Rosuvastatin 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rosuvastatin calcium

Available from:

Krka 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: 5391512455132

Patient Information leaflet

READ ALL OF THESE 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 are Rosuvastatin tablets are and what they are used for
2. What you need to know before taking Rosuvastatin tablets
3. How to take Rosuvastatin tablets
4. Possible side effects
5. How to store Rosuvastatin tablets
6. Contents of the pack and other information
1.
WHAT ROSUVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Rosuvastatin belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUVASTATIN BECAUSE:
•
You have a high cholesterol level. This means you are at
risk from a heart attack or stroke. Rosuvastatin tablets are
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 Rosuvastatin tablets.
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 IS IT IMPORTANT TO KEEP TAKING ROSUVASTATIN TABLETS?
Rosuvastatin tablets are 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 cholesterol found in the blood –
‘bad’ cholesterol (LDL-C) an

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