Simvastatin Bluefish 40mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Simvastatin

Saatavilla:

Bluefish Pharmaceuticals AB

ATC-koodi:

C10AA; C10AA01

INN (Kansainvälinen yleisnimi):

Simvastatin

Annos:

40 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

HMG CoA reductase inhibitors; simvastatin

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2008-11-21

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMVASTATIN BLUEFISH 10 MG FILM-COATED TABLETS
SIMVASTATIN BLUEFISH 20 MG FILM-COATED TABLETS
SIMVASTATIN BLUEFISH 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 Bluefish is and what it is used for
2.
What you need to know before you take Simvastatin Bluefish
3.
How to take Simvastatin Bluefish
4.
Possible side effects
5.
How to store Simvastatin Bluefish
6.
Contents of the pack and other information
1.
WHAT SIMVASTATIN
BLUEFISH IS AND WHAT IT IS USED FOR
Simvastatin Bluefish contains the active substance simvastatin.
Simvastatin Bluefish 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 Bluefish
raises levels of “good” cholesterol
(HDL cholesterol). Simvastatin Bluefish 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 becaus

Valmisteyhteenveto

Health Products Regulatory Authority
11 May 2023
CRN00DCFH
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simvastatin Bluefish 40mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg simvastatin.
Excipient(s) with known effect: Lactose monohydrate
One film-coated tablet contains 280 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
Pink, round and biconvex film-coated tablets with “A” debossed on
one side and “03” on the other side.
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 (such as 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-lowerin