Simvastatin Teva 20 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Simvastatin

Available from:

Teva Pharma B.V.

ATC code:

C10AA; C10AA01

INN (International Name):

Simvastatin

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; simvastatin

Authorization status:

Marketed

Authorization date:

2007-10-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVASTATIN TEVA 10 MG FILM COATED TABLETS
SIMVASTATIN TEVA 20 MG FILM COATED TABLETS
SIMVASTATIN TEVA 40 MG FILM COATED TABLETS
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 Simvastatin Teva Film-coated Tablets is and what it is used for
2.
What you need to know before you take Simvastatin Teva Film-coated
Tablets
3.
How to take Simvastatin Teva Film-coated Tablets
4.
Possible side effects
5.
How to store Simvastatin Teva Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT SIMVASTATIN TEVA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Simvastatin Teva Film-coated Tablets contains the active substance
simvastatin. Simvastatin Teva
Film-coated Tablets is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In addition, Simvastatin Teva Film-
coated Tablets raises levels of “good” cholesterol (HDL
cholesterol). Simvastatin Teva Film-coated
Tablets is a member of the class of medicines called statins.
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
narrowing of the arteries. This
narrowing can slow or block blood flow to vital organs such as the
heart and b

Summary of Product characteristics

Health Products Regulatory Authority
04 May 2023
CRN00DJCY
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin Teva 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg simvastatin.
Excipient(s) with known effect:
Each film-coated tablet contains 142.86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Tan oval-shaped film-coated tablet with a breakline one one side.
The 20 mg tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as
an adjunct to diet, when response to diet and other
non-pharmacological treatments (e.g. exercise, weight reduction) is
inadequate.
Treatment of homozygous familial hypercholesterolaemia (HoFH) as an
adjunct to diet and other lipid-lowering treatments (e.g.
LDL apheresis) or if such treatments are not appropriate.
Cardiovascular prevention
Reduction of cardiovascular mortality and morbidity in patients with
manifest atherosclerotic cardiovascular disease or diabetes
mellitus, with either normal or increased cholesterol levels, as an
adjunct to correction of other risk factors and other
cardioprotective therapy (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage range is 5-80 mg/day of simvastatin given orally as a
single dose in the evening. Adjustments of dosage, if
required, should be made at intervals of not less than 4 weeks, to a
maximum of 80 mg/day given as a single dose in the
evening. The 80-mg dose is only recommended in patients with severe
hypercholesterolaemia and at high risk for
cardiovascular complications who have not achieved their treatment
goals on lower doses and when the benefits are expected
to outweigh the potential risks (see sections 4.4 and 5.1).
_Hypercholesterolaemia_
The patient should be placed on a standard cholesterol-lowering diet,
and shou