TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack

Main information

  • Trade name:
  • TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179840
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179840

TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

23/09/2011

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. TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

7/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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.,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, Prevention of Cardiovascular Disease) 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

Other plastic

laminate/Al

48 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

48 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, elliptical, film-coated tablets debossed 'AS40' on one

side and plain on the other side.

Active Ingredients

atorvastatin calcium trihydrate

43.38 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 08:49:25 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

TROVAS

TROVAS

Atorvastatin Calcium 10/20/40/80 mg Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about TROVAS.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be available.

The latest Consumer Medicine

Information is available from

https://www.ebs.tga.gov.au/ and may

contain important information about

the medicine and its use of which

you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking TROVAS

against the benefits it is expected to

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 TROVAS is used

for

TROVAS is used to lower high

cholesterol levels in your blood.

TROVAS also helps reduce the risk

of having a heart attack or stroke in

people who have high blood pressure

and coronary heart disease (CHD) or

who have multiple risk factors for

CHD, including diabetes, a history of

stroke, or small blood vessel disease.

Cholesterol is a type of blood fat

needed by the body for many things,

such as building cell lining, 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 its level

may become too high.

High cholesterol is more likely to

occur with certain diseases or if you

have a family history of high

cholesterol.

When you have high levels of 'bad'

cholesterol in your blood, it may

begin to '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 patches called plaque 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 are different types of

cholesterol. LDL-C, or low-density-

lipoprotein cholesterol, is the 'bad'

cholesterol that can block your blood

vessels. HDL-C, or high-density-

lipoprotein cholesterol, is the 'good'

cholesterol that is thought to remove

the bad cholesterol from the blood

vessels.

There is another type of blood fat

called triglyceride, which is a source

of energy. High levels of triglyceride

and a low level of 'good' cholesterol

may increase the risk of heart

disease.

In some patients, atorvastatin is used

to treat high levels of 'bad'

cholesterol and high levels of

triglyceride together.

The symptoms of high cholesterol

and triglycerides are usually not

noticeable, but your doctor can

measure their levels with a simple

blood test.

How TROVAS works

TROVAS contains atorvastatin,

which belongs to a group of

medicines called HMG-CoA

reductase inhibitors. It works by

reducing the amount of 'bad'

cholesterol made by the liver and

also raises the level of the 'good'

cholesterol. TROVAS also helps to

reduce the risk of a heart attack or

stroke.

To get the best results, you also

need to follow a low-fat diet. Your

doctor may suggest other ways to

help control your condition,

including regular exercise, weight

control and quitting smoking.

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

Treatment with TROVAS does not

lessen the need to control other risk

factors for CHD, such as high blood

pressure, high blood sugar (diabetes)

and smoking. Therefore it is

important to follow the lifestyle

changes recommended by your

doctor.

TROVAS V3

Ask your doctor if you want more

information about why TROVAS

has been prescribed for you.

Your doctor may have prescribed

TROVAS for another reason.

TROVAS is not addictive. It is

available only with a doctor's

prescription.

Before you take

TROVAS

When you must not take

TROVAS

Do not take TROVAS if:

You have or have ever had an

allergy to atorvastatin or any of

the ingredients of TROVAS listed

at the end of this leaflet.

Some of the symptoms of an

allergic reaction may include

shortness of breath, wheezing or

difficulty in breathing, swelling

of the face, lips, tongue or other

parts of the body, rash, itching or

hives on the skin.

You have active liver disease.

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.

Atorvastatin may affect your

developing baby if you take it

during pregnancy.

You are breast-feeding or intend

to breast-feed. Atorvastatin

passes into breast milk and may

affect your baby.

You are taking the antibiotic

fusidic acid which is used to treat

infections.

TROVAS contains lactose. If you

have intolerance to some sugars,

contact your doctor before taking

TROVAS.

Do not take if the packaging is torn

or shows signs of tampering.

Do not take this medicine after the

expiry date printed on the pack.

If you take this medicine after the

expiry date has passed, it may not

work as well. If it has expired or is

damaged, return it to your pharmacist

for disposal.

If you are not sure whether to start

taking TROVAS, talk to your

doctor.

Before you start to take it

Before starting treatment with

TROVAS, your doctor will test

your liver function. You will also

need to get these tests done

regularly while you are taking

TROVAS.

Tell your doctor if:

You have any allergy to any other

medicines or any other

substances, such as foods,

preservatives or dyes

You have problem(s) with your

liver or kidney(s)

You have had a type of stroke

called a haemorrhagic stroke or a

type of stroke called a lacunar

stroke. This medicine may

increase the risk of you having

another haemorrhagic stroke.

You have unexplained/persistent

muscle pain, weakness or

tenderness from other medicines

used to treat high cholesterol or

triglycerides.

You have breathing problems.

If you have not told your doctor

about any of the above, tell

him/her before you take any

TROVAS.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including all

prescription medicines, all

medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may interfere with

how TROVAS works. These include:

Digoxin, a medicine used to treat

some heart problems

The antibiotics erythromycin,

clarithromycin, rifampicin or

fusidic acid

Phenytoin, a medicine used to

treat epilepsy (seizures)

Oral contraceptive pills for birth

control

Other medicines used to lower

cholesterol or triglyceride

Cyclosporin, a medicine used to

suppress the immune system

Some medicines used to treat

some fungal infections, such as

itraconazole or ketoconazole

Protease inhibitors for the

treatment of HIV infection and/or

Hepatitis C, such as efavirenz,

fosamprenavir, ritonavir and

boceprevir

Diltiazem, a medicine used to

treat angina

Antacids, medicines used to treat

reflux or ulcers

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

Excessive grapefruit juice

consumption (over 1.2 litres) may

result in increased plasma

concentrations of atorvastatin

causing side effects.

These medicines may be affected by

TROVAS 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 will advise you.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

TROVAS.

TROVAS V3

How to take TROVAS

Follow all directions given to you

by your doctor and pharmacist

carefully.

These instructions may differ from

the information contained in this

leaflet.

Your doctor will discuss with you the

need to be on a diet while you are

taking TROVAS.

Follow your agreed diet plan

carefully.

If you do not understand the

directions on the label, ask your

doctor or pharmacist for help.

How much to take

Take TROVAS exactly as your

doctor has prescribed. The usual dose

of TROVAS is between 10-80 mg

taken once a day.

How to take it

Swallow TROVAS whole with a

glass of water. Do not crush or chew

the tablets. If the tablets are chewed

or crushed they will not work

properly.

TROVAS can be taken with food or

on an empty stomach.

When to take it

Take TROVAS at about the same

time each day.

Taking your tablet(s) at the same

time each day will have the best

effect. It will also help you remember

when to take them.

How long to take it

TROVAS helps lower your

cholesterol. It does not cure your

condition. You may have to take

cholesterol-lowering medicine for the

rest of your life.

You must continue to take

TROVAS for as long as your

doctor directs, even if you feel well.

If you stop taking it, your cholesterol

may rise again.

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 medicines as you would

normally.

If you are not sure what to do, ask

your doctor or pharmacist.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chances of

your getting unwanted side effect(s).

If you have trouble remembering to

take your medicine, ask your

pharmacists for some hints.

Taking too much (overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(13 11 26), or go to Accident and

Emergency at your nearest

hospital if you think that you or

anyone else may have taken too

much TROVAS. Do this even if

there are no signs of discomfort.

You may need urgent medical

attention. Keep telephone numbers

of these facilities handy.

While you are taking

TROVAS

Things you must do

Keep all of your doctor's

appointments so that your progress

can be checked.

Have your liver function tested by

your doctor before you start taking

TROVAS and while you are taking

it.

Your cholesterol, triglyceride levels

and your liver function tests need

to be checked regularly while you

are taking this medicine. This will

allow you and your doctor to see if

TROVAS is helping you to reach

your target levels of cholesterol

and to avoid some possible side

effects.

Have your blood fats checked

when your doctor says to.

This is to make sure that TROVAS is

helping you to reach the desired

levels of cholesterol or triglyceride.

If you become pregnant while you

are taking TROVAS, stop taking it

and tell your doctor immediately.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are taking

TROVAS.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

Things you must not do

Do not give TROVAS to anyone

else, even if they have the same

condition as you.

Do not use TROVAS to treat any

other complaints unless your

doctor tells you to.

Things to be careful of

Avoid drinking large quantities of

alcohol.

Drinking large quantities of alcohol

may increase your chance of

TROVAS causing liver problems.

Be careful driving or operating

machinery until you know how

TROVAS affects you.

Atorvastatin generally does not cause

any problems with the ability to drive

a car or operate machinery. However,

as with many other medicines, it may

cause dizziness in some people.

If you feel dizzy, do not drive,

operate machinery or do anything

else that could be dangerous.

Avoid eating large quantities of

grapefruit or drinking large

quantities (over 1.2 litres) of

grapefruit juice.

Grapefruit contains one or more

substances which change how the

body processes some medicines,

including atorvastatin.

TROVAS V3

Drinking very large quantities (over

1.2 litres) of grapefruit juice each day

while taking TROVAS increases

your chance of getting side effects.

Things you must do

Some self-help measures suggested

below may assist your condition.

Your doctor or pharmacist can give

you more information about these

measures.

Weight: While you are taking

TROVAS, 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

TROVAS.

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.

Do not be alarmed by the list of

possible 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:

muscle and joint pain, muscle

weakness

constipation, diarrhoea

stomach or belly pain, nausea

(feeling sick)

headache

urine infection

heartburn, indigestion or wind

nose bleeds

rash

stuffy or runny nose

These side effects are more common

and 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

These are serious side effects that

may require medical attention.

Serious side effects are rare.

If you notice any of the following,

stop taking TROVAS and tell your

doctor immediately or go to

casualty at your nearest hospital:

symptoms of allergy such as skin

rash, itching, swelling of the face,

lips, mouth, tongue, throat or

neck which may cause difficulty

in swallowing and breathing

severe blisters and bleeding of the

lips, eyes, mouth, nose or genitals

chest pain

unexpected muscle pain,

tenderness or weakness not

caused by exercise, particularly if

you also feel unwell with or

without 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

These may be serious side effects.

You may need urgent medical

attention. Serious side effects are

rare.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

Do not be alarmed by the list of

possible side effects. You may not

experience any of them.

After taking TROVAS

Storage

Keep your TROVAS in the blister

pack until it is time to take them.

If you take TROVAS out of the

blister pack it will not keep as well.

Keep TROVAS in a cool, dry place

where the temperature stays below

25°C.

Do not store it or any other

medicine in the bathroom or near a

sink. Do not leave it in the car or

on a window sill.

Heat and dampness can destroy some

medicines.

Keep TROVAS where young

children cannot reach them.

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

TROVAS or the tablets have passed

TROVAS V3

their expiry date, ask your pharmacist

what to do with any tablets you have

left over.

Product description

What TROVAS looks like

TROVAS 10 mg tablets are white to

off-white, elliptical, film-coated

tablets debossed with 'AS10' on one

side and plain on the other side.

TROVAS 20 mg tablets are white to

off-white, elliptical, film-coated

tablets debossed with 'AS20' on one

side and plain on the other side.

TROVAS 40 mg tablets are white to

off-white, elliptical, film-coated

tablets debossed with 'AS40' on one

side and plain on the other side.

TROVAS 80 mg tablets are white to

off-white, elliptical, film-coated

tablets debossed with 'AS80' on one

side and plain on the other side.

TROVAS tablets are available in

blister packs of 30 tablets and bottles

of 30 and 100 tablets.

Ingredients

Active ingredient:

TROVAS 10 mg tablets -

atorvastatin calcium equivalent to 10

mg of atorvastatin

TROVAS 20 mg tablets -

atorvastatin calcium equivalent to 20

mg of atorvastatin

TROVAS 40 mg tablets -

atorvastatin calcium equivalent to 40

mg of atorvastatin

TROVAS 80 mg tablets -

atorvastatin calcium equivalent to 80

mg of atorvastatin

Inactive ingredients:

Lactose monohydrate,

microcrystalline cellulose, calcium

carbonate, croscarmellose sodium,

hyrolose, polysorbate 80, magnesium

stearate, Opadry White YS-1-7040

(PI 2695) and Antifoam AF

Emulsion Q7-2587. In addition the

10, 20 and 40 mg tablets contain

Euphorbia antisyphilitica leaf wax.

TROVAS tablets do not contain

gluten, sucrose or glucose.

Sponsor

Sun Pharma ANZ Pty Ltd.

Macquarie Park NSW 2113

Australia

Australian Registration

Numbers

TROVAS 10 mg tablets: AUST R

179844 (bottles); AUST R 179846

(blisters)

TROVAS 20 mg tablets: AUST R

179834 (bottles); AUST R 179829

(blisters)

TROVAS 40 mg tablets: AUST R

179860 (bottles); AUST R 179840

(blisters)

TROVAS 80 mg tablets: AUST R

179821 (bottles); AUST R 179847

(blisters)

This leaflet was prepared in May

2019.