SIMVASTATIN-DRLA simvastatin 10mg tablet blister pack

Main information

  • Trade name:
  • SIMVASTATIN-DRLA simvastatin 10mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SIMVASTATIN-DRLA simvastatin 10mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 194752
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

194752

SIMVASTATIN-DRLA simvastatin 10mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

1/06/2012

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. SIMVASTATIN-DRLA simvastatin 10mg tablet blister pack

Product Type

Single Medicine Product

Effective date

28/05/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SIMVASTATIN-DRLA is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with SIMVASTATIN-DRLA,

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-DRLA is indicated in patients at high risk of 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. SIMVASTATIN-DRLA is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of

age, with heterozygous familial hypercholesterolaemia (HeFH). Prior to initiating therapy with SIMVASTATIN-DRLA, 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablet

(S4) Prescription Only Medicine

100 tablet

(S4) Prescription Only Medicine

7 tablet

(S4) Prescription Only Medicine

90 tablet

(S4) Prescription Only Medicine

30 tablet

(S4) Prescription Only Medicine

60 tablet

(S4) Prescription Only Medicine

5 tablet

(S4) Prescription Only Medicine

10 tablet

(S4) Prescription Only Medicine

Components

1. simvastatin 10mg tablet

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

brown coloured, round, biconvex, film coated tablets debossed 'RDY' on

one side and '198' on the other side

Active Ingredients

Simvastatin

10 mg

Public Summary

Page 1 of

Produced at 28.11.2017 at 05:37:48 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

© 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 2 of

Produced at 28.11.2017 at 05:37:48 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

SIMVASTATIN-DRLA

Simvastatin

Consumer Medicine Information

Page 1 of 6

Simvastatin-DRLA_CMI_v02_January, 2012

What is in this leaflet

This leaflet answers some common

questions about SIMVASTATIN-

DRLA. 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 SIMVASTATIN-DRLA

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 SIMVASTATIN-

DRLA is used for?

SIMVASTATIN-DRLA helps to lower

cholesterol and triglyceride levels.

SIMVASTATIN-DRLA 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).

SIMVASTATIN-DRLA 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. 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, SIMVASTATIN-

DRLA 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 SIMVASTATIN-DRLA

works

SIMVASTATIN-DRLA 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, SIMVASTATIN-

DRLA reduces the bad cholesterol and

raises the good cholesterol.

SIMVASTATIN-DRLA does not

reduce the cholesterol and triglycerides

that come from fat in food.

Therefore, when you are taking

SIMVASTATIN-DRLA, you also

need to follow a low fat diet and

other measures, such as exercise and

weight control.

Page 2 or 6

Simvastatin-DRLA_CMI_v02_January, 2012

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.

Safety and effectiveness have been

studied in 10-17 year old boys and in

girls, who had started their menstrual

period at least one year before (see

How to take SIMVASTATIN-DRLA).

SIMVASTATIN-DRLA has not been

studied in children under the age of 10

years. For more information, talk to

your doctor.

Your doctor may have prescribed

SIMVASTATIN-DRLA for another

reason. Ask your doctor if you have

any questions about why

SIMVASTATIN-DRLA has been

prescribed for you.

SIMVASTATIN-DRLA is not

addictive.

Before you take

SIMVASTATIN-DRLA

When you must not take it

Do not take SIMVASTATIN-DRLA

if:

you have an allergy to

SIMVASTATIN-DRLA or other

brands of simvastatin, or to 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

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 SIMVASTATIN-

DRLA, talk to your doctor.

Before you start to take it

Tell your doctor if:

1. you intend to become pregnant or

plan to breast feed

SIMVASTATIN-DRLA should not

be used during pregnancy or while

breastfeeding.

2. 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.

3. you are taking niacin or a

niacin-containing product,

particularly if 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

SIMVASTATIN-DRLA.

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 SIMVASTATIN-DRLA as they

may increase the risk of muscle side

effects with SIMVASTATIN-DRLA. It

is particularly important to tell your

doctor if you are taking:

nefazodone, used to treat depression

protease inhibitors, used to treat

HIV infection, including indinavir,

nelfinavir, ritonavir, saquinavir

gemfibrozil, used to treat high

cholesterol levels

cyclosporin, used to suppress the

immune system

danazol

erythromycin, clarithromycin,

telithromycin and fusidic acid

antibiotics used to treat infections

ketoconazole, itraconazole and

posaconazole, used to treat certain

fungal infections.

If you are taking any of the above, your

doctor may suggest stopping

SIMVASTATIN-DRLA temporarily or

permanently.

Page 3 or 6

Simvastatin-DRLA_CMI_v02_January, 2012

Some medicines and SIMVASTATIN-

DRLA may interfere with each other.

Because taking SIMVASTATIN-

DRLA with any of the following drugs

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,

other fibrates, nicotinic acid (also

known as niacin)

warfarin, or other drugs used to

prevent blood clots.

colchicine, used for gout

verapamil, diltiazem or amlodipine,

used to treat high blood pressure,

angina or other heart conditions

amiodarone, used to treat irregular

heart beat

digoxin, used to treat heart failure.

These medicines may be affected by

SIMVASTATIN-DRLA, may affect

how well it works, or may increase the

risk of side effects with

SIMVASTATIN-DRLA. 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

SIMVASTATIN-DRLA.

You should also tell any doctor who is

prescribing a new medication for you

that you are taking SIMVASTATIN-

DRLA.

How to take

SIMVASTATIN-DRLA

How much to take

Take SIMVASTATIN-DRLA 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 of the increased risk of muscle

problems, the 80mg dose is only for

patients at high risk of heart disease

problems who have not reached their

cholesterol goal on lower doses.

People with CHD or risk factors for

CHD are usually started on 40 mg per

day, taken in the evening.

For children (10-17 years old), the

recommended usual starting dose is 10

mg a day in the evening. The

maximum recommended dose is 40 mg

a day.

Swallow SIMVASTATIN-DRLA

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 SIMVASTATIN-DRLA 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, SIMVASTATIN-

DRLA is 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 SIMVASTATIN-DRLA 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

SIMVASTATIN-DRLA 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 SIMVASTATIN-

DRLA, 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.

Page 4 or 6

Simvastatin-DRLA_CMI_v02_January, 2012

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 SIMVASTATIN-DRLA.

Do this even if there are no signs of

discomfort or poisoning.

While you are using

SIMVASTATIN-DRLA

Things you must do

If you become pregnant while you

are taking SIMVASTATIN-DRLA,

stop taking it and contact your

doctor immediately.

Have your blood fats checked when

your doctor says, to make sure

SIMVASTATIN-DRLA is working.

If you are about to be started on any

new medicine tell your doctor and

pharmacist that you are taking

SIMVASTATIN-DRLA.

If you are about to have elective

surgery, tell your doctor that you are

taking SIMVASTATIN-DRLA.

Your doctor may suggest stopping the

tablets a few days before surgery.

Things you must not do

Do not give SIMVASTATIN-DRLA

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

may increase your chance of

SIMVASTATIN-DRLA 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

SIMVASTATIN-DRLA. Therefore,

drinking very large quantities (over 1

litre) of grapefruit juice each day

increases your chance of

SIMVASTATIN-DRLA 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

SIMVASTATIN-DRLA affects you.

SIMVASTATIN-DRLA generally does

not cause any problems with your

ability to drive a car or operate

machinery. However, as with many

other medicines, SIMVASTATIN-

DRLA may cause dizziness in some

people. Make sure you know how you

react to SIMVASTATIN-DRLA 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

SIMVASTATIN-DRLA.

SIMVASTATIN-DRLA 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

Page 5 or 6

Simvastatin-DRLA_CMI_v02_January, 2012

stomach upset or pain, feeling sick

(nausea)

headache

dizziness

These are the more common side

effects of SIMVASTATIN-DRLA. 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

that can lead to death.

The risk of muscle problems is greater

for:

patients taking higher doses of

SIMVASTATIN-DRLA,

particularly the 80 mg dose

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

SIMVASTATIN-DRLA. Some of

these may be symptoms of an allergic

reaction to SIMVASTATIN-DRLA.

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 in swallowing or

breathing

shortness of breath

These are serious side effects. If you

have them, you may have had a

serious allergic reaction to

SIMVASTATIN-DRLA. 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 SIMVASTATIN-

DRLA.

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 using

SIMVASTATIN-DRLA

Storage

Keep your tablets in the original

pack until it is time to take them.

If you take the tablets out of the

original pack they may not keep well.

Keep SIMVASTATIN-DRLA in a

cool dry place where the

temperature stays below 25 degrees

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

SIMVASTATIN-DRLA or the

tablets have passed their expiry date,

ask your pharmacist what to do with

any that are left over.

Product description

Page 6 or 6

Simvastatin-DRLA_CMI_v02_January, 2012

What it looks like

SIMVASTATIN-DRLA comes in four

types of tablets:

SIMVASTATIN-DRLA

Brown coloured, round, biconvex,

film coated tablets debossed ‘RDY’

on one side and ‘198’ on the other

side.

SIMVASTATIN-DRLA

Brown coloured, round, biconvex,

film coated tablets debossed ‘RDY’

on one side and ‘199’ on the other

side

SIMVASTATIN-DRLA

Brown coloured, round, biconvex,

film coated tablets debossed ‘RDY’

on one side and ‘200’ on the other

side

SIMVASTATIN-DRLA

Brown

coloured,

oval

shaped,

biconvex,

film

coated

tablets

debossed ‘RDY’ on one side and

‘268’ on the other side

SIMVASTATIN-DRLA is supplied in

HDPE bottle pack of 30’s and 90’s*

tablets.

SIMVASTATIN-DRLA is also

supplied in blister packs* (PVC-

PVdC/Alu) containing 5’s, 7's, 10's,

28's, 30's, 60's, 90's and 100's tablets.

*

NOT MARKETED

Ingredients

Active ingredient:

SIMVASTATIN-DRLA 10 mg - 10

mg simvastatin per tablet

SIMVASTATIN-DRLA 20 mg - 20

mg simvastatin per tablet

SIMVASTATIN-DRLA 40 mg - 40

mg simvastatin per tablet

SIMVASTATIN-DRLA 80 mg - 80

mg simvastatin per tablet

Inactive ingredients:

butylated hydroxyanisole

ascorbic acid

citric acid-anhydrous

cellulose-microcrystalline

starch - pregelatinised maize

magnesium stearate

lactose

hypromellose

hydroxypropylcellulose

titanium dioxide

iron oxide yellow CI77492

iron oxide red CI77491

iron oxide black CI77499

SIMVASTATIN-DRLA does not

contain gluten, sucrose, tartrazine or

any other azo dyes.

Manufacturer/Supplier

SIMVASTATIN-DRLA is supplied in

Australia by:

Dr. Reddy’s Laboratories (Australia)

Pty Ltd

Level 1, 181 Bay Street

Brighton Victoria 3186

Australia

This leaflet was prepared in January,

2012.

This CMI leaflet was current at the

time of printing. To check if it has been

updated, please ask your pharmacist.

Australian Register Numbers:

SIMVASTATIN-DRLA 10 mg -

AUST R 164082 and AUST R 194752

SIMVASTATIN-DRLA 20 mg -

AUST R 164087 and AUST R 194754

SIMVASTATIN-DRLA 40 mg -

AUST R 164088 and AUST R 194759

SIMVASTATIN-DRLA 80 mg -

AUST R 164089 and AUST R 194758