SIMVASTATIN TEVA 80 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SIMVASTATIN

Available from:

TEVA ISRAEL LTD

ATC code:

C10AA01

Pharmaceutical form:

TABLETS

Composition:

SIMVASTATIN 80 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY

Therapeutic group:

SIMVASTATIN

Therapeutic area:

SIMVASTATIN

Therapeutic indications:

Coronary Heart Disease : In patients with coronary heart disease and hypercholesterolemia Simvastatin-teva is indicated to: Reduce the risk of total mortality by reducing coronary death Reduce the risk of non-fatal myocardial infarction Reduce the risk for undergoing myocardial revascularization procedures.Reduce the risk of stroke and transient ischemic attacks (TIA). Hyperlipidemia: Simvastatin-teva is indicated as an adjunct to diet to reduce elevated TOTAL-C LDL-C Apo B and TG and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb) Simvastatin-teva therefore lowers the LDL-C/HDL-C and the total-C/HDL-C ratios. Homozygous familial hypercholesterolemia: Simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol LDL-cholesterol and apolipoprotein B in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. Hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Dysbetalipoproteinemia (Fredrickson type III hyperlipidemia): Simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).

Authorization date:

2023-03-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a
doctor's prescription only
SIMVASTATIN TEVA 10 MG
SIMVASTATIN TEVA 20 MG
SIMVASTATIN TEVA 40 MG
SIMVASTATIN TEVA 80 MG
TABLETS
COMPOSITION:
Each tablet of Simvastatin Teva 10 mg
contains:
Simvastatin 10 mg
Each tablet of Simvastatin Teva 20 mg
contains:
Simvastatin 20 mg
Each tablet of Simvastatin Teva 40 mg
contains:
Simvastatin 40 mg
Each tablet of Simvastatin Teva 80 mg
contains:
Simvastatin 80 mg
For information regarding inactive
ingredients and allergens in the preparation
see section 6 - “Additional information”
and section 2 - “Important information
about some ingredients of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE
USING THE MEDICINE. This leaflet contains
concise information about the medicine.
If you have additional questions, refer to
the doctor or the pharmacist.
This medicine has been prescribed for
treatment of your illness. Do not pass it
on to others. It may harm them even if it
seems to you that their medical condition
is similar.
Do not use in children and adolescents
under the age of 20.
1. WHAT IS THE MEDICINE INTENDED
FOR?
In patients with coronary heart disease
and hypercholesterolemia, Simvastatin
Teva reduces:
•
The overall mortality risk by lowering
mortality from heart disease.
•
The risk of a non-fatal heart attack.
•
The risk of invasive procedures to
restore blood flow to the heart (such
as balloon dilation or bypass surgery).
•
The risk of stroke and Transient
Ischemic Attack - TIA.
Simvastatin Teva is indicated for lowering
the levels of LDL and other fatty substances
in the blood and raising HDL blood levels
in patients with hyperlipidemia (high level
of fats in the blood).
THERAPEUTIC CLASS: Statins, HMG-CoA
reductase enzyme inhibitors.
HOW DOES SIMVASTATIN TEVA WORK:
Simvastatin Teva contains the active
ingredient simvastatin. Simvastatin Teva
is used to lower blood levels of total
cholesterol, levels of the “bad” cholestero

Summary of Product characteristics

Page 1 of 23
Simvastatin-Teva-10mg-20mg-40mg-80mg-tabs-KK-12-2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Simvastatin Teva 10 mg
Simvastatin Teva 20 mg
Simvastatin Teva 40 mg
Simvastatin Teva 80 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Simvastatin Teva 10 mg:
Each tablet contains 10 mg simvastatin.
Excipients with known effect:
Each tablet contains 70.65 mg lactose monohydrate.
Simvastatin Teva 20 mg:
Each tablet contains 20 mg simvastatin.
Excipients with known effect:
Each tablet contains 141.30 mg lactose monohydrate.
Simvastatin Teva 40 mg:
Each tablet contains 40 mg simvastatin.
Excipients with known effect:
Each tablet contains 282.60 mg lactose monohydrate.
Simvastatin Teva 80 mg:
Each tablet contains 80 mg simvastatin.
Excipients with known effect:
Each tablet contains 565.24 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Simvastatin Teva 10 mg:
Light pink oval-shaped film-coated tablet with a breakline on one
side.
Simvastatin Teva 20 mg:
Tan oval-shaped film-coated tablet with a breakline on one side.
Simvastatin Teva 40 mg:
Pink oval-shaped film-coated tablet with a breakline on one side.
Simvastatin Teva 80 mg:
Page 2 of 23
Simvastatin-Teva-10mg-20mg-40mg-80mg-tabs-KK-12-2021
Brick-red oval-shaped film-coated tablet with a breakline on one side.
Tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Coronary Heart Disease:
In patients with coronary heart disease and hypercholesterolemia
Simvastatin Teva is
indicated to:

Reduce the risk of total mortality by reducing coronary death;

Reduce the risk of non-fatal myocardial infarction;

Reduce the risk for undergoing myocardial revascularization
procedures.

Reduce the risk of stroke and transient ischemic attacks (TIA).
Hyperlipidemia:
Simvastatin Teva is indicated as an adjunct to diet to reduce elevated
TOTAL-C LDL-
C Apo B and TG and to increase HDL-C in patients with primary
hypercholesterolemia
(heterozygous