Ezetimibe/Atorvastatin Althera 10 mg/10 mg film-coated tablet

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

EZETIMIBE, ATORVASTATIN

Inapatikana kutoka:

Althera Laboratories Ltd 1st Floor, 9 Exchange Place, I.F.S.C. Dublin 1, Ireland

ATC kanuni:

C10BA05

INN (Jina la Kimataifa):

EZETIMIBE 10 mg ATORVASTATIN 10 mg

Dawa fomu:

FILM-COATED TABLET

Tungo:

EZETIMIBE 10 mg ATORVASTATIN 10 mg

Dawa ya aina:

POM

Eneo la matibabu:

LIPID MODIFYING AGENTS

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2021-08-13

Taarifa za kipeperushi

Page 1 of 9
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/ATORVASTATIN ALTHERA 10 MG/10 MG FILM-COATED TABLETS
EZETIMIBE AND ATORVASTATIN
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 EZETIMIBE/ATORVASTATIN ALTHERA is and what it is used for
2.
What you need to know before you take EZETIMIBE/ATORVASTATIN
ALTHERA
3.
How to take EZETIMIBE/ATORVASTATIN ALTHERA
4.
Possible side effects
5.
How to store EZETIMIBE/ATORVASTATIN ALTHERA
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/ATORVASTATIN ALTHERA IS AND WHAT IT IS USED FOR
EZETIMIBE/ATORVASTATIN ALTHERA is a medicine to lower increased levels
of
cholesterol. EZETIMIBE/ATORVASTATIN ALTHERA contains ezetimibe and
atorvastatin.
EZETIMIBE/ATORVASTATIN ALTHERA is used in adults to lower levels of
total
cholesterol, “bad” cholesterol (LDL cholesterol), and fatty
substances called triglycerides
in the blood. In addition, EZETIMIBE/ATORVASTATIN ALTHERA raises
levels of
“good” cholesterol (HDL cholesterol).
EZETIMIBE/ATORVASTATIN ALTHERA 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.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total
cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in the walls of
your arteries forming plaque. Eventually this plaque build-up can lead
to a narrow

Tabia za bidhaa

Page 1 of 28
SUMMARY OF PRODUCT CHARAERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EZETIMIBE/ATORVASTATIN ALTHERA 10 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg ezetimibe and 10 mg
atorvastatin (as atorvastatin calcium
trihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
10 mg/10 mg tablets: Pink, oval shaped, “V1” debossed on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EZETIMIBE/ATORVASTATIN ALTHERA as an adjunct to diet is indicated as
substitution
therapy for treatment of adults with primary (heterozygous and
homozygous familial and non-
familial) hypercholesterolaemia or mixed hyperlipidaemia already
controlled with atorvastatin and
ezetimibe given concurrently at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypercholesterolaemia and/or Coronary Heart Disease (with ACS
History) _
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with EZETIMIBE/ATORVASTATIN ALTHERA.
The dose range of EZETIMIBE/ATORVASTATIN ALTHERA is 10/10 mg/day. The
typical dose
is 10/10 mg once a day. The patient’s low-density lipoprotein
cholesterol (LDL-C) level, coronary
heart disease risk status, and response to current
cholesterol-lowering therapy should be considered
when starting therapy or adjusting the dose.
The dose of EZETIMIBE/ATORVASTATIN ALTHERA should be individualised
based on the
known efficacy of the various dose strengths of EZETIMIBE/ATORVASTATIN
ALTHERA (see
section 5.1, Table 3) and the response to the current
cholesterol-lowering therapy. Adjustment of
dose should be made at intervals of 4 weeks or more.
_Homozygous Familial Hypercholesterolaemia _
The dose of EZETIMIBE/ATORVASTATIN ALTHERA in patients with homozygous
FH is
10/10 to 10/80 mg daily. EZETIMIBE/ATORVASTATIN ALTHERA may be used as
an adjunct
Page 2 of 28
to other lipid-lowering treatments (e.g. LDL apheresis) in these
patients or if