VASCALACE 1.25 ramipril 1.25mg tablet bottle

Main information

  • Trade name:
  • VASCALACE 1.25 ramipril 1.25mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VASCALACE 1.25 ramipril 1.25mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175218
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175218

VASCALACE 1.25 ramipril 1.25mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

6/10/2011

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. VASCALACE 1.25 ramipril 1.25mg tablet bottle

Product Type

Single Medicine Product

Effective date

1/07/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

? Treatment of hypertension. Data are currently not available to support the use of Ramipril in renovascular hypertension. ,? Post MI heart failure ,?

Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. ,? For reducing the risk of myocardial infarction, stroke,

cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery

disease, stroke, or peripheral vascular disease. ,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularization

procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160mmHg or diastolic blood

pressure >90mmHg (or on antihypertensive treatment); total cholesterol >5.2mmol/L; HDL cholesterol <0.9mmol/L; current smoker; known

microalbuminuria; any evidence of previous vascular disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

2 Years

Store below 25

degrees Celsius

Child resistant closure

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off-white coloured, flat faced bevel edged round uncoated tablet

debossed with 'H' &'17' on one side and plain on other side

Active Ingredients

Ramipril

1.25 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 02:21:24 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

VASCALACE

CONSUMER MEDICINE INFORMATION

Ver 1.0

Page 1 of 6

VASCALACE

Ramipril

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about VASCALACE.

It does not contain all the available

information about this medicine.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

risks

taking

VASCALACE 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 VASCALACE is used

for

VASCALACE belongs to a group of

medicines

called

angiotensin

converting enzyme (ACE) inhibitors.

VASCALACE is used to treat:

high blood pressure (hypertension)

some

heart

conditions

such

heart failure after a heart attack

kidney problems in some patients

VASCALACE is also used to reduce

the risk of cardiovascular problems

and complications in patients aged

55 years or more with heart or blood

vessel disease, or diabetes.

Hypertension

VASCALACE is used to lower high

blood

pressure

(hypertension).

Everyone has blood pressure. This

pressure

helps

your

blood

around

your

body.

Your

blood

pressure may be different at different

times

influenced by how busy or worried

are.

have

hypertension

when

your

blood

pressure

stays

higher than is needed, even when

you are calm and relaxed.

There are usually no symptoms of

hypertension.

only

knowing that you have hypertension

have

your

blood

pressure

checked on a regular basis. If high

blood pressure is not treated it can

lead

serious

health

problems,

including stroke, heart disease and

kidney failure.

Heart Failure after a Heart Attack

VASCALACE may be used after a

heart attack. A heart attack occurs

when one of the major blood vessels

supplying

blood

your

heart

becomes blocked. This means that

your heart muscle cannot receive the

oxygen

needs

becomes

damaged. This may lead to further

problems,

such

heart

failure,

irregular

heart

rhythms

blood

clots.

Heart failure means that the heart

muscle

weak

cannot

pump

blood strongly enough to supply all

blood

needed

throughout

body. Heart failure is not the same as

heart attack and does not mean that

the heart stops. Heart failure may

start off with no symptoms, but as

condition

progresses,

patients

may feel short of breath or may get

tired

easily

after

light

physical

activity

such

walking.

Some

patients may wake up short of breath

night.

Fluid

collect

different parts of the body, often first

noticed as swollen ankles and feet.

Kidney Problems

VASCALACE may be used to treat

some

kidney

problems.

Some

conditions

such

diabetes

hypertension

lead

kidney

problems. These problems develop

slowly

over

several

years.

Good

control

your

blood

sugar

blood

pressure

important

keeping

your

kidneys

healthy,

always

prevent

kidney

damage from occurring.

Prevention

of

Cardiovascular

Problems and Complications

VASCALACE

used

reduce

risk

some

problems

complications

that

arise

patients

aged

more

who have problems

such

coronary

artery

disease

(heart

disease caused by poor blood flow in

blood

vessels

heart),

peripheral

vascular

disease

(poor

circulation in the hands or feet), or

stroke.

VASCALACE may also be used to

reduce

risk

cardiovascular

problems

complications

patients with diabetes aged 55 years

or more who may be considered at

risk

because

more

additional factors such as high blood

pressure,

high

cholesterol

levels,

kidney problems, a current smoker,

previous

disease

blood

vessels.

How VASCALACE works

VASCALACE

works

widening

the blood vessels, which reduces the

pressure

vessels,

making

easier for your heart to pump blood

around

your

body.

This

helps

increase

supply

oxygen

your heart, so that when you place

extra demands on your heart, such as

during exercise, your heart may cope

better and you may not get short of

breath as easily.

By increasing the supply of oxygen

to your heart, your heart does not

have to work as hard and it is under

less

stress,

which

reduce

risk of further damage occurring to it

following a heart attack.

VASCALACE also improves blood

flow through the small blood vessels

found in the kidneys, which helps

the kidneys to work more efficiently.

This in turn can help to slow down

progression

kidney

damage

that

might

result

from

having

diabetes or high blood pressure.

Therefore,

there

quite

reasons why your doctor might have

VASCALACE

CONSUMER MEDICINE INFORMATION

Ver 1.0

Page 2 of 6

decided

treat

with

VASCALACE.

Your

doctor

have also prescribed this medicine

for another reason.

Ask your doctor or pharmacist if

you have any questions about why

VASCALACE

has

been

prescribed for you.

VASCALACE is not addictive.

VASCALACE is available only with

a doctor's prescription.

Before you take

VASCALACE

When you must not take it

Do not take VASCALACE if you:

have

had

an

allergy

to

VASCALACE

or

any

other

medicine containing ramipril, or

an ACE inhibitor 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

face,

lips

tongue,

abdominal

pain, muscle pain or

tenderness, or

joint pain.

have

taken

any

other

"ACE

inhibitor"

medicine

before,

which

caused

your

face,

lips,

tongue, throat, hands or feet to

swell up, or made it hard for

you

to breathe.

have

allergic

reaction

inhibitor

before,

allergic

VASCALACE.

or your family have a history of

swelling of the face, lips,

tongue,

throat, intestines, hands

or feet,

for no apparent reason.

have

kidney

problems

or

a

condition

called

"renal

artery

stenosis".

have

problems

or

conditions

affecting

the

flow

of

blood

in

and out of your heart (e.g.

aortic

or valvular stenosis).

have low blood pressure.

undergo

dialysis

using

certain

high-flux membranes.

are

diabetic

or

have

kidney

problems and are being treated

with

aliskiren-containing

medicines

or

a

group

of

medicines known as AIIRAs (a

medicine also used to treat high

blood pressure).

are

pregnant

or

intend

to

become pregnant.

VASCALACE

affect

your

developing

baby

take

during pregnancy.

are breastfeeding.

VASCALACE may pass into the

breast

milk

affect

your

breastfed

baby.

Do not use VASCALACE after the

expiry date (EXP) printed on the

pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not use VASCALACE if the

packaging is torn or shows signs of

tampering.

Before you start to take it

Tell

your

doctor

if

you

have

allergies to:

any other medicines

other

substances,

such

foods, preservatives or dyes

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney

problems,

having

dialysis (note that your doctor

give you VASCALACE because

your kidney problems)

liver problems

heart

problems

(note

that

your

doctor

give

VASCALACE

because

your

heart problems)

blood

pressure,

which

may notice as dizziness or

light-

headedness

low white blood cell counts

diabetes

(note

that

your

doctor

give

VASCALACE

because of

your diabetes)

high levels of potassium in your

blood

Systemic

Lupus

Erythematosus

(SLE),

scleroderma

other

autoimmune conditions

Tell

your

doctor

if

you

have

a

family history of swelling of the

face,

lips,

tongue,

throat,

intestines, hands or feet.

You must also tell your doctor if

you:

are following a very low or very

high salt diet

dehydrated,

have

recent

bout

vomiting

diarrhoea

about

have

surgery

general anaesthetic

plan

become

pregnant

breastfeed

If you have not told your doctor

about any of the above, tell them

before

you

start

taking

VASCALACE.

Taking other medicines

Tell your doctor or pharmacist if

you

are

taking

any

other

medicines, including any that you

buy without a prescription from

your

pharmacy,

supermarket

or

health food store.

Some medicines and VASCALACE

may interfere with each other. These

include:

other medicines used to treat high

blood pressure.

diuretics, also known as fluid or

water tablets

lithium, a medicine used to treat

mood swings and some types of

depression

potassium

supplements

potassium-containing

salt

substitutes

non-steroidal

anti-inflammatory

drugs (NSAIDs), medicines used

to relieve pain, swelling and other

symptoms of inflammation

VASCALACE

CONSUMER MEDICINE INFORMATION

Ver 1.0

Page 3 of 6

insulin and tablets used to treat

diabetes

heparin

general anaesthetics

medicines

which

affect

blood

cells,

such

allopurinol,

procainamide,

corticosteroids,

immunosuppressants,

medicines used to treat cancer

temsirolimus

if you are taking VASCALACE

high

blood

pressure,

take any medicines (including the

ones

bought

without

prescription) for appetite control,

asthma, colds, coughs, hayfever or

sinus

problems

unless

have

discussed it with your doctor or

pharmacist.

These medicines may be affected by

VASCALACE, or may affect how

well it works. You may need to use

different amounts of your medicine,

or you may need to take different

medicines.

Your

doctor

pharmacist will advise you.

Your doctor or pharmacist may have

more information on medicines to be

careful with or to avoid while taking

VASCALACE.

How to take VASCALACE

How much to take

Your doctor or pharmacist will tell

you how many capsules you will

need

to

take

each

day.

This

depends

on

your

condition

and

whether or not you are taking any

other medicines.

Take

VASCALACE

only

when

prescribed by your doctor.

Your doctor will select a dose when

they

prescribe

VASCALACE

you.

Some

patients

need

lower starting dose. The usual dose

of VASCALACE is:

for high blood pressure, 2.5 mg to

10 mg per day.

for heart failure, 5 mg to 10 mg

per day.

for kidney problems, 1.25 mg to 5

mg per day.

for cardiovascular risk, 2.5 mg to

10 mg per day.

Depending on your response, your

doctor may adjust the dose.

If two tablets are prescribed, your

doctor may want you to take them

both together or at different times.

This will depend on the condition

being treated and how you respond

to VASCALACE.

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

They

differ

from

information contained in this leaflet.

If

you

do

not

understand

the

instructions on the box, ask your

doctor or pharmacist for help.

How to take it

VASCALACE

should

be

swallowed

whole

with

plenty

of

fluid.

When to take it

Take VASCALACE at about the

same time each day.

Taking

your capsules

same

time

each

will

have

best

effect.

will

also

help

remember

when

take

your

medicine.

It

does

not

matter

if

you

take

VASCALACE

before

or

after

food.

How long to take it

VASCALACE

helps

control

your

condition,

does

cure

Therefore

must

take

VASCALACE every day. Continue

taking your medicine for as long as

your doctor tells you.

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 medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

If you are not sure what to do or if

you

have

trouble

remembering

when to take VASCALACE, ask

your doctor or pharmacist.

If

you

take

too

much

(Overdose)

Immediately

telephone

your

doctor or the Poisons Information

Centre (in Australia telephone 13

11

26),

or

go

to

Accident

and

Emergency at the nearest hospital

if you think that you or anyone

else

may

have

taken

too

much

VASCALACE.

Do

this

even

if

there are no signs of discomfort or

poisoning.

need

urgent

medical

attention.

If you take too much VASCALACE,

you may feel light-headed, dizzy or

faint.

also

experience slow heart beat.

While you are taking

VASCALACE

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking VASCALACE.

If you are about to be started on

any new medicine, tell your doctor

and

pharmacist

that

you

are

taking VASCALACE.

Make

sure

you

drink

enough

water

during

exercise

and

hot

weather

when

you

are

taking

VASCALACE,

especially

if

you

sweat a lot.

If you do not drink enough water

while

taking

VASCALACE,

may feel faint, light-headed or sick.

This is because your blood pressure

dropping

suddenly.

continue

feel

unwell,

tell

your

doctor.

VASCALACE

CONSUMER MEDICINE INFORMATION

Ver 1.0

Page 4 of 6

If

you

have

excess

vomiting

or

diarrhoea

while

taking

VASCALACE, tell your doctor.

You may lose too much water and

salt

your

blood

pressure

drop too much.

If you feel light-headed or dizzy

after

taking

your

first

dose

of

VASCALACE, or when your dose

is

increased,

tell

your

doctor

immediately.

If you plan to have surgery that

needs

a

general

anaesthetic,

tell

your doctor or dentist that you are

taking VASCALACE.

Your

blood

pressure

drop

suddenly.

If you become pregnant or intend

to become pregnant while taking

VASCALACE,

tell

your

doctor

immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking VASCALACE.

VASCALACE

interfere

with

the results of some tests.

Have your blood pressure checked

when your doctor says, to make

sure VASCALACE is working.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do a

blood test to check your potassium

levels and see how your kidneys are

working.

Things you must not do

Do

not

give

VASCALACE

to

anyone else, even if they have the

same condition as you.

Do not take VASCALACE to treat

any other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking VASCALACE,

or lower or increase the dosage,

without

checking

with

your

doctor.

Things to be careful of

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help

your

body

used

change

position

blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Be

careful

driving

or

operating

machinery

until

you

know

how

VASCALACE affects you.

with

other

inhibitor

medicines,

VASCALACE

cause

dizziness,

light-headedness,

tiredness

drowsiness

some

people. Make sure you know how

you react to VASCALACE before

you drive a car, operate machinery,

or do anything else that could be

dangerous if you are dizzy or light-

headed. If this occurs do not drive. If

you drink alcohol, dizziness or light-

headedness may be worse.

Things that may help your

Condition

Some self help measures suggested

below may help your condition. Talk

to your doctor or pharmacist about

these

measures

more

information.

Alcohol - your doctor may advise

you to limit your alcohol intake.

Diet - eat a healthy low-fat diet

which

includes

plenty

fresh

vegetables,

fruit,

bread,

cereals

fish.

Also

less

sugar.

Exercise - regular exercise helps to

reduce blood pressure and helps

heart

fitter,

important

overdo

Walking is good exercise, but try

to find a route that is reasonably

flat. Before starting any exercise,

your

doctor

about

best

kind of programme for you.

Salt - your doctor may advise you

to watch the amount of salt in your

diet. To reduce your salt intake

should

avoid

using

salt

cooking or at the table.

Smoking - your doctor may advise

you to stop or at least cut down

smoking.

Weight - your doctor may suggest

losing some weight to help lower

your

blood

pressure

help

lessen the amount of work your

heart has to do. Some people may

need

dietician's

help

lose

weight.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well

while

you

are

taking

VASCALACE.

VASCALACE

helps

most

people,

have

unwanted

side

effects

people.

medicines

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.

Following is a list of possible side

effects. Do not be alarmed by this

list. You may not experience any of

them.

Tell your doctor if you notice any

of the following and they worry

you:

feeling light-headed, dizzy or

faint

dry cough

headache

feeling sick (nausea) or vomiting

stomach pain or discomfort

diarrhoea

indigestion

loss of taste or taste disturbances

upper respiratory tract infections

muscle cramps or spasms

aching muscles, muscle tenderness

weakness,

caused

exercise

unusual

tiredness

weakness,

fatigue

VASCALACE

CONSUMER MEDICINE INFORMATION

Ver 1.0

Page 5 of 6

ringing or buzzing in the ears

forgetfulness or confusion

These side effects are usually mild.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following:

disturbed vision

symptoms

sunburn

(such

redness,

itching,

swelling,

blistering) which may occur more

quickly than normal

itchy or raised skin rash, hives or

nettlerash

signs of anaemia such as

tiredness,

being short of breath

and looking

pale

yellowing of the skin and/or eyes

fast or irregular heart beat

shortness of breath or tightness in

the chest

numbness,

tingling

colour

change (white, blue then red) in

the fingers or toes when exposed

to the cold

severe upper stomach pain, often

with nausea and vomiting

frequent infections such as fever,

severe chills, sore throat or

mouth

ulcers

passing little or no urine or more

urine than is normal for you

bleeding or bruising more easily

than normal

These may be serious side effects.

need

medical

attention.

Serious side effects are rare.

If

any

of

the

following

happen,

stop

taking

VASCALACE

and

either tell your doctor immediately

or go to Accident and Emergency

at your nearest hospital:

fainting

within

hours

taking a dose

severe

dizziness

confusion

with

visual

disturbances

speech problems

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty

swallowing

breathing

pink or red itchy spots on the

skin

which may blister and

progress to

form

raised,

red,

pale-centred

marks

severe blisters and bleeding in the

lips,

eyes,

mouth,

nose

genitals

chest pain

These are very serious side effects.

need

urgent

medical

attention

hospitalisation.

These

side effects are very rare.

Other side effects not listed above

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

After using VASCALACE

Storage

Keep your VASCALACE tablets

or capsules in the pack until it is

time to take them.

If you take them out of the pack they

may not keep well.

Keep your VASCALACE tablets

or

capsules

in

a

cool

dry

place

where the temperature stays below

25 degrees C.

Do not store VASCALACE or any

other medicine in the bathroom or

near a sink. Do not leave it on

window sills or in the car.

Heat

dampness

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 or pharmacist tells

you to stop taking VASCALACE,

or

the

tablets

or

capsules

have

passed their expiry date, ask your

pharmacist what to do with any

that are left over.

Product Description

What it looks like

VASCALACE is available in four

different strengths containing 1.25,

2.5, 5 & 10 mg ramipril.

VASCALACE is available in tablet

formulation as VASCALACE tablets

capsule

formulation

VASCALACE CAPS.

VASCALACE is available in blister

packs of 28 & 30 and bottle packs of

30 tablets or capsules.

VASCALACE tablets 1.25

(Blister

pack:

AUST

R

175217

&

Bottle: AUST R 175218)

White to off-white colored, flat faced

bevel edged round uncoated tablet

debossed with “H” and “17” on one

side and plain on other side.

VASCALACE tablets 2.5

(Blister

pack:

AUST

R

175221

&

Bottle: AUST R 175223)

Light yellow to yellow colored flat

faced bevel edged, round uncoated

tablet

debossed

with

“H”

“18”separated by score line on one

side and plain on other side.

VASCALACE tablets 5

(Blister

pack:

AUST

R

175224

&

Bottle: AUST R 175237)

Light

pink

colored

mottled,

flat

faced bevel edged round uncoated

tablet debossed with “H” and “19”

separated by score line on one side

and plain on other side.

VASCALACE tablets 10

(Blister

pack:

AUST

R

175238

&

Bottle: AUST R 175240)

White to off-white colored, flat faced

bevel edged round uncoated tablet

debossed

with

“H”

“20”separated by score line on one

side and plain on other side.

VASCALACE CAPS 1.25

(Blister

pack:

AUST

R

203720

&

Bottle: AUST R 203718)

Yellow / White size '4' hard gelatin

capsules

imprinted

with

yellow cap and '40' on white body

VASCALACE

CONSUMER MEDICINE INFORMATION

Ver 1.0

Page 6 of 6

with

black

edible

filled

with

white to almost white powder.

VASCALACE CAPS 2.5

(Blister

pack:

AUST

R

203712

&

Bottle: AUST R 203702)

Orange / White size '4' hard gelatin

capsules

imprinted

with

orange cap and '41' on white body

with

black

edible

filled

with

white to almost white powder.

VASCALACE CAPS 5

(Blister

pack:

AUST

R

203713

&

Bottle: AUST R 203716)

White

size

hard

gelatin

capsules imprinted with 'D' on Red

'42'

White

body

with

black edible ink filled with white to

almost white powder.

VASCALACE CAPS 10

(Blister

pack:

AUST

R

203719

&

Bottle: AUST R 203717)

Blue / White size ‘4’ hard gelatin

capsules imprinted with ‘D’ on Blue

cap and ‘43’ on White body with

black edible ink filled with white to

almost white powder.

Ingredients

Active ingredient

Ramipril

Inactive ingredients

VASCALACE

tablets

contains

following inactive ingredients.

Pregelatinised maize starch

Lactose

Sodium bicarbonate

Croscarmellose sodium

Sodium stearyl fumarate

Iron oxide yellow (2.5mg tablets

only)

Iron oxide red (5mg tablets only)

VASCALACE

CAPS

contains

colloidal

anhydrous

silica

&

pregelatinised maize starch.

The capsules are made of gelatin,

sodium

lauryl

sulphate

coloured with titanium dioxide, iron

oxide yellow (1.25 mg & 2.5 mg

capsules),

brilliant

scarlet

(2.5

mg, 5 mg & 10 mg capsules) and

patent

blue

&

capsules).

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink Business

Park

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Date of Approval

VASCALACE tablets:

4 October 2011

VASCALACE CAPS:

9 August 2013

Date of Most Recent Amendment

1 May 2014