Rostar FC Tablet 10mg

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

ROSUVASTATIN CALCIUM

Saatavilla:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Kansainvälinen yleisnimi):

ROSUVASTATIN CALCIUM

Kpl paketissa:

2 x 14 Tablets

Valmistaja:

Recipharm Pharmaservices Private Limited

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ROSTAR FC TABLET
Rosuvastatin Film Coated Tablet 10mg
Rosuvastatin Film Coated Tablet 20mg
1
What is in this leaflet
1.
What Rostar is used for
2.
How Rostar works
3.
Before you use Rostar
4.
How to use Rostar
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Rostar
8.
Product description
9.
Manufacturer
10.
Product Registration
Holder
11.
Date of Revision
12.
Serial Number
WHAT ROSTAR IS USED FOR
You have been prescribed
Rostar because you have a high
cholesterol level. This means
you are at risk from a heart
attack or stroke.
HOW ROSTAR WORKS
Rostar 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
cholesterol found in the blood
‘bad’ cholesterol (LDL-C) and
‘good’ cholesterol (HDL-C).
•
Rostar can reduce the ‘bad’
cholesterol and increase the
‘good’ cholesterol.
•
It works by helping to
block your body’s
production of ‘bad’
cholesterol. It is also
improving your body’s
ability to remove it from
your blood.
For most people, high
cholesterol does not affect the
way they feel because it does
not produce any symptoms.
However, if it is left untreated,
fatty deposits can build up in
the walls of your blood vessels
causing them to narrow.
Sometimes, these narrowed
blood vessels can get blocked
which can cut off the blood
supply to the heart or brain
leading to a heart attack or a
stroke. By lowering your
cholesterol levels, you reduce
your risk of having a heart
attack, a stroke or related
health problems.
You need to keep taking
Rostar, even if it has got your
cholesterol to the right level,
because it prevents your
cholesterol levels from
creeping up again and causing
buildup of fatty deposits.
BEFORE YOU USE ROSTAR
-
_When you must not use it _
Do not take Rostar:
•
If you have ever had an
allergic reaction to Rostar
or similar medicines, or to
any of its ingredients.
Rostar contains lactose,
which may cause a problem
i

Valmisteyhteenveto

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RA Submission Artwork
Internal Artwork Circulation
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Previous Approved Artwork
Approval Copy Artwork
Draft Artwork
: T - ROSTAR FILM COATED TABLET [FRONT]
Product
SAP No.
: -
: RAS/V1
Version
: 13 Dec 2023
Date
Pages No : 1 of 2
Font
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Dimension : 297mm(w) x 420mm(h)
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N/A
ROSTAR FC TABLET
recommended by guidelines.
TABLE 1: CANADIAN RECOMMENDATIONS FOR TARGET LIPID VALUES BASED ON
LEVEL OF RISK
*Start medication and lifestyle change concomitantly if values are
above target values
**Start medication if target values are not achieved after 3 months of
lifestyle modification
***Start medication if target values are not achieved after 6 months
of lifestyle modification
The following reductions in total cholesterol, LDL-C, TG, Total-C/HDL
and increase in HDL-C have been observed in a
dose-response study, and may serve as a guide to treatment of patients
with mild to moderate hypercholesterolemia.
TABLE 2: DOSE-RESPONSE IN PATIENTS WITH MILD TO MODERATE
HYPERCHOLESTEROLEMIA
(MEAN PERCENT CHANGE FROM BASELINE)
_Dosage in patients with renal insufficiency_
The usual dose range applies in patients with mild to moderate renal
impairment. For patients with severe renal impairment
(CLcr <30mL/min/1.73 m
2
) not on hemodialysis, dosing of Rosuvastatin should be started at 5
mg once daily and not exceed 10
mg once daily.
_Dosage in patients with hep