BOSENTAN

Main information

  • Trade name:
  • BOSENTAN APOTEX bosentan (as monohydrate) 62.5mg tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOSENTAN APOTEX bosentan (as monohydrate) 62.5mg tablets bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222214
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222214

BOSENTAN APOTEX bosentan (as monohydrate) 62.5mg tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

25/02/2016

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. BOSENTAN APOTEX bosentan (as monohydrate) 62.5mg tablets bottle

Product Type

Single Medicine Product

Effective date

4/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Bosentan is indicated for the treatment of:

·idiopathic pulmonary arterial hypertension;

·familial pulmonary arterial hypertension;

·pulmonary arterial hypertension associated with scleroderma; or

·pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology,in patients with WHO

Functional Class II, III or IV symptoms.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. BOSENTAN APOTEX bosentan (as monohydrate) 62.5mg tablets bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Orange-white coloured, round shaped, biconvex film coated tablet,

engraved "APO" on one side and "62.5" on the other side.

Active Ingredients

bosentan monohydrate

64.542 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 26.11.2017 at 11:53:22 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

Bosentan APOTEX

Contains the active ingredient bosentan (as monohydrate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about bosentan. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Bosentan APOTEX tablets. It

contains the active ingredient

bosentan (as monohydrate).

It is used to treat high blood pressure

in the blood vessels between the

heart and the lungs. This condition is

called pulmonary arterial

hypertension.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Bosentan acts to reduce abnormally

high blood pressure by widening the

blood vessels between the heart and

lungs. It belongs to the class of

medicines known as endothelin

antagonists.

There is no evidence that this

medicine is addictive.

Use in children

There is limited experience with the

use of this medicine in children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are pregnant or intend to

become pregnant. You must

stop taking the medicine at least

3 months before trying to

become pregnant.

Bosentan is known to cause harm

to a developing baby if you take it

during pregnancy and in the three

months before becoming

pregnant.

You have a moderate to severe

liver disorder.

You are being treated with

cyclosporin A

(a medicine used after a

transplant or to treat psoriasis)

You are being treated with

glibenclamide

(a medicine used for diabetes)

You are hypersensitive to, or

have had an allergic reaction to,

bosentan or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

BOSENTAN APOTEX TABLETS

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does

not look quite right.

Before you start to take it

Bosentan may harm sperm. All

men should use effective birth

control while taking this medicine

and for 3 months after they stop

taking it.

If sexually active, you must use a

hormonal and a barrier method of

contraception.

This medicine may reduce the

effectiveness of hormonal

contraceptives such as the pill and

hormone patches, implants or

injections. It is important to use other

contraceptives, like condoms or an

intrauterine device (IUD).

Your doctor will advise you about

using reliable contraceptives

before taking this medicine.

Before you start taking this

medicine, tell your doctor if:

You are a woman of childbearing

potential and not using reliable

contraceptive methods. You must

have a negative pregnancy test

before beginning treatment. The

test should be performed on the

second day of a normal menstrual

period or 11 days after the last

unprotected sexual intercourse,

whichever is later. Your doctor

will advise you about using

reliable contraception before

taking or whilst taking this

medicine.

Hormonal contraception on its

own is not a reliable option

because this medicine may make

this method ineffective in

preventing pregnancy. Hormonal

contraceptives include ones you

take orally (the pill), patches you

put on your skin, ones that are

injected and implants. You should

ALWAYS use additional

methods of contraception, such as

condoms and IUDs and not rely

only on hormonal contraception.

You should have a pregnancy test

every month while you are taking

this medicine. You must stop

taking this medicine for at least 3

months prior to becoming

pregnant.

You are currently breastfeeding

or you plan to breastfeed.

It is not known whether bosentan

passes into breast milk. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

anaemia

hypotension

liver or kidney disorders

pulmonary veno-occlusive

disease (PVOD)

pulmonary arterial hypertension

with heart failure

coronary heart disease (CHD)

HIV infection

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines must not be taken

with bosentan, these include:

cyclosporin A, used to prevent

organ transplantation rejection

glibenclamide, used to treat

diabetes.

Some medicines may also interact

with bosentan. These include:

hormonal contraceptives (oral,

injectable, transdermal and

implantable)

simvastatin, medicines for

lowering blood fats

medicines for bacterial infections

such as rifampicin

medicines to prevent organ

transplantation rejection such as

tacrolimus or sirolimus

lopinavir and ritonavir or other

ritonavir-boosted protease

inhibitors (used to treat HIV)

digoxin (used to treat heart

rhythm disorders)

sildenafil (used to treat erectile

dysfunction and/or also

pulmonary hypotension)

warfarin used to prevent blood

clots

fluconazole used for fungal

infections

nimodipine a type of medication

used to treat narrow blood vessels

in the brain.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with bosentan.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

BOSENTAN APOTEX TABLETS

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

The usual starting dose is one

62.5mg tablet, twice daily for the

first 4 weeks.

Depending on how you respond to

the medicine, your doctor may

increase the dosage after four weeks

to a 125mg tablet twice daily.

If you do not think the medicine is

working or you think it is working

too well, talk to your doctor. Your

doctor may need to change the dose

you are taking.

When to take it

Take one tablet in the morning and

one in the evening.

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

Stopping your treatment may lead to

worsening of your symptoms. Your

doctor may tell you to reduce the

dose over a few days before stopping

completely.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

this medicine

Things you must do

It is very important that you have a

liver function blood test before you

start treatment and every month after

that.

Bosentan can cause liver damage if it

is not found early. As this side effect

may not cause symptoms at first,

only a blood test can show that you

have early liver damage. Regular

blood tests let your doctor change or

stop your therapy before there is

permanent damage.

You should have a blood test for

anaemia after 1 and 3 months and

then every 3 months for the rest of

your treatment.

You need to have pregnancy tests

monthly if you are a female of

childbearing age.

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Do not become pregnant whilst

taking this medicine.

You must have a pregnancy test

every month while you are taking

this medicine. You doctor will

need evidence that you are not

pregnant before prescribing the

medicine again.

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking bosentan or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

BOSENTAN APOTEX TABLETS

headache

inflamed throat and irritated nose

passages

flushing (hot flushes)

ankle and leg swelling

low blood pressure

blood disorders

fast heart beat

tiredness

itching, rash, skin inflammation,

skin redness

diarrhoea.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

shortness of breath or difficulty in

breathing.

nausea

vomiting

fever

unusual tiredness

stomach pain

yellowing of your skin or the

whites of your eyes (jaundice).

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to bosentan, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 30°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine 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

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Bosentan APOTEX

tablets looks like

62.5 mg tablets: Orange-white

coloured, round shaped, biconvex

film-coated tablet, engraved "APO"

on one side and "62.5" on the other

side.

125 mg tablets: Orange-white

coloured, oval shaped biconvex film-

coated tablet, engraved "APO" on

one side and "125" on the other side.

* Not all strengths may be available.

Ingredients

Each tablet contains 62.5 mg or 125

mg bosentan (as monohydrate) as the

active ingredient.

It also contains the following inactive

ingredients:

methylcellulose

poloxamer

crospovidone

silicon dioxide

magnesium stearate

Film coating containing:

hypromellose

hydroxypropylcellulose

macrogol 8000

titanium dioxide

iron oxide red

iron oxide yellow

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Bosentan APOTEX 62.5 mg tablets

(Bottle of 60s): AUST R 222214.

Bosentan APOTEX 125 mg tablets

(Bottle of 60s): AUST R 222215.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

January 2015.

BOSENTAN APOTEX TABLETS

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety