LORSTAT 20 atorvastatin (as calcium) 20 mg tablets blister pack

Main information

  • Trade name:
  • LORSTAT 20 atorvastatin (as calcium) 20 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LORSTAT 20 atorvastatin (as calcium) 20 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 181404
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

181404

LORSTAT 20 atorvastatin (as calcium) 20 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

11/07/2012

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. LORSTAT 20 atorvastatin (as calcium) 20 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

5/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

LORSTAT is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,Prior to initiating therapy with atorvastatin,

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

liver disease, other drug therapy, and alcoholism) should be identified and treated.,LORSTAT is indicated in hypertensive patients with multiple risk

factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or

existing asymptomatic CHD (see Clinical Trials) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,These effects do not replace

the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Blister Pack

PVC/PCTFE (Aclar)/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. LORSTAT 20 atorvastatin (as calcium) 20 mg tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, oval, biconvex, film coated tablet with break line on one side and

debossed '20' on the other side.

Active Ingredients

atorvastatin calcium trihydrate

21.688 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 14.11.2017 at 12:46:39 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

LORSTAT

Atorvastatin (as calcium trihydrate) tablets

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about LORSTAT.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking LORSTAT

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What LORSTAT is

used for

LORSTAT is used to treat

lowers high cholesterol levels

to reduce the risk of having a

heart attack or stroke in people

who have high blood pressure and

coronary heart disease (CHD) or

who are at risk of CHD.

Examples of risk factors for CHD

include diabetes, a history of

stroke, or small blood vessel

disease.

What is cholesterol

Everyone has cholesterol and in their

blood. It is a type of blood fat needed

by the body for many things, such as

building cell walls, making bile acids

(which help to digest food) and some

hormones. However, too much

cholesterol can be a problem.

Cholesterol is present in many foods

and is also made in your body by the

liver. If your body makes too much

cholesterol or you have too much

cholesterol in your diet, then your

cholesterol becomes too high.

High cholesterol is more likely to

occur with certain diseases or if you

have a family history of high

cholesterol.

There are different types of

cholesterol. LDL, or low-density

lipoprotein, is the 'bad' cholesterol

that can block your blood vessels.

HDL, or high density lipoprotein

cholesterol is the 'good' cholesterol

that is thought to remove the 'bad'

cholesterol from the blood vessels.

When you have high levels of

cholesterol in your blood, it may

'stick' to the inside of your blood

vessels instead of being carried to the

parts of the body where it is needed.

Over time, this can form hard areas

(called plaques) on the walls of your

blood vessels, making it more

difficult for the blood to flow.

Sometimes, the plaque can detach

from the vessel wall and float in the

bloodstream; it can then reach a

smaller vessel and completely block

it. This blocking of your blood

vessels can lead to several types of

blood vessel disease, heart attack,

angina and stroke.

There is another type of fat called

triglyceride, which is a source of

energy. However, high levels of be

associated with low level of 'good'

cholesterol and may increase your

risk of heart disease.

In some patients, LORSTAT is used

to treat high cholesterol and high

triglycerides together.

In most people, there are no

symptoms of abnormal cholesterol or

triglyceride levels. Your doctor can

measure your levels with a simple

blood test.

How LORSTAT works

LORSTAT belongs to a group of

medicines known as HMG-CoA

reductase inhibitors. It works by

reducing the amount of cholesterol

made by the liver. LORSTAT 'bad'

cholesterol and can raise the 'good'

cholesterol. LORSTAT also helps to

protect you from a heart attack or

stroke.

When you are taking LORSTAT,

you also need to follow a low fat

diet and other measures, such as

exercise and weight control.

LORSTAT may be used alone, or in

combination with other medicines, to

treat your condition.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

This medicine is not expected to

affect your ability to drive a car or

operate machinery.

There is not enough information to

recommend the use of this medicine

for children.

LORSTAT

Before you take

LORSTAT

When you must not take it

Do not take LORSTAT if you have

an allergy to:

any medicine containing

atorvastatin calcium

any of the ingredients listed at the

end of this leaflet

Some of the symptoms of an allergic

reaction may include

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not take this medicine if you

have active liver disease.

Do not take this medicine if you

are pregnant or intend to become

pregnant.

If you are a woman of child-

bearing age and are taking this

medicine, use a proven method of

birth control to avoid pregnancy.

It may affect your developing baby if

you take it during pregnancy.

Do not breast-feed if you are

taking this medicine.

The active ingredient in LORSTAT

passes into breast milk and there is a

possibility that your baby may be

affected.

Do not give this medicine to a

child.

Information of safety and

effectiveness in children is limited.

Do not take this medicine if you

are taking the antibiotic fusidic

acid which is used to treat

infections.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

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 Lorstat.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

liver problems

kidney problems

muscle pain, tenderness or

weakness from other medicines

used to treat high cholesterol or

triglycerides

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

Tell your doctor if you drink

alcohol regularly.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.

Your doctor can discuss with you the

risks and benefits involved.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

LORSTAT.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines and LORSTAT may

interfere with each other. These

include:

digoxin, a medicine used to treat

some heart problems

diltiazem, a medicine used to

treat angina other medicines to

treat high cholesterol or

triglycerides

antacids, medicines used to treat

reflux or ulcers

the antibiotics erythromycin,

clarithromycin, rifampicin or

fusidic acid

phenytoin, a medicine used to

treat epilepsy (seizures)

oral contraceptives for birth

control

ciclosporin, a medicine used to

suppress the immune system

some medicines used to treat

some fungal infections, such as

itraconazole and ketoconazole

protease inhibitors for the

treatment of HIV infection and/or

Hepatitis C, such as efavirenz and

protease inhibitors which are used

to treat HIV infections

spironolactone, a medicine used

to treat high blood pressure and

certain types of swelling

vitamin B3

colchicine, a medicine used to

treat a disease with painful,

swollen joints caused by uric acid

crystals.

These medicines may be affected by

LORSTAT or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take LORSTAT

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box/bottle, ask

LORSTAT

your doctor or pharmacist for

help.

How much to take

Take LORSTAT only when

prescribed by your doctor.

Your doctor will tell you how many

tablets you need to take each day.

This may depend on your condition

and whether or not you are taking

any other medicines.

The usual dose of LORSTAT is

between 10-80 mg taken once a day.

Follow all directions given to you

by your doctor and pharmacist

carefully.

If you do not understand the

instructions ask your doctor or

pharmacist for help.

How to take it

Swallow the tablets/capsules whole

with a full glass of water.

Do not crush or chew the tablets.

When to take it

Take your medicine 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.

It does not matter if you take this

medicine before or after food.

How long to take it

Continue taking your medicine for

as long as your doctor tells you to.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

If it is less than 12 hours before

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 medicine as you would

normally.

Do not take a double dose to make

up for the dose you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

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 LORSTAT. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

LORSTAT

Things you must do

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor will ask you to have

your liver function tested from time

to time while you are taking Lorstat

to make sure the medicine is working

and to prevent unwanted side effects.

Your cholesterol and triglyceride

levels also need to be checked

regularly while you are taking this

medicine.

A regular blood test to check an

enzyme called creatine kinase (CK)

may be needed. CK in your blood

can rise after muscle injury which

can be caused by medicines used to

treat cholesterol or triglycerides, such

as Lorstat.

If you become pregnant while

taking this medicine, stop taking it

and contact your doctor

immediately.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking LORSTAT.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Things you must not do

Do not take LORSTAT to treat

any other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

If you stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects.

If possible, your doctor will

gradually reduce the amount you take

each day before stopping the

medicine completely.

Things to be careful of

Be careful driving or operating

machinery until you know how

LORSTAT affects you.

LORSTAT generally does not cause

any problems with your ability to

drive a car or operate machinery.

However, as with many other

medicines, LORSTAT may cause

dizziness in some people. If you have

any of these symptoms, do not drive,

operate machinery or do anything

else that could be dangerous.

LORSTAT

Be careful when drinking alcohol

while you are taking this medicine.

Drinking large quantities of alcohol

may increase your chance of

LORSTAT causing liver problems.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Be careful when drinking large

quantities of grapefruit juice.

Grapefruit juice contains one or more

constituents that alter the metabolism

of some medicines, including

LORSTAT. Therefore, drinking very

large quantities of grapefruit juice

(over 1 litre) each day increases the

chance of LORSTAT causing side

effects.

Things that would be helpful

for your condition

Some self-help measures suggested

below may help your condition. Your

doctor or pharmacist can give you

more information about these

measures.

Weight: While you are taking

Lorstat, you need to follow a diet

plan agreed to with your doctor.

This may include measures to

lose some weight.

Exercise: Regular exercise can

help lower your cholesterol

levels. It is important not to

overdo it. Before commencing

regular exercise, you should

consult your doctor who will

suggest the most suitable exercise

for you. If you experience any

discomfort when exercising, see

your doctor.

Alcohol: Excessive alcohol intake

can raise your cholesterol levels

or affect your liver function,

which could increase the chance

of you getting unwanted side

effects. Your doctor may discuss

with you whether you should

reduce the amount of alcohol you

drink.

Smoking: Smoking increases the

risk of you suffering from heart

problems. Your doctor may

advise you to stop smoking.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

LORSTAT.

This medicine helps most people

with lowering high cholesterol levels

and reducing the risk of having a

heart attack or stroke in people who

have high blood pressure and

coronary heart disease (CHD) or who

are at risk of CHD, but it may have

unwanted side effects in some

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

list 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 or pharmacist if

you notice any of the following and

they worry you:

muscle and joint pain, muscle

weakness, especially in the

forearms, thighs, hips, shoulders,

neck, and back

difficulty climbing stairs or

standing up from a chair

difficulty lifting arms over the

head

falling and difficulty getting up

from a fall

constipation, diarrhea

stomach or belly pain, nausea

(feeling sick)

heartburn, indigestion or wind

urine infection

headache

stuffy or runny nose

nose bleeds

rash

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

yellowing of the skin and eyes

and dark coloured urine

feeling weak and tired,

excessively thirsty and passing

more urine

problems with breathing,

including shortness of breath,

persistent cough and fever

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

symptoms of allergy such as skin

rash, itching, swelling of the face,

lips, mouth, throat or neck which

may cause difficulty in

swallowing or breathing

chest pain

unexpected muscle pain,

tenderness or weakness not

caused by exercise, particularly if

you also feel unwell or have a

fever

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.

These side effects are very rare.

LORSTAT

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.

Some of these side effects (for

example, changes in thyroid function,

cholesterol level or blood pressure)

can only be found when your doctor

does tests from time to time to check

your progress.

After taking LORSTAT

Storage

Keep your tablets in the pack/

bottle until it is time to take them.

If you take the tablets out of the

pack/bottle they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store LORSTAT 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 this medicine 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

LORSTAT tablets are available in 4

different strengths:

LORSTAT 10 mg - White, oval,

biconvex, film coated tablet plain

on one side and debossed '10' on

the other side.

LORSTAT 20 mg - White, oval,

biconvex, film coated tablet with

break line on one side and

debossed '20' on the other side.

LORSTAT 40 mg - White, oval,

biconvex, film coated tablet with

break line on one side and

debossed '40' on the other side.

LORSTAT 80 mg - White, oval,

biconvex, film coated tablet with

break line on one side and

debossed '80' on the other side.

Each blister pack contains 30 tablets.

Discard blister pack 30 days after the

first tablet is taken.

Ingredients

The active ingredient of Lorstat is

atorvastatin.

It also contains the following inactive

ingredients:

colloidal anhydrous silica

sodium carbonate anhydrous

microcrystalline cellulose

arginine

lactose anhydrous

croscarmellose sodium

hyprolose

magnesium stearate

Opadry AMB white OY-B-28920

(Proprietary Ingredient ID no.

10274)

This medicine contains lactose and

soya bean products.

Supplier

LORSTAT is supplied in Australia

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.mylan.com.au

Medical Information

Phone: 1800 028 365

Australian registration numbers:

LORSTAT 10 mg blister pack:

AUST R 181407

LORSTAT 10 mg bottle:

AUST R 181403

LORSTAT 20 mg blister pack:

AUST R 181404

LORSTAT 20 mg bottle:

AUST R 181410

LORSTAT 40 mg blister pack:

AUST R 181405

LORSTAT 40 mg bottle:

AUST R 181409

LORSTAT 80 mg blister pack:

AUST R 181406

LORSTAT 80 mg bottle:

AUST R 181408.

This leaflet was prepared on

03 October 2018

LORSTAT_cmi\OCT18/00

LORSTAT