Ezetimibe/Simvastatin Teva 10 mg/20 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe; Simvastatin

Available from:

Teva B.V.

ATC code:

C10BA; C10BA02

INN (International Name):

Ezetimibe; Simvastatin

Dosage:

10/20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe

Authorization status:

Not marketed

Authorization date:

2017-05-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE/SIMVASTATIN TEVA 10 MG/20 MG TABLETS
EZETIMIBE/SIMVASTATIN TEVA 10 MG/40 MG TABLETS
EZETIMIBE/SIMVASTATIN TEVA 10 MG/80 MG TABLETS
ezetimibe and simvastatin
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/Simvastatin Teva is and what it is used for
2.
What you need to know before you take Ezetimibe/Simvastatin Teva
3.
How to take Ezetimibe/Simvastatin Teva
4.
Possible side effects
5.
How to store Ezetimibe/Simvastatin Teva
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/SIMVASTATIN TEVA IS AND WHAT IT IS USED FOR
Ezetimibe/Simvastatin Teva contains the active substances ezetimibe
and simvastatin.
Ezetimibe/Simvastatin Teva is a medicine used to lower levels of total
cholesterol, “bad” cholesterol
(LDL cholesterol), and fatty substances called triglycerides in the
blood. In addition,
Ezetimibe/Simvastatin Teva raises levels of “good” cholesterol
(HDL cholesterol).
Ezetimibe/Simvastatin Teva works to reduce your cholesterol in two
ways. The active ingredient
ezetimibe reduces the cholesterol absorbed in your digestive tract.
The active ingredient simvastatin
belonging to the class of “statins” inhibits the production of 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 arter

Summary of Product characteristics

Health Products Regulatory Authority
06 June 2019
CRN008VJM
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatin Teva 10 mg/20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 20 mg simvastatin
Excipient with known effect:
Ezetimibe/Simvastatin Teva 10 mg/20 mg tablets contains 126.450 mg
lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Ezetimibe/Simvastatin Teva 10 mg/20 mg tablets: White to off-white
capsule shaped tablets. Debossed with “E10” on one side
of the tablet and with “S20” on the other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
Ezetimibe/Simvastatin Tevais indicated to reduce the risk of
cardiovascular events (see section 5.1) in patients with coronary
heart disease (CHD) and a history of acute coronary syndrome (ACS),
either previously treated with a statin or not.
Hypercholesterolaemia
Ezetimibe/Simvastatin Teva is indicated as adjunctive therapy to diet
for use in patients with primary (heterozygous familial and
non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use
of a combination product is appropriate:
● patients not appropriately controlled with a statin alone
● patients already treated with a statin and ezetimibe
Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe/Simvastatin Teva is indicated as adjunctive therapy to diet
for use in patients with HoFH. Patients may also receive
adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypercholesterolaemia_
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with
Ezetimibe/Simvastatin Teva.
Route of administration is oral. The dosage range of
Ezetimibe/Simvastatin Teva is 10/10 mg/day through 10/80 mg/day in the
evening. All dosages may not be available in all member states. The
typical dose is