Auro-Simvastatin 40
Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Bijsluiter
(PIL)
16-06-2017
Productkenmerken
(SPC)
05-09-2017
Werkstoffen:
Simvastatin 40mg;
Beschikbaar vanaf:
Aurobindo Pharma NZ Limited
INN (Algemene Internationale Benaming):
Simvastatin 40 mg
Dosering:
40 mg
farmaceutische vorm:
Film coated tablet
Samenstelling:
Active: Simvastatin 40mg Excipient: Ascorbic acid Butylated hydroxyanisole Citric acid monohydrate Starch, pregelatinised (Starch 1500) Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink 20A54211
Eenheden in pakket:
Blister pack, PVC/PE/PVDC/AL, 30 tablets
klasse:
Prescription
Prescription-type:
Prescription
Geproduceerd door:
Southwest Synthetic Pharmaceuticals Corporation, Limited
therapeutische indicaties:
Paediatric Patients with Heterozygous Familial Hypercholesterolaemia: Simvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, TG, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (HeFH).
Product samenvatting:
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/AL - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AL - 90 tablets - 36 months from date of manufacture stored at or below 25°C
Autorisatie datum:
2010-09-24
Bijsluiter
AURO-SIMVASTATIN
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 5
AURO-SIMVASTATIN 5, 10, 20, 40 & 80
Simvastatin
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some common
questions
about
AURO-
SIMVASTATIN.
It
does not
contain
all
the available information.
It
does
not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
taking
AURO-SIMVASTATIN
against the benefits they expect it will
have for you.
IF
YOU HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
AURO-SIMVASTATIN IS
USED FOR
AURO-SIMVASTATIN
helps
to
lower
cholesterol
and
triglyceride
levels.
AURO-SIMVASTATIN is
used
in
people
who
have
coronary
heart
disease (CHD) or who are at high risk
of
CHD (for
example,
if
they have
diabetes,
a history of stroke,
or other
blood vessel disease).
AURO-SIMVASTATIN may be used
in these
people,
regardless
of
their
cholesterol level to:
help prolong your life by reducing
the risk of a heart attack
reduce the risk of stroke
reduce
the
need
for
surgery
to
increase blood flow to the heart
reduce the need for hospitalisation
due to angina.
CHOLESTEROL
Everyone
has
cholesterol
and
triglycerides in their blood.
They are
types of blood fat needed by the body
for
many things,
including building
cell
walls,
making bile acids (which
help
to
digest
food)
and
certain
hormones.
However,
too
much
cholesterol can be a problem.
Your
body makes cholesterol,
but
it
also comes from food.
Normally
the
body
balances
the
cholesterol
it
makes
with
the
cholesterol
it
gets
from food.This
means
if
more
cholesterol
comes
from food,
less is made by the body.
However, if you eat a diet high in fat,
your body may not keep this balance
and your cholesterol levels rise.
High cholesterol
is
more
likely to
occur with certain diseases or if you
have
a
family
history
of
high
cholesterol.
When
you
have
high
levels
of
cholesterol, it m
Lees het volledige document
Productkenmerken
Data Sheet:
AURO-SIMVASTATIN (Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg & 80
mg)
Ver 2.1
Page 1 of 21
NAME OF MEDICINE
AURO-SIMVASTATIN 5 (5 MG SIMVASTATIN TABLETS)
AURO-SIMVASTATIN 10 (10 MG SIMVASTATIN TABLETS)
AURO-SIMVASTATIN 20 (20 MG SIMVASTATIN TABLETS)
AURO-SIMVASTATIN 40 (40 MG SIMVASTATIN TABLETS)
AURO-SIMVASTATIN 80 (80 MG SIMVASTATIN TABLETS)
PRESENTATION
AURO-SIMVASTATIN 5
Yellow coloured, round shaped, biconvex, film coated tablets, debossed
with ‘A’ on one
side and ‘15’ on the other side.
AURO-SIMVASTATIN 10
Light pink coloured, round shaped, biconvex, film coated tablets
debossed with ‘A’ on
one side and ‘01’ on the other side.
AURO-SIMVASTATIN 20
Light pink coloured, round shaped, biconvex, film coated tablets,
debossed with ‘A’ on
one side and ‘02’ on the other side.
AURO-SIMVASTATIN 40
Pink coloured, round shaped, biconvex, film coated tablets, debossed
with ‘A’ on one
side and ‘03’ on the other side.
AURO-SIMVASTATIN 80
Pink coloured, capsule shaped, biconvex, film coated tablets, debossed
with ‘A’ on one
side and ‘04’ on the other side.
In addition to simvastatin, each AURO-SIMVASTATIN tablet contains the
following
inactive ingredients: ascorbic acid, lactose, cellulose
microcrystalline cellulose (PH 101
& 112), pregelatinised starch, citric acid monohydrate, butylated
hydroxyanisole,
magnesium stearate, Opadry yellow 20A52229-Proprietary ingredient ARTG
number
12350 (AURO-SIMVASTATIN 5 mg), Opadry pink 20A54239-Proprietary
ingredient
ARTG number 11891 (AURO-SIMVASTATIN 10 mg & 20 mg) and Opadry pink
20A54211-Proprietary ingredient ARTG number 12531 (AURO-SIMVASTATIN 40
mg &
80 mg).
THERAPEUTIC CLASS
Simvastatin is a lipid lowering agent derived synthetically from a
fermentation product of
Aspergillus terreus.
Data Sheet:
AURO-SIMVASTATIN (Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg & 80
mg)
Ver 2.1
Page 2 of 21
INDICATIONS
PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING
CHD
In patients at high risk of CHD (with or without h
Lees het volledige document
