JARDIANCE

Main information

  • Trade name:
  • JARDIANCE empagliflozin 25 mg film-coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • JARDIANCE empagliflozin 25 mg film-coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208827
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208827

JARDIANCE empagliflozin 25 mg film-coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Boehringer Ingelheim Pty Ltd

Postal Address

PO Box 1969,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

30/04/2014

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. JARDIANCE empagliflozin 25 mg film-coated tablets blister pack

Product Type

Single Medicine Product

Effective date

21/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Glycaemic control

JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:

- Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered

inappropriate due to intolerance.

- Add-on combination therapy: In combination with other glucose±lowering medicinal products including insulin, when these, together with diet and

exercise, do not provide adequate glycaemic control (see CLINICAL TRIALS).

Prevention of cardiovascular death

JARDIANCE is indicated in patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see

CLINICAL TRIALS).

To prevent cardiovascular deaths, JARDIANCE should be used in conjunction with other measures to reduce cardiovascular risk in line with the current

standard of care.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/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

Components

1. JARDIANCE empagliflozin 25 mg film-coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pale yellow, oval, biconvex film-coated tablet, debossed with 'S25' on one

side, the other side debossed with the BI company symbol

Active Ingredients

empagliflozin

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 27.11.2017 at 10:52:38 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

JARDIANCE CMI0142-06

Jardiance

®

Film-coated tablets

empagliflozin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Jardiance.

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 Jardiance

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be available.

The latest Consumer Medicine

Information is available from your

pharmacist, doctor, or from

www.medicines.org.au (Australia)

and www.medsafe.govt.nz/

Consumers/cmi/CMIForm.asp (New

Zealand) and may contain important

information about the medicine and

its use of which you should be aware.

Keep this leaflet with the medicine.

You may need to read it again.

What Jardiance is

used for

Jardiance is used to lower blood

sugar levels in patients with type 2

diabetes mellitus.

It may be used when diet plus

exercise do not provide adequate

blood sugar level control either:

alone as a single medicine, or

in combination with certain other

anti-diabetic medicines such as:

metformin, or

sulfonylurea medicines such

as glimepiride and

glibenclamide, or

pioglitazone, or

insulin, or

dipeptidyl peptidase-4

inhibitor medicines such as

linagliptin or sitagliptin.

If you have type 2 diabetes mellitus

and cardiovascular disease, Jardiance

can be used to reduce your risk of

dying from your cardiovascular

disease.

Type 2 diabetes mellitus is also

called non-insulin-dependent

diabetes mellitus or NIDDM. Type 2

diabetes develops if the body does

not make enough insulin, or if the

insulin that your body makes does

not work as well as it should.

Insulin is a substance which helps to

lower the level of sugar in your

blood, especially after meals.

When the level of sugar builds up in

your blood, this can cause damage to

the body's cells and lead to serious

problems with your heart, eyes,

circulation or kidneys.

How Jardiance works

Jardiance contains the active

ingredient, empagliflozin, which

belongs to a group of medicines

called SGLT2 (sodium-glucose co-

transporter 2) inhibitors.

Jardiance works by blocking a

protein in the kidneys called SGLT2.

Jardiance removes blood sugar,

which is too high because of your

type 2 diabetes mellitus, via the

urine. As a result, the levels of

glucose in your blood are reduced.

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.

Jardiance is available only with a

doctor's prescription.

Before you take

Jardiance

When you must not take it

Do not take Jardiance if you have

an allergy to:

any medicine containing

empagliflozin (the active

ingredient in Jardiance)

any of the other 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.

JARDIANCE CMI0142-06

Do not take Jardiance if you have

severe problems with your kidneys.

Do not take this medicine if you

are pregnant.

It may affect your developing baby if

you take it during pregnancy.

Do not breastfeed if you are taking

this medicine.

It is not known if the active

ingredient in Jardiance passes into

human breast milk and there is a

possibility that your baby may be

affected.

Do not give this medicine to a child

under the age of 18 years.

Safety and effectiveness in children

younger than 18 years has not been

established.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or 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.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

type 1 diabetes, a condition where

your body does not produce

insulin

diabetic ketoacidosis, a condition

in which substances called

‘ketone bodies’ accumulate in the

blood and which can lead to

diabetic pre-coma. Symptoms

include: rapid weight loss, feeling

sick or being sick, stomach pain,

excessive thirst, fast and deep

breathing, unusual sleepiness or

tiredness, a sweet smell to your

breath, a sweet or metallic taste in

your mouth, or a different odour

to your urine or sweat

kidney problems

galactosaemia, a rare hereditary

condition of galactose intolerance

frequent genital or urinary tract

infections (infections of the

bladder, kidney, or tubes that

carry urine)

illnesses that will make you

dehydrated (e.g. diarrhoea or a

severe infection)

increased urine loss which may

affect the fluid balance in your

body.

Tell your doctor if you have heart

problems, a history of low blood

pressure or are 75 years of age or

older.

Increased passing of urine due to the

medicine may affect fluid balance in

your body and increase your risk of

dehydration.

Tell your doctor if you are 85 years

of age or older.

You should not start taking Jardiance

if you are over 85 years of age.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

Jardiance.

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.

Some medicines and Jardiance may

interfere with each other. These

include medicines used to treat high

blood pressure known as water pills

(diuretics).

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take Jardiance

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The recommended dose is one 10 mg

tablet once a day.

Your doctor may increase your dose

to 25 mg once a day if your blood

glucose levels remain high after

starting treatment on 10 mg.

Your doctor will prescribe Jardiance

alone, or in combination with another

anti-diabetic medicine if that

medicine alone is not sufficient to

control your blood sugar level.

How to take it

Swallow the tablet whole with a

full glass of water.

When to take it

Take your medicine 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.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

This medicine helps to control your

condition, but will not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

If it is less than 12 hours before

your next dose, skip the dose you

missed and take your next dose

when you are meant to.

JARDIANCE CMI0142-06

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.

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.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre (in

Australia telephone 13 11 26; in

New Zealand telephone 0800 764

766) for advice, or go to

Emergency if you think that you or

anyone else may have taken too

much Jardiance. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are using

Jardiance

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Jardiance.

Tell any other doctors and

pharmacists who treat you that

you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any blood

or urine tests, tell your doctor that

you are taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Follow your doctor's and/or

dietician's advice on diet, drinking

alcohol and exercise.

Diet and exercise can help your body

use its blood sugar better. It is

important to stay on the diet and

exercise program recommended by

your doctor while taking Jardiance.

Make sure you check your blood

glucose regularly.

This is the best way to tell if your

diabetes is being controlled properly.

Your doctor or diabetes educator will

show you how and when to do this.

Things you must not do

Do not take Jardiance 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 dosage without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

Jardiance affects you.

When taken with other anti-diabetic

medicines, such as sulfonylurea or

insulin, your risk of getting low

blood sugar is higher.

This may cause dizziness, light-

headedness, tiredness, drowsiness in

some people. Low blood glucose

levels may also slow your reaction

time and affect your ability to drive

or operate machinery.

If you have any of these symptoms,

do not drive, operate machinery or do

anything else that could be

dangerous.

Be careful when doing any of the

following things, which may

increase the risk of your blood

glucose becoming too low:

drinking alcohol

not eating enough

doing unexpected or vigorous

exercise.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Jardiance.

This medicine helps most people

with type 2 diabetes mellitus, 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 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:

genital burning, redness, pain and

discharge which may be signs of

a genital yeast infection

passing more urine than normal

itching

thirst.

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible

if you notice any of the symptoms

of low blood sugar such as:

sweating

weakness

hunger

JARDIANCE CMI0142-06

dizziness

trembling

headache

flushing or paleness

numbness

a fast pounding heartbeat.

Low blood sugar may occur in

patients who already take another

medication to treat diabetes, such as

a sulfonylurea or insulin. The dose of

your sulfonylurea or insulin medicine

may need to be reduced while taking

Jardiance.

Tell your doctor as soon as possible

if you notice any of the following:

burning sensation when passing

urine

urine that appears cloudy

pain in the pelvis, or mid-back

pain

straining or pain when passing

urine

unusual thirst

light-headedness, or dizziness

upon standing

fainting or loss of consciousness.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

Tell your doctor immediately or go

to Emergency if you notice any of

the following:

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

severe and sudden onset of itchy

or raised skin rash, hives or nettle

rash.

Tell your doctor immediately or go

to Emergency if you notice any of

the symptoms of diabetic

ketoacidosis such as:

rapid weight loss

feeling sick or being sick

stomach pain

excessive thirst

fast and deep breathing

confusion

unusual sleepiness or tiredness

a sweet smell to your breath, a

sweet or metallic taste in your

mouth or a different odour to

your urine or sweat.

In rare cases, empagliflozin, the

active substance in Jardiance, can

cause a serious side effect called

diabetic ketoacidosis.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

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.

Some of these side effects can only

be found when your doctor does tests

from time to time to check your

progress.

After using Jardiance

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 your tablets in a cool dry

place where the temperature stays

below 30°C.

Do not store Jardiance 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 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 this medicine 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

Jardiance is the brand name of your

medicine.

Jardiance is available in two

strengths:

Jardiance 10 mg tablets are pale

yellow, round, biconvex and

bevel-edged, marked with the BI

company logo on one side and

'S10' on the other side.

Jardiance 25 mg tablets are pale

yellow, oval and biconvex,

marked with the BI company logo

on one side and 'S25' on the other

side.

Jardiance tablets are available in

PVC/Aluminium blister packs of 10

(sample) or 30 tablets.

Ingredients

Active ingredient:

Jardiance 10 mg - 10 mg of

empagliflozin.

Jardiance 25 mg - 25 mg of

empagliflozin.

Inactive ingredients:

lactose

microcrystalline cellulose

hydroxypropylcellulose

croscarmellose sodium

colloidal anhydrous silica

magnesium stearate.

Tablet coating:

hypromellose

titanium dioxide

talc

macrogol 400

JARDIANCE CMI0142-06

iron oxide yellow.

This medicine does not contain

sucrose, gluten, tartrazine or any

other azo dyes.

Supplier

Jardiance tablets are supplied in

Australia by:

Boehringer Ingelheim Pty Limited

ABN 52 000 452 308

78 Waterloo Road

North Ryde NSW 2113

They are supplied in New Zealand

Boehringer Ingelheim (N.Z.) Limited

Auckland.

This leaflet was updated in January

2017.

® Jardiance is a registered trade

mark of Boehringer Ingelheim.

© Boehringer Ingelheim Pty Limited

2017.

Australian Registration

Numbers:

Jardiance 10 mg (AUST R 208829)

Jardiance 25 mg (AUST R 208827)