DULOXETINE DR-LUPIN duloxetine (as hydrochloride) 60mg enteric capsules blister pack

Main information

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

Documents

Localization

  • Available in:
  • DULOXETINE DR-LUPIN 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:
  • 197164
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

197164

DULOXETINE DR-LUPIN 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 DR-LUPIN 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

14 Capsules (2 x 7 Capsules)

(S4) Prescription Only Medicine

28 Capsules (4 x 7 Capsules)

(S4) Prescription Only Medicine

7 Capsules (1 x 7 Capsules)

(S4) Prescription Only Medicine

Components

1. DULOXETINE DR-LUPIN 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 12:48:34 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 DR –Lupin Capsules

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Duloxetine DR-Lupin Capsules. 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 DR-Lupin Capsules 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-DR

Lupin Capsules against the benefits they expect it will have for you.

Always follow the instructions that your doctor and pharmacist give you about Duloxetine DR–

Lupin Capsules.

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 DR–LUPIN CAPSULES ARE USED FOR

Duloxetine DR-Lupin Capsules is used to treat major depressive disorder (depression), Generalised

Anxiety Disorder (excessive worry) Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules is not recommended for use in children and adolescents under the age of

18 years.

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Before you take DULOXETINE DR-LUPIN CAPSULES

WHEN YOU MUST NOT TAKE IT

Do not take Duloxetine DR-Lupin Capsules if:

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 DR-Lupin Capsules.

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.

After the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

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. 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 DR-Lupin Capsules

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 DR-Lupin Capsules 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 DR-Lupin Capsules.

Drinking too much alcohol could increase the chance of you having liver problems during treatment

with Duloxetine DR-Lupin Capsules.

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If you have not told your doctor about any of the above, tell them before you start taking Duloxetine

DR-Lupin Capsules.

TAKING DULOXETINE DR-LUPIN CAPSULES 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 DR-Lupin Capsules. 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 DR-Lupin Capsules.

You must stop taking Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules 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 DR-LUPIN CAPSULES

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 DR-Lupin Capsules in Major Depressive Disorder is one

60 mg capsule taken once daily.

The recommended dose of Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules 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.

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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 DR-Lupin Capsules 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:

The length of treatment with Duloxetine DR-Lupin Capsules 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 miss a dose:

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.

If you take too much (overdose)

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 DR-Lupin Capsules.

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 using Duloxetine DR-Lupin Capsules

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 DR-Lupin Capsules

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 anaesthetist 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.

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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

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.

Things you must not do:

Do not take Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules 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 DR-Lupin Capsules affects you.

Duloxetine DR-Lupin Capsules may cause dizziness or drowsiness in some people.

Do not let yourself run out of Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules can cause

severe liver injury.

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You should avoid 'binge drinking' or drinking excessively during treatment with Duloxetine DR-Lupin

Capsules.

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 DR-Lupin Capsules.

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 DR-Lupin Capsules 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

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

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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)

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.

After using Duloxetine DR-Lupin Capsules

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.

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Store below 25°C. Store in original package.

Do not store Duloxetine DR-Lupin Capsules 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

Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules 30 mg is available in Clear PVC/PE/Aclar/ Peelable Child

Resistant Alu foil blisters of 7, 14 and 28 Capsules. All packs may not be marketed.

AUST R 197162

Duloxetine DR-Lupin Capsules 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 DR-Lupin Capsules 60 mg is available in Clear PVC/PE/Aclar/ Peelable Child

Resistant Alu foil blisters of 7, 14 and 28 Capsules. All packs may not be marketed.

AUST R 197164

Who makes Duloxetine DR-Lupin Capsules?

Duloxetine DR-Lupin Capsules is made available by Lupin Ltd.

Active ingredients

Duloxetine DR-Lupin Capsules 30 mg – contains Duloxetine Hydrochloride equivalent to Duloxetine

30 mg per capsule.

Duloxetine DR-Lupin Capsules 60 mg - contains Duloxetine Hydrochloride equivalent to Duloxetine 60

mg per capsule.

Other Ingredients

Duloxetine DR-Lupin Capsules also contain Lactose, Croscarmellose Sodium, Starch Pregelatinised

maize,

Polysorbate

Magnesium

stearate,

Hypromellose,

Isopropyl

alcohol,

Dichloromethane,

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Hypromellose Phthalate, Talc-purified, Triethyl citrate, Methanol. The Empty Hard Gelatin Capsule

Shells Cap & Body - Dark Blue & White Size 3 (ARTG No.108081) contains Indigo carmine CI73015,

Gelatin, Titanium dioxide E171, and Empty Hard Gelatin Capsule Shells Cap & Body - Dark Blue &

Green Size 1

(ARTG No.108080) contains Indigo carmine CI73015, Gelatin, Titanium dioxide E171

and iron oxide yellow CI77492. Capsules are imprinted with TekPrint SW-9008 Black Ink (ARTG

No.2328) and TekPrint SW-0012 White Ink (ARTG No.13175).

NAME AND ADDRESS OF SPONSOR

Lupin Australia Pty Ltd

Skipping Girl Place, Suite 6,

651 Victoria Street, Abbotsford,

Victoria 3067

Australia

AUSTRALIAN REGISTRATION NUMBER

30 Capsules: AUST R 197162

60 Capsules: AUST R 197164

DATE OF PREPARATION

This leaflet was prepared in April 2012.