Rosuvastatin 5mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Rosuvastatin calcium

Tersedia dari:

Mawdsley-Brooks & Company Ltd

Kode ATC:

C10AA07

INN (Nama Internasional):

Rosuvastatin calcium

Dosis:

5mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02120000

Selebaran informasi

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

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin 5mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatin 5 mg
Each tablet contains 5 mg rosuvastatin (as rosuvastatin zinc 5.34 mg).
Excipient with known effect:
Each 5mg film-coated tablet contains 60.6 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Rosuvastatin 5 mg: Round, slightly biconvex, white or almost white,
6.0 mm
diameter tablet, with a stylized ‘E’ engraving on one side and
‘591’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLEMIA
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolemia (type IIa including heterozygous familial
hypercholesterolemia)
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 hypercholesterolemia 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’s
response, using current
consensus guidelines.
Posology
_Treatment of hypercholesterolemia _
The recommended start dose is 5 mg or 10 mg orally once daily in both
statin-naive
or patients or patients switched from another HMG CoA reductase
inhibitor to
rosuvastatin. The choice of start dose should take into account the
individual patient’s
cholesterol level and future cardiovascular risk a