FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film coated tablets blister pack

Main information

  • Trade name:
  • FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 180147
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

180147

FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

AstraZeneca Pty Ltd

Postal Address

PO Box 131,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

22/10/2012

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. FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film coated tablets blister pack

Product Type

Single Medicine Product

Effective date

28/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Monotherapy: FORXIGA is indicated as an adjunct to diet and exercise in patients with type 2 diabetes mellitus for whom metformin is otherwise

indicated but was not tolerated.,Initial combination: FORXIGA is indicated for use as initial combination therapy with metformin, as an adjunct to diet and

exercise, to improve glycemic control in patients with type 2 diabetes mellitus when diet and exercise have failed to provide adequate glycemic control

and there are poor prospects for response to metformin monotherapy (for example, high initial HbA1c levels).,Add-on combination: FORXIGA is

indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with other anti-hyperglycemic agents, when these together

with diet and exercise, do not provide adequate glycemic control (see CLINICAL TRIALS and PRECAUTIONS for available data on different add-on

combination therapies).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/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. dapagliflozin (as propanediol monohydrate) 10 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

yellow, biconvex, diamond, film coated tablets with '10' engraved on one

side and '1428' debossed on the other side.

Active Ingredients

Dapagliflozin propanediol monohydrate

12.3 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 08:25:45 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

FORXIGA

®

Dapagliflozin (dap-ah-gli-flows-in)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about FORXIGA. It does

not contain all of 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 FORXIGA

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 FORXIGA is

used for

FORXIGA is a prescription medicine

used with diet, exercise and

sometimes other medicines (which

may include metformin; insulin; a

sulfonylurea medicine such as

gliclazide, glimepiride and

glibenclamide; or a dipeptidyl

peptidase-4 inhibitor [DPP 4

inhibitor] such as sitagliptin or

saxagliptin or a glucagon like peptide

1 [GLP-1] receptor agonist such as

exenatide) to control the levels of

blood sugar (glucose) in patients with

type 2 diabetes mellitus.

Type 2 diabetes mellitus

Type 2 diabetes mellitus (also called

non-insulin-dependent diabetes

mellitus, or NIDDM) is the condition

of having high levels of blood sugar

(hyperglycaemia). This is usually

because your body does not make

enough insulin and /or the insulin

that your body produces does not

work as well as it should. Left

uncontrolled, the build-up of high

levels of sugar in your blood can lead

to serious medical problems.

The main goal of treating type 2

diabetes is to control your blood

sugar to a normal level. Lowering

and controlling blood sugar may help

prevent or delay complications of

diabetes, which include kidney

disease, blindness and amputation.

FORXIGA is a member of a class of

medicines you take by mouth called

SGLT-2 (Sodium Glucose

Cotransporter-2) inhibitors that lower

blood sugar levels in patients with

type 2 diabetes mellitus.

FORXIGA lowers the level of

your blood sugar by removing the

excess sugar from the body in the

urine.

FORXIGA by itself is unlikely to

cause low blood sugar

(hypoglycaemia) because it does

not interfere with the insulin

hormone that regulates blood

sugar.

Your doctor may have prescribed this

medicine for another reason. Ask

your doctor if you have any questions

about why FORXIGA has been

prescribed for you.

This medicine is only available with

a doctor's prescription.

FORXIGA is not addictive.

Before you take

FORXIGA

When you must not take it

Do not take FORXIGA if you

have:

Poorly functioning kidneys

since FORXIGA requires good

functioning kidneys to work

well

An allergy to dapagliflozin, the

active ingredient in FORXIGA

or 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 or

you may feel faint.

Do not take FORXIGA after the

use by (expiry) date printed on the

pack.

Do not take FORXIGA if the

packaging is torn or shows signs of

tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

FORXIGA is not recommended for

use in children.

It has not been studied in children

younger than 18 years old.

If you are not sure whether you

should start taking FORXIGA,

talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor if you have any

allergies to:

any other medicines

FORXIGA

any other substances such as

foods, dyes or preservatives

Tell your doctor or pharmacist if

you have, or have had, any medical

conditions, especially the following:

type 1 diabetes mellitus

kidney, liver or pancreas

problems

you are taking a medicine for

high blood pressure or taking a

water pill (diuretic)

frequently get genital or urinary

tract infections (infections of the

bladder, kidney, or tubes that

carry urine)

an illness that will make you

dehydrated such as diarrhoea or a

severe infection.

diabetic ketoacidosis. This is a

symptom of uncontrolled

diabetes, in which substances

called ketone bodies build up in

the blood. You may notice this 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.

Tell your doctor if you are

pregnant or intend to become

pregnant.

The safety of FORXIGA in pregnant

women has not been established.

FORXIGA must not be used during

the second and third trimesters of

your pregnancy. If you are pregnant,

stop taking FORXIGA and speak

with your doctor immediately as

good control of your type 2 diabetes

(control your blood sugar) is

important while you are pregnant and

it is not known if FORXIGA will

harm your unborn baby.

Tell your doctor if you are

breastfeeding or plan to

breastfeed.

FORXIGA should not be used while

breastfeeding or if planning to

breastfeed. It is not known if

FORXIGA will pass into your breast

milk. Talk with your doctor about the

best way to feed your baby if you are

taking FORXIGA.

Tell your doctor if you are lactose

intolerant.

FORXIGA tablets contain lactose.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

FORXIGA can be taken with most

other medicines.

If you have not told your doctor

about any of these things, tell them

before you take any FORXIGA.

How to take FORXIGA

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 pack ask your

doctor or pharmacist for help.

How to take it

Swallow your FORXIGA tablet

with a full glass of water.

How much to take

The dose of FORXIGA is one 10 mg

tablet once a day. You should not

take more than one FORXIGA tablet

per day.

Your doctor may prescribe

FORXIGA along with certain other

medicines that lower blood sugar.

When to take it

FORXIGA should be taken once

daily at any time of the day

regardless of meals.

Taking your tablets at the same time

each day will have the best effect. It

will also help you remember when to

take the tablets.

FORXIGA tablets can be taken with

or without food.

How long to take it

Continue taking the tablets for as

long as your doctor tells you. Make

sure you keep enough FORXIGA

to last over weekends and holidays.

FORXIGA helps control your

condition, but does not cure it.

Therefore, you must take FORXIGA

every day.

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 have trouble remembering

when to take your medicine, ask your

pharmacist for some hints.

If you take too much

Immediately telephone your doctor

or the Poisons Information Centre

(13 11 26) for advice, or go to

Accident and Emergency at your

nearest hospital if you think that

you or anyone else may have taken

too much FORXIGA. Do this even

if there are no signs of discomfort

or poisoning.

You may need urgent medical

attention.

While you are taking

FORXIGA

Things you must do

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are taking

FORXIGA.

FORXIGA

If you are about to be started on

any new medicines, tell your

doctor, dentist or pharmacist that

you are taking FORXIGA.

Make sure that you, your friends,

family and work colleagues can

recognise the symptoms of

hypoglycaemia and

hyperglycaemia and know how to

treat them.

It is important to have regular

check-ups with your doctor or

diabetes centre.

Like for all diabetic patients it is

important to check your feet

regularly and adhere to any other

advice regarding foot care given by

your doctor.

Tell your doctor if you experience

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. These

symptoms could be a sign of

diabetic ketoacidosis.

Talk to your doctor if you are

having surgery to discuss when to

stop taking FORXIGA and when

to start taking it again.

HYPOGLYCAEMIA

FORXIGA does not normally cause

hypoglycaemia, although you may

experience it if you take certain other

medicines, such as insulin or a

sulfonylurea.

Hypoglycaemia can occur suddenly.

Initial signs may include:

weakness, trembling or shaking

sweating

lightheadedness, dizziness,

headache or lack of concentration

irritability, tearfulness or crying

hunger

numbness around the lips and

tongue.

If not treated promptly, these may

progress to:

loss of co-ordination

slurred speech

confusion

fits or loss of consciousness.

If you experience any of the

symptoms of hypoglycaemia, you

need to raise your blood glucose

immediately.

You can do this by doing one of the

following:

eating 5 to 7 jelly beans

eating 3 teaspoons of sugar or

honey

drinking half a can of non-diet

soft drink

taking 2 to 3 concentrated glucose

tablets.

Unless you are within 10 to 15

minutes of your next meal or

snack, follow up with extra

carbohydrates such as plain

biscuits, fruit or milk.

Taking this extra carbohydrate will

prevent a second drop in your blood

glucose level.

HYPERGLYCAEMIA

If you notice the return of any of

the signs of hyperglycaemia,

contact your doctor immediately.

Your doctor may need to consider

additional or other treatments for

your diabetes.

The risk of hyperglycaemia is

increased in the following situations:

uncontrolled diabetes

illness, infection or stress

taking less FORXIGA than

prescribed

taking certain other medicines

too little exercise

eating more carbohydrates than

normal.

Tell your doctor if you:

become ill

become dehydrated

are injured

have a fever

have a serious infection

are having surgery (including

dental surgery).

Your blood glucose may become

difficult to control at these times.

If you become pregnant while

taking FORXIGA, tell your doctor

immediately.

If you need to have any medical

tests while you are taking

FORXIGA, tell your doctor.

FORXIGA may affect the results of

some tests.

Visit your doctor regularly for

check ups.

Your doctor may want to perform

blood tests to check your kidneys,

liver, heart, and levels of cholesterol

and fats in your blood while you are

taking FORXIGA.

Things you must not do

Do not take FORXIGA to treat any

other complaints unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if their symptoms seem

similar or they have the same

condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

FORXIGA affects you.

Although rare, FORXIGA may cause

dizziness in some people. Low blood

sugar levels may also slow your

reaction time and affect your ability

to drive or operate machinery.

Make sure you know how you

react to FORXIGA before you

drive a car, operate machinery or

do anything else that could be

dangerous if you are dizzy or

lightheaded.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

FORXIGA.

FORXIGA

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.

Ask your doctor or pharmacist to

answer any questions you may

have.

Side effects of FORXIGA include:

hypoglycaemia (see below)

genital infections as suggested by

irritation of the genitals

urinary tract infections

back pain

changes in the amount of

cholesterol or fats in your blood

sore throat

headache

diarrhoea

Low blood sugar (hypoglycaemia)

may become worse in people who

already take another medication to

treat diabetes, such as sulfonylureas

or insulin. Tell your doctor if you

take other diabetes medicines. If you

have symptoms of low blood sugar,

you should check your blood sugar

and treat if low, then call your

doctor. Signs of low blood sugar may

include weakness, trembling or

shaking, sweating, light-headedness,

headache, dizziness, rapid heartbeat,

lack of concentration, tearfulness or

crying, irritability, hunger and

numbness around the lips and

fingers. Do not drive a car if you

have signs of low blood sugar.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital.

Kidney problems. If you have

kidney problems you should use

FORXIGA only if your doctor

tells you to.

Volume depletion (loss of needed

fluids from the body;

dehydration). Tell your doctor if

you are unable to keep fluids

down or if you have any of these

symptoms of too much loss of

body fluids (volume depletion or

dehydration) while taking

FORXIGA: dry sticky mouth,

severe thirst, severe diarrhoea or

vomiting, dizziness, or urinating

less often than normal or not at

all.

severe allergic reaction (may

include shortness of breath,

wheezing or severe difficulty in

breathing; shock, swelling of the

face, lips, tongue or other parts of

the body; skin rash, itching or

hives on the skin, hayfever, or

you may feel faint)

Genital infections. If you take

FORXIGA, you may be at a

greater risk for genital infections.

Tell your doctor if you experience

painful urination, soreness and

more severe irritation or redness

and swelling of your genitals, or

an unpleasant odour or discharge

associated with your genitals.

Urinary tract infection. If you

take FORXIGA, you may be at a

greater risk for urinary tract

infections. If you have symptoms,

such as burning or pain when you

pass urine, more frequent or

urgent need to urinate, fever,

chills, or blood in the urine,

contact your doctor as soon as

possible.

If you experience pain or

tenderness, redness, swelling of

the genitals or the area from the

genitals to the rectum, fever, and

generally feeling unwell. These

may be symptoms of a rare but

serious and potentially life-

threating infection called

Necrotising fasciitis of the

perineum (Fournier's gangrene)

and you will require prompt

treatment. Your doctor may tell

you to stop taking FORXIGA.

Diabetic ketoacidosis. In rare

cases dapagliflozin, the active

ingredient in FORXIGA, may

cause a serious side effect called

diabetic ketoacidosis. Symptoms

of diabetic ketoacidosis may

include feeling sick or being sick,

difficulty breathing, severe thirst,

feeling weak and tired, confusion,

a sweet smell to your breath, a

sweet or metallic taste in your

mouth, a strange odour to your

urine or sweat and frequent

urination. The risk of developing

diabetic ketoacidosis may be

increased with prolonged fasting,

excessive alcohol consumption,

dehydration, sudden reductions in

insulin dose, or a higher need of

insulin due to major surgery or

serious illness.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

Other side effects not listed here

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After taking FORXIGA

Storage

Keep your FORXIGA tablets in

the blister until it is time to take

them.

If you take FORXIGA out of the

blister it will not keep well.

Keep it in a cool dry place where

the temperature stays below 30°C.

Do not store it or any other

medicine in the bathroom or near a

sink. Do not leave it in the car or

on a window sill.

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 FORXIGA or the tablets

have passed their expiry date, ask

FORXIGA

your pharmacist what to do with

any that are left over.

Product description

What FORXIGA looks like

FORXIGA tablets are available in

one strength i.e. 10 mg. The tablets

are film-coated, yellow, biconvex

and diamond-shaped with "10"

engraved on one side and "1428"

engraved on the other side.

FORXIGA tablets are available in

blister packs of 7 and 28.

Ingredients

Each FORXIGA tablet contains

dapagliflozin 10 mg as the active

ingredient.

Plus the following inactive

ingredients:

microcrystalline cellulose

lactose

crospovidone

silicon dioxide

magnesium stearate

polyvinyl alcohol

titanium dioxide

polyethylene glycol

talc

yellow iron oxide

FORXIGA tablets do not contain

gluten or sucrose.

Sponsored by

AstraZeneca Pty Ltd

ABN 54 009 682 311

66 Talavera Road

MACQUARIE PARK NSW 2113

Telephone: 1800 805 342

This leaflet was prepared on: January

2019

FORXIGA Australian Registration

Number:

10 mg - AUST R 180147

FORXIGA is a registered trademark

of the AstraZeneca group of

companies.

Doc ID-002678542 v7.0

FORXIGA