hovid-Rosuvastatin Tablet 20 mg

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

ROSUVASTATIN CALCIUM

Fáanlegur frá:

HOVID BERHAD

INN (Alþjóðlegt nafn):

ROSUVASTATIN CALCIUM

Einingar í pakka:

10tablet Tablets; 30tablet Tablets; 100tablet Tablets

Framleitt af:

HOVID BERHAD

Upplýsingar fylgiseðill

_Consumer Medication Information Leaflet (RiMUP) _
HOVID-ROSUVASTATIN TABLET
Rosuvastatin (20mg)
1
What is in this leaflet
1.
What hovid-Rosuvastatin Tablet is
used for
2.
How Rosuvastatin Tablet works
3.
Before
you
use
hovid-
Rosuvastatin Tablet
4.
How
to
use
hovid-Rosuvastatin
Tablet
5.
While
you
are
using
hovid-
Rosuvastatin Tablet
6.
Side effects
7.
Storage
and
Disposal
of
hovid-
Rosuvastatin Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
What hovid- Rosuvastatin Tablet is
used for
hovid-Rosuvastatin Tablet is used:

To lower level of cholesterol.

To prevent heart disease.
When
response
to
diet
and
exercise
alone has been inadequate.
How
hovid-Rosuvastatin
Tablet
works
This medicine contains rosuvastatin as
the
active
ingredient.
Rosuvastatin
blocks an enzyme in the liver causing
the liver to make less cholesterol, and
rosuvastatin increases the uptake and
breakdown by the liver of cholesterol
already in the blood.
Before
you
use
hovid-Rosuvastatin
Tablet
_- When you must not use it _
_ _
Do not take this medicine if:

you are hypersensitive to any of
the ingredients listed at the end of
this leaflet.

you have liver disease

you have kidney disease

you have muscular disease

you are using cyclosporine

you
are
pregnant,
trying
to
get
pregnant or think you are pregnant.

you are breastfeeding.
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
_ _
Tell your doctor if:

you
have
your
creatine
kinase
measurement

you have hypothyroidism

you consumed alcohol

you are aging more than 70 years
old

your plasma level increases

you have or with previous history
of muscular problem

you have liver problem

you have lactose intolerance

you have interstitial lung disease

you have diabetes

you
are
pregnant,
trying
to
get
pregnant or think you are pregnant.

you are breastfeeding.
_- Taking other medicines _
_ _
hovid-R

Vara einkenni

HOVID-ROSUVASTATIN TABLET
VIROS04-0 (MY)
-
renal impairment
-
hypothyroidism
-
personal or family history of hereditary muscular disorders
-
previous history of muscular toxicity with another HMG-CoA reductase
inhibitor
or fibrate
-
alcohol abuse
-
age >70 years
-
situations where an increase in plasma levels may occur
-
concomitant use of fibrates.
In such patients the risk of treatment should be considered in
relation to possible
benefit and clinical monitoring is recommended. If CK levels are
significantly
elevated at baseline (>5xULN) treatment should not be started.
•
_WHILST ON TREATMENT:_ Patients should be asked to report inexplicable
muscle
pain, weakness or cramps immediately, particularly if associated with
malaise or
fever. CK levels should be measured in these patients. Therapy should
be
discontinued if CK levels are markedly elevated (>5xULN) or if
muscular symptoms
are severe and cause daily discomfort (even if CK levels are ≤ 5x
ULN). If
symptoms resolve and CK levels return to normal, then consideration
should be given
to re-introducing rosuvastatin or an alternative HMG-CoA reductase
inhibitor at the
lowest
dose
with
close
monitoring.
Routine
monitoring
of
CK
levels
in
asymptomatic patients is not warranted. There have been very rare
reports of an
immune-mediated necrotising myopathy (IMNM) during or after treatment
with
statins, including rosuvastatin. IMNM is clinically characterised by
proximal muscle
weakness
and
elevated
serum
creatine
kinase,
which
persist
despite
discontinuation of statin treatment.
An increase in the incidence of myositis and myopathy has been seen in
patients
receiving other HMG-CoA reductase inhibitors together with fibric acid
derivatives
including
gemfibrozil,
ciclosporin,
nicotinic
acid,
azole
antifungals,
protease
inhibitors and macrolide antibiotics. Gemfibrozil increases the risk
of myopathy
when given concomitantly with some HMG-CoA reductase inhibitors.
Therefore,
the combination of rosuvastatin and gemfibrozil is not recommended.
The benefit
of further alt