APO-DESVENLAFAXINE

Main information

  • Trade name:
  • APO-DESVENLAFAXINE MR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-DESVENLAFAXINE MR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218307
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218307

APO-DESVENLAFAXINE MR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/11/2014

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. APO-DESVENLAFAXINE MR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack

Product Type

Single Medicine Product

Effective date

13/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Desvenlafaxine is indicated for the treatment of major depressive disorder, including the prevention of relapse.,Desvenlafaxine is not indicated for

paediatric use.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

7 , 14 , 28 tablets

(S4) Prescription Only Medicine

Components

1. APO-DESVENLAFAXINE MR desvenlafaxine (as benzoate) 50 mg extended release tablets blister pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

Light pink, biconvex, round shaped film coated tablets debossed with "DV"

on one side and "50"on the other side.

Active Ingredients

desvenlafaxine benzoate

73.16 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 26.11.2017 at 05:07:34 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

APO-Desvenlafaxine

MR Tablets

Contains the active ingredient desvenlafaxine (as benzoate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about APO-Desvenlafaxine

MR Tablets. It does not contain all

the available information. It does not

take the place of talking to your

doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Desvenlafaxine MR Tablets. It

contains the active ingredient

desvenlafaxine (as benzoate).

It is used in the treatment and

prevention of relapse of depression.

Depression can affect your whole

body and may cause emotional and

physical symptoms such as feeling

low in spirit, being unable to enjoy

life, poor appetite or overeating,

disturbed sleep, loss of sex drive,

lack of energy and feeling guilty over

nothing.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

This medicine contains the active

ingredient called desvenlafaxine

benzoate. It belongs to a class of

medications called Serotonin-

Noradrenaline Reuptake Inhibitors

(SNRIs).

Serotonin and noradrenaline are

chemical messengers that allow

certain nerves in the brain to work.

This medicine increases the level of

these two messengers. Experts think

this is how it helps to restore your

feeling of wellness.

There is no evidence that this

medicine is addictive.

It is available only with a doctor's

prescription.

Use in children

This medicine should not be used in

children or adolescents under 18

years of age.

The safety and effectiveness of this

medicine in this age group have not

been established.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are taking other

medications for depression

known as monoamine oxidase

inhibitors, even if you have

stopped taking them, but have

taken them within the last 14

days.

You are allergic to,

desvenlafaxine, venlafaxine or

any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include: skin rash; itching or

hives on the skin; swelling of the

face, lips, tongue, throat or other

parts of the body; shortness of

breath, wheezing troubled

breathing or difficulty

swallowing.

APO-DESVENLAFAXINE MR TABLETS

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does

not look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

a history of fits (seizures or

convulsions)

a personal history or family

history of bipolar disorder

blood pressure problems

glaucoma (increased pressure in

the eye)

a tendency to bleed more than

normal or you are taking a blood

thinning medication

raised cholesterol or lipid levels

problems with your kidneys or

liver

problems with your heart

low sodium levels in your blood

or any other medical conditions.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

One of these risks is that newborn

babies whose mothers have been

taking this medicine may have

several problems including

breathing difficulties, seizures

and lack of oxygen in their blood.

You are currently breastfeeding

or you plan to breastfeed. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

This medicine passes into breast

milk and there is a possibility that

the breastfed baby may be

affected.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines.

This includes vitamins and

supplements or natural therapies

you buy without a prescription

that are available from your

pharmacy, supermarket,

naturopath or health food shop,

such as St John's wort or

tryptophan supplements.

Taking other medicines

Some medicines may interact with

desvenlafaxine. These include:

Medications for depression

known as monoamine oxidase

inhibitors (MAOIs) (such as

moclobemide, phenelzine and

tranylcypromine).

Tell your doctor if you are

taking or have stopped taking

them within the last 14 days.

Ask your doctor or pharmacist if

you are unsure if you are taking

any of these medicines.

It is important that you do not

take this medicine or medicines

similar to desvenlafaxine with

MAOIs or within 14 days of

taking an MAOI as this may

result in a serious life-

threatening condition.

Your doctor or pharmacist can

tell you what to do if you are

taking any of these medicines:

any other medications for bipolar

disorder, depression, anxiety,

obsessive-compulsive disorder or

pre-menstrual dysphoric disorder,

including St John's wort.

drugs that affect serotonin levels

e.g. tramadol, dextromethorphan,

fentanyl, methadone and

pentazocine. medicines for

weight loss

triptans (used to treat migraine)

linezolid (used to treat infections)

drugs that affect your tendency to

bleed, e.g., aspirin, NSAIDs,

warfarin.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Your doctor will advise you.

Other medicines not listed above

may also interact with

desvenlafaxine.

Switching to this medicine from

other antidepressants

Side effects from discontinuing

antidepressant medication may occur

if you are switched from other

antidepressants, including

venlafaxine, to this medicine. Your

doctor may gradually reduce the dose

of your initial antidepressant

medication to help reduce these side

effects.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

The usual dose is 50 mg taken once

daily with or without food.

APO-DESVENLAFAXINE MR TABLETS

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

If you have kidney problems you

may need a lower dose of

desvenlafaxine.

How to take it

Swallow the tablets whole with a

glass of water or other non-alcoholic

liquid.

Do not divide, crush, chew or place

the tablets in water.

Do not be concerned if you see a

tablet 'shell' in your faeces after

taking this medicine.

As the tablet travels the length of

your gastrointestinal tract, the active

ingredient desvenlafaxine is slowly

released. The tablet 'shell' remains

undissolved and is eliminated in your

faeces. Therefore, even though, you

may see a tablet 'shell' in your faeces,

your dose of desvenlafaxine has been

absorbed.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Although you may begin to feel

better after two weeks, it may take

several weeks before you feel much

better. It is important to give this

medicine time to work.

This medicine helps to control your

condition, so it is important to keep

taking your medicine even if you feel

well.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is less than 12 hours until your

next dose, skip the missed dose and

take your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Keep the telephone number for these

places handy whilst taking any

medications.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Go to your doctor regularly for a

check-up so that your progress can

be checked.

Always discuss any questions you

have about this medicine with your

doctor.

Take this medicine as your doctor

has prescribed.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

This medicine helps to control your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

Watch carefully for signs that your

depression is getting worse,

especially in the first few weeks of

treatment or if your dose has

changed.

Sometimes people with depression

can experience a worsening of their

depressive symptoms. This can

happen even when taking an

antidepressant.

Tell your doctor there is the

potential for a false positive

urinary drug screen while on this

medicine.

Tell your doctor immediately if

you experience any of the following

symptoms, especially if they are

severe, you have not had these

symptoms before or they happen

very suddenly.

anxiety or agitation

panic attacks

difficulty sleeping

irritability

aggressiveness

hostility or impulsiveness

restlessness

overactivity or uninhibited

behaviour

other unusual changes in

behaviour

thoughts of suicide.

Tell your doctor immediately if

you have any thoughts about

suicide or doing harm to yourself.

Warning signs of suicide:

APO-DESVENLAFAXINE MR TABLETS

If you or someone you know is

showing the following warning signs,

contact your doctor or a mental

health advisor right away or go to the

nearest hospital for treatment.

All thoughts or talk about suicide or

violence are serious.

Thoughts or talk about death or

suicide

Thoughts or talk about self-harm

or doing harm to others

Any recent attempts of self-harm

An increase in aggressive

behaviour, irritability or agitation.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Your doctor may want to slowly

decrease your dose of this

medicine to help avoid side

effects. Side effects are known to

occur when people stop taking

this medicine, especially when

they suddenly stop therapy.

Some of these side effects

include:

headache

nausea

dizziness

tiredness

irritability

anxiety

abnormal dreams

diarrhoea

excessive sweating.

Slowly reducing the amount of

this medicine being taken reduces

the possibility of these effects

occurring.

Things to be careful of

Avoid drinking alcohol while you are

taking this medicine.

Be careful when driving or operating

machinery until you know how this

medicine affects you. It may make

you feel drowsy.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking desvenlafaxine or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

Stomach, bowel or urinary tract

problems:

nausea or vomiting

loss of appetite

diarrhoea

constipation

difficulty passing urine.

Changes in your behaviour:

difficulty sleeping, abnormal

sleepiness or abnormal dreams

sexual function problems such as

decreased sex drive, delayed

ejaculation, problems achieving

erection or difficulties achieving

orgasm

nervousness or anxiety

feeling jittery or irritable.

Difficulty thinking or working

because of:

yawning

disturbances in concentration

fainting or dizziness after

standing up

fatigue

rapid heart beat

chills

headache.

Changes in your appearance:

excessive sweating

hot flushes

rash

weight loss or weight gain

Blurred vision

Ringing in the ears

Altered taste, dry mouth.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

Muscle spasms, stiffness,

weakness or movement disorders

Abnormal facial movements such

as tongue thrusting, repetitive

chewing, jaw swinging, or

grimacing

A feeling of apathy or not caring

about things

Feeling detached from yourself

Hallucinations, confusion

Agitation

Unusually overactive

Problems with breathing,

shortness of breath

Bleeding or bruising more easily

than normal

Numbness or pins and needles

Sensitivity to sunlight.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

swelling of the face, lips, tongue,

throat or other parts of the body

seizures or fits

symptoms of sudden fever with

sweating, rapid heartbeat and

muscle stiffness, which may lead

to loss of consciousness.

APO-DESVENLAFAXINE MR TABLETS

Tell your doctor or pharmacist if you

notice anything else that is making

you feel unwell.

Some of these side effects (for

example, increase in blood pressure,

increase in blood cholesterol,

changes to liver function, protein in

the urine) can only be found when

your doctor does tests from time to

time to check your progress.

This is not a complete list of all

possible side effects. There may be

some side effects not yet known.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to desvenlafaxine,

do not take any more of this

medicine and tell your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C.

Do not store your medicine, 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 this medicine 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 it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO-Desvenlafaxine

MR Tablet looks like

50 mg Tablet

Light pink, biconvex, round shaped,

film coated tablets debossed with

"DV" on one side and "50"on the

other side.

Blister pack of 7, 14 and 28 tablets.

100 mg Tablet

Reddish-orange, biconvex, round

shaped, film coated tablets, debossed

with "DV" on one side and "100"on

the other side.

Blister pack of 7, 14 and 28 tablets.

* Not all strengths and/or pack sizes

may be available.

Ingredients

Each modified release tablet contains

50 mg or 100 mg of desvenlafaxine

benzoate as the active ingredient.

It also contains the following inactive

ingredients:

Cellulose-microcrystalline,

purified talc,

stearic acid,

colloidal anhydrous silica,

magnesium stearate,

hypromellose.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Desvenlafaxine MR 50 mg

Tablet (Blister Pack): AUSTR No. -

218307

APO-Desvenlafaxine MR 100 mg

Tablet (Blister Pack): AUSTR No. -

227802

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in

April 2017.

APO-DESVENLAFAXINE MR TABLETS

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