VOLIROP 3.125 carvedilol 3.125mg tablets Bottle

Main information

  • Trade name:
  • VOLIROP 3.125 carvedilol 3.125mg tablets Bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VOLIROP 3.125 carvedilol 3.125mg tablets Bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 174786
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

174786

VOLIROP 3.125 carvedilol 3.125mg tablets 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

11/11/2011

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. VOLIROP 3.125 carvedilol 3.125mg tablets Bottle

Product Type

Single Medicine Product

Effective date

6/03/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease.,Carvedilol

is indicated for the treatment of patients with symptomatic mild to severe (NYHA Class II - IV) congestive heart failure (CHF) as an adjunct to

conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators).

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

1000

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. VOLIROP 3.125 carvedilol 3.125mg tablets Bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval shaped, film-coated tablets debossed with 'E' on

one side and '01' on the other side

Active Ingredients

Carvedilol

3.125 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 03:01:33 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

VOLIROP

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 1 of 5

VOLIROP 3.125, 6.25, 12.5 & 25

Carvedilol

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers some

common

questions about VOLIROP.

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

taking

VOLIROP

against

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 VOLIROP used for

VOLIROP

contains

active

ingredient carvedilol.

VOLIROP is used to treat

heart failure,

high blood pressure, which is called

hypertension.

VOLIROP

belongs

group

medicines called beta-blockers. These

medicines work by relaxing tightened

blood vessels and slowing the heart

rate.

VOLIROP

additional

effect of being an antioxidant.

Heart Failure:

Heart failure occurs when the heart

can no longer pump blood strongly

enough for the body's needs. Often the

heart grows in size to try to improve

the blood flow but this can make the

heart failure worse.

Symptoms

heart

failure

include

shortness of breath and swelling of

the feet or legs due to fluid build-up.

VOLIROP reduces the pressure that

the heart has to pump against as well

as controlling your heart rate. Over 6

months or more this will reduce the

size of an oversized heart and increase

its efficiency.

VOLIROP reduces the chances of you

being

admitted

hospital

and/

dying from this condition.

VOLIROP is often used with other

medicines to treat heart failure.

Hypertension:

All people have blood pressure. This

pressure

helps

push

blood

around

your

body.

Your

blood

pressure

changes

during

day,

depending on how busy you are or

how you are feeling.

You have hypertension (high blood

pressure) when your blood pressure

stays

higher

than

needed,

even

when you are calm and relaxed.

Regular blood pressure checks are the

only way of knowing that you have

hypertension.

There

usually

symptoms

hypertension

may feel fine. If hypertension is not

treated, serious health problems such

as stroke, heart disease and kidney

failure may occur.

VOLIROP helps to lower your blood

pressure.

Your

doctor,

however,

have

prescribed

VOLIROP

another

purpose.

Ask your doctor if you have any

questions about why VOLIROP has

been prescribed for you.

VOLIROP is not addictive.

This medicine is available only with a

doctor's prescription.

Before you take VOLIROP

When

you

must

not

take

VOLIROP

Do not take VOLIROP if:

1.

you

have

had

an

allergic

reaction to:

any

medicine

containing

carvedilol

any ingredients listed at the end

of this leaflet.

Some

symptoms

allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

2.

you

have

asthma

or

other

conditions which make you short

of breath from time to time.

3.

you

have

a

history

of

allergic

problems,

including

hayfever.

Symptoms

of

an

allergy

may

include:

rash,

itching,

watery

eyes or sneezing

4.

you have a history of a very slow

heart

rate

or

uneven

heart

beating.

5.

you

have

certain

other

heart

conditions.

6.

you

have

liver

problems

including liver failure.

7.

you

have

very

low

blood

pressure.

8.

the

package

is

torn

or

shows

signs of tampering.

9.

the expiry date (EXP) printed on

the

pack

has

passed

or

if

the

tablets appear damaged in some

way.

If you take this medicine after the

expiry date has passed, it may not

work as well.

VOLIROP

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 2 of 5

If you are not sure if you should be

taking

VOLIROP,

talk

to

your

doctor.

Do not give VOLIROP to people

under 18 years of age.

Safety and effectiveness in children

have not been established.

Before

you

start

to

take

VOLIROP

Tell your doctor if:

1.

you

are

pregnant

or

plan

to

become pregnant.

It is not known whether VOLIROP

is harmful to an unborn baby when

taken by a pregnant woman. Your

doctor will discuss the risks and

benefits of using VOLIROP during

your pregnancy.

2.

you are breastfeeding or plan to

breastfeed.

VOLIROP passes into breast

milk.

Your doctor will discuss the

risks

and benefits of taking

VOLIROP if

you are breast-feeding.

3.

you

have

any

other

health

problems,

especially

the

following:

angina

chest

pain/tightness

which occurs even when you are

rest

(also

called

unstable

angina)

low blood pressure

high blood pressure which varies

widely

very

poor

circulation

your

fingers

and/or

toes

(also

called

peripheral vascular disease)

a history of poor kidney function

chronic bronchitis or emphysema

causing breathing difficulties

diabetes

sudden

blood

sugar

levels

(also called hypoglycaemia)

thyroid disorders

severe

allergic

reactions

causing

swelling

and/or

difficulty

breathing

a rare cancer of the adrenal gland

called phaeochromocytoma which

being

treated

with

other

medicines.

skin

disease

such

psoriasis

(hardened patches of red skin)

4.

you

are

allergic

to

any

other

medicines,

foods,

dyes

or

preservatives

5.

you plan to have surgery.

Your

surgeon

anaesthetist

should know well ahead of the date

of your surgery so they can allow

your

condition

medications.

If you have not told your doctor

about any of the above, tell them

before you start taking VOLIROP.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that

you

have

bought

from

a

pharmacy,

supermarket

or

health

food shop.

Some medicines may interfere with

VOLIROP. These medicines include:

rifampicin,

medicine

used

treat tuberculosis (e.g. Rimycin

Rifadin

cimetidine,

medicine

used

treat stomach ulcers or reflux (e.g.

Tagamet

, Magicul

digoxin, a medicine used to treat

heart failure (e.g. Lanoxin

monoamine-oxidase

inhibitors

(MAOIs)

such

phenelzine

(Nardil

tranylcypromine

(Parnate

), medicines used to treat

depression

clonidine, a medicine used to treat

high blood pressure, migraine or

menopausal

symptoms

(e.g.

Catapres

diltiazem, a medicine used to treat

high blood pressure or angina (e.g.

Cardizem

Coras

Diltahexal

Dilzem

, Vasocardol

verapamil,

medicine

used

treat high blood pressure, angina

fast

heart rate

(e.g.

Isoptin

Cordilox

, Anpec

drugs for when your heart doesn't

beat

smoothly,

including

disopyramide

(Rythmodan

mexiletine (Mexitil

), lignocaine,

flecainide

(Tambocor

amiodarone

(Cordarone

Aratac

drugs

diabetes,

including

insulin

injections,

glibenclamide

(Daonil

Glimel

metformin

(Diabex

Diaformin

Glucohexal

Glucomet

Glucophage

gliclazide

(Diamicron

glipizide

(Minidiab

, Melizide

cyclosporin,

medicine

used

treat

certain

problems

with

immune

system

(e.g.

Neoral

Cicloral

, Sandimmun

Aspirin and other pain relievers or

non-steroidal

anti-inflammatory

medicines

such

ibuprofen

(Nurofen

naproxen

(Naprosyn

medicines

which

relieve

asthma or help you breath better

such

salbutamol

(Ventolin

salmeterol

(Serevent

Seretide

fluoxetine,

medicine

used

treat

depression

other

conditions (e.g. Prozac

other

medicines

that

help

lower your blood pressure.

These medicines may be affected by

VOLIROP, or may affect how well it

works. You may need to use different

amounts

your

medicine,

may need to take different medicines.

Your doctor will advise you.

Your doctor or pharmacist has more

information

medicines

careful

with

avoid

while

taking

VOLIROP.

Ask your doctor or pharmacist if

you are not sure about this list of

medicines.

How to take VOLIROP

Follow all directions given to you by

your

doctor

or

pharmacist

carefully.

They may differ from the information

contained in this leaflet.

How much to take VOLIROP

Take

VOLIROP

exactly

as

your

doctor has prescribed.

VOLIROP

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 3 of 5

Your doctor will tell you how many

VOLIROP

take

each

day.

This

depends

your

condition

whether or not you are taking other

medicines.

Heart Failure

The usual starting dose in heart failure

is 3.125mg twice daily. The dose is

usually increased every two weeks to

6.25mg

twice

daily,

12.5mg

twice

daily

then

25mg

twice

daily.

However,

this

done

more

slowly

side

effects

occur.

tablets slow your heart too much you

may go back to a lower dose.

High Blood Pressure

Adults:

The recommended dose for initiation

of therapy is 12.5 mg a day for the

first two days.

Thereafter, the recommended dosage

is 25 mg once a day.

necessary,

dosage

increased every two weeks up to the

recommended maximum daily dose of

50 mg given once a day or in divided

doses (twice daily).

Elderly:

The recommended dose for initiation

therapy

12.5

once

daily,

which

provided

satisfactory

control

some

patients.

response is inadequate, the dose may

be increased every two weeks up to

recommended

maximum

daily

dose.

Your

doctor

will

monitor

carefully

each

time

dose

increased.

How to take VOLIROP

Swallow

tablets

whole

or

halved

with a glass of water.

Do not crush or chew the tablets.

When to take VOLIROP

Take

VOLIROP

during

or

immediately after a meal, at about

the same times each day.

Taking

your

medicine

same

time

each

will

have

best

effect.

will

also

help

remember when to take it.

If you take VOLIROP on an empty

stomach, it may increase the risk of

some of the side effects.

How long to take VOLIROP

Continue

taking

VOLIROP

until

your doctor tells you to stop.

Make sure you have enough to last

over weekends and holidays.

It is very important that VOLIROP is

not ceased suddenly. If you are to stop

taking

VOLIROP

your

doctor

will

advise you to reduce the dose slowly

over approximately two weeks.

If you forget to take VOLIROP

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 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.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

your dose, ask your pharmacist for

some hints.

In case of an overdose

If you think you or anyone else may

have

taken

too

much

VOLIROP,

immediately telephone your doctor,

or

Poisons

Information

Centre

(telephone

13

11

26),

or

go

to

Accident

and

Emergency

at

your

nearest

hospital,.

Do

this

even

if

there are no signs of discomfort or

poisoning.

Keep telephone numbers for these

places handy.

If

you

are

not

sure

what

to

do,

contact your doctor or pharmacist.

need

urgent

medical

attention.

The following are some symptoms,

which may or may not occur.

blood

pressure,

causing

dizziness or fainting

a very slow heart rate

difficulty breathing

vomiting

shock

seizures.

While

you

are

taking

VOLIROP

Things you must do

Tell

all

doctors,

dentists

and

pharmacists who are treating you

that you are taking VOLIROP. You

should also tell your surgeon and

anaesthetist

if

you

are

having

surgery.

If you

feel

light-headed, dizzy

or

faint

when getting out

of

bed or

standing up, get up slowly.

Make sure you drink enough water

during

exercise

and

hot

weather

when

you

are

taking

VOLIROP,

especially if you sweat a lot.

Tell

your

doctor

if

you

become

pregnant while taking VOLIROP.

Tell your doctor that you are taking

VOLIROP if you are going to have

any laboratory tests.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed.

Otherwise, your doctor may think that

it was not effective and change your

treatment unnecessarily.

Tell

your

doctor

if

you

feel

the

tablets

are

not

helping

your

condition.

Be

sure

to

keep

all

of

your

appointments with your doctor so

that your progress can be checked.

VOLIROP

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 4 of 5

Your doctor may examine your eyes,

test

your

blood

glucose

kidney function from time to time.

Things you must not do

Do not stop taking VOLIROP or

change

the

dose

without

first

checking with your doctor.

Do

not

let

yourself

run

out

of

medicine over the weekend or on

holidays.

VOLIROP should only be stopped by

gradually reducing the amount over a

two-week period.

Do not give VOLIROP to anyone

else

even

if

they

have

the

same

condition as you.

Do not use VOLIROP to treat other

complaints unless your doctor says

to.

Do

not

take

any

other

medicines

whether they require a prescription

or

not

without

first

telling

your

doctor or consulting a pharmacist.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

VOLIROP affects you.

VOLIROP may affect your ability to

drive a car or operate machinery when

started

when

dosage

increased.

If you wear contact lenses you may

also notice a reduction in the amount

of tear fluid in your eyes.

When taken with grapefruit juice the

amount

VOLIROP

absorbed

your body may be increased.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well

while

you

are

taking

VOLIROP.

VOLIROP

helps

most

people

with

heart

failure

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.

Do not be alarmed by the following

list

of

side

effects.

You

may

not

experience any of them.

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:

headache (this is usually mild and

happens

start

your

treatment)

tiredness, drowsiness

blood

pressure.

signs

include

feeling

dizzy

lightheaded

especially

after

stand up

abnormal or blurry vision

slow heart rate

diarrhoea

nausea or vomiting

bronchitis

loss of control of blood sugar in

diabetics

weight increase

fluid retention. The signs include

overall swelling of parts of your

body for example your hands, feet,

ankles and legs.

unusual hair loss or thinning

These

more

common

side

effects

VOLIROP.

Mostly

these

are mild and will decrease as you get

used to your medicine.

Tell your doctor immediately or go

to Accident and Emergency at your

nearest hospital if you notice any of

the following:

itching,

dark

urine,

loss

appetite,

yellowing

skin

eyes, or feeling "flu-like" with no

clear cause.

shortness of breath or swelling of

the mouth or tongue

uneven heart beating

swelling of the feet or legs due to

fluid build up

bleeding or bruising more easily

than normal

These

serious

side

effects.

need

urgent

medical

attention. Serious side effects are rare.

This

complete

list

possible

side

effects.

Others

occur in some people and there may

be some side effects not yet known.

Tell your doctor or pharmacist if

you

notice

anything

else

that

is

making you feel unwell, even if it is

not on this list.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

After Taking VOLIROP

Storage

Keep

your

tablets

in

the

blister

until it is time to take them.

take

tablets

blister pack they may not keep well.

VOLIROP

known

fade

when

exposed to light.

Keep VOLIROP in a cool dry place

where the temperature stays below

25°C.

Do

not

store

it,

or

any

other

medicine, in a bathroom or near a

sink, or any other place where there

is high humidity.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep

VOLIROP

where

young

children cannot reach it.

A locked cupboard at least one-and-a-

half

metres

above

ground

good place to store medicines.

Disposal

If

your

doctor

tells

you

to

stop

taking

VOLIROP,

or

the

tablets

have passed their expiry date, ask

your pharmacist what to do with

any tablets that are left over.

VOLIROP

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 5 of 5

Product Description

What it looks like

VOLIROP

3.125,

6.25,

12.5

&

(3.125,

6.25,

12.5

&

carvedilol) are presented in pack size

of 30 & 60 tablets in blister and 30,

60 & 1000 tablets in bottle.

VOLIROP 3.125

(Blister

pack:

AUST

R

174802

&

Bottle: AUST R 174786)

White to off-white, oval shaped, film-

coated tablets debossed with ‘E’ on

one side and ‘01’ on the other side.

VOLIROP 6.25

(Blister

pack:

AUST

R

174796

&

Bottle: AUST R 174806)

White to off-white, oval shaped, film-

coated tablets debossed with ‘F 57’ on

one side and deep break line on the

other side.

VOLIROP 12.5

(Blister

pack:

AUST

R

174795

&

Bottle: AUST R 174800)

White to off-white, oval shaped, film-

coated tablets debossed with ‘F 58’ on

one side and deep break line on the

other side.

VOLIROP 25

(Blister

pack:

AUST

R

174788

&

Bottle: AUST R 174789)

White to off-white, oval shaped, film-

coated tablets debossed with ‘F 59’ on

one side and deep break line on the

other side.

Ingredients

Active Ingredient:

Carvedilol

Each tablet may contain either 3.125

mg, 6.25 mg, 12.5 mg or 25 mg of

carvedilol.

Other Ingredients:

Lactose

Colloidal anhydrous silica

Crospovidone (Type A & Type B)

Povidone

Sucrose

Magnesium stearate

Macrogol 400

Polysorbate 80

Titanium dioxide &

Hypromellose

Please

read

this

leaflet

carefully

before you start taking VOLIROP.

You may wish to keep it to read

again.

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3 North Rydelink

277-283 Lane Cove Road

Macquarie Park NSW 2113

Australia

Date of Approval

7 November 2011