ATOZET

Main information

  • Trade name:
  • ATOZET ezetimibe/atorvastatin 10mg/20mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATOZET ezetimibe/atorvastatin 10mg/20mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216956
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216956

ATOZET ezetimibe/atorvastatin 10mg/20mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/02/2015

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. ATOZET ezetimibe/atorvastatin 10mg/20mg tablet blister pack

Product Type

Single Medicine Product

Effective date

14/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Prevention of Cardiovascular Disease

ATOZET is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated

dose of atorvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events

following at least one year of therapy (see Clinical Trials).

Primary Hypercholesterolaemia

ATOZET is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a

combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with

atorvastatin and ezetimibe

Homozygous Familial Hypercholesterolaemia (HoFH)

ATOZET is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ATOZET ezetimibe/atorvastatin 10mg/20mg tablet blister pack

Dosage Form

Tablet, multilayer

Route of Administration

Oral

Visual Identification

Capsule shaped, biconvex, white to off white tablets, with "333" debossed

on one side of the tablet

Active Ingredients

atorvastatin calcium trihydrate

21.7 mg

Ezetimibe

10 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 26.11.2017 at 07:07:22 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

ATOZET

®

ezetimibe and atorvastatin calcium trihydrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Atozet. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Atozet 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 Atozet is used

for

Atozet helps to lower cholesterol and

triglyceride levels. It is used in

people whose cholesterol and

triglyceride levels are too high and

when diet alone cannot lower these

levels adequately.

What is high cholesterol

Cholesterol is one of several fatty

substances found in the bloodstream.

Your total cholesterol is made up

mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad"

cholesterol because it can build up in

the walls of your arteries forming

plaque. Eventually this plaque build-

up can lead to a narrowing of the

arteries. This narrowing can slow or

block blood flow to vital organs such

as the heart and brain. This blocking

of blood flow can result in a heart

attack or stroke.

HDL cholesterol is often called

"good" cholesterol because it helps

keep the bad cholesterol from

building up in the arteries and

protects against heart disease.

Triglycerides

Triglycerides are another form of fat

in your blood that may increase your

risk for heart disease.

Heart Disease

If you have heart disease and a

history of heart attack or

hospitalisation for unstable angina

(chest pain), Atozet reduces the risk

of heart attack, stroke, surgery to

increase heart blood flow, or

hospitalization for chest pain.

How Atozet works

Atozet contains two different

medicines. One is Ezetrol (ezetimibe)

and the other is atorvastatin

(atorvastatin calcium trihydrate).

Atozet reduces elevated total-

cholesterol, LDL ('bad') cholesterol

and triglycerides and increases HDL

('good') cholesterol.

Atozet works by decreasing the

absorption of cholesterol in the small

intestine and by reducing the amount

of cholesterol made in the liver.

Your doctor may have prescribed

Atozet for another reason.

Ask your doctor if you have any

questions about why Atozet has

been prescribed for you.

Atozet is not addictive.

Atozet does not help you lose weight.

Atozet is available only with a

doctor's prescription.

Use in children

Atozet is not recommended for use in

children, as there have been no

studies of its effects in children.

Before you take

Atozet

When you must not take it

Do not take Atozet if:

you have an allergy to Atozet or

any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include:

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

you have had muscle pain,

tenderness or weakness from

other medicines used to treat

high cholesterol or

triglycerides.

you are pregnant or intend to

become pregnant or you are

breastfeeding.

If you are a woman of child-

bearing age and are taking

Atozet, use a proven method of

birth control to avoid

pregnancy.

ATOZET

ATOZET is contraindicated (i.e.

should not be used) during

pregnancy and breastfeeding. If

you take this medicine during

pregnancy and breastfeeding your

baby may absorb this medicine

and it may affect your baby's

normal development causing fetal

malformations (birth defects) or

irreversible damage.

you have active liver disease or

repeated blood tests indicating

possible liver problems.

the expiry date on the pack has

passed or if the packaging is

torn or shows signs of

tampering.

If you take Atozet after the expiry

date has passed, it may not work.

Return any expired or damaged

Atozet to your pharmacist for

disposal

Do not take Atozet together with

fenofibrate if you have gall bladder

disease.

Do not take Atozet together with

fusidic acid (an antibiotic).

If you are not sure whether you

should start taking Atozet, talk to

your doctor.

Before you start to take it

Your doctor will ask you to have

your liver function tested before you

start to take Atozet.

Tell your doctor if:

you have any allergies to any

other medicines or any other

substances, such as foods,

preservatives or dyes.

you have, or have had, any medical

condition, including:

liver problems

Your doctor will do blood tests

sometimes to make sure you have

no problems with your liver.

kidney problems

you have unexplained muscle

pain, tenderness or weakness

not caused by exercise. This is

because on rare occasions,

muscle problems can be serious,

including muscle breakdown

resulting in kidney damage that

can lead to death.

Your doctor may do a blood test

to check for certain muscle

problems.

a type of stroke called a

haemorrhagic stroke or a type

of stroke called a lacunar stroke

If you have had one of these

strokes before, this medicine may

increase the risk of you having a

haemorrhagic stroke.

breathing problems

you drink alcohol regularly.

If you have not told your doctor

about any of the above, tell him/

her before you start taking Atozet.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines may be affected by

Atozet, or may affect how well it

works, or may increase the risk of

side effects with Atozet. You may

need different amounts of your

medicines, or you may need to take

different medicines or take your

medicines at different times. Your

doctor will advise you.

Tell your doctor if...

Tell your doctor if you are taking

any of the following:

bile acid sequestrants, such as

cholestyramine, used to lower

cholesterol levels

other medicines to lower

cholesterol or triglyceride levels,

for example, gemfibrozil,

fenofibrate, other fibrates,

Vitamin B3 (niacin)

warfarin or fluindione, used to

prevent blood clots

erythromycin, clarithromycin,

rifampicin or fusidic acid,

antibiotics used to treat infection

some medicines used to treat

certain fungal infections, such as

ketoconazole or itraconazole

efavirenz and protease inhibitors

such as fosamprenevir and

combinations of lopinavir/

ritonavir, darunavir/ritonavir and

saquinavir/ritonavir for the

treatment of HIV infections

hepatitis C protease inhibitors, for

example, telaprevir, boceprevir

phenytoin, used to treat epilepsy

(seizures)

ciclosporin, used to suppress the

immune system

colchicine, used for gout

spironolactone, used to treat high

blood pressure and certain types

of swelling

diltiazem used to treat angina

digoxin, used to treat heart failure

oral contraceptives for birth

control

antacids and cimetidine, used to

treat reflux or ulcers

St. John's Wort (hypericum

perforatum) (a medicine to treat

depression)

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

Atozet.

If you have not told your doctor

about any of the above, tell them

before you start taking Atozet.

How to take Atozet

Take Atozet only when prescribed

by your doctor.

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand these

instructions, ask your doctor or

pharmacist for help.

If you are currently taking a

medicine that contains ezetimibe

ATOZET

and/or atorvastatin which are

contained in Atozet:

stop taking your current

medicine(s) that contain

ezetimibe and/or atorvastatin as

this may result in you taking

more medicine than you need

take the remaining medicine(s) to

your pharmacist for safe disposal

Check with your doctor if you are not

sure about the medicines you are

taking.

How much to take

The recommended dose in adults

(18 years and over) is one Atozet

10/10 mg, 10/20 mg, 10/40 mg or

10/80 mg tablet once a day.

How to take it

Swallow the tablet whole with a

full glass of water.

When to take it

Atozet can be taken at any time of

the day. However, Atozet should be

taken at about the same time each

day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

Take Atozet with or without food.

Taking Atozet with other

cholesterol-lowering agents

Your doctor may ask you to take

Atozet with other cholesterol-

lowering agents such as bile acid

sequestrants.

If you are taking a bile acid

sequestrant, such as

cholestyramine, take your Atozet

either at least two hours before or

four hours after taking the bile

acid sequestrant.

How long to take it

Take Atozet every day and

continue taking it for as long as

your doctor tells you.

Atozet helps to lower your

cholesterol levels but does not cure

your condition. If you stop taking

Atozet your cholesterol levels may

rise again.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to. Otherwise, take it as

soon as you remember, and then go

back to taking your tablet as you

would normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting a side effect.

If you are not sure what to do, talk

to your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) 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 Atozet. Do this

even if there are no signs of

discomfort or poisoning.

You or anyone else may need urgent

medical attention.

While you are taking

Atozet

Things you must do

If you become pregnant while you

are taking Atozet, stop taking it

and tell your doctor immediately.

Keep all your doctor's

appointments.

Even if you are taking medicines to

treat high cholesterol, it is important

to have your cholesterol measured

regularly. You should also know

your cholesterol levels and goals.

Your doctor will ask you to have

your liver function tested from time

to time while you are taking Atozet

to make sure the medicine is working

and to prevent unwanted side effects.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are taking

Atozet.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking Atozet.

Things you must not do

Do not take Atozet to treat any

other conditions unless your doctor

tells you to.

Do not give Atozet to anyone else,

even if they have the same

condition as you.

Things to be careful of

Avoid drinking large quantities of

alcohol.

Drinking large quantities of alcohol

while taking Atozet may increase

your chance of getting liver

problems.

Avoid drinking large quantities of

grapefruit juice.

Grapefruit juice contains one or more

components that alter the metabolism

of some medicines, including Atozet.

Drinking very large quantities (over

1.2 litres) of grapefruit juice each day

while taking Atozet increases your

chance of getting side effects.

Be careful driving or operating

machinery until you know how

Atozet affects you.

There have been side effects reported

with Atozet that may affect your

ability to drive or operate machinery.

Individual responses to Atozet may

vary.

Things that may help your

condition

Lifestyle Changes -

This includes a cholesterol-lowering

diet, increasing physical activity, and

weight management. Ask your doctor

ATOZET

for advice before increasing physical

activity.

Medicines -

Cholesterol-lowering medicines are

used together with lifestyle changes

to help lower cholesterol.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Atozet.

Atozet helps most people with high

cholesterol levels or triglyceride

levels, 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 attention if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if...

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

diarrhoea

muscle aches, spasms, tiredness

or weakness

constipation

frequent bowel movements

nausea

stomach or belly pain

heartburn, indigestion or wind

aches and pain

stiffness

leg cramps

taste disturbance

depression

trouble sleeping

influenza

dizziness

headache

tingling or numbness of the hands

or feet

slow heart beat

hot flush

shortness of breath

unusual tiredness or weakness

generally feeling unwell

elevation in some laboratory

blood tests of liver or muscle

function

weight gain

acne

pain in arms and legs

swelling

poor memory

confusion

The above list includes the more

common and uncommon side effects

of your medicine. They are usually

mild and short-lived.

Tell your doctor immediately

if...

Tell your doctor immediately if

you notice any of the following:

skin rash and hives

raised red rash, sometimes with

circle-shaped lesions

steady abdominal pain with

nausea and vomiting

joint pain

bleeding or bruising more easily

than normal

yellowing of the skin and eyes

dark coloured urine

light coloured bowel motions

problems with breathing

including shortness of breath,

persistent cough and fever that

may also occur with fatigue or

unexplained weight loss.

These may be serious side effects.

You may need urgent medical

attention.

Go to hospital if...

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty in swallowing or

breathing.

These may be serious side effects.

If you have them, you may have

had a serious allergic reaction to

Atozet. You may need urgent

medical attention or

hospitalisation. These side effects

are very rare.

chest pain

unexpected muscle pain,

tenderness, or weakness not

caused by exercise.

This may be a serious side effect.

This is because on rare occasions,

muscle problems can be serious

including muscle breakdown

resulting in kidney damage. You

may need urgent medical

attention.

sudden severe headache, which

may be accompanied by nausea,

vomiting, loss of sensation,

tingling in any part of the body or

ringing in the ears.

severe blisters and bleeding of the

lips, eyes, mouth, nose or

genitals.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

If you are prescribed Atozet, your

healthcare professional may want to

conduct routine blood tests to check

your liver function before and after

starting treatment.

ATOZET

After taking Atozet

Storage

Keep your tablets in a cool dry

place where the temperature stays

below 30°C.

Do not store Atozet or any other

medicine in the bathroom or near a

sink. Do not leave it on a window

sill or in the car.

Heat 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 Atozet or the expiry date

has passed, ask your pharmacist

what to do with any medicine that

is left over.

Product description

What it looks like

Atozet comes in four different

strengths:

Atozet 10/10 mg

Atozet 10/20 mg

Atozet 10/40 mg

Atozet 10/80 mg

Atozet 10/10 mg is a white to off-

white capsule-shaped, biconvex,

film-coated tablet with code 257 on

one side and plain on the other.

Atozet 10/20 mg is a white to off-

white, capsule-shaped, biconvex,

film-coated tablet with code 333 on

one side and plain on the other side.

Atozet 10/40 mg is a white to off-

white, capsule-shaped, biconvex,

film-coated tablet with 337 on one

side and plain on the other.

Atozet 10/80 mg is a white to off-

white, capsule-shaped, biconvex,

film-coated tablet with code 357 on

one side and plain on the other.

Ingredients

Active ingredients:

Atozet 10/10 mg -

Ezetimibe 10 mg / Atorvastatin (as

calcium trihydrate) 10 mg per tablet.

Atozet 10/20 mg -

Ezetimibe 10 mg / atorvastatin (as

calcium trihydrate) 20 mg per tablet

Atozet 10/40 mg -

Ezetimibe 10 mg / atorvastatin (as

calcium trihydrate) 40 mg per tablet

Atozet 10/80 mg -

Ezetimibe 10 mg / atorvastatin (as

calcium trihydrate) 80 mg per tablet

Inactive ingredients:

calcium carbonate

silicon dioxide

croscarmellose sodium

hyprolose

lactose monohydrate

magnesium stearate

microcrystalline cellulose

polysorbate 80

povidone

sodium lauryl sulfate

hypromellose

macrogol 8000

titanium dioxide

purified talc

Date of Preparation

This Consumer Medicine

Information was prepared in

August 2017.

Ask your pharmacist about any

updates.

Supplier

Atozet is supplied in Australia by:

Merck Sharp & Dohme (Australia)

Pty Limited

ABN 14 000 173 508

Level 1, Building A

26 Talavera Road

Macquarie Park

NSW 2113

Australia

Australian Registration

Numbers

Atozet 10/10 mg - Aust R 216961

Atozet 10/20 mg - Aust R 216956

Atozet 10/40 mg - Aust R 216958

Atozet 10/80 mg - Aust R 216962

CCPPI-MK0653C-T-042017

ATOZET

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