DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack

Main information

  • Trade name:
  • DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 197151
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

197151

DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Lupin Australia Pty Limited

Postal Address

Generic Health Pty Ltd,Level 1 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

29/04/2013

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. DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack

Product Type

Single Medicine Product

Effective date

7/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Duloxetine Hydrochloride is indicated for the following:,-Treatment of major depressive disorder (MDD). ,-Treatment of generalised anxiety disorder

(GAD).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PCTFE

(Aclar)/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

7 Capsules (1 x 7 Capsules)

(S4) Prescription Only Medicine

28 Capsules (4 x 7 Capsules)

(S4) Prescription Only Medicine

14 Capsules (2 x 7 Capsules)

(S4) Prescription Only Medicine

Components

1. DULOXETINE GH duloxetine (as hydrochloride) 60mg enteric capsules blister pack

Dosage Form

Capsule, enteric

Route of Administration

Oral

Visual Identification

Size '1' Capsules with dark blue cap & green body, imprinted with "DU" in

white ink on cap & "60" in black ink on body,containing twelve mini tablets.

Active Ingredients

Duloxetine hydrochloride

67.36 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 12:51:50 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

Duloxetine GH CMI v2 Sep2017

Page 1 of 6

CONSUMER MEDICINE INFORMATION

DULOXETINE GH

duloxetine hydrochloride

What is in this leaflet

This leaflet answers some

common questions about

Duloxetine GH. It does not

contain all the available

information. It does not take

the place of talking to your

doctor or pharmacist. Always

follow the instructions that

your doctor and pharmacist

give you about the medicine.

The information in this leaflet

was last updated on the date

shown on the final page.

More recent information on

this medicine may be

available. Make sure you

speak to your pharmacist or

doctor to obtain the most up

to date information on this

medicine. The updated leaflet

may contain important

information about Duloxetine

GH and its use that you

should be aware of.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you

taking Duloxetine GH against

the benefits they expect it will

have for you.

Always follow the

instructions that your

doctor and pharmacist give

you about Duloxetine GH.

If you have any concerns,

or are unsure about taking

this medicine, ask your

doctor or pharmacist for

more advice.

Keep this leaflet with the

medicine. Do not throw this

leaflet away.

You may need to read it

again.

What Duloxetine GH is

used for

Duloxetine GH is used to

treat major depressive

disorder (depression) and

Generalised Anxiety Disorder

(excessive worry). Duloxetine

GH belongs to a group of

medicines called Serotonin

and Noradrenaline Reuptake

Inhibitors (SNRIs). SNRIs are

believed to work by their

action on serotonin and

noradrenaline in the brain.

Serotonin and noradrenaline

are the chemical messengers

responsible for controlling the

psychological and painful

physical symptoms of

depression.

Ask your doctor if you have

any questions about why

this medicine has been

prescribed for you.

This medicine is available

only with a doctor's

prescription.

Duloxetine GH is not

recommended for use in

children and adolescents

under the age of 18 years.

Before you take

Duloxetine GH

When not to take it

Do not take Duloxetine GH

You have any allergy to

any medicine containing

duloxetine hydrochloride.

You have any allergy to

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.

You have liver disease.

This could increase the

chance of you having liver

problems during

treatment with Duloxetine

You are taking another

medicine for depression

called a monoamine

oxidase inhibitor (MAOI)

or have been taking a

MAOI within the last 14

days. Check with your

doctor or pharmacist if

you are unsure as to

whether or not you are

taking a MAOI.

You are taking a MAOI,

you may experience

shaking (tremor),

shivering, muscle

stiffness, fever, rapid

pulse, rapid breathing or

confusion.

You are taking another

medicine for depression

called fluvoxamine.

Expired or the expiry date

printed on the pack or if

the packaging is torn or

shows signs of tampering.

Duloxetine GH CMI v2 Sep2017

Page 2 of 6

It has expired or is

damaged; return it to your

pharmacist for disposal.

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. If

you have or have had any

medical conditions,

especially if you have:

a condition in which the

pressure of fluid in the

eye may be high

(glaucoma)

high blood pressure

heart problems

kidney problems as you

may need to take a lower

dose of Duloxetine GH

history of fits (seizures)

bipolar disorder

diabetes

If you have high blood

pressure or heart problems

your doctor may monitor your

blood pressure.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-

feeding.

Your doctor can discuss with

you the risks and benefits

involved. If Duloxetine GH is

taken during pregnancy, you

should be careful, particularly

at the end of pregnancy.

Transitory withdrawal

symptoms have been

reported rarely in the

newborn after maternal use in

the last 3 months of

pregnancy.

Talk to your doctor about how

much alcohol you drink.

People who drink excessive

amounts of alcohol should

not take Duloxetine GH.

Drinking too much alcohol

could increase the chance of

you having liver problems

during treatment with

Duloxetine GH.

If you have not told your

doctor about any of the

above, tell them before you

start taking Duloxetine GH.

Taking Duloxetine GH with

other medicines

Tell your doctor if you are

taking or intend to take any

other medicines, including

medicines that you buy

without a prescription from

your pharmacy,

supermarket or health food

shop.

Some medicines and

Duloxetine GH may interfere

with each other. These

include:

Monoamine oxidase

inhibitors (MAOIs),

medicines used to treat

some types of

depression.

You should stop taking

MAOIs at least two weeks

before starting Duloxetine

You must stop taking

Duloxetine GH at least 5 days

before you start taking a

MAOI.

Other medicines used to

treat depression, panic

disorder, anxiety or

obsessive illnesses,

including tryptophan

Strong painkillers such as

tramadol, pethidine

A type of migraine

treatment called 'triptans',

such as sumatriptan or

zolmitriptan

Medicines used to treat

stress urinary

incontinence such as

tolteridone

Medicines used to treat

heart problems such as

flecainide or propafenone

Thioridazine, a medicine

used to treat

schizophrenia

Herbal medicines such as

St John's Wort

(Hypericum perforatum)

Warfarin, a medicine

used to thin the blood

(anticoagulant)

Do not start to take any other

medicine unless prescribed

or approved by your doctor.

These medicines may be

affected by Duloxetine GH 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 this

medicine.

How to take Duloxetine

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 carton,

ask your doctor or pharmacist

for help.

How much to take

Your doctor will tell you how

many capsules to take each

day.

The usual recommended

dose of Duloxetine GH in

Duloxetine GH CMI v2 Sep2017

Page 3 of 6

Major Depressive Disorder is

one 60 mg capsule taken

once daily.

The recommended dose of

Duloxetine GH in Generalised

Anxiety Disorder is between

30 mg and 120 mg, taken

once daily. Your doctor may

start you on a lower dose to

help reduce side effects.

If you have severe kidney

disease, the recommended

starting dose of Duloxetine

GH is one 30 mg capsule

taken once daily.

If you do not understand the

instructions on the box, ask

your doctor or pharmacist for

help.

How to take it

Swallow the capsule whole

with a full glass of water.

Do not open the capsules

and crush the pellets inside

because the medicine may

not work as well.

Duloxetine GH may be taken

with or without meals.

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.

How long to take it for

The length of treatment with

Duloxetine GH will depend on

how quickly your symptoms

improve. Most medicines of

this type take time to work so

don't be discouraged if you

do not feel better right away.

Although you may notice an

improvement, continue taking

your medicine for as long as

your doctor tells you.

If you take too much

Immediately telephone your

doctor or the Poisons

Information Centre

(telephone 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 Duloxetine

Do this even if there are no

signs of discomfort or

poisoning. You may need

urgent medical attention.

Symptoms of an overdose

may include drowsiness,

convulsions, and vomiting.

Symptoms may also include

some or all of the following:

feeling confused, feeling

restless, sweating, shaking,

shivering, hallucinations,

muscle jerks, fast heart beat.

While you are taking

Duloxetine GH

Things you must do

If you are about to be started

on any new medicine, remind

your doctor and pharmacist

that you are taking Duloxetine

Tell any other doctors,

dentists and pharmacists who

treat you that you are taking

this medicine.

If you are going to have

surgery, tell the surgeon or

anesthetist that you are

taking this medicine

If you become pregnant while

taking this medicine, tell your

doctor immediately.

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.

Tell your doctor immediately

if you have any suicidal

thoughts or other mental/

mood changes.

Occasionally, the symptoms

of depression or other

psychiatric conditions may

include thoughts of harming

yourself or committing

suicide. These symptoms

may continue or get worse

during the first one or two

months of treatment, until the

full antidepressant effect of

the medicine becomes

apparent. This is more likely

to occur in young adults

under 25 years of age.

Contact your doctor or a

mental health professional

right away or go to the

nearest hospital for treatment

if you or someone you know

is showing any of the

following warning signs of

suicide:

worsening of your

depression

thoughts or talk of death

or suicide

thoughts or talk of self-

harm or harm to others

any recent attempts of

self-harm

increase in aggressive

behaviour, irritability or

any other unusual

changes in behaviour or

mood.

All mentions of suicide or

violence must be taken

seriously.

Duloxetine GH CMI v2 Sep2017

Page 4 of 6

If you notice any of the

following contact your doctor

right away.

Your doctor may do some

blood tests to check your liver

or tell you to stop taking your

medicine. Signs of liver

problems include:

itchy skin

dark urine

yellowing of the skin or

eyes

tenderness over the liver

symptoms of the 'flu'

These may be signs of

serious liver damage.

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 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.

Things you must not do

Do not take Duloxetine GH to

treat any other complaints.

Do not give your medicine to

anyone else, even if they

have the same condition as

you.

Do not stop taking Duloxetine

GH or lower the dosage

without checking with your

doctor.

If you stop taking it suddenly,

your condition may worsen or

you may have unwanted side

effects. If possible, your

doctor will gradually reduce

the amount you take each

day before stopping the

medicine completely.

Do not drive or operate

machinery until you know

how Duloxetine GH affects

you.

Duloxetine GH may cause

dizziness or drowsiness in

some people.

Do not let yourself run out of

Duloxetine GH over the

weekend or on holidays.

Things to be careful of

Be careful when drinking

alcohol while you are taking

this medicine.

Drinking large amounts of

alcohol during treatment with

Duloxetine GH can cause

severe liver injury.

You should avoid 'binge

drinking' or drinking

excessively during treatment

with Duloxetine GH.

Drinking alcohol with this

medicine may also cause

dizziness or drowsiness in

some people. If you have any

of these symptoms, do not

drive, operate machinery or

do anything else that could

be dangerous.

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are

taking Duloxetine GH.

This medicine helps many

people with depression, 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.

The following side effects are

the more common side

effects of Duloxetine GH and

are often mild and short-lived.

Tell your doctor or pharmacist

if you notice any of the

following and they worry you:

dry mouth, mouth ulcers,

thirst, bad taste

burping or belching,

indigestion, stomach pain,

nausea, vomiting,

constipation, diarrhoea,

wind (flatulence)

bad breath

loss of appetite, weight

loss

headache

trouble sleeping

dream abnormalities

drowsiness

feeling tired or having no

energy

sexual problems

dizziness

tremor

blurred vision

feeling anxious, agitated

or restless

confusion and attention

problems

Duloxetine GH CMI v2 Sep2017

Page 5 of 6

tingling and numbness of

hands, face, mouth and

feet

yawning or throat

tightness

difficulty urinating

(passing water), urinating

frequently or needing to

urinate at night

irregular heart beat

hot and cold sweats

sore ears, sore throat

ringing in ears

muscle pain, stiffness or

twitching

walking problems

flushing

skin rash

restless legs

These are the more common

side effects of your medicine.

Tell your doctor immediately

if you notice any of the

following:

signs of a possible

serious liver problem:

such as nausea, vomiting,

loss of appetite, feeling

generally unwell, fever,

itching, yellowing of the

skin and/or eyes, dark

urine

high pressure in the eye

(glaucoma)

feeling tired, weak or

confused and having

achy, stiff or

uncoordinated muscles.

This may be because you

have low sodium levels in

the blood (hyponatraemia

or syndrome of

inappropriate antidiuretic

hormone)

abdominal pain, traces of

blood in your stools, or if

your stools are dark in

colour. This may be

because you have

increased bleeding,

possibly in the gastric

tract (gastrointestinal

bleeding). You may also

feel weakness, dizziness

and experience nausea

and/or vomiting

seeing or hearing things

(hallucinations)

dizziness or fainting when

you stand up, especially

from a lying or sitting

position

uncontrollable

movements

if you have some or all of

the following symptoms

you may have something

called serotonin

syndrome: feeling

confused, feeling restless,

sweating, shaking,

shivering, hallucinations,

sudden jerks in your

muscles or a fast heart

beat

stiff neck or jaw muscles

(lockjaw)

fits or seizures

mood of excitement, over-

activity and uninhibited

behaviour.

aggression or anger

especially after starting or

stopping taking this

medicine

You may need urgent

medical attention. Other

changes you may not be

aware of:

increased blood pressure

heart rhythm changes

underactive thyroid gland

liver function changes

If any of the following

happen, tell your doctor

immediately or go to Accident

and Emergency at your

nearest hospital:

itching, skin rash or hives

shortness of breath,

wheezing or trouble

breathing

swelling of the face, lips,

tongue or other parts of

the body

These are very serious side

effects. You may need urgent

medical attention or

hospitalisation.

Tell your doctor or pharmacist

if you notice anything that is

making you feel unwell.

This is not a complete list of

all possible side effects.

Others may occur in some

people and there may be

some side effects not yet

known.

How to store Duloxetine

Storage

Keep your capsules in the

pack until it is time to take

them.

If you take the capsules out

of the pack they may not

keep as well.

Store below 25°C.

Do not store Duloxetine GH

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.

Duloxetine GH CMI v2 Sep2017

Page 6 of 6

Product description

What Duloxetine GH

tablets look like

Duloxetine GH 30 mg - Size

'3' Capsules with dark blue

cap and white body,

imprinted with "DU" in white

ink on cap and "30" in black

ink on body, containing six

white to off white mini tablets.

Duloxetine GH Capsules 30

mg is available in clear

PVC/PE/Aclar/Peelable Child

Resistant aluminium foil

blisters of 7, 14 and 28

Capsules. All pack sizes may

not be marketed.

Duloxetine GH 60mg - Size

'1' Capsules with dark blue

cap and green body,

imprinted with "DU" in white

ink on cap and "60" in black

ink on body, containing

twelve white to off white mini

tablets.

Duloxetine GH Capsules 60

mg is available in clear

PVC/PE/Aclar/Peelable Child

Resistant aluminium foil

blisters of 7, 14 and 28

Capsules. All packs may not

be marketed.

Ingredients

Active ingredients

Duloxetine GH 30 mg –

contains duloxetine

hydrochloride equivalent to

duloxetine 30 mg per

capsule.

Duloxetine GH 60 mg -

contains duloxetine

hydrochloride equivalent to

duloxetine 60 mg per

capsule.

Other Ingredients

Duloxetine GH also contain

Lactose, Croscarmellose

Sodium, Pregelatinised maize

Starch, Polysorbate 80,

Magnesium stearate,

Hypromellose, Hypromellose

Phthalate, Purified Talc,

Triethyl citrate.

The 30 mg capsule is a Size

3 hard gelatin capsule (ARTG

No. 108081) with a dark blue

cap and a white body and

contains Indigo carmine

CI73015, Gelatin, Titanium

dioxide and Sodium lauryl

sulphate.

The 60 mg capsule is a Size

1 hard gelatin capsule (ARTG

No. 108080) with a dark blue

cap and a green body and

contains Indigo carmine

CI73015, Gelatin, Titanium

dioxide, Iron oxide yellow

CI77492 and Sodium lauryl

sulphate.

Both capsule shells are

imprinted with TekPrint SW-

9008 Black Ink, (ARTG No.

2328) and TekPrint SW-0012

White Ink (ARTG No. 13175).

Sponsor

Lupin Australia Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australia

Distributed in Australia

Generic Health Pty Ltd

Level 1, 1102 Toorak Road,

Camberwell,

Victoria, 3124

Australia

Australian Registration

Number

30 mg capsule: AUST R

197150

60 mg capsule: AUST R

197151

This leaflet was prepared in

September 2017.