CROSUVA 40 rosuvastatin (as calcium) 40mg tablet blister pack

Main information

  • Trade name:
  • CROSUVA 40 rosuvastatin (as calcium) 40mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CROSUVA 40 rosuvastatin (as calcium) 40mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 183743
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

183743

ROSUVASTOR rosuvastatin (as calcium) 40mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Partners Pty Ltd

Postal Address

Level 1 / 313 Burwood Road,Hawthorn, VIC, 3122

Australia

ARTG Start Date

2/02/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ROSUVASTOR rosuvastatin (as calcium) 40mg tablet blister pack

Product Type

Single Medicine Product

Effective date

8/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ROSUVASTOR should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Cardiovascular Events:

ROSUVASTOR is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal

to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension,

low HDL-C, smoking, or a family history of premature coronary heart disease). ROSUVASTOR is indicated to: Reduce the risk of nonfatal myocardial

infarction; Reduce the risk of nonfatal stroke; Reduce the risk of coronary artery revascularisation procedures. In patients with hypercholesterolaemia:

ROSUVASTOR is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with

ROSUVASTOR, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,

dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, oval, biconvex, coated tablet, debossed with 'ROS' on one side and

'40' on the other side.

Active Ingredients

Rosuvastatin calcium

41.7 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 05:35:27 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CROSUVA

Rosuvastatin calcium

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some of the

common questions people ask

about CROSUVA. It does not

contain all the information that is

known about CROSUVA.

It does not take the place of

talking to your doctor and

pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you taking

CROSUVA against the benefits

they expect it will have for you.

If you have any concerns

about taking this medicine, ask

your doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read

it again.

WHAT CROSUVA IS FOR

CROSUVA is used to lower high

cholesterol levels.

Although you may have normal

cholesterol, Rosuvastatin can

also be used to reduce the risk of

you having a stroke or heart

attack if you are a male, 50 years

or over, or female, 60 years or

over, and have at least 2 risk

factors for having a heart attack

or stroke. Examples of such risk

factors would be high blood

pressure, low levels of good

cholesterol (HDL), smoking or a

family history of premature

coronary heart disease. Your

doctor may also do a blood test

to measure a substance called C

Reactive Protein to help

determine whether Rosuvastatin

should be prescribed for this use.

Cholesterol and trigylcerides

Everyone has cholesterol and

triglycerides in their blood. They

are fatty substances needed by

the body for many things.

Triglycerides are an energy

source for the body. Cholesterol

is used for such things as

building cells, making bile acids

(which help to digest foods) and

making some hormones.

There are different types of

cholesterol. Too much of the

“bad” cholesterol (LDL) can block

the blood vessels that supply

your heart and brain with blood,

and can cause heart attack,

angina and stroke. The “good”

cholesterol (HDL) helps to

remove the bad cholesterol from

the blood vessels. High levels of

triglycerides can be associated

with a low level of “good”

cholesterol and may increase the

risk of heart disease.

How CROSUVA works

CROSUVA belongs to a group of

medicines known as HMG-CoA

reductase inhibitors (also known

as ‘statins’). It lowers the “bad”

cholesterol, and raises the “good”

cholesterol when exercise and

changes to diet are not enough

on their own.

Cholesterol is present in many

foods and is also made by your

body. CROSUVA does not

reduce the cholesterol that

comes from fat in food. Because

of this, when you are taking

CROSUVA, you need to follow a

low-fat diet, control your weight

and exercise regularly.

High cholesterol is also more

likely to occur with certain

diseases or if you have a family

history of high cholesterol.

Your doctor will have explained

why you are being treated with

CROSUVA and told you what

dose to take. Your doctor may

need to check your cholesterol

levels before prescribing

CROSUVA or changing your

dose.

Follow all directions given to

you by your doctor carefully.

They may differ from the

information contained in this

leaflet.

Your doctor may prescribe this

medicine for another use. Ask

your doctor if you want more

information.

CROSUVA is not addictive.

CROSUVA is not recommended

for use in children as its effects in

children have not been

established.

BEFORE YOU USE CROSUVA

When you must not use it

Do not use CROSUVA if you

are pregnant or intend to

become pregnant. Ask your

doctor about effective

methods of contraception.

If you become pregnant, stop

taking CROSUVA as soon as

you find out and see your

doctor immediately.

Do not use CROSUVA if you

are breast feeding.

We do not know if your baby can

take in CROSUVA from breast

milk if you are breast feeding.

Do not use CROSUVA if you

have active liver disease or if

tests show you have elevated

levels of liver enzymes which

may show that you have a

problem with your liver.

Do not use CROSUVA 40 mg if

you have:

low thyroid hormone levels

(hypothyroidism)

a personal or family history

of hereditary muscular

disorders

a previous history of

muscular problems from

using other lipid-lowering

agents

a history of very heavy

alcohol use

Asian heritage

been prescribed another

class of lipid lowering agent

called a fibrate

been prescribed any

medicine containing fusidic

acid

severe kidney impairment

situations that may increase

CROSUVA blood levels

Do not use after the use by

(expiry) date printed on the

pack.

It may have no effect at all, or

worse, an entirely unexpected

effect if you take it after the

expiry date.

Do not use CROSUVA if the

packaging is torn or shows

signs of tampering.

Do not use it to treat any other

complaints unless your doctor

tells you to. Do not give this

medicine to anyone else.

Before you start to use it

You must tell your doctor if:

1. you have any allergies to:

any other statins such as

simvastatin (e.g. ZOCOR,

LIPEX); pravastatin (e.g.

PRAVACHOL); atorvastatin

(e.g. LIPITOR); fluvastatin

(e.g.VASTIN)

any ingredients listed at the

end of this leaflet

If you have an allergic reaction,

you may get a skin rash, hay

fever, difficulty in breathing or

feel faint.

2. you have any of these

medical conditions:

liver problems

kidney problems

low thyroid hormone levels

(hypothyroidism)

a personal or family history of

muscle disorders

a history of muscle problems

from using other lipid-lowering

agents

It may not be safe for you to take

CROSUVA if you have any of

these conditions. Your doctor

may do a blood test to check if

you have any problems, and may

adjust the dose of CROSUVA.

3. you have any unexplained

aches or pains in your

muscles

4. you regularly drink large

amounts of alcohol

Excessive alcohol consumption

may not be safe in patients

taking CROSUVA.

Taking other medicines

Tell your doctor if you are

taking any other medicines

including

cyclosporin (e.g.

SANDIMMUN and NEORAL,

used, for example, after organ

transplant)

antacids (medicines used to

treat heartburn and

indigestion). CROSUVA can

be taken 2 hours before or 2

hours after taking an antacid

warfarin (e.g. COUMADIN

and MAREVAN, used to stop

blood clots)

gemfibrozil (e.g. LOPID,

JEZIL, and AUSGEM, used to

lower blood lipids)

fusidic acid (e.g. FUCIDIN)

used to treat some infections

various protease inhibitor

combinations with ritonavir

used to treat HIV infection

medicines that you buy at the

chemist, supermarket or

health food shop, including

herbal medicines.

Your doctor will consider if

CROSUVA should be used

together with any of these

medicines, or may wish to adjust

the dose of CROSUVA or the

other medicines. These

medicines may affect the way

CROSUVA works.

Your doctor or pharmacist can

tell you what to do if you are

taking any of these medicines.

If you have not told your doctor

about any of these things, tell

them before you take

CROSUVA.

Effects on driving and using

machinery

Be careful driving a car or

operating machinery until you

know if CROSUVA affects you.

CROSUVA generally does not

cause any problems with your

ability to drive a car or operate

machinery. However, as with

many other medicines,

CROSUVA may cause dizziness

in some people.

TAKING CROSUVA

How to take it

Depending on your condition and

ethnic background, your doctor

will decide the most appropriate

starting dose for you.

If you have high cholesterol, the

usual starting dose is one 5 mg

or 10 mg tablet taken once daily.

Your doctor will monitor your

cholesterol and triglyceride levels

during your treatment, and, if

needed, may increase your dose

to 20 mg once daily. For most

patients a maximum daily dose of

20 mg CROSUVA is sufficient to

treat high cholesterol.

A small number of patients may

need to further increase their

CROSUVA dose to 40 mg once

daily, for example patients whose

high cholesterol is hereditary.

If your cholesterol is not high but

you have risk factors for having a

heart attack or stroke, your

doctor may start you on 20 mg.

Your doctor will advise you on

the dose that’s right for your

condition. The daily dose of

CROSUVA must not exceed 40

mg daily.

DO NOT INCREASE OR

ADJUST YOUR CROSUVA

DOSE YOURSELF.

Take CROSUVA once a day, at

about the same time each day.

Keeping a regular time for taking

CROSUVA will help to remind

you to take it.

Swallow each tablet whole with a

drink of water.

CROSUVA can be taken at any

time of the day. It does not

matter whether you take

CROSUVA with food or on an

empty stomach.

While taking CROSUVA you

also need to follow a low-fat

diet, control your weight and

exercise regularly.

How long to take it

You must continue to take it as

directed.

CROSUVA helps lower your

blood cholesterol and

triglycerides. It does not cure

your condition. If you stop taking

CROSUVA, your cholesterol and

triglycerides levels may rise

again.

You may have to take

cholesterol-lowering medicines

for the rest of your life.

If you forget to take it

If you forget to take a dose of

CROSUVA, take it as soon as

you remember, as long as it is

more than 6 hours before your

next dose is due.

Otherwise, wait until your next

dose is due and take it as

normal.

Do not double the dose to

make up for the one you

missed.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

Overdose

Telephone your doctor or the

Poisons Information Centre (13

11 26), or go to Accident and

Emergency at your nearest

hospital immediately if you

think that you or anyone else

may have taken too much

CROSUVA even if there are no

signs of discomfort or

poisoning.

WHILE YOU ARE TAKING

CROSUVA

Things you must do

Have your blood cholesterol

and triglycerides checked

when your doctor says so to

make sure CROSUVA is

working.

Stop taking CROSUVA and

contact your doctor

immediately if you become

pregnant while you are taking

CROSUVA.

Things you must not do

Do not stop taking CROSUVA

unless you have discussed it

with your doctor.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are

taking CROSUVA.

CROSUVA helps most people

with too much cholesterol, but it

may have unwanted side effects

in a few people.

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

headache

constipation

dizziness

nausea (feeling sick)

stomach pain

unusual tiredness

itchy skin

memory loss

stiff or painful joints

(arthralgia)

These are all mild side effects.

Tell your doctor if you notice a

significant increase in your

need to urinate or if you are

significantly more hungry or

thirsty than usual.

Tell your doctor immediately

or go to casualty at your

nearest hospital if you notice

any of the following:

aching muscles, muscle

tenderness or weakness not

caused by exercise,

particularly if you also have a

fever or generally feel unwell

swelling of the face, eyelids

and lips

These are all serious side

effects. You may need urgent

medical attention.

Serious side effects are rare.

Tell your doctor if you notice

anything else that is making

you feel unwell.

Some people may get other side

effects while taking CROSUVA.

Do not be alarmed by this list

of possible side effects. You

may not experience any of them.

AFTER TAKING CROSUVA

Storage

Keep your tablets in the blister

pack until it is time to take

them.

If you take CROSUVA out of the

blister pack it will not keep well.

Keep it in a cool dry place

where the temperature stays

below 25°C. Protect from light

and moisture.

Do not store it or any other

medicine in the bathroom or

near a sink.

Heat and dampness can destroy

some medicines.

Keep it where young children

cannot reach it.

A locked cupboard, at least one-

and-a-half metres above the

ground, is a good place to store

medicines.

Do not leave it in the car on

hot days.

Disposal

Ask your pharmacist what to

do with any CROSUVA tablets

you have left over if your

doctor tells you to stop taking

them, or you find that the

expiry date has passed.

PRODUCT DESCRIPTION

What CROSUVA looks like

CROSUVA 5 are Yellow, round,

biconvex, coated tablet debossed

with “ROS” over “5” on one side

and plain on the other side.

CROSUVA 10 are Pink, round,

biconvex, coated tablet debossed

with “ROS” over “10” on one side

and plain on the other side

CROSUVA 20 are Pink, round,

biconvex, coated tablet debossed

with “ROS” over “20” on one side

and plain on the other side.

CROSUVA 40 are Pink, oval,

biconvex, coated tablet debossed

with “ROS” on one side and “40”

on the other side.

Available in blister packs of 30

tablets.

Ingredients:

CROSUVA contains rosuvastatin

calcium as the active ingredient,

equivalent to rosuvastatin 5mg,

10mg, 20mg and 40mg.

The tablets also contain the

following in-active ingredients:

Microcrystalline cellulose

Colloidal anhydrous silica

Crospovidone

Lactose monohydrate

Magnesium stearate

Opadry II Yellow 33K620000

ARTG 109007, contains

hypromellose, titanium

dioxide, lactose

monohydrate, triacetin,

quinolone yellow aluminium

lake, sunset yellow FCF,

indigo carmine) – 5mg

Opadry II Pink 33K640001

ARTG 109004, contains

hypromellose, titanium

dioxide, lactose

monohydrate, triacetin,

sunset yellow FCF, indigo

carmine, allura red AC

aluminium lake) – 10mg &

20mg

Opadry II Pink 33K640000

(ARTG 109005, contains

hypromellose, titanium

dioxide, lactose

monohydrate, triacetin,

sunset yellow FCF, indigo

carmine, allura red AC

aluminium lake) – 40mg

Supplier:

Arrow Pharma Pty Ltd

15-17 Chapel Street

Cremorne VIC 3121

This leaflet was prepared in

January 2019.

Australian Registration Numbers:

AUST R 183737

10mg

AUST R 183739

20mg

AUST R 183741

40mg

AUST R 183743