Ezehron Duo 10 mg/10 mg, tablet

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

ROSUVASTATIN, EZETIMIBE

थमां उपलब्ध:

Adamed Sp. Z.o.o. Pieńków 149, 05-152 Czosnów, Poland

ए.टी.सी कोड:

C10BA06

INN (इंटरनेशनल नाम):

ROSUVASTATIN 10 mg EZETIMIBE 10 mg

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

ROSUVASTATIN 10 mg EZETIMIBE 10 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

LIPID MODIFYING AGENTS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2018-02-16

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZEHRON DUO 20 MG/10 MG, TABLET EZEHRON DUO 10 MG/10 MG, TABLET
EZEHRON DUO 5 MG/10 MG, TABLET
rosuvastatin and ezetimibe
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 Ezehron Duo tablets is and what it is used for
2.
What you need to know before you take Ezehron Duo tablets
3.
How to take Ezehron Duo tablets
4.
Possible side effects
5.
How to store Ezehron Duo tablets
6.
Contents of the pack and other information
1. WHAT EZEHRON DUO TABLETS IS AND WHAT IT IS USED FOR
Ezehron Duo tablets contains two different active substances in one
tablet. One of the active substances is
rosuvastatin, belonging to the group of so called statins, the other
active substance is ezetimibe.
Ezehron Duo tablets is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol) and fatty substances called triglycerides in your blood.
In addition, it also raises levels of “good”
cholesterol (HDL cholesterol). This medicine works to reduce your
cholesterol in two ways: it reduces the
cholesterol absorbed in your digestive tract, as well as the
cholesterol your body makes by itself.
For most people, high cholesterol does not affect the way they feel
because it does not produce any
symptoms. However, if it is left untreated, fatty deposits can build
up in the walls of your blood vessels
causing them to narrow. Sometimes, these narrowed blood vessels can
get blocked which can cut off the
blood supply to the heart or brain leading to

उत्पाद विशेषताएं

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezehron Duo 20 mg/10 mg, tablet
Ezehron Duo 10 mg/10 mg, tablet
Ezehron Duo 5 mg/10 mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ezehron Duo 20 mg/10 mg tablet
Each tablet contains 20 mg rosuvastatin (as calcium salt) and 10 mg of
ezetimibe.
Excipients of known activity: lactose monohydrate (each tablet
contains 228.29 mg lactose monohydrate)
Ezehron Duo 10 mg/10 mg tablet
Each tablet contains 10 mg rosuvastatin (as calcium salt) and 10 mg of
ezetimibe.
Excipients of known activity: lactose monohydrate (each tablet
contains 238.39 mg lactose monohydrate)
Ezehron Duo 5 mg/10 mg tablet
Each tablet contains 5 mg rosuvastatin (as calcium salt) and 10 mg of
ezetimibe.
Excipients of known activity: lactose monohydrate (each tablet
contains 243.89 mg lactose monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Ezehron Duo 20 mg/10 mg tablet: white to off-white, round, biconvex,
uncoated tablet. The diameter
of the tablet is 11 mm.
Ezehron Duo 10 mg/10 mg tablet: white to off-white, oval, biconvex,
uncoated tablet, engraved E1 on one
side and 1 on the other side. The dimensions of the tablet are 15 mm x
7 mm
Ezehron Duo 5 mg/10 mg tablet: white to off-white, round, flat,
uncoated tablet, engraved E2 on one side
and 2 on the other side. The diameter of the tablet is 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
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Ezehron Duo is indicated as adjunct to diet for treatment of primary
hypercholesterolemia as substitution
therapy in adult patients adequately controlled with the individual
substances given concurrently at the
same dose level as in the fixed dose combination, but as separate
products.
_ _
Prevention of Cardiovascular Events
Ezehron Duo is indicated to reduce the risk of cardiovascular events
(see section 5.1) as substitution therapy
in patients with coronary heart disease (CHD) and a history of acute
coronary syndrome (ACS), who