Triveram 20mg/10mg/10mg Film coated tablets

Šalis: Malta

kalba: anglų

Šaltinis: Malta Medicines Authority

Veiklioji medžiaga:

ATORVASTATIN, PERINDOPRIL, AMLODIPINE

Prieinama:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC kodas:

C10BX11

INN (Tarptautinis Pavadinimas):

ATORVASTATIN 20 mg PERINDOPRIL 10 mg AMLODIPINE 10 mg

Vaisto forma:

FILM-COATED TABLET

Sudėtis:

ATORVASTATIN 20 mg PERINDOPRIL 10 mg AMLODIPINE 10 mg

Recepto tipas:

POM

Gydymo sritis:

LIPID MODIFYING AGENTS

Autorizacija statusas:

Withdrawn

Leidimo data:

2015-07-31

Pakuotės lapelis

Page 1 of 11
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIVERAM 10MG/5MG/5MG FILM-COATED TABLETS
TRIVERAM 20MG/5MG/5MG FILM-COATED TABLETS
TRIVERAM 20MG/10MG/5MG FILM-COATED TABLETS
TRIVERAM 20MG/10MG/10MG FILM-COATED TABLETS
TRIVERAM 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 Triveram is and what it is used for
2.
What you need to know before you take Triveram
3.
How to take Triveram
4.
Possible side effects
5.
How to store Triveram
6.
Contents of the pack and other information
1.
WHAT TRIVERAM IS AND WHAT IT IS USED FOR
Triveram 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.
Triveram is used to treat high blood pressure (hypertension) and/or
stable corona

Prekės savybės

Page 1 of 38
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Triveram 10mg/5mg/5mg film-coated tablets
[Triveram 20mg/5mg/5mg film-coated tablets]
[Triveram 20mg/10mg/5mg film-coated tablets]
[Triveram 20mg/10mg/10mg film-coated tablets]
[Triveram 40mg/10mg/10mg 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
[One film-coated tablet contains 21.64 mg atorvastatin calcium
trihydrate equivalent to 20 mg
atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg
perindopril and 6.94 mg amlodipine
besilate equivalent to 5 mg amlodipine]
[One film-coated tablet contains 21.64 mg atorvastatin calcium
trihydrate equivalent to 20 mg
atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg
perindopril and 6.94 mg amlodipine
besilate equivalent to 5 mg amlodipine]
[One film-coated tablet contains 21.64 mg atorvastatin calcium
trihydrate equivalent to 20 mg
atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg
perindopril and 13.87 mg amlodipine
besilate equivalent to 10 mg amlodipine]
[One film-coated tablet contains 43.28 mg atorvastatin calcium
trihydrate equivalent to 40 mg
atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg
perindopril and 13.87 mg amlodipine
besilate equivalent to 10 mg amlodipine]
Excipient with known effect: lactose monohydrate (27.46 mg for
Triveram 10/5/5 mg, 54.92 mg for
Triveram 20/5/5 mg, 20/10/5 mg and 20/10/10 mg, and 109.84 mg for
Triveram 40/10/10 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Triveram 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.
[Triveram 20/5/5 mg: Yellow, round, film-coated tablet of 8.8 mm
diameter, with a curvature radius
of 32 m