Atorvastatin TAD 10mg film-coated Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

ATORVASTATIN

זמין מ:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

קוד ATC:

C10AA05

INN (שם בינלאומי):

ATORVASTATIN 10 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

ATORVASTATIN 10 mg

סוג מרשם:

POM

איזור תרפויטי:

LIPID MODIFYING AGENTS

מצב אישור:

Authorised

תאריך אישור:

2012-03-14

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATIN TAD 10 MG FILM-COATED TABLETS
ATORVASTATIN TAD 20 MG FILM-COATED TABLETS
ATORVASTATIN TAD 40 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 Atorvastatin TAD is and what it is used for
2.
What you need to know before you take Atorvastatin TAD
3.
How to take Atorvastatin TAD
4.
Possible side effects
5.
How to store Atorvastatin TAD
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN TAD IS AND WHAT IT IS USED FOR
Atorvastatin TAD belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin TAD 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, Atorvastatin TAD 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 ATORVASTATIN TAD
DO NOT TAKE ATORVASTATIN TAD
-
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)
-
if you have or have ever had a disease which affects the liver
-
if you have had any unexplained abnormal blood tests for liver
function
-
if you are a woman able to have children and not using reliable
contraception
-
if you are p

מאפייני מוצר

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1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin TAD 10 mg film-coated tablets
Atorvastatin TAD 20 mg film-coated tablets
Atorvastatin TAD 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Atorvastatin TAD 10 mg film-coated tablets _
Each film-coated tablet contains 10 mg atorvastatin as atorvastatin
calcium.
_Atorvastatin TAD 20 mg film-coated tablets _
Each film-coated tablet contains 20 mg atorvastatin as atorvastatin
calcium.
_Atorvastatin TAD 40 mg film-coated tablets _
Each film-coated tablet contains 40 mg atorvastatin as atorvastatin
calcium.
Excipient with known effect:
10 mg film-
coated tablets
20 mg film-
coated tablets
40 mg film-
coated tablets
Lactose monohydrate (mg/tablet)
56.9
113.8
227.6
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
10 mg tablets: White, round, slightly convex, bevel-edged, with
diameter 6 mm.
20 mg tablets: White, round, slightly convex, bevel-edged, with
diameter 8 mm.
40 mg tablets: White, round, slightly convex, bevel-edged, with
diameter 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin TAD is indicated as an adjunct to diet for reduction of
elevated total cholesterol (total-
C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in
adults, adolescents and children
aged 10 years or older with primary hypercholesterolaemia including
familial hypercholesterolaemia
(heterozygous variant) or combined (mixed) hyperlipidaemia
(corresponding to Types IIa and IIb of
the Fredrickson classification) when response to diet and other
nonpharmacological measures is
inadequate.
Atorvastatin TAD is also indicated to reduce total-C and LDL-C in
adults with homozygous familial
hypercholesterolaemia as an adjunct to other lipid-lowering treatments
(e.g. LDL apheresis) or if such
treatments are unavailable.
Prevention of cardiovascular disease
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Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first
cardiovascula