Crestor 10 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Rosuvastatin calcium

可用日期:

AstraZeneca UK Limited

ATC代码:

C10AA; C10AA07

INN（国际名称）:

Rosuvastatin calcium

剂量:

10 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

HMG CoA reductase inhibitors; rosuvastatin

授权状态:

Marketed

授权日期:

2003-04-17

资料单张

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
CRESTOR
®
5
MG
FILM-
COATED
TABLETS
CRESTOR
®
10
MG
FILM-COATED
TABLETS
CRESTOR
®
20
MG
FILM-COATED
TABLETS
CRESTOR
®
40
MG
FILM-COATED
TABLETS
ROSUVASTATIN
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 Crestor is and what it is used for
2) What you need to know before you take
Crestor
3) How to take Crestor
4)
Possible side effects
5) How to store Crestor
6) Contents of the pack and other information
1) WHAT CRESTOR IS AND WHAT IT IS USED FOR
Crestor belongs
to
a
group of
medicines
called statins.
YOU HAVE BEEN PRESCRIBED CRESTOR BECAUSE:
•
You
have a
high
cholesterol
level.
This
means you are at risk from a heart attack
or
stroke. Crestor
is
used
in
adults,
adolescents
and
children
6
years
or older
to
treat high
cholesterol.
• You have been advised to take a statin,
because changing
your diet and
taking
more exercise
were not
enough
to
correct
your cholesterol levels. You should continue
with your
cholesterol-lowering
diet
and
exercise
while you are taking
Crestor.
Or
• You have other factors that increase your
risk of having
a heart attack, stroke or
related health problems.
Heart attack, stroke and other problems can
be
caused
by
a disease called atherosclerosis.
Atherosclerosis is due to build-up of fatty
deposits in your arteries.
WHY IT IS IMPORTANT TO KEEP TAKING CRESTOR
Crestor is used to correct the levels of fatty
substances in the blood called lipids, the most
common of which is cholesterol.
There are different types of

产品特点

Health Products Regulatory Authority
07 November 2018
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Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crestor 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium).Each
tablet contains
91.3 mg lactose monohydrate.
For a full list of excipients,see section 6.1_._
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, pink coloured tablets, intagliated with 'ZD4522' and '10' on
one side and plain
on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolaemia (type IIa including heterozygous familial
hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct
to diet when
response to diet and other non-pharmacological treatments (e.g.
exercise, weight
reduction) is inadequate.
Adults, adolescents and children aged 6 years or older with homozygous
familial
hypercholesterolaemia as an adjunct to diet and other lipid lowering
treatments (e.g.
LDL apheresis) or if such treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are
estimated to have a
high risk for a first cardiovascular event (see section 5.1), as an
adjunct to correction
of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that should continue during treatment. The
dose should be
Health Products Regulatory Authority
07 November 2018
CRN008JCN
Page 2 of 23
individualised according to the goal of therapy and patient response,
using current
consensus guidelines.
Crestor may be given at any time of day, with or without food.
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 or 10 mg orally once daily in both
statin-naïve or
patients switched from another HMG CoA reductase inhibitor. The choice
of start
dose should