XOLSTAT TABLETS 20 mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Active ingredient:
ROSUVASTATIN CALCIUM
Available from:
RANBAXY (MALAYSIA) SDN. BHD.
INN (International Name):
ROSUVASTATIN CALCIUM
Units in package:
4x7tablet Tablets; 4x7tablet Tablets
Manufactured by:
RANBAXY LABORATORIES LIMITED
Authorization number:
MAL15045125AZ

XOLSTAT

Page 1

XOLSTAT

Consumer Medication Information Leaflet (RiMUP)

Rosuvastatin Calcium Tablets 5, 10, 20 mg

What is in this leaflet

What

XOLSTAT

is used for

XOLSTAT

works

Before you use

XOLSTAT

How to use

XOLSTAT

While you are using it

Side Effects

Storage and disposal of

XOLSTAT

Product description

Manufacturer

Product registration holder

Date of revision

What XOLSTAT is used for

XOLSTAT

is used along with diet to:

lower

level

cholesterol

(LDL)

(triglycerides)

increase the level of good cholesterol

(HDL) in the blood.

slow

buildup

fatty

deposits

(plaque) in the walls of blood vessels

reduce

risk

heart

attack

stroke if you are elderly and have

additional

risk

factor

having

heart disease or stroke such as high

blood pressure, low HDL, smoking,

family

history

early

heart

disease.

How XOLSTAT works

XOLSTAT

belongs

group

medicines known as statins. It reduces

the ‘bad’ cholesterol and increases the

‘good’ cholesterol in your blood.

Ask

your

doctor

if

you

have

any

questions about why XOLSTAT has

been prescribed for you.

Before you use XOLSTAT

When you must not use it

Do not take XOLSTAT if you:

have ever had an allergic reaction to

XOLSTAT

ingredients.

have liver disease

have severe kidney problems

have repeated or unexplained muscle

aches or pains

take a drug called cyclosporin (used

after organ transplants)

pregnant

intend

become

pregnant.

Women

should

avoid

becoming

pregnant

while

taking

XOLSTAT

using

suitable

contraception.

are breast-feeding currently.

In addition,

do not take 40 mg dose of

rosuvastatin

if you:

have moderate kidney problems

have

underactive

thyroid

gland

(hypothyroidism)

have

previous

history

muscle

problems

when

taking

other

cholesterol-lowering medicines.

regularly consume large amounts of

alcohol

are in situations where an increase in

blood

levels

this

medicine

occur

are of Asian origin

take other medicines called fibrates

(such as gemfibrozil, fenofibrate) to

lower your cholesterol.

Do not take

XOLSTAT

if any of the

above applies to you.

Do not take this medicine after the

expiry date printed on the pack or if

the packaging is torn or shows signs

of tampering.

The expiry date refers to

the last day of that month.

If it has expired or is damaged, return it

to your pharmacist for disposal.

Before you start to use it

Take special care with XOLSTAT,

tell your doctor or pharmacist if:

you have problems with your kidneys

you have liver problems

have

repeated

unexplained muscle aches or pains, a

personal or family history of muscle

problems,

previous

history

muscle problems when taking other

cholesterol-lowering medicines. Tell

your doctor immediately if you have

unexplained

muscle aches or pains

especially if you feel unwell or have

a fever.

regularly

consume

large

amounts of alcohol

if your thyroid gland is not working

properly

if you are an elderly person (more

than 65 years old)

take

other

medicines

called

fibrates

(such

gemfibrozil,

bezafibrate) to lower your cholesterol

Asian

origin

that

Japanese,

Chinese,

Filipino,

Vietnamese,

Korean

Indian.

Your doctor needs to choose the right

start dose of

XOLSTAT

to suit you

taking

certain

medicines

known

protease

inhibitors

(lopinavir/

ritonavir

atazanavir/

ritonavir), used to treat certain viral

infections.

you have serious problems with your

breathing. Interstitial lung disease has

been

reported

with

some

statins

(medicines

same

type

atorvastatin).

disorder

that

results in progressive scarring of lung

tissue

that

eventually

affects

ability

breathe

enough

oxygen

into

bloodstream.

presenting

features

include

shortness of breath, persistent cough

deterioration

general

health

(fatigue, weight loss and fever)

have

develop

diabetes

mellitus (characterized by high blood

sugar

levels,

increased

thirst,

increased urination etc.)

If any of these conditions applies to

you now or has in the past, talk to

your

doctor

before

taking

this

medicine.

Taking other medicines

Tell your doctor or pharmacist if you

taking

other

medicines,

including

cyclosporin

(used

after

organ

transplants)

fibrates

such

gemfibrozil,

fenofibrate

other

cholesterol

lowering

drug

such as nicotinic acid, ezetimibe

azole

antifungals

such

itraconazole,

ketoconazole,

fluconazole

(medicines

used

treat fungal infections)

erythromycin (an antibiotic used to

treat infections)

warfarin (or any other drug used

for thinning the blood)

antacid

preparation

containing

aluminium

magnesium

hydroxide

used

indigestion

Consumer Medication Information Leaflets(RiMUP)

XOLSTAT

Page 2

remedies (used to neutralise acid

in your stomach)

protease inhibitors (used to treat

certain

viral

infections)

such

lopinavir/ritonavir

atazanavir/ritonavir

oral

contraceptive

(the

pill)

hormone replacement therapy

colchicine

medicine

used

treat gout)

The effects of these medicines could be

changed by

XOLSTAT

or they could

change the effect of

XOLSTAT

How to use XOLSTAT

Follow all directions given to you by

your doctor or pharmacist carefully.

They may differ from the information

contained in this leaflet.

How much to use

Your doctor or pharmacist will tell you

how much and how often you should

take

XOLSTAT.

Make

sure

continue

with

recommended low fat diet even while

taking

XOLSTAT

Usual recommended dose:

The dose range for rosuvastatin is 5 to

orally

once

daily.

Your

treatment must start with the 10 mg to

20 mg once daily, even if you have

taken a higher dose of a different statin

before. The choice of your start dose

will depend upon:

Your cholesterol level.

level

risk

have

experiencing a heart attack or stroke.

Whether you have a factor that may

make you more sensitive to possible

side effects.

Depending

your

condition

ethnic

background,

your

doctor

will

decide

most

appropriate

starting

dose for you.

Increasing

the

dose

and

maximum

daily dose:

Your

doctor

decide

increase

your dose gradually that is right for

you. If you started with a 5 mg dose,

your doctor may decide to double this

to 10 mg then 20 mg and subsequently

40 mg if necessary. There will be a gap

four

weeks

between

every

dose

adjustment.

maximum

daily

dose

rosuvastatin is 40 mg. It is only for

patients

with

high

cholesterol

levels

high

risk

heart

attacks

stroke whose cholesterol levels are not

lowered enough with 20 mg.

XOLSTAT

recommended

use in children younger than 10 years

of age.

important

back

your

doctor for regular cholesterol checks,

make

sure

your

cholesterol

reached and is staying at the correct

level.

When to use it

You can take

XOLSTAT

at any time

of day, with or without food.

Swallow each tablet whole with a drink

of water. Take

XOLSTAT

tablet once

daily

How long to use it

must

take

this

medicine

long as your doctor has told you to.

If you forget to use it

Don’t

worry;

just

take

your

next

scheduled dose at the correct time. Do

not take a double dose to make up for

the one you missed.

have

trouble

remembering

take

your

medicine,

your

pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor

or the Poisons Information Centre

for

advice,

or go

to

Accident

and

Emergency at the nearest hospital, if

you think that you or anyone else

may

have

taken

too

much

XOLSTAT. Do this even if there are

no signs of discomfort or poisoning.

While you are using it

Things you must do

Follow

your

doctor's

instructions

carefully. If you do not follow your

doctor's

instructions,

your

treatment

help

have

unwanted side effects.

If you are about to be started on any

new medicine, remind your doctor and

pharmacist

that

taking

XOLSTAT.

take

XOLSTAT

pregnant

breast

feeding.

become

pregnant

while

taking

XOLSTAT

stop taking it immediately

and tell your doctor. Women should

avoid becoming pregnant while taking

XOLSTAT

using

suitable

contraception.

Ask

your

doctor

or

pharmacist

for

advice before taking any medicine.

Things you must not do

Do not stop taking your medicine to

because

feel

better,

unless

advised by your doctor.

Do not give your medicine to anyone

else,

even

they

have

same

condition as you.

Things to be careful of

Most people can drive a car and

operate

machinery

while

using

XOLSTAT

– it will not affect their

ability.

However,

some

people

feel

dizzy

during

treatment

with

XOLSTAT

. If you feel dizzy, consult

your doctor before attempting to drive

or use machines.

XOLSTAT

contains

lactose

monohydrate.

If you have been told by your doctor

that

have

intolerance

some

sugars,

contact

your

doctor

before

taking this medicinal product.

Side Effects

Tell your doctor or pharmacist as soon

possible

feel

well

while you are taking

XOLSTAT.

Consumer Medication Information Leaflets(RiMUP)

XOLSTAT

Page 3

Like

medicines

XOLSTAT

cause

side

effects,

although

everybody gets them.

your

doctor

pharmacist

answer any questions you may have.

Serious Side Effects

If any of the following happen, stop

taking

XOLSTAT

and

tell

your

doctor

immediately

or

go

to

the

casualty department at your nearest

hospital.

Difficulty

breathing,

with

without swelling of the face, severe

itching,

lips,

tongue

and/or

throat,

difficulty in swallowing.

Serious

blistering

condition

skin,

mouth,

eyes

genitals

(Stevens-Johnson syndrome)

Unusual

aches

pains

your

muscles. As with other statins, a very

small

number

people

have

experienced

unpleasant

muscle

effects and rarely these have become

a potentially life threatening muscle

damage known as rhabdomyolysis.

Tell your doctor immediately if you

notice any of the following:

Muscle

pain,

weakness,

rupture

tendons

Inflammation

pancreas

(pancreatitis), which may show up as

severe abdominal pain with nausea

and vomiting.

Jaundice (yellowing of the skin and

eyes),

hepatitis

(abdominal

pain

distention;

dark

urine

pale

clay-colored stools; fatigue; general

itching)

Kidney failure

Diabetes

mellitus

(characterized

high

blood

sugar

levels,

increased

thirst, increased urination etc.)

Interstitial lung disease (shortness of

breath,

persistent

cough

deterioration

general

health,

fatigue, weight loss and fever)

The above list includes serious side

effects.

You

may

need

urgent

medical attention or hospitalization.

Others

Tell your doctor if you notice any of

the following:

Headache, Dizziness

Stomach

pain,

Constipation,

Feeling sick (nausea)

Laboratory tests

There may be changes in the results

of certain laboratory tests:

An increase in the amount of protein

in the urine

Increase in blood sugar

Abnormalities

liver

functions

(GGT, ALP, bilirubin)

Traces of blood in your urine

Increase

Creatine

Kinase

(CK)

levels

Low blood platelet count

Tell

your

doctor

or

pharmacist

if

you notice anything that is making

you feel unwell.

If any of the side effects gets serious,

or if you notice any side effects not

listed in this leaflet, please tell your

doctor or pharmacist.

Other side effects not listed above may

also occur in some people.

You may report any side effects or

adverse

drug

reactions

directly

to

the

National

Centre

for

Adverse

Drug Reaction Monitoring by calling

Tel:

03-78835550,

or

visiting

the

website

portal.bpfk.gov.my

(Consumers→ Reporting)

Storage and Disposal of XOLSTAT

Storage

Store

below

protected

from

moisture.

Disposal

Return any unused or expired medicine

to your doctor, pharmacist or health

care professional for safe disposal.

Product Description

What XOLSTAT looks like

For

5

mg

Light

yellow

yellow

colored round film coated tablets with

'RT1'

on one side and plain on the

other side.

For 10 mg

: Light pink to pink colored

round film coated tablets with

'RT2'

on one side and plain on the other side.

For 20 mg

: Light pink to pink colored

round film coated tablets with 'RT3' on

one side and plain on the other side.

Ingredients

Active ingredient:

Rosuvastatin calcium

Inactive ingredients:

XOLSTAT

5

MG

tablets

also

contain:

Lactose

monohydrate,

crospovidone,

microcrystalline

cellulose,

sodium

citrate,

magnesium

stearate, opadry yellow (hypromellose,

titanium dioxide, polyethylene glycol /

macrogol, yellow iron oxide).

XOLSTAT 10 MG & 20 MG tablets

also

contain:

Lactose

monohydrate,

crospovidone,

microcrystalline

cellulose,

sodium

citrate,

magnesium

stearate,

opadry

pink

(hypromellose,

titanium dioxide, polyethylene glycol /

macrogol, red iron oxide).

MAL number

Manufacturer

RANBAXY

LABORATORIES

LIMITED

PAONTA SAHIB, DIST. SIRMOUR

H.P.- 173025

Product Registration Holder

RANBAXY

(MALAYSIA)

SDN.

BHD.

Lot 23, Bakar Arang Industrial Estate,

08000 Sungai Petani, Kedah, Malaysia.

Date of Revision:

18 March 2015

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