SIMVACOR 40

Main information

  • Trade name:
  • SIMVACOR 40
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SIMVACOR 40
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 182912
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

182912

SIMVACOR 40 simvastatin 40 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

15/06/2011

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. SIMVACOR 40

Product Type

Single Medicine Product

Effective date

2/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Simvastatin is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of

hypercholesterolaemia (eg 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 CHD (coronary heart disease) (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

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

180 tablets

(S4) Prescription Only Medicine

100 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink coloured, oval, biconvex film-coated tablets debossed with 'SVN 40' on

one side and 'NEO' on the other side.

Active Ingredients

Simvastatin

40 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 06:41:17 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

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SIMVACOR

10,

SIMVACOR

20,

SIMVACOR

40

&

SIMVACOR 80

Consumer Medicine Information

Simvastatin 10mg, 20mg, 40mg and 80mg Tablets

What is in this leaflet

This leaflet answers some common questions about SIMVACOR. 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

SIMVACOR 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 is SIMVACOR used for

SIMVACOR helps to lower cholesterol and triglyceride levels.

SIMVACOR is used in people who have coronary heart disease (CHD) or who are at high risk of

CHD (for example, if they have diabetes, a history of stroke or other blood vessel disease).

SIMVACOR may be used in 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 the need for surgery to increase blood flow to the heart

reduce the need for hospitalisation due to angina

Cholesterol

Everyone has cholesterol and 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 to digest

food) and certain hormones. However, too much cholesterol can be a problem.

Your body makes cholesterol, but it also comes from food. Normally the body balances the

cholesterol it makes with the cholesterol it gets from food. This means if 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 is more likely to occur with certain diseases or if you have a family history of

high cholesterol. When you have high levels of 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.

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Over time, this can form hard areas, called plaque, on the walls of blood vessels, making it

more difficult for the blood to flow. This blocking of your blood vessels can lead to coronary

heart disease (such as heart attack and angina) and stroke. In people with CHD, SIMVACOR

may slow down the hardening of blood vessels and reduce the risk of developing new plaques.

There are different types of cholesterol, called LDL and HDL cholesterol. LDL cholesterol is the

'bad' cholesterol that can block your blood vessels. HDL cholesterol, on the other hand, is the

'good' cholesterol that is thought to remove the bad cholesterol from the blood vessels.

Triglycerides

Triglycerides are an energy source for the body. However, as with cholesterol, too much

triglycerides can be a problem.

How SIMVACOR works

SIMVACOR belongs to a group of medicines known as HMG–CoA reductase inhibitors. It

works by reducing the amount of cholesterol made by the liver. In terms of good and bad

cholesterol, SIMVACOR reduces the bad cholesterol and raises the good cholesterol.

SIMVACOR does not reduce the cholesterol and triglycerides that come from fat in food.

Therefore, when you are taking SIMVACOR, you also need to follow a low fat diet and

other measures, such as exercise and weight control.

In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can

measure your cholesterol and triglycerides with a simple blood test.

SIMVACOR is not recommended for use in children, as there have been no studies of its effects

in children.

Your doctor may have prescribed SIMVACOR for another reason. Ask your doctor if you have

any questions about why SIMVACOR has been prescribed for you.

SIMVACOR is not addictive.

Before you take SIMVACOR

When you must not take it

Do not take SIMVACOR if:

you have an allergy to SIMVACOR, other brands of simvastatin, or any of the

ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may

include skin rash, itchiness, shortness of breath, swelling of the tongue or face, or painful

joints.

you are pregnant or breast-feeding. Your baby may absorb this medicine in the womb

or 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

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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 SIMVACOR, talk to your doctor.

Before you start to take it

Tell your doctor if:

you intend to become pregnant or plan to breastfeed. SIMVACOR should not be

used during pregnancy or while breast-feeding.

you have ever had liver disease. Your doctor will do a blood test to make sure you

have no problems with your liver.

you have kidney disease or any other medical problems

you have severe respiratory failure

you drink alcohol regularly

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

SIMVACOR.

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 SIMVACOR as they may increase the risk of muscle

side effects with SIMVACOR. These include:

nefazodone, used to treat depression

protease inhibitors, used to treat HIV infection (including indinavir, nelfinavir, ritonavir,

saquinavir) and Hep C infections

erythromycin, telithromycin, clarithromycin and fusidic acid antibiotics used to treat

infections

ketoconazole, itraconazole, pasoconazole and variconazole used to treat certain fungal

infections

If you are taking any of the above, your doctor may suggest stopping SIMVACOR temporarily or

permanently.

Some medicines and SIMVACOR may interfere with each other. As taking SIMVACOR with any

of the following medicines can increase the risk of muscle problems (see Side Effects), it is

particularly important to tell your doctor if you are taking:

other medicines to lower cholesterol levels, for example, fibric acid derivatives (such as

gemfibrozil) or nicotinic acid (also known as niacin)

cyclosporin, used to suppress the immune system

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danazol

verapamil, diltiazem or amlodipine used to treat high blood pressure, angina or other

heart conditions

amiodarone, used to treat irregular heart beat

medicines for preventing blood clots, eg. warfarin

digoxin (a medicine used to control the rhythm of the heart)

It is also important to tell your doctor if you are taking anticoagulants (drugs that prevent blood

clots) such as warfarin, nicotinic acid (also known as niacin) or fenofribrate, another fibric acid

derivative.

Also tell your doctor if you are taking niacin or a niacin containing product and you are Chinese.

These medicines may be affected by SIMVACOR, may affect how well it works or may increase

the risk of side effects with SIMVACOR. You may need different amounts of your medicine or

you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while

taking SIMVACOR.

How to take SIMVACOR

How much to take

Take SIMVACOR 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.

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.

The 80mg dose is only for patients who have not reached their cholesterol goal on the 40mg

dose.

People with CHD or risk factors for CHD are usually started on 40 mg per day, taken in the

evening.

Swallow SIMVACOR 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, ask your doctor or pharmacist for help.

When to take it

Take SIMVACOR once a day in the evening.

The liver produces its greatest amount of cholesterol when the body is at rest and when there is

no dietary intake. For most people, this is at night when asleep. Therefore, SIMVACOR is more

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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 SIMVACOR at about the same time each evening. Taking your tablet(s) at the same

time each evening will have the best effect. It will also help you remember when to take the

tablets.

How long to take it

SIMVACOR helps lower your cholesterol. It does not cure your condition. Therefore, you must

continue to take it as directed by your doctor if you expect to lower your cholesterol and keep it

down. You may have to take cholesterol-lowering medicine for the rest of your life. If you stop

taking SIMVACOR, 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(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.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 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 SIMVACOR. Do this even if there are no signs of

discomfort or poisoning.

While you are taking

SIMVACOR

Things you must do

If you become pregnant while you are taking SIMVACOR , stop taking it and contact your

doctor immediately.

Have your blood fats checked when your doctor says, to make sure SIMVACOR is

working.

If you are about to be started on any new medicine, tell your doctor and pharmacist that

you are taking SIMVACOR.

If you are about to have elective surgery, tell your doctor that you are taking SIMVACOR.

Your doctor may suggest stopping the tablets a few days before surgery.

Things you must not do

Do not give SIMVACOR to anyone else, even if they have the same condition as you.

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Things to be careful of

Avoid drinking large quantities of alcohol. Drinking large quantities of alcohol may increase

your chance of SIMVACOR causing liver problems.

Avoid drinking large quantities of grapefruit juice. Grapefruit juice contains one or more

components that alter the metabolism of some medicines, including SIMVACOR. Therefore,

drinking very large quantities (over 1 litre) of grapefruit juice each day increases your chance of

SIMVACOR causing side effects. These include aching muscles, muscle tenderness or

weakness, not caused by exercise. However, one glass (250mL) of grapefruit juice each day

has not been shown to have any significant effect.

Be careful driving or operating machinery until you know how SIMVACOR affects you.

SIMVACOR generally does not cause any problems with your ability to drive a car or operate

machinery. However, as with many other medicines, SIMVACOR may cause dizziness in some

people. Make sure you know how you react to SIMVACOR 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 of having coronary heart disease

(CHD). However, your chances of having CHD may be increased by several other factors

including high blood pressure, cigarette smoking, diabetes, excess weight, family history of

CHD, being a male and being a woman who has reached menopause.

Some self help measures suggested below may help your condition and help reduce your

chances of having CHD. Talk to your doctor, pharmacist or dietician about these measures and

for more information.

Diet - continue the low fat diet recommended by your doctor, dietician or pharmacist.

Weight - your doctor may advise you to lose weight if you are 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 or at least cut down.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

taking SIMVACOR. SIMVACOR helps most people with high cholesterol 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 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

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These are the more common side effects of SIMVACOR. 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 or weakness, not caused by exercise

brown/black coloured urine

On rare occasions, muscle problems can be serious, including muscle breakdown

resulting in kidney damage. The risk of muscle problems is greater for:

patients taking higher doses of SIMVACOR

older patients (65 years of age 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 on the 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 SIMVACOR. Some of these may be symptoms of an

allergic reaction to SIMVACOR. 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

face,

lips,

mouth,

throat

tongue

which

cause

difficulty

swallowing or breathing

shortness of breath

These are serious side effects. If you have them, you may have had a serious allergic reaction

to SIMVACOR. 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

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sexual difficulties

depression

breathing problems including persistent cough and/or shortness of breath or fever

These are possible side effects of SIMVACOR.

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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking SIMVACOR

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out

of the pack they may not keep well.

Keep SIMVACOR 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 SIMVACOR or the tablets have passed their expiry

date, ask your pharmacist what to do with any that are left over.

Product description

SIMVACOR 10, 10 mg: Light pink coloured, oval, biconvex film-coated tablets, marked ‘SVN 10’

on one side and ‘NEO’ on the other side.

SIMVACOR 20, 20 mg: Tan coloured, oval, biconvex film-coated tablets, marked with ‘SVN 20’

on one side and ‘NEO’ on the other side.

SIMVACOR 40, 40 mg: Pink coloured, oval, biconvex film coated tablets, marked ‘SVN’ 40 on

one side and ‘NEO’ on the other side.

SIMVACOR 80, 80 mg: Pink coloured, oval, biconvex film coated tablets marked with ‘SVN 80’

on one side and ‘NEO’ on the other side.

SIMVACOR tablets are available in blister & bottle packs..

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INGREDIENTS

Active ingredient

Simvastatin

Other ingredients (excipients)

Butylated hydroxyanisole

Ascorbic acid

Citric acid monohydrate

Cellulose – microcrystalline

Starch – pregelatinised maize

Magnesium stearate

Lactose

Hypromellose – 15

Hydroxypropyl cellulose

Titanium dioxide E171

Talc

Each tablet may also contain one or all of the following: iron oxide red E172, iron oxide black

E172, iron oxide yellow E172.

Supplier

Sponsor

Cipla Australia Pty Ltd

Level 1 / 132-136 Albert Rd

South Melbourne

VIC 3025

Distributor

Pharmacor Ltd

Unit 5/36 Campbell Ave

CROMER NSW 2099

Australian Register Numbers:

BOTTLE

10mg - AUST R 182910

20mg - AUST R 182911

40mg - AUST R 182912

80mg - AUST R 182913

BLISTER

10mg - AUST R 182906

20mg - AUST R 182907

40mg - AUST R 182908

80mg - AUST R 182909

This leaflet was prepared in April 2013.