Simvastatine CF 80 mg, filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

SIMVASTATINE

Dostupné s:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ATC kód:

C10AA01

INN (Mezinárodní Name):

SIMVASTATIN

Léková forma:

Filmomhulde tablet

Složení:

BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Podání:

Oraal gebruik

Terapeutické oblasti:

Simvastatin

Přehled produktů:

Hulpstoffen: BUTYLHYDROXYANISOL (E 320); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 0-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TALK (E 553 B); TITAANDIOXIDE (E 171);

Datum autorizace:

2007-01-08

Informace pro uživatele

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2020-01-20/DD
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVASTATINE CF 80 MG, FILMOMHULDE TABLETTEN
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 80 mg is and what it is used for
2. What you need to know before you take Simvastatin 80 mg
3. How to take Simvastatin 80 mg
4. Possible side effects
5. How to store Simvastatin 80 mg
6. Contents of the pack and other information
1. WHAT SIMVASTATIN 80 MG IS AND WHAT IT IS USED FOR
Simvastatin 80 mg contains the active substance simvastatin.
Simvastatin 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 raises
levels of “good” cholesterol
(HDL cholesterol). Simvastatin 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 an

Charakteristika produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Simvastatine CF 80 mg, filmomhulde tabletten.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of simvastatin.
Excipient with known effect
Each tablet contains 596.0 mg of lactose anhydrous
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong, biconvex-shaped film-coated tablet with length of 16.50
– 16.90 mm, width of
8.30 – 8.80 mm and height of 6.30 – 6.80 mm,
marked with a score line on one side,
debossed with “SVT” on the unscored side and “80” on the
scored 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 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 a