medicines known as statins, which
are lipid (fat) regulating medicines.
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.
Amlodipine belongs to a group of medicines called calcium antagonists.
In patients with high blood pressure
it works by relaxing blood vessels, so that blood passes through them
more easily. In patients with angina
(which causes chest pain), it works by improving blood supply to the
heart muscle which then receives more
oxygen and as a result chest pain is prevented.
Lipertance is used to treat high blood pressure (hypertension) and/or
stable coronary

Summary of Product characteristics

Health Products Regulatory Authority
06 June 2023
CRN00DK0P
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipertance 10mg/5mg/5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10.82 mg atorvastatin calcium
trihydrate equivalent to 10 mg atorvastatin, 5 mg perindopril
arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine
besilate equivalent to 5 mg amlodipine.
Excipient with known effect: lactose monohydrate 27.46 mg (contains
26.09 mg of lactose), for Lipertance 10/5/5 mg, 54.92 mg
(contains 52.17 mg of lactose) for Lipertance 20/5/5 mg, 20/10/5 mg
and 20/10/10 mg, and 109.84 mg (contains 104.35 mg of
lactose) for Lipertance 40/10/10 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Lipertance 10/5/5 mg: Yellow, round, film-coated tablet of 7 mm
diameter, with a curvature radius of 25 mm, engraved with
on one face and
on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lipertance is indicated for the treatment of essential hypertension
and/or stable coronary artery disease, in association with
primary hypercholesterolaemia or mixed hyperlipidaemia, as
substitution therapy in adult patients adequately controlled with
atorvastatin, perindopril and amlodipine given concurrently at the
same dose level as in the combination, but as separate
products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual posology is one tablet 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.
_Co-administration with other medicines (see sections 4.4 and 4.5)_
In patients taking hepatitis C antiviral agents elbasvir/grazoprevir
or letermovir for cytomegalovirus infection prophylaxis
concomitantly with Lipertance the dose of atorvastatin in Lipertance
should not exceed 20 mg/day.
Use of Lipertance is not recommended in patients taking letermovir
co-administered