MYVAST 10 simvastatin 10 mg film-coated tablet blister pack

Main information

  • Trade name:
  • MYVAST 10 simvastatin 10 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MYVAST 10 simvastatin 10 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186683
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186683

MYVAST 10 simvastatin 10 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

27/04/2012

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. MYVAST 10 simvastatin 10 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

17/07/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, 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. Simvastatin is indicated in patients at high risk of coronary heart disease (CHD) (with or without hypercholesterolaemia)

including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD to reduce the risk of

cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. 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

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 Tablets

(S4) Prescription Only Medicine

Components

1. MYVAST 10 simvastatin 10 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light pink coloured, round shaped, biconvex, film coated tablets, debossed

with 'A' on one side and '01' on the other side

Active Ingredients

Simvastatin

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 29.11.2017 at 02:33:47 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

MYVAST

CONSUMER MEDICINE INFORMATION

Version 1.2

MYVAST 5, 10, 20, 40 & 80

Simvastatin

Consumer Medicine Information

What is in this leaflet?

This

leaflet

answers

some

common questions about MYVAST.

It does not contain all of the available

information.

It does not take the place of talking to

your doctor or pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed

risks

taking

MYVAST

against the benefits they expect it will

have for you.

If

you

have

any

concerns

about

using MYVAST, ask your doctor

or pharmacist.

Keep

this

leaflet

with

your

MYVAST tablets.

You may need to read it again.

MYVAST helps to lower cholesterol

and triglyceride levels.

MYVAST

used

people

have coronary heart disease (CHD) or

who are at high risk of CHD (for

example,

they

have

diabetes,

history

stroke,

other

blood

vessel disease).

MYVAST

used

these

people, regardless of their cholesterol

level to:

help prolong life by reducing the

risk of a heart attack

reduce the risk of stroke

reduce

need

surgery

increase blood flow to the heart

reduce the need for hospitalisation

due to angina.

Cholesterol

Everyone

cholesterol

triglycerides in their blood. They are

types of blood fat needed by the body

for many things, including building

cell walls, making bile acids (which

help

digest

food)

certain

hormones.

However,

much

cholesterol can be a problem.

Your body makes cholesterol, but it

also comes from food.

Normally

body

balances

cholesterol

makes

with

cholesterol it gets

from food. This

means

more

cholesterol

comes

from food, less is made by the body.

However, if you eat a diet high in fat,

your body may not keep this balance

and your cholesterol levels rise.

High

cholesterol

more

likely

occur with certain diseases or if you

have

family

history

high

cholesterol.

When

have

high

levels

cholesterol, 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

plaque,

walls

blood

vessels,

making

more difficult for the blood to flow.

This blocking of your blood vessels

lead

coronary

heart

disease

(such as heart attack and angina), and

stroke.

In people with CHD, MYVAST may

slow down the hardening of blood

vessels

reduce

risk

developing new plaques.

There

different

types

cholesterol,

called

cholesterol.

cholesterol

'bad' cholesterol that can block your

blood vessels. HDL cholesterol, on

other

hand,

'good'

cholesterol that is thought to remove

the bad cholesterol from the blood

vessels.

Triglycerides

Triglycerides

energy

source

body.

However,

with

cholesterol,

much

triglycerides

can be a problem.

How MYVAST works

MYVAST

belongs

group

medicines

known

HMG-CoA

reductase

inhibitors.

works

reducing the amount of cholesterol

made by the liver. In terms of good

cholesterol,

MYVAST

reduces the bad cholesterol and raises

the good cholesterol.

MYVAST

does

reduce

cholesterol

triglycerides

that

come from fat in food.

Therefore,

when

you

are

taking

MYVAST, you also need to follow

a low fat diet and other measures,

such

as

exercise

and

weight

control.

What MYVAST is used for

MYVAST

CONSUMER MEDICINE INFORMATION

Version 1.1

most

people,

there

symptoms

high

cholesterol

triglycerides.

Your

doctor

measure

your

cholesterol

triglycerides with a simple blood test.

Your

doctor

have

prescribed

MYVAST

another

reason.

your doctor if you have any questions

about

MYVAST

been

prescribed for you.

MYVAST is not addictive.

Use in children

This medicine is not recommended

for use in boys or girls under the age

of 10 years, or girls who have not yet

started their periods.

Before you take MYVAST

When

must

take

MYVAST

Do not take MYVAST if:

you have an allergy to MYVAST

or other brands of simvastatin,

or to any of the ingredients listed

at the end of this leaflet

Symptoms of an allergic reaction

include

skin

rash,

itchiness,

shortness of breath, swelling of the

tongue or face, or painful joints.

you

are

pregnant

or

breast-

feeding

Your

baby

absorb

this

medicine

womb

from

breast milk and therefore there is a

possibility of harm to the baby.

you have liver disease

you

have

had

muscle

pain,

tenderness

or

weakness

from

other

medicines

used

to

treat

high cholesterol or triglycerides

the packaging is torn or shows

signs of tampering

the expiry date on the pack has

passed.

If you take this medicine after the

expiry date has passed, it may not

work.

If you are not sure whether you

should start taking MYVAST, talk

to your doctor.

Before

start

take

MYVAST

Tell your doctor if:

1. you intend to become pregnant

or plan to breast feed

MYVAST

should

used

during pregnancy or while breast-

feeding.

2.

you

have

unexplained

muscle

pain,

tenderness

or

weakness

not caused by exercise. This is

because

on

rare

occasions,

muscle problems an 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.

3. you are taking niacin or a niacin-

containing product, particularly

you are Chinese.

4. you have ever had liver disease

Your doctor will do a blood test to

make sure you have no problems

with your liver.

5. you have kidney disease or any

other medical problems

6. you drink alcohol regularly

7.you

have

any

allergies

to

any

other

medicines

or

any

other

substances,

such

as

foods,

preservatives or dyes.

If you have not told your doctor

about any of the above, tell them

before you take any MYVAST.

Taking other medicines

Tell your doctor if you are taking

any

other

medicines,

including

medicines that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines should not be taken

with MYVAST as they may increase

the risk of muscle side effects with

MYVAST.

particularly

important to tell your doctor if you

are taking:

nefazodone,

used

treat

depression

protease

inhibitors,

used

treat

HIV infection, including indinavir,

nelfinavir, ritonavir, saquinavir

gemfibrozil,

used

treat

high

cholesterol levels

cyclosporin, used to suppress the

immune system

danazol

erythromycin,

clarithromycin,

telithromycin

fusidic

acid

antibiotics used to treat infections

ketoconazole,

itraconazole

posaconazole, used to treat certain

fungal infections

If you are taking any of the above,

your

doctor

suggest

stopping

MYVAST

temporarily

permanently.

Some medicines and MYVAST may

interfere

with

each

other.

Because

taking

MYVAST

with

following drugs can increase the risk

MYVAST

CONSUMER MEDICINE INFORMATION

Version 1.1

muscle

problems

(see

Side

Effects), it is particularly important to

tell your doctor if you are taking:

other

medicines

lower

cholesterol

levels,

example,

other fibrates, nicotinic acid (also

known as niacin)

warfarin,

other

drugs

used

prevent blood clots

colchicine, used for gout

verapamil,

diltiazem

amlodipine,

used

treat

high

blood

pressure,

angina

other

heart conditions

amiodarone, used to treat irregular

heart beat

digoxin, used to treat heart failure

These medicines may be affected by

MYVAST, may affect how well it

works, or may increase the risk of

side

effects

with

MYVAST.

may need different amounts of your

medicine, or you may need to take

different medicines.

Your doctor or pharmacist has more

information

medicines

careful

with

avoid

while

taking

MYVAST.

You should also tell any doctor who

is prescribing a new medication for

that

taking

AURO-

SIMVSTATIN.

How much to take MYVAST

Take

MYVAST

only

when

prescribed by your doctor.

Your doctor will tell you how many

tablets you need to take each day.

This depends on your cholesterol and

triglyceride levels and other factors,

such as kidney disease.

For adults, the recommended starting

dose is 10mg or 20 mg per day, taken

in the evening, which may need to be

increased up to 80 mg daily to have

the best effect.

Because

increased

risk

muscle problems, the 80 mg dose is

only for patients at high risk of heart

disease

problems

have

reached their cholesterol goal on the

lower doses.

People with CHD or risk factors for

CHD are usually started on 40 mg per

day, taken in the evening.

Swallow MYVAST with a glass of

water.

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, ask your

doctor or pharmacist for help.

When to take MYVAST

Take MYVAST once a day in the

evening.

liver

produces

greatest

amount of cholesterol when the body

is at rest and when there is no dietary

intake.

most

people

this

night

when

asleep.

Therefore,

MYVAST

more

effective

when

taken in the evening. A good time

would be after your evening meal.

However, it does not matter whether

you take it before or after food.

Take MYVAST at about the same

time each evening.

Taking

your

tablet(s)

same

time each evening will have the best

effect. It will also help you remember

when to take the tablets.

How long to take MYVAST

MYVAST

helps

lower

your

cholesterol.

does

cure

your

condition.

Therefore,

must

continue to take it as directed by your

doctor if you expect to lower your

cholesterol and keep it down. You

have

take

cholesterol-

lowering

medicine

rest

your

life.

stop

taking

MYVAST,

your

cholesterol

levels

may rise again.

If you forget to take MYVAST

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(s)

as

you

would normally.

If you are not sure whether to skip

the

dose,

talk

to

your

doctor

or

pharmacist.

Do not take a double dose to make

up for the dose that you missed.

If you have trouble remembering

to

take

your

tablets,

ask

your

pharmacist for some hints.

take

much

(Overdose)

Immediately telephone your doctor

or

Poisons

Information

Centre

(telephone

13

11

26),

or

go

to

accident

and

emergency

at

your

How to take MYVAST

MYVAST

CONSUMER MEDICINE INFORMATION

Version 1.1

nearest hospital, if you think that

you or anyone else may have taken

too much MYVAST. Do this even if

there are no signs of discomfort or

poisoning.

Things you must do

If you become pregnant while you

are taking MYVAST, stop taking it

and

contact

your

doctor

immediately.

Have your blood fats checked when

your doctor says, to make sure

MYVAST is working.

If you are about to be started on

any new medicine tell your doctor

and pharmacist that you are taking

MYVAST.

If you are about to have elective

surgery, tell your doctor that you

are taking MYVAST.

Your

doctor

suggest

stopping

the tablets a few days before surgery.

Things you must not do

Do not give MYVAST 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

increase

your

chance

MYVAST causing liver problems.

Avoid drinking large quantities of

grapefruit juice.

Grapefruit juice contains one or more

components that alter the metabolism

some

medicines,

including

MYVAST. Therefore, drinking very

large

quantities

(over

litre)

grapefruit

juice

each

increases

your

chance

MYVAST

causing

side

effects.

These

include

aching

muscles,

muscle

tenderness

weakness,

caused

exercise.

However,

glass

(250mL)

grapefruit juice each day has not been

shown to have any significant effect.

Be

careful

driving

or

operating

machinery

until

you

know

how

MYVAST affects you.

MYVAST generally does not cause

problems

with

your

ability

drive

operate

machinery.

However,

with

many

other

medicines,

MYVAST

cause

dizziness in some people. Make sure

know

react

MYVAST before you drive a car or

operate machinery.

Changes to lifestyle that may help

reduce

the

chance

of

coronary

heart disease

Lowering high cholesterol can help

reduce

your

chances

having

coronary

heart

disease

(CHD).

However,

your

chances

having

may be increased by several

other

factors

including

high

blood

pressure, cigarette smoking, diabetes,

excess

weight,

family

history

CHD,

being

male

being

woman who has reached menopause.

Some self help measures suggested

below may help your condition and

help reduce your chances of having

CHD.

Talk

your

doctor,

pharmacist, or dietician about these

measures and for more information.

Diet

continue

diet

recommended by your doctor,

dietician or pharmacist.

Weight

- your doctor may advise you to

lose

weight

overweight.

Exercise

- make exercise a part of your

routine - walking is good. Ask

your doctor for advice before

starting exercise.

Smoking

- your doctor may advise you to

stop

smoking

least

down.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well

while

you

are

taking

MYVAST.

MYVAST

helps

most

people

with

high

cholesterol,

have

unwanted

side

effects

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:

constipation, diarrhoea, wind

stomach upset or pain, feeling sick

(nausea)

headache

dizziness

While

you

are

using

MYVAST

Side Effects

MYVAST

CONSUMER MEDICINE INFORMATION

Version 1.1

These

more

common

side

effects of MYVAST. For the most

part these have been mild and short-

lived.

Tell your doctor immediately if you

notice any of the following:

aching muscles, muscle tenderness

weakness,

caused

exercise

brown/black coloured urine

On rare occasions, muscle problems

can be serious, including

muscle

breakdown

resulting

kidney damage that can lead to death.

risk

muscle

problems

greater for:

patients

taking

higher

doses

MYVAST, particularly the 80 mg

dose

older

patients

years

and older)

female patients

patients

with

abnormal

kidney

function

patients with thyroid problems

Tell your doctor immediately if

you notice any of the following:

tingling in the hands or feet

yellowing of the skin and/or eyes,

also called jaundice

signs of anaemia, such as tiredness,

being short of breath, and looking

pale

fever, generally feeling unwell

skin rash, itchiness

pinkish,

itchy

swellings

skin, also called hives or nettlerash

painful, swollen joints

bruising more easily than normal

larger breasts than normal in men

These may be serious side effects of

MYVAST. Some of these may be

symptoms of an allergic reaction to

MYVAST. You may need urgent

medical

attention.

Serious

side

effects are rare.

Tell your doctor immediately or go

to accident and emergency at your

nearest hospital if you notice any of

the following:

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty

swallowing

breathing

shortness of breath

These

are

serious

side

effects.

If

you have them, you may have had

a

serious

allergic

reaction

to

MYVAST. You may need urgent

medical

attention

or

hospitalisation. Serious side effects

are rare.

Also, tell your doctor if you notice:

hair loss

muscle cramps

trouble sleeping

poor memory

feelings of depression

erectile dysfunction

breathing

problems

including

persistent

cough

and/or

shortness

of breath or fever

These are other side effects that have

been reported with MYVAST.

Liver problems can also occur and

may be serious. Your doctor will do

blood tests to check your liver.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

alarmed

this

list

possible side effects. You may not

experience any of them.

Storage

Keep

your

tablets

in

the

blister

pack until it is time to take them.

take

tablets

blister pack they may not keep well.

Keep MYVAST 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

window sills.

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

MYVAST

or

the

tablets

have passed their expiry date, ask

your pharmacist what to do with

any that are left over.

After using MYVAST

MYVAST

CONSUMER MEDICINE INFORMATION

Version 1.1

What it looks like

You can identify

MYVAST Tablets

by their colour and shape.

This is

important because there are 5 types

MYVAST,

each

containing

different amounts of simvastatin:

MYVAST 5 (AUST R 186682) are

yellow

coloured,

round

shaped,

biconvex,

film

coated

tablets,

debossed with ‘A’ on one side and

‘15’ on the other side.

MYVAST 10 (AUST R 186683)

light

pink

coloured,

round

shaped,

biconvex,

film

coated

tablets debossed with ‘A’ on one

side and ‘01’ on the other side

MYVAST 20 (AUST R 186684)

light

pink

coloured,

round

shaped,

biconvex,

film

coated

tablets, debossed with ‘A’ on one

side and ‘02’ on the other side.

MYVAST 40 (AUST R 186685)

are pink coloured, round shaped,

biconvex,

film

coated

tablets,

debossed with ‘A’ on one side and

‘03’ on the other side.

MYVAST 80 (AUST R 186686)

are pink coloured, capsule shaped,

biconvex,

film

coated

tablets,

debossed with ‘A’ on one side and

‘04’ on the other side.

MYVAST

contains

tablets.

Ingredients

Active Ingredient:

Simvastatin

The tablets contain either 5, 10, 20,

(milligrams)

simvastatin.

Inactive ingredients:

Ascorbic acid

Lactose

Microcrystalline cellulose

Pregelatinized maize starch

Citric acid monohydrate

Butylated hydroxyanisole

Magnesium stearate

5mg tablets also contain:

OPADRY

complete

film

coating

system 20A52229 YELLOW

10 & 20 mg tablets also contain:

OPADRY

complete

film

coating

system 20A54239 PINK

40 & 80 mg tablets also contain:

OPADRY

complete

film

coating

system 20A54211 PINK

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, Macquarie Link

277-283 Lane Cove Road

Macquarie Park NSW 2113

Australia

Date of Approval

20 April 2012.

Date of Most Recent Amendment

14 July 2014

Product Description