Astator 80 mg Filmdragerad tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

atorvastatinkalcium, amorft

Available from:

Krka d.d., Novo mesto

ATC code:

C10AA05

INN (International Name):

atorvastatinkalcium, amorphous

Dosage:

80 mg

Pharmaceutical form:

Filmdragerad tablett

Composition:

atorvastatinkalcium, amorft 82,88 mg Aktiv substans; laktosmonohydrat Hjälpämne

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Atorvastatin

Authorization status:

Avregistrerad

Authorization date:

2011-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASTATOR 30 MG FILM-COATED TABLETS
ASTATOR 60 MG FILM-COATED TABLETS
ASTATOR 80 MG FILM-COATED TABLETS
Atorvastatin
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 Astator is and what it is used for
2.
What you need to know
before you take Astator
3.
How to take Astator
4.
Possible side effects
5.
How to store Astator
6.
Contents of the pack and other information
1.
WHAT ASTATOR IS AND WHAT IT IS USED FOR
Astator belongs to a group of medicines known as statins, which are
lipid (fat) regulating medicines.
Astator is used to lower lipids known as cholesterol and triglycerides
in the blood when a low fat diet
and life style changes on their own have failed. If you are at an
increased risk of heart disease, Astator
can also be used to reduce such risk even if your cholesterol levels
are normal. You should maintain a
standard cholesterol lowering diet during treatment.
2.
What you need to know
BEFORE YOU TAKE ASTATOR
DO NOT TAKE ASTATOR
a.
if you are allergic to atorvastatin or to any similar medicines used
to lower blood lipids or to any
of the other ingredients of this medicine (listed in section 6).
b.
if you have or have ever had a disease which affects the liver
c.
if you have had any unexplained abnormal blood tests for liver
function
d.
if you are a woman able to have children and not using reliable
contraception
e.
if you are pregnant or trying to become pregnant
f.
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacis

Summary of Product characteristics

Produktinformationen för Astator 30 mg, 60 mg, 80 mg filmdragerad
tablett, MTnr 44175,
44176, 44177, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att
uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma
anledning finns inte
någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Astator 30 mg film-coated tablets
Astator 60 mg film-coated tablets
Astator 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Astator 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of atorvastatin as atorvastatin
calcium .
Astator 60 mg film-coated tablets
Each film-coated tablet contains 60 mg of atorvastatin as atorvastatin
calcium .
Astator 80 mg film-coated tablets
Each film-coated tablet contains 80 mg of atorvastatin as atorvastatin
calcium .
Excipient:
30 mg tablets
60 mg tablets
80 mg tablets
Lactose monohydrate (mg/tablet)
175 mg
350 mg
467 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
30 mg tablets: White to almost white, round, slightly convex,
film-coated tablets, bevel-edged, tablet
diameter 9 mm.
60 mg tablets: White to almost white, oval, biconvex, film-coated
tablets, tablet dimensions 16 mm x
8.5 mm.
80 mg tablets: White to almost white, capsule shape, biconvex,
film-coated tablets, tablet dimensions
18 mm x 9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Astator is indicated as an adjunct to diet for reduction of elevated
total cholesterol (total­C), LDL-
cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults,
adolescents and children aged 10
years or older with primary hypercholesterolaemia including familial
hyperchole