DESVENLAFAXINE

Main information

  • Trade name:
  • DESVENLAFAXINE SANDOZ desvenlafaxine 50mg modified release tablets blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DESVENLAFAXINE SANDOZ desvenlafaxine 50mg modified release tablets blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218083
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218083

DESVENLAFAXINE SANDOZ desvenlafaxine 50mg modified release tablets blister

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

26/11/2014

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. DESVENLAFAXINE SANDOZ desvenlafaxine 50mg modified release tablets blister

Product Type

Single Medicine Product

Effective date

4/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of major depressive disorder, including the preventiton of relapse. Not indicated for paediatric use.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

4 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. DESVENLAFAXINE SANDOZ desvenlafaxine 50mg modified release tablets blister

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

Light pink colored, diamond shaped, biconvex tablets, debossed with 'Ll89'

on one side and plain on other side.

Active Ingredients

Desvenlafaxine

50 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 05:27:22 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

DESVENLAFAXINE SANDOZ

DESVENLAFAXINE SANDOZ

desvenlafaxine modified release tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Desvenlafaxine

Sandoz.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist or asking questions.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking

Desvenlafaxine Sandoz against the

expected benefits it will have for

you.

If you have any questions about

Desvenlafaxine Sandoz, ask your

doctor or pharmacist.

Keep this leaflet with your

Desvenlafaxine Sandoz tablets.

You may need to read it again.

What Desvenlafaxine

Sandoz is used for

What it does

Desvenlafaxine 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

Desvenlafaxine Sandoz has been

prescribed for you.

Your doctor may have prescribed it

for another reason.

How it works

Desvenlafaxine

SandozDesvenlafaxine Sandoz

contains the active ingredient called

desvenlafaxine. 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.

Desvenlafaxine

SandozDesvenlafaxine Sandoz

tablets increase the level of these two

messengers. Experts think this is how

it helps to restore your feeling of

wellness.

Desvenlafaxine Sandoz is not

addictive. It is available only with a

doctor's prescription.

Before you take

Desvenlafaxine

Sandoz

When you must not take it

Do not take Desvenlafaxine Sandoz

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.

Do not take Desvenlafaxine Sandoz

if you are allergic to

desvenlafaxine, venlafaxine or to

any of the ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction

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.

Do not give Desvenlafaxine Sandoz

to children or adolescents under 18

years of age.

The safety and effectiveness of

desvenlafaxine in this age group have

not been established.

Do not take this medicine after the

expiry date (EXP) 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 or pharmacist if

you have allergies to any other

medicines, foods, preservatives or

dyes.

Tell your doctor or pharmacist if

you are pregnant or intend to

become pregnant.

Desvenlafaxine Sandoz is not

recommended for use during

pregnancy. Your doctor will discuss

the risks and benefits of taking

desvenlafaxine if you are pregnant.

One of these risks is that newborn

babies whose mothers have been

taking desvenlafaxine may have

several problems including breathing

difficulties, seizures and lack of

oxygen in their blood.

Tell your doctor or pharmacist if

you are breast-feeding or plan to

breast-feed.

Desvenlafaxine passes into breast

milk and there is a possibility that the

breast-fed baby may be affected. For

DESVENLAFAXINE SANDOZ

this reason, the use of desvenlafaxine

is not recommended in breast-feeding

women.

Tell your doctor if 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

any other medical conditions.

Tell your doctor if you plan to have

surgery. If you have not told your

doctor about any of the above, tell

them before you start to take

Desvenlafaxine Sandoz.

Taking other medicines

Tell your doctor or pharmacist if

you take any other medicines,

including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop,

such as St John's Wort or

tryptophan supplements.

Do not start to take any other

medicine while you are taking

Desvenlafaxine Sandoz, unless it is

prescribed or approved by your

doctor.

Some medicines may interfere with

desvenlafaxine or desvenlafaxine

may interfere with these medicines.

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 Desvenlafaxine

Sandoz or medicines similar to

Desvenlafaxine Sandoz 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,

including sibutramine

triptans (used to treat migraine)

linezolid (used to treat

infections)

drugs that affect your tendency

to bleed eg: aspirin, NSAIDS,

warfarin.

You may need to take different

amounts of your medicine, or you

may need to take different medicines.

Your doctor will advise you.

Your doctor or pharmacist has more

information on medicines to be

careful with or to avoid while taking

Desvenlafaxine Sandoz.

Switching to Desvenlafaxine

Sandoz from other

antidepressants

Side effects from discontinuing

antidepressant medication may occur

if you are switched from other

antidepressants, including

venlafaxine, to Desvenlafaxine

Sandoz. Your doctor may gradually

reduce the dose of your initial

antidepressant medication to help

reduce these side effects.

How to take

Desvenlafaxine

Sandoz

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 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 Desvenlafaxine Sandoz.

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.

How much to take

The usual dose is 50 mg taken once

daily with or without food.

Do not change your dose unless

your doctor tells you to.

Your doctor will gradually increase

your dose if needed. If you have

kidney problems, you may need a

lower dose of Desvenlafaxine

Sandoz.

When to take it

Desvenlafaxine Sandoz should be

taken once daily and can be taken

with or without food.

Take Desvenlafaxine Sandoz at

approximately the same time each

day.

DESVENLAFAXINE SANDOZ

This could be either in the morning

or in the evening. 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

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

Desvenlafaxine Sandoz time to work.

This medicine helps to control your

condition, so 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 until your

next dose, skip the dose you missed

and then take your next dose when

you are meant to. Otherwise, take

it as soon as you remember, and

then go back to taking as you

would normally.

Do not take a double dose to make

up for the dose 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 when 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

(tel: 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 Desvenlafaxine Sandoz.

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

Desvenlafaxine

Sandoz

Things you must do

Visit your doctor regularly for a

check-up so that your progress can

be checked. Always discuss any

questions you have about

Desvenlafaxine Sandoz with your

doctor.

Take Desvenlafaxine Sandoz

tablets as your doctor has

prescribed. Tell any other doctors,

dentists and pharmacists who treat

you that you are taking this

medicine.

Keep enough Desvenlafaxine

Sandoz tablets to last weekends

and holidays.

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 Desvenlafaxine

Sandoz.

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:

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 to be careful of

Be careful driving or operating

dangerous machinery until you

know how Desvenlafaxine Sandoz

affects you.

Desvenlafaxine Sandoz tablets may

make you feel drowsy.

Things you must not do

Do not stop taking Desvenlafaxine

Sandoz or change the dose without

the advice of your doctor, even if

you feel better.

Your doctor may want to slowly

decrease your dose of

Desvenlafaxine Sandoz to help avoid

side effects. Side effects are known

to occur when people stop taking

DESVENLAFAXINE SANDOZ

Desvenlafaxine Sandoz, 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

Desvenlafaxine Sandoz being taken

reduces the possibility of these

effects occurring.

Some of these symptoms may

impair driving, or the operation of

dangerous machinery. Avoid these

activities if you experience any of

these symptoms.

Avoid drinking alcohol while you

are taking Desvenlafaxine Sandoz.

Do not give this medicine to anyone

else even if they have the same

condition as you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Desvenlafaxine Sandoz.

All medicines can have side effects.

Sometimes they are serious; often

they are not. You may need medical

attention if you get some of the side

effects.

It can be difficult to tell whether side

effects are the result of taking this

medicine, symptoms of your

condition, or side effects of other

medicines you may be taking. For

this reason it is important to tell your

doctor of any change in your

condition.

Do not be alarmed by the list 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 if...

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

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

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...

Tell your doctor as soon as possible

if you notice any of the following:

muscle spasm, 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

Go to hospital if...

Tell your doctor immediately, or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

Severe upper abdominal pain

Swollen and tender abdomen

Fever

Rise or decrease in blood

pressure. You may experience

headache, blurred vision,

palpitations, confusion or loss of

consciousness. Sometimes you

may not experience any of these

symptoms. It is important to

keep your routine doctor’s

appointments so that your blood

pressure can be checked.

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.

DESVENLAFAXINE SANDOZ

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

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. Others may

occur in some people and there may

be some side effects not yet known.

Tell your doctor if you notice

anything that is making you feel

unwell.

After taking

Desvenlafaxine

Sandoz

Storage

Keep your Desvenlafaxine Sandoz

tablets in their original packaging

material until it is time to take

them.

The tablets may not last as well if

you take them out of the original

packaging material.

Keep Desvenlafaxine Sandoz

tablets in a cool dry place where

the temperature stays below 25°C.

Do not store Desvenlafaxine

Sandoz tablets or any other

medicine in the bathroom or near a

sink. Do not leave Desvenlafaxine

Sandoz tablets in the car or on

windowsills.

Heat and dampness can destroy some

medicines.

Keep Desvenlafaxine Sandoz

tablets and all medication where

young 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 Desvenlafaxine

Sandoz looks like

There are two strengths of

Desvenlafaxine Sandoz tablets:

50 mg, light pink coloured,

diamond shaped, biconvex

tablets, debossed with ‘L189’ on

one side and plain on other side.

Blister packs containing 28

tablets.

100 mg, dark brown to red

coloured, diamond shaped,

biconvex tablets, debossed with

‘L190’ on one side and plain on

other side. Blister packs

containing 28 tablets.

Ingredients

Active ingredient:

Desvenlafaxine Sandoz 50 mg – 50

mg desvenlafaxine

Desvenlafaxine Sandoz 100 mg –

100 mg desvenlafaxine

Inactive ingredients:

alginic acid

citric acid monohydrate

microcrystalline cellulose

povidone

purified talc

magnesium stearate

hypromellose.

The 50 mg tablets are film coated

with OPADRY film coating system

03F84770 PINK (ARTG No.

109228) and the 100 mg tablets are

coated with OPADRY film coating

system 03F86990 BROWN (ARTG

No. 109232).

This medicine does not contain

lactose or gluten.

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 634 500

This leaflet was revised in July 2017.

Australian Register

Numbers

50 mg modified release tablets:

AUST R 218083

(blisters)

100 mg modified release tablets:

AUST R 218082

(blisters)

20-3-2018

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Therapeutic Goods Administration - Australia

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