ADEMPAS

Main information

  • Trade name:
  • ADEMPAS riociguat 2.5 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADEMPAS riociguat 2.5 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207596
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207596

ADEMPAS riociguat 2.5 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

14/04/2014

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. ADEMPAS riociguat 2.5 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

10/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Pulmonary arterial hypertension: Adempas, as monotherapy or in combination with approved PAH treatments (endothelin receptor antagonists or inhaled

or subcutaneous prostanoids), is indicated for the treatment of: · idiopathic pulmonary arterial hypertension · heritable pulmonary arterial hypertension

· pulmonary arterial hypertension associated with connective tissue diseases or · pulmonary arterial hypertension associated with congenital heart

disease in adult patients with WHO functional Class II, lll or IV symptoms,Chronic thromboembolic pulmonary hypertension: Adempas is indicated for the

treatment of:

Persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH in adult patients with

WHO functional Class II, lll or IV symptoms

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PP/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ADEMPAS riociguat 2.5 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Red orange, round, biconvex tablets marked with the Bayer cross on one

side and 2.5 and an 'R' on the other side.

Active Ingredients

riociguat

2.5 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 28.11.2017 at 12:17:48 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

170317 Adempas

ADEMPAS

®

(Ah-Dem-Pas)

riociguat

Consumer Medicine Information

ADEMPAS may cause birth defects and must not be taken during

pregnancy.

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about

Adempas. 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

Adempas 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 ADEMPAS IS

USED FOR

Adempas is used to treat adults

with high blood pressure in the

lung vessels caused by:

blood clots in the lungs

(known as chronic

thromboembolic pulmonary

hypertension or CTEPH)

narrowing of the vessels that

carry blood from the heart to

the lungs (known as

pulmonary arterial

hypertension or PAH)

If the high blood pressure in the

lung vessels is caused by

CTEPH it can sometimes be

treated with surgery. Adempas

may be used if surgery is not

possible or if there is still high

blood pressure in the lung

vessels after surgery.

High blood pressure in the lung

vessels means that the heart

needs to work harder to pump

blood through the lungs. This

may cause you to feel tired,

dizzy and short of breath.

Adempas contains the active

substance riociguat. Riociguat

is a soluble guanylate cyclase

(sGC)-stimulator.

Adempas relaxes the lung

vessels making it easier for the

heart to pump blood through

them. This lowers the pressure

in these vessels, relieves the

symptoms, and can lead to an

improvement in the ability to

exercise and perform physical

tasks.

Ask your doctor if you have

any questions about why this

medicine has been prescribed

for you.

Your doctor may have

prescribed it for another reason.

This medicine is only available

with a doctor’s prescription.

BEFORE YOU TAKE

ADEMPAS

When you must not take

it

Do not take Adempas if you

have an allergy to:

riociguat, the active

ingredient in Adempas

any of the ingredients listed

at the end of this leaflet

Some of the symptoms of an

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

Do not take this medicine if

you are pregnant, think you

might be pregnant or if you

could become pregnant

because you are not using

reliable birth control

(contraception).

It may affect the development

of your baby if you take it

during pregnancy or if you

become pregnant within one

month of stopping Adempas.

If you could become pregnant,

your doctor will ask you to take

a pregnancy test before you

start Adempas.

Women who may become

pregnant should have a

negative pregnancy test prior

to starting treatment with

Adempas.

If there is a chance

that you could become

pregnant, use at least two

reliable forms of birth control

(contraception) while you are

taking Adempas. You must

continue to use contraception

for at least 1 month after

170317 Adempas

stopping Adempas. Speak with

a gynaecologist for

contraceptive advice if you are

unsure of what to do.

Women must not become

pregnant for at least 1 month

after stopping treatment with

Adempas.

Do not use Adempas if you are

breast-feeding. If you are

breast-feeding, ask your doctor

or pharmacist for advice before

taking Adempas because it

might harm your baby. A

decision must be made whether

to discontinue breast feeding or

to stop therapy with Adempas.

Do not take this medicine if you

are taking nitrate medicines

which include:

glyceryl trinitrate (also

called nitroglycerine)

nicorandil

sodium nitroprusside

isosorbide mononitrate

isosorbide dinitrate

amyl nitrite (also known as

‘poppers’, ‘amyl’ or ‘rush’)

Do not take this medicine if you

are taking:

medicines known as PDE-5

inhibitors, such as

sildenafil, vardenafil or

tadalafil (used to treat high

blood pressure in lung

vessels in men and women

and/or erectile dysfunction

in men)

medicines known as non-

specific PDE inhibitors,

such as dipyridamole or

theophylline used in

cardiovascular and

respiratory conditions

Do not take this medicine if you

have increased pressure in your

pulmonary circulation

associated with scarring of the

lungs, of unknown cause

(idiopathic pulmonary

pneumonia).

Do not take this medicine

after the expiry date printed

on the pack and blister.

The expiry date is printed on

the carton and on each blister

after “EXP” (e.g. 11 18 refers

to November 2018). The expiry

date refers to the last day of that

month. If it has expired return it

to your pharmacist for disposal.

Do not take this medicine if

the packaging is torn or

shows signs of tampering.

If the packaging is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether

you should start taking this

medicine, talk to your doctor.

Adempas is not recommended

for children or adolescents.

safety and efficacy of Adempas

has not been proven in patients

less than 18 years of age.

Before you start to take

it

Tell your doctor if you have

allergies to any medicines,

foods, preservatives or dyes.

Tell your doctor if you have

or have had any of the

following medical conditions:

recent serious bleeding,

especially from the lungs, or

if you have undergone

treatment to stop coughing

up blood (bronchial arterial

embolization)

problems with your heart

and circulation

low blood pressure

liver disease

kidney disease

Tell your doctor if you are

breast-feeding or planning to

breast-feed.

Adempas should not be used

while breast-feeding.

If you are breast-feeding, ask

your doctor or pharmacist for

advice before taking Adempas

because it might harm your

baby. A decision must be made

whether to discontinue breast

feeding or to stop therapy with

Adempas.

Tell your doctor if you smoke.

The metabolism of Adempas is

affected by smoking, making it

less effective. You should not

smoke while taking Adempas.

If you have not told your

doctor about any of the

above, tell him/her before you

start taking Adempas.

Taking other medicines

Tell your doctor or

pharmacist if you are taking

any other medicines,

including any that you get

without a prescription from

your pharmacy, supermarket

or health food shop.

Do not take this medicine if you

are taking:

medicines known as nitrate

medicine such as glyceryl

trinitrate, isosorbide

mononitrate, nicorandil,

amyl nitrite (also known as

‘poppers’, ‘amyl’ or ‘rush’)

or sodium nitroprusside

medicines known as PDE-5

inhibitors, such as

sildenafil, vardenafil or

tadalafil (used to treat high

blood pressure in lung

vessels in men and women

and/or erectile dysfunction

in men)

medicines known as non-

specific PDE inhibitors,

such as dipyridamole or

theophylline used in

cardiovascular and

respiratory conditions

In particular, tell your doctor

if you are taking:

medicines known as

protease inhibitors for the

treatment of HIV infection,

such as ritonavir

170317 Adempas

medicines used to treat

fungal infections such as

ketoconazole or itraconazole

It is not recommended to take

Adempas at the same time as

these other medicines.

Also tell your doctor if you

are taking:

cancer medicines called

tyrosine kinase inhibitors

such as erlotinib or gefitinib

cyclosporin, a medicine used

to prevent rejection of

transplanted organs

epoprostenol, a medicine

used to treat pulmonary

arterial hypertension

antacids, used to treat

heartburn (indigestion)

granisetron, a medicine used

to prevent nausea and

vomiting

medicines used to treat

epilepsy, e.g. phenytoin,

carbamazepine,

phenobarbitone

anticoagulants, which are

medicines used to prevent

blood clots

other medicines used to treat

blood pressure

clarithromycin, an antibiotic

St. John’s Wort, a herbal

treatment for depression

These medicines may be

affected by Adempas or may

affect how well it works. You

may need different amounts of

your medicines, or you may

need to take different

medicines.

Your doctor and pharmacist

have more information on

medicines to be careful with or

avoid while taking Adempas.

HOW TO TAKE

ADEMPAS

Follow all directions given to

you by your doctor or

pharmacist carefully.

They may differ from the

information in this leaflet.

If you do not understand the

instructions printed on the

label, ask your doctor or

pharmacist for help.

How much to take

The recommended starting dose

of Adempas is one 1 mg tablet,

three times daily for 2 weeks.

Your doctor may advise you to

start on a lower dose.

Take

Adempas exactly as your doctor

tells you.

After 2 weeks, your doctor will

adjust your dose depending on

your blood pressure and your

response to the medicine. At the

start of treatment your doctor

will measure your blood

pressure at least every two

weeks.

If you have no side effects and

your blood pressure is above a

certain level, your doctor will

increase your dose every 2

weeks. The doctor may increase

your dose up to a maximum of

2.5 mg three times a day.

Tell your doctor if you have

any side effects as they may

need to lower your dose.

How to take it

Swallow the tablet whole with

water.

Adempas can be taken with or

without food.

When to take it

Take your medicine three

times a day at about the same

time each day.

Taking it at the same time each

day will have the best effect. It

will also help you remember

when to take it. It does not

matter if you take this medicine

before or after food.

If you are taking an antacid

(a medicine to treat stomach

disease or heartburn), take it

at least 1 hour after taking

Adempas.

How long to take it

Continue taking Adempas for

as long as your doctor tells

you.

Adempas helps to control your

condition, but does not cure it.

It is important to keep taking

Adempas even if you feel well.

In case treatment has to be

interrupted for 3 days or

more, please contact your

doctor before restarting

Adempas.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed

and take the next dose when

you are meant to.

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 to take your

medicine, ask your pharmacist

for some hints.

170317 Adempas

If you take too much

(overdose)

Immediately telephone your

doctor or the Poisons

Information Centre (Australia:

13 11 26) for advice, or go to

Accident and Emergency at the

nearest hospital, if you think

that you or anyone else may

have taken too much Adempas.

Do this even if there are no

signs of discomfort or

poisoning. You may need

urgent medical attention.

WHILE YOU ARE

TAKING ADEMPAS

Things you must do

If you are about to start on any

new medicine, remind your

doctor and pharmacist that you

are taking Adempas.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this

medicine.

Tell your doctor if your

shortness of breath is getting

worse during treatment with

Adempas.

This can be caused by a build-

up of fluid in the lungs due to

another lung vessel disease,

known as pulmonary veno-

occlusive disease.

If you are going to have

surgery, tell the surgeon or

anaesthetist that you are

taking this medicine.

It may affect other medicines

used during surgery.

If there is a chance you could

become pregnant, you should

have a negative pregnancy

test monthly during treatment

and one month after you stop

taking Adempas. You should

use two reliable forms of

contraception while you are

taking Adempas. If you

become pregnant while taking

Adempas, tell your doctor

immediately. You must

continue to use contraception

for at least 1 month after

stopping Adempas.

Do not smoke while taking

Adempas. Tell your doctor if

you stop or start smoking

during treatment.

Smoking may reduce the

effectiveness of Adempas and

your doctor may have to adjust

your dose if required.

If treatment is interrupted for

3 days or more, contact your

doctor before restarting

Adempas.

Keep all of your doctor’s

appointments so that your

progress can be checked.

Your doctor will measure your

blood pressure and do other

tests from time to time to make

sure the medicine is working

and to check for unwanted side

effects.

Things you must not do

Do not take Adempas to treat

any other complaints unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have

the same condition as you.

Do not stop taking your

medicine or lower the dose

without checking with your

doctor.

If you stop taking it, your

condition may worsen.

Things to be careful of

Be careful driving or

operating machinery until

you know how Adempas

affects you.

Dizziness is a common side

effect of Adempas. If you

experience dizziness during

treatment, do not drive or

operate machinery.

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 get

used to the change in position

and blood pressure.

Tell your doctor if you feel

dizzy or faint. They may want

to check your blood pressure.

SIDE EFFECTS

Tell your doctor or

pharmacist as soon as

possible if you do not feel well

while you are taking

Adempas.

All medicines can have side

effects. Sometimes they are

serious, most of the time they

are not. You may need medical

attention if you get some of the

side effects.

Do not be alarmed by the

following lists 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 or

pharmacist if you notice any

of the following and they

worry you:

light headedness

(hypotension)

dizziness

headache

indigestion

diarrhoea

nausea

vomiting

swelling of extremities

(hands, ankles or feet)

tiredness (may be due to

decrease in red blood cells)

anaemia (decrease in red

blood cells)

fast or irregular heart beats

170317 Adempas

nosebleed

nasal congestion

heartburn

difficulty in swallowing

constipation

stomach pain

stomach bloating

The above list includes the

more common side effects of

your medicine.

If any of the following

happen, tell your doctor

immediately or go to Accident

and Emergency at your

nearest hospital:

coughing up blood

The most serious side effects

are coughing up blood and

bleeding from the lungs which

can be fatal.

You may need urgent medical

attention or hospitalisation.

These side effects are not

common.

Tell your doctor or

pharmacist if you notice

anything that is making you

feel unwell.

Other side effects not listed

above may also occur in some

people.

AFTER TAKING

ADEMPAS

Storage

Keep your tablets in the pack

until it is time to take them.

If you take the tablets out of the

pack they may not keep well.

Keep the medicine in a cool

dry place where the

temperature stays below

30

C.

Do not store it or any other

medicine in the bathroom,

near a sink, or on a window-

sill.

Do not leave it in the car.

Heat and damp 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 Adempas or the expiry

date has passed, ask your

pharmacist what to do with

any medicine that is left over.

PRODUCT

DESCRIPTION

What it looks like

Adempas tablets are round

film-coated tablets supplied in

blister packs of 21, 42 or 84

tablets (not all pack sizes may

be marketed).

Adempas 0.5 mg tablets:

White, tablets marked with the

Bayer cross on one side and 0.5

and an “R” on the other side.

Adempas 1 mg tablets:

Pale yellow, tablets marked

with the Bayer cross on one

side and 1 and an “R” on the

other side.

Adempas 1.5 mg tablets:

Yellow-orange, tablets marked

with the Bayer cross on one

side and 1.5 and an “R” on the

other side.

Adempas 2 mg tablets:

Pale orange, tablets marked

with the Bayer cross on one

side and 2 and an “R” on the

other side.

Adempas 2.5 mg tablets:

Red-orange, tablets marked

with the Bayer cross on one

side and 2.5 and an “R” on the

other side.

Ingredients

Active ingredients:

Adempas 0.5 mg

contains 0.5 mg of

riociguat

Adempas 1 mg contains

1 mg of riociguat

Adempas 1.5 mg

contains 1.5 mg of

riociguat

Adempas 2 mg contains

2 mg of riociguat

Adempas 2.5 mg

contains 2.5 mg of

riociguat

Inactive ingredients:

cellulose microcrystalline

crospovidone

hypromellose

lactose monohydrate

magnesium stearate

sodium lauryl sulfate

hyprolose

propylene glycol

titanium dioxide

iron oxide yellow (1 mg, 1.5

mg, 2 mg and 2.5 mg)

iron oxide red (2 mg and 2.5

Suppliers

Made in Germany for:

Bayer Australia Ltd

ABN 22 000 138 714

875 Pacific Highway

Pymble NSW 2073

Bayer Medical Information and

Drug safety: 1800 673 270

(Toll free)

Australian registration

number

Adempas 0.5 mg

- AUST R 207595

Adempas 1 mg

- AUST R 207599

Adempas 1.5 mg

- AUST R 207597

Adempas 2 mg

- AUST R 207598

Adempas 2.5 mg

- AUST R 207596

170317 Adempas

Date of preparation

March 2017

See TGA website

(www.ebs.tga.gov.au) for latest

Australian Consumer Medicine

Information.

® Registered Trademark of

Bayer AG, Germany

© Bayer Australia Ltd

All rights reserved.