Atorab 30 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATORVASTATIN CALCIUM, TRIHYDRATE

Available from:

Basics GmbH Hemmelrather Weg 201 51377 Leverkusen, Germany

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE 30 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ATORVASTATIN CALCIUM TRIHYDRATE 30 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2015-03-18

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORAB 30 MG FILM-COATED TABLETS
ATORAB 60 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Atorab is and what it is used for
2.
What you need to know before you take Atorab
3.
How to take Atorab
4.
Possible side effects
5.
How to store Atorab
6.
Contents of the pack and other information
1.
WHAT ATORAB IS AND WHAT IT IS USED FOR
Atorab belongs to a group of medicines known as statins, which are
lipid (fat) regulating medicines.
Atorab 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
Atorab 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 ATORAB
DO NOT TAKE ATORAB:
•
if you are allergic to Atorab 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 pregnant, or trying to become pregnant.
•
if you are breast-feeding.
•
if you use the combination of glecaprevir/pibrentasvir in the
treatment of hepatitis C.
Page 2 of 8
WARNIN

Summary of Product characteristics

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Atorab 30 mg, 60 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg or 60 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient with known effect:
30mg: Each tablet contains 98 mg lactose monohydrate and 2.59 mg
sodium.
60mg: Each tablet contains 197 mg lactose monohydrate and 5.16 mg
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
30mg: White to off white, elliptical, tablets about 7mm wide and 14 mm
long marked “AS 30”
on one side and plain on the other side.
60mg: White to off white, elliptical, tablets about 9mm wide and 17 mm
long marked “AS 60”
on one side and plain on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypercholesterolaemia: _
Atorvastatin 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 wit
h pr
i
mary
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 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 _
Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first
cardiovascular event (see section 5.1), as an adjunct to correction of
other risk factors.
Page 2 of 24
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The patient should be placed on a standard cholesterol-lowering diet
before receiving
atorvastatin and should continue on this diet during treatment w