Ezetimibe/Simvastatin Krka 10 mg/10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ezetimibe; Simvastatin

Available from:

KRKA, d.d., Novo mesto

ATC code:

C10BA; C10BA02

INN (International Name):

Ezetimibe; Simvastatin

Dosage:

10 mg/10 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:

Marketed

Authorization date:

2017-03-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/SIMVASTATIN KRKA 10 MG/10 MG TABLETS
EZETIMIBE/SIMVASTATIN KRKA 10 MG/20 MG TABLETS
EZETIMIBE/SIMVASTATIN KRKA 10 MG/40 MG TABLETS
ezetimibe/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 Krka is and what it is used for
2.
What you need to know before you take Ezetimibe/Simvastatin Krka
3.
How to take Ezetimibe/Simvastatin Krka
4.
Possible side effects
5.
How to store Ezetimibe/Simvastatin Krka
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/SIMVASTATIN KRKA IS AND WHAT IT IS USED FOR
Ezetimibe/Simvastatin Krka contains the active substances ezetimibe
and simvastatin.
Ezetimibe/Simvastatin Krka 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 Krka raises levels of “good” cholesterol
(HDL cholesterol).
Ezetimibe/Simvastatin Krka 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 arteries
formin

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2023
CRN00DHZ5
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatin Krka 10 mg/10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10 mg simvastatin.
Excipients with known effect
10 mg/10 mg tablets
lactose
56.05 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
10 mg/10 mg tablets appear as yellowish white, round, slightly
biconvex tablets with bevelled edges. Tablet diameter 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
Ezetimibe/Simvastatin Krka is 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 Krka 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 Krka 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
Not all dosing is possible with the approved strengths for
Ezetimibe/Simvastatin Krka.
_ _
_Hypercholesterolaemia_
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with
Ezetimibe/Simvastatin Krka.
Health Products Regulatory Authority
14 December 2023
CRN00DHZ5
Page 2 of 27
Route of administration is oral. The dosage range of
Ezetimibe/Simvastatin Krka is 10/10 mg/day through 10/80 mg/day in the
evening. The typic