EZETROL 10 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EZETIMIBE

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

C10AX09

Pharmaceutical form:

TABLETS

Composition:

EZETIMIBE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

EZETIMIBE

Therapeutic area:

EZETIMIBE

Therapeutic indications:

Primary hypercholesterolemia: Ezetrol administered with an HMG-CoA reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. Homozygous familial hypercholesterolemia (HoFH): Ezetrol administered with a statin are indicated for use in patients with HoFH.Patients may also receive adjunctive treatments (e.g. LDL apheresis).Homozygous sitosterolemia (Phytosterolemia): Ezetrol are indicated for use in patients with homozygous familial sitosterolemia.

Authorization date:

2023-05-31

Patient Information leaflet

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) - 1986
THIS MEDICINE CAN BE SOLD UNDER DOCTOR’S PRESCRIPTION ONLY
EZETROL
® 10 MG TABLETS
Each tablet contains:
Ezetimibe 10 mg
For a list of inactive ingredients please refer to section 6.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about EZETROL. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
ailment seems similar to yours.
•
EZETROL is not intended for children under age 10.
1. WHAT EZETROL IS AND WHAT IT IS USED FOR?
1.1 WHAT IS EZETROL?
THERAPEUTIC GROUP:
Ezetimibe, a member of a class of medicines called _CAI_ (Cholesterol
Absorption Inhibitors), which inhibits
the intestinal absorption of cholesterol.
1.2 WHAT IS EZETROL USED FOR?
_ _
EZETROL is intended for patients with:
_ _
-
Primary hypercholesterolemia heterozygous familial and non-familial
(conditions in which there is a high
cholesterol level in the blood) as a single treatment or in
combination with a statin (HMG-CoA reductase
inhibitor) as adjunctive to diet.
-
Homozygous familial hypercholesterolemia (HoFH) (condition in which
there is a high cholesterol level
in the blood) in combination with a statin and other treatments for
reduction of lipid levels in the blood
(e.g. LDL apheresis).
-
Homozygous familial sitosterolemia (disorder of lipid absorption and
removal from the gastrointestinal
tract)
EZETROL 10 mg tablets are used for lowering high blood lipid levels.
EZETROL is sometimes given together with medicines of the Statins
family (e.g., simvastatin, atorvastatin,
etc.); if that is the case, a thorough review of the patient’s
circular of the statin should be done before
starting treatment and you should consult your physician.
2. BEFORE YOU TAKE EZETROL
2.1 DO NOT TAKE EZETROL:
•
if you are allergic (hypersensitive) to ezetimibe

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Ezetrol
®
10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect:
Each tablet contains 55 mg of lactose monohydrate.
Ezetrol contains less than 1mmol (23 mg) sodium per tablet.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule-shaped tablets, debossed with “414” on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_PRIMARY HYPERCHOLESTEROLAEMIA _
Ezetrol
administered
with
an
HMG-CoA
reductase
inhibitor
(statin)
or
alone
are
indicated as adjunctive therapy to diet for use in patients with
primary (heterozygous
familial and non-familial) hypercholesterolaemia.
_ _
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) _
Ezetrol administered with a statin, are indicated for use in patients
with HoFH. Patients
may also receive adjunctive treatments (e.g., LDL apheresis).
_HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA) _
Ezetrol is indicated for use in patients with homozygous familial
sitosterolaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with Ezetrol.
Route of administration is oral. The recommended dose is one Ezetrol
10 mg tablet daily. Ezetrol can be
administered at any time of the day, with or without food.
When Ezetrol is added to a statin, either the indicated usual initial
dose of that particular statin or the
already established higher statin dose should be continued. In this
setting, the dosage instructions for that
particular statin should be consulted.
_ _
_Co-administration with bile acid sequestrants _
Dosing of Ezetrol should occur either
≥
2 hours before or
≥
4 hours after administration of a bile acid
sequestrant.
2
_ _
_Older people_
No dosage adjustment is required for elderly patients (see section
5.2).
_Paediatric population _
Initiation of treatment must be performed under review of a
specialist.