Sivatin 20 mg film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Simvastatin

Tersedia dari:

Rowex Ltd

Kode ATC:

C10AA; C10AA01

INN (Nama Internasional):

Simvastatin

Dosis:

20 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

HMG CoA reductase inhibitors; simvastatin

Status otorisasi:

Marketed

Tanggal Otorisasi:

2002-04-19

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIVATIN 20 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 Sivatin is and what it is used for
2.
What you need to know before you take Sivatin
3.
How to take Sivatin
4.
Possible side effects
5.
How to store Sivatin
6.
Contents of the pack and other information
1.
WHAT SIVATIN IS AND WHAT IT IS USED FOR
Sivatin contains the active substance simvastatin. Sivatin is a
medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL cholesterol), and fatty
substances called triglycerides in the
blood.
In addition, Sivatin raises levels of “good” cholesterol (HDL
cholesterol). Sivatin 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 brain. This
blocking of blood flow can result in a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it
helps keep the bad cholesterol from
building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in your blood that may increase
your risk for heart disease.
You should stay on a

Karakteristik produk

Health Products Regulatory Authority
03 July 2023
CRN00DPC0
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sivatin 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of simvastatin.
Excipient with known effect
Each film-coated tablets contains 58.2 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange coated, oval, biconvex tablet with score line on both sides
coded 20 on one side.
The tablet 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 dose range is 5–80 mg/day of simvastatingiven orally as a single
dose in the evening. Adjustments of dose, if required,
should be made at intervals of not less than 4 weeks, to a maximum of
80mg/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 4.4and5.1).
Hypercholesterolaemia
The patient should be placed on a standard cholesterol-lowering diet,
a