EUVASCOR Capsules Hard 10mg/10mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATORVASTATIN CALCIUM, TRIHYDRATE, PERINDOPRIL ARGININE

Available from:

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

ATC code:

C10BX

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE 10.82 mg PERINDOPRIL ARGININE 10 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ATORVASTATIN CALCIUM TRIHYDRATE 10.82 mg PERINDOPRIL ARGININE 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2018-02-23

Patient Information leaflet

PACKAGE LEAFLET
2
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EUVASCOR 10 MG/5 MG HARD CAPSULES
EUVASCOR 20 MG/5 MG HARD CAPSULES EUVASCOR 40 MG/5 MG HARD CAPSULES EUVASCOR 10 MG/10 MG HARD CAPSULES EUVASCOR 20 MG/10 MG HARD CAPSULES
EUVASCOR 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 Euvascor is and what it is used for
2.
What you need to know before you take Euvascor
3.
How to take Euvascor
4.
Possible side effects
5.
How to store Euvascor
6.
Contents of the pack and other information
1.
WHAT EUVASCOR IS AND WHAT IT IS USED FOR
Euvascor 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.
Euvascor is intended for adult patients already on treatment with
atorvastatin and perindopril arginine as
single tablets as part of cardiovascular risk management. Instead of
taking

Summary of Product characteristics

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Euvascor 10 mg/5 mg, hard capsules
[Euvascor 20 mg/5 mg, hard capsules]
[Euvascor 40 mg/5 mg, hard capsules]
[Euvascor 10 mg/10 mg, hard capsules]
[Euvascor 20 mg/10 mg, hard capsules]
[Euvascor 40 mg/10 mg, hard capsules]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate
equivalent to 10 mg atorvastatin, 5 mg
perindopril arginine equivalent to 3.395 mg perindopril
[Each hard capsule contains 21.64 mg atorvastatin calcium trihydrate
equivalent to 20 mg atorvastatin, 5 mg
perindopril arginine equivalent to 3.395 mg perindopril]
[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]
[Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate
equivalent to 10 mg atorvastatin,
10 mg perindopril arginine equivalent to 6.79 mg perindopril]
[Each hard capsule contains 21.64 mg atorvastatin calcium trihydrate
equivalent to 20 mg atorvastatin,
10 mg perindopril arginine equivalent to 6.79 mg perindopril]
[Each hard capsule contains 43.28 mg atorvastatin calcium trihydrate
equivalent to 40 mg atorvastatin,
10 mg perindopril arginine equivalent to 6.79 mg perindopril]
Excipient with known effect: sucrose (33.9 mg for Euvascor 10/5 mg,
46.8 mg for Euvascor 20/5 mg,
72.6 mg for Euvascor 40/5 mg, 54.9 mg for Euvascor 10/10 mg, 67.8 mg
for Euvascor 20/10 mg, 93.6 mg
for Euvascor 40/10 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Euvascor 10/5 mg: Size 2 hard gelatin capsule, with black imprint
“10 5” on light blue body and black
imprint “
” on light blue cap, containing white to slightly white spherical
pellets.
Euvascor 20/5 mg: Size 2 hard gelatin capsule, with black imprint
“20 5” on light blue body and black
imprint “
” on blue cap, containing white to slightly white spherical pellets.
Euvascor 40/5 mg: S