DESVENLAFAXINE

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218064
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218064

DESVENLAFAXINE AMNEAL 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 AMNEAL 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

Components

1. DESVENLAFAXINE AMNEAL 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 05:36:49 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

Medis Pharma Pty Ltd

Version 1

DESVENLAFAXINE ACTAVIS

desvenlafaxine

Modified Release Tablets

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about

Desvenlafaxine Actavis.

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

Actavis against the expected

benefits it will have for you.

If you have any questions

about Desvenlafaxine

Actavis, ask your doctor

or pharmacist.

Keep this leaflet with your

Desvenlafaxine Actavis

tablets.

You may need to read it

again.

What Desvenlafaxine

Actavis 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

Actavis has been

prescribed for you.

Your doctor may have

prescribed it for another

reason.

How it works

Desvenlafaxine Actavis

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

Actavis tablets increase the

level of these two

messengers. Experts think this

is how it helps to restore your

feeling of wellness.

Desvenlafaxine Actavis is not

addictive. It is available only

with a doctor's prescription.

Before you take

Desvenlafaxine

Actavis

When you must not take

it

Do not take Desvenlafaxine

Actavis 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

Actavis 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

Actavis to children or

adolescents under 18 years

of age.

The safety and

effectiveness of

desvenlafaxine in this age

Medis Pharma Pty Ltd

Version 1

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 Actavis 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

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 Actavis.

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

Actavis, 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

Actavis or medicines

similar to Desvenlafaxine

Actavis 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,

Medis Pharma Pty Ltd

Version 1

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 Actavis.

Switching to

Desvenlafaxine

Actavis from other

antidepressants

Side effects from

discontinuing antidepressant

medication may occur if you

are switched from other

antidepressants, including

venlafaxine, to

Desvenlafaxine Actavis. Your

doctor may gradually reduce

the dose of your initial

antidepressant medication to

help reduce these side effects.

How to take

Desvenlafaxine

Actavis

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 Actavis.

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 Actavis.

When to take it

Desvenlafaxine Actavis

should be taken once daily

and can be taken with or

without food.

Take Desvenlafaxine

Actavis at approximately

the same time each day.

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 Actavis 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

Medis Pharma Pty Ltd

Version 1

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

Actavis.

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

Actavis

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 Actavis with

your doctor.

Take Desvenlafaxine

Actavis 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 Actavis

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 Actavis.

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 Actavis

affects you.

Desvenlafaxine Actavis

tablets may make you feel

drowsy.

Things you must not do

Do not stop taking

Desvenlafaxine Actavis 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 Actavis to

help avoid side effects. Side

effects are known to occur

when people stop taking

Desvenlafaxine Actavis,

especially when they

suddenly stop therapy.

Some of these side effects

include:

headache

nausea

dizziness

tiredness

irritability

Medis Pharma Pty Ltd

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anxiety

abnormal dreams

diarrhoea

excessive sweating.

Slowly reducing the amount

of Desvenlafaxine Actavis

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 Actavis. 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 Actavis.

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

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...

Tell your doctor as soon as

possible if you notice any of

the following:

muscle 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

bleeding or bruising more

easily than normal

numbness or pins and

needles.

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:

swelling of the face, lips,

tongue, throat or other

parts of the body

seizures or fits

symptoms of sudden fever

Medis Pharma Pty Ltd

Version 1

with sweating, rapid

heartbeat and muscle

stiffness, which may lead

to loss of consciousness.

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

Actavis

Storage

Keep your Desvenlafaxine

Actavis tablets in their

blister pack until it is time

to take them.

The tablets may not last as

well if you take them out of

the blister pack.

Keep Desvenlafaxine

Actavis tablets in a cool

dry place where the

temperature stays below

25°C.

Do not store Desvenlafaxine

Actavis tablets or any other

medicine in the bathroom or

near a sink. Do not leave

Desvenlafaxine Actavis

tablets in the car or on

windowsills.

Heat and dampness can

destroy some medicines.

Keep Desvenlafaxine

Actavis 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

Actavis looks like

There are two strengths of

Desvenlafaxine Actavis

tablets:

50 mg, light pink

coloured, diamond

shaped, biconvex tablets,

debossed with ‘L189’ on

one side and plain on

other side. Blister packs

and bottles containing 7,

14 or 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

and bottles containing 7,

14 or 28 tablets*.

*not all pack sizes are available in

Australia

Ingredients

Desvenlafaxine Actavis

tablets contain 50 mg or 100

mg desvenlafaxine as the

active ingredient.

It also contains the following

inactive ingredients:

alginic acid

citric acid monohydrate

microcrystalline cellulose

povidone

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).

Supplier

Desvenlafaxine Actavis

tablets are supplied by:

Actavis Pty Ltd

117 Harrington Street

THE ROCKS

NSW 2000

Australian Registration

Numbers:

Bottles*

Desvenlafaxine Actavis 50

mg modified release tablets: -

AUST R 218070

Desvenlafaxine Actavis 100

mg modified release tablets: -

AUST R 218078

Medis Pharma Pty Ltd

Version 1

Blister packs

Desvenlafaxine Actavis 50

mg modified release tablets: -

AUST R 218064

Desvenlafaxine Actavis 100

mg modified release tablets: -

AUST R 218071

* Not marketed in Australia

Date of Preparation

This leaflet was last revised in

February 2015

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

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