Atorvastatin Krka d.d. 40 mg Filmdragerad tablett

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

atorvastatinkalciumtrihydrat

Disponível em:

Krka d.d., Novo mesto

Código ATC:

C10AA05

DCI (Denominação Comum Internacional):

atorvastatin calcium trihydrate

Dosagem:

40 mg

Forma farmacêutica:

Filmdragerad tablett

Composição:

atorvastatinkalciumtrihydrat 43,38 mg Aktiv substans; laktosmonohydrat Hjälpämne

Tipo de prescrição:

Receptbelagt

Resumo do produto:

Förpacknings: Blister, 4 tabletter; Blister, 7 tabletter; Blister, 10 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter

Status de autorização:

Godkänd

Data de autorização:

2019-05-20

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATIN KRKA D.D. 10 MG FILM-COATED TABLETS
ATORVASTATIN KRKA D.D. 20 MG FILM-COATED TABLETS
ATORVASTATIN KRKA D.D. 40 MG FILM-COATED TABLETS
ATORVASTATIN KRKA D.D. 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
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, 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
DO NOT TAKE
a.
if you are allergic to atorvastatin 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 pregn

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin Krka d.d. 10 mg film-coated tablets
Atorvastatin Krka d.d. 20 mg film-coated tablets
Atorvastatin Krka d.d. 40 mg film-coated tablets
Atorvastatin Krka d.d. 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg film-coated tablets
Each film-coated tablet contains atorvastatin calcium trihydrate
equivalent to
_ _
10 mg atorvastatin.
20 mg film-coated tablets
Each film-coated tablet contains atorvastatin calcium trihydrate
equivalent to
_ _
20 mg atorvastatin.
40 mg film-coated tablets
Each film-coated tablet contains atorvastatin calcium trihydrate
equivalent to
_ _
40 mg atorvastatin.
80 mg film-coated tablets
Each film-coated tablet contains atorvastatin calcium trihydrate
equivalent to
_ _
80 mg atorvastatin.
Excipient with known effect
10 mg tablets
20 mg tablets
40 mg tablets
80 mg tablets
Lactose monohydrate (mg/tablet)
27
55
109
218
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
10 mg film-coated tablets
The tablets are white to almost white, round, biconvex, film-coated
tablets with beveled edges and
engraved with a mark 10 on one side of the tablet. Tablet diameter:
approximately 6 mm.
20 mg film-coated tablets
The tablets are white to almost white, round, biconvex, film-coated
tablets with beveled edges and
engraved with a mark 20 on one side of the tablet. Tablet diameter:
approximately 8 mm.
40 mg film-coated tablets
The tablets are white to almost white, round, biconvex, film-coated
tablets with beveled edges and
engraved with a mark 40 on one side of the tablet. Tablet diameter:
approximately 10 mm.
80 mg film-coated tablets
The tablets are white to almost white, oval, biconvex, film-coated
tablets engraved with a mark 80 on
one side of the tablet. Tablet dimension: approximately 18 mm x 9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEU