Rosuvastatin 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rosuvastatin calcium

Available from:

Teva UK Ltd

ATC code:

C10AA07

INN (International Name):

Rosuvastatin calcium

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5017007027706

Patient Information leaflet

_S267 LEAFLET Crestor 20190923_
PACKAGE LEAFLET: INFORMATION FOR THE USER
CRESTOR
® 20MG TABLETS (rosuvastatin calcium)
Your medicine is known as Crestor 20mg Tablets but will be
referred to as Crestor throughout the following leaflet.
Information for other strengths of Crestor (Crestor 5mg, 10mg and
40mg tablets) also may be present in this leaflet.
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 doing 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 20 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg of
rosuvastatin
as rosuvastatin calcium.
Excipient with known effect: Lactose monohydrate.
Each 20 mg film-coated tablet contains 193.57 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Rosuvastatin 20 mg film-coated tablets: Pink, round, biconvex, coated
tablet,
embossed ‘ROS’ over ‘20’ on one side and nothing on the other,
with diameter
9 mm.
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.
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
_Method of administration _
For oral use.
Rosuvastatin may be given at any time of day, with or without food.
Before
treatment
initiation
the
patient
should
be
placed
on
a
standard
cholesterol-lowering diet that should continue during treatment. The
dose
should be individualised according to the goal of therapy and patient
response,
using current consensus guidelines.
Posology
TREATMENT OF HYPERCHOLESTEROLAEMIA
The recommended start dose is 5 mg or 10 mg orally once daily in both
statin
naïve or patients switched from another HMG CoA reductase inhibitor.
The
choi