APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack

Main information

  • Trade name:
  • APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 183057
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

183057

APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/11/2011

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. APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

19/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Rosuvastatin 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). Rosuvastatin 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:

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

Rosuvastatin, 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

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White, round, biconvex, film-coated tablet, engraved APO' on one side,

'ROS' over '20' on the other side

Active Ingredients

Rosuvastatin calcium

20.79 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 06:29:58 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

APO-Rosuvastatin

5 MG/ 10 MG/ 20 MG/ 40 MG

Contains the active ingredient rosuvastatin calcium

Consumer Medicine Information

For a copy of a large print leaflet ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about rosuvastatin. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may need to read it again.

What this medicine is

used for

The name of your medicine is APO-

Rosuvastatin. It contains the active

ingredient rosuvastatin (as

rosuvastatin calcium).

This medicine is used to lower high

cholesterol levels.

Even though you may have normal

cholesterol, this medicine can also be

used to reduce the risk of you having

a stroke or heart attack if you are a

man 50 or more years old or a

woman 60 or more years old and

have at least 2 risk factors for having

a heart attack or stroke. Risk factors

include: 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 decide if you

should be given this medicine for this

use.

Cholesterol and

triglycerides

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 vessel 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.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Rosuvastatin 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.

Rosuvastatin does not reduce the

cholesterol that comes from fat in

food. Because of this, when you are

taking rosuvastatin, you need to

follow a low-fat diet, control your

weight and exercise regularly.

APO-ROSUVASTATIN

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

rosuvastatin and told you what dose

to take. Your doctor may need to

check your cholesterol levels before

prescribing rosuvastatin or changing

your dose.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have active liver disease. If

tests show you have elevated

levels of liver enzymes, this may

indicate that you have a

problem with your liver.

You have been prescribed any

medicine containing fusidic

acid.

You are pregnant, you intend to

become pregnant or you are not

taking an effective method of

contraception.

Rosuvastatin may affect your

developing baby if you take it

during pregnancy. Ask your

doctor about effective methods of

contraception. If you become

pregnant, stop taking this

medicine as soon as you find out

and see your doctor immediately.

You are breastfeeding.

Rosuvastatin may pass into

human breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

rosuvastatin or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows signs

of tampering or it does not look

quite right.You must not use APO-

Rosuvastatin 40 mg if you have:

low thyroid hormone levels

(hypothyroidism)

personal or family history of

hereditary muscular disorders

history of muscular problems

from using other lipid-lowering

agents

history of heavy alcohol use

Asian heritage

been prescribed another class

of lipid-lowering agent called a

fibrate

severe kidney impairment

situations that may increase

rosuvastatin blood levels (ask

your doctor).

Before you start to take it

Before you start taking this, tell

your doctor if:

You have allergies to:

any other statins such as

simvastatin, pravastatin,

atorvastatin, fluvastatin

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

liver problems

kidney problems

low thyroid hormone levels

(hypothyroidism)

personal or family history of

muscle disorders

history of muscle problems from

using other lipid-lowering agents

unexplained aches or pains in

your muscles.

You regularly drink large

amounts of alcohol. Excessive

alcohol consumption may not be

safe in patients taking this

medicine.

You are currently pregnant, you

plan to become pregnant or you

are not taking an effective method

of contraception. Do not take this

medicine whilst pregnant.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

rosuvastatin. These include:

cyclosporins (may be used after

organ transplant)

antacids (medicines used to treat

heartburn and indigestion). This

medicine can be taken 2 hours

before or 2 hours after taking an

antacid

warfarin (used to stop blood

clots)

clopidogrel (used to prevent

blood clots)

APO-ROSUVASTATIN

gemfibrozil (used to lower blood

lipids)

fusidic acid used to treat some

infections, you must not take this

medicine with fusidic acid

various protease inhibitors used

in combination with ritonavir to

treat HIV infection.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with rosuvastatin.

Your doctor can tell you what to do if

you are taking any of these

medicines. These medicines may

affect the way rosuvastatin works.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition,

your ethnicity and whether you are

taking any other medicines.

If you have high cholesterol, your

doctor will probably start you on 5

mg or 10 mg tablet taken once daily.

Your doctor will then monitor your

cholesterol and triglyceride levels

during your treatment and, if needed,

may increase your rosuvastatin dose

to 20 mg once daily. For most

patients, a maximum 20 mg

rosuvastatin daily dose is sufficient

to treat their condition.

A small number of patients may need

to further increase their rosuvastatin

dose to 40 mg once daily, for

example, patients whose high

cholesterol is hereditary.

If your cholesterol is not high but

you have risks 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 rosuvastatin must

not exceed 40 mg.

DO NOT INCREASE OR

ADJUST YOUR

ROSUVASTATIN DOSE

YOURSELF.

How to take it

Tablets must not be broken or

crushed and must be swallowed

whole with a glass of water.

When to take it

Take this medicine once a day, at

about the same time each day.

Taking it at the same time each day

will have the best effect and will also

help you remember when to take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

This medicine helps lower your

blood cholesterol and triglycerides. It

does not cure your condition. If you

stop taking this medicine, your

cholesterol and triglyceride levels

may rise again.

You may have to take cholesterol-

lowering medicines for the rest of

your life.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is within 6 hours your next dose

is due, skip the missed dose and take

your next dose at the usual time.

Otherwise, take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant, are planning to

become pregnant or are not taking

an effective method of

contraception. Stop taking this

medicine immediately if you are

pregnant.

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

APO-ROSUVASTATIN

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

While taking this medicine, you also

need to follow a low-fat diet, to

control your weight and to exercise

regularly.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking rosuvastatin or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious, most of

the time they are not.

Tell your doctor if you notice any

of the following:

headache

constipation

dizziness

nausea (feeling sick)

stomach pain

unusual tiredness

itchy skin

memory loss

stiff or painful joints (arthralgia).

Tell your doctor if you notice an

increase in your need to urinate if

you are more hungry or thirsty than

usual.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following.

These may be serious side effects and

you may need medical attention:

aching muscles, muscle

tenderness or weakness not

caused by exercise, particularly if

you also have a fever or generally

feel unwell

severe skin reaction with painful

red areas, large blisters and

peeling of layers of the skin, may

be accompanied by fever and

chills, aching muscles and

generally feeling unwell

difficulty breathing, coughing,

particularly if you also feel

generally unwell (e.g. fatigue,

weight loss, fever).

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to rosuvastatin, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 30°C and protected from light

and moisture.

Do not store your medicine, or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat, light

and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or it has passed its

expiry date, ask your pharmacist

what to do with any medicine that is

left over.

Product description

What this medicine looks

like*

APO-Rosuvastatin 5mg tablets:

White, round, biconvex, film coated

tablet, engraved "APO" on one side,

"ROS" over "5" on the other side.

APO-Rosuvastatin 10mg tablets:

White, round, biconvex, film-coated

tablet, engraved "APO" on one side,

"ROS" over "10" on the other side.

APO-Rosuvastatin 20mg tablets:

White, round, biconvex, film-coated

tablet, engraved "APO" on one side,

"ROS" over "20" on the other side.

APO-Rosuvastatin 40mg tablets:

White, oval, biconvex, film-coated

tablet, engraved "APO" on one side,

"ROS40" on the other side.

Tablets are packaged in blister packs

of 7 and 30.

Tablets are also packaged in bottles

of 30, 100 and 500.

APO-ROSUVASTATIN

* Not all strengths, pack types and/or

pack sizes are marketed. Alternative

brands should be used if required.

Ingredients

Each tablet contains 5 mg, 10 mg, 20

mg or 40 mg of rosuvastatin calcium,

as the active ingredient.

The tablets also contain the following

inactive ingredients:

lactose

cellulose-microcrystalline

crospovidone

magnesium stearate

colloidal anhydrous silica

hypromellose

hydroxypropylcellulose

macrogol 8000.

This medicine is gluten-free,

tartrazine-free and free of other azo

dyes.

Australian Registration

Numbers

APO-Rosuvastatin 5 mg tablets

(blister pack): AUST R 183061.

APO-Rosuvastatin 10 mg tablets

(blister pack): AUST R 183073.

APO-Rosuvastatin 20 mg tablets

(blister pack): AUST R 183057.

APO-Rosuvastatin 40 mg tablets

(blister pack): AUST R 183074.

APO-Rosuvastatin 5 mg tablets

(bottle): AUST R 183075.

APO-Rosuvastatin 10 mg tablets

(bottle): AUST R 183067.

APO-Rosuvastatin 20 mg tablets

(bottle): AUST R 183060.

APO-Rosuvastatin 40 mg tablets

(bottle): AUST R 183059.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in

August 2018.

APO-ROSUVASTATIN