Rosuvastatin 10mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Rosuvastatin calcium

Saadav alates:

Dowelhurst Ltd

ATC kood:

C10AA07

INN (Rahvusvaheline Nimetus):

Rosuvastatin calcium

Annus:

10mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02120000

Infovoldik

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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 10mg Film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of rosuvastatin (as rosuvastatin calcium).
Excipient with known effect:
Each tablet contains 103.655 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Peach coloured, circular shaped, 7.18 mm diameter, biconvex
film-coated tablets,
debossed with ‘IR’ on one side and ‘10’ on other side.
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
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.
Rosuvastatin Film-coated tablets 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 naive and
patients switched from another HMG CoA reductase inhibitor. The choice
of start
dose should take into account the individual patient's cholesterol
level and future
cardiovascular risk as well as