LEXAPRO

Main information

  • Trade name:
  • LEXAPRO escitalopram (as oxalate) 20 mg/mL oral solution bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LEXAPRO escitalopram (as oxalate) 20 mg/mL oral solution bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209721
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209721

LEXAPRO escitalopram (as oxalate) 20 mg/mL oral solution bottle

ARTG entry for

Medicine Registered

Sponsor

Lundbeck Australia Pty Ltd

Postal Address

PO Box 1973,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

27/03/2014

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. LEXAPRO escitalopram (as oxalate) 20 mg/mL oral solution bottle

Product Type

Single Medicine Product

Effective date

19/01/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of

obsessive-compulsive disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type II

Coloured

8 Weeks

Store below 25

degrees Celsius

Child resistant closure

and restricted flow

insert

Not recorded

Bottle

Glass Type II

Coloured

3 Years

Store below 25

degrees Celsius

Child resistant closure

and restricted flow

insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

15 mL

(S4) Prescription Only Medicine

Components

1. LEXAPRO escitalopram (as oxalate) 20 mg/mL oral solution bottle

Dosage Form

Oral Liquid, solution

Route of Administration

Oral

Visual Identification

Clear, nearly colourless to yellowish solution

Active Ingredients

escitalopram oxalate

25.551 mg/mL

© 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 11.11.2017 at 12:55:43 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

Lexapro

®

Oral Solution

(LEX-a-pro)

Escitalopram oxalate (ES-sigh-talo-pram OX-a-late)

Consumer Medicine Information

What is in this leaflet

This leaflet contains answers to some

common questions about LEXAPRO.

It does not contain all the information

that is known about LEXAPRO. It

does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risk of you using this medicine

against the benefits he/she expects it

will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again

What LEXAPRO is

used for

LEXAPRO is used to treat

depression.

It belongs to a group of medicines

called selective serotonin reuptake

inhibitors (SSRIs). They are thought

to work by their actions on brain

chemicals called amines which are

involved in controlling mood.

Depression is longer lasting or more

severe than the "low moods"

everyone has from time to time due

to the stress of everyday life. It is

thought to be caused by a chemical

imbalance in parts of the brain. This

imbalance affects your whole body

and can cause emotional and physical

symptoms such as feeling low in

spirit, loss of interest in activities,

being unable to enjoy life, poor

appetite or overeating, disturbed

sleep, often waking up early, loss of

sex drive, lack of energy and feeling

guilty over nothing.

LEXAPRO corrects this chemical

imbalance and may help relieve the

symptoms of depression.

LEXAPRO may also be used to treat

patients who may avoid and/or are

fearful of social situations.

LEXAPRO may also be used to treat

patients who have excessive anxiety

and worry.

LEXAPRO may also be used to treat

irrational fears or obsessional

behaviour (obsessive-compulsive

disorder). Obsessive-compulsive

disorder involves having both

obsessions and compulsions.

Obsessions are unwanted thoughts

that occur over and over again.

Compulsions are the ongoing need to

repeat certain actions as a result of

these thoughts.

Your doctor, however, may prescribe

it for another purpose.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

This medicine is only available with

a doctor's prescription.

LEXAPRO is not addictive.

However, if you suddenly stop taking

it, you may get side effects.

Tell your doctor if you get any side

effects after stopping LEXAPRO.

Before you take it

When you must not take it

Do not take LEXAPRO if you are

allergic to it, to any medicine

containing escitalopram,

citalopram, or any of the

ingredients listed at the end of this

leaflet.

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, or rash,

itching or hives on the skin.

Do not take LEXAPRO at the

same time as the following other

medicines:

pimozide, a medicine used to

treat mental disorders

monoamine oxidase inhibitors

(MAOIs), such as phenelzine,

tranylcypromine and

moclobemide which are also used

for the treatment of depression.

One day must elapse after you

have finished taking

moclobemide before you start

taking LEXAPRO. If you have

taken any other MAOI you will

need to wait 14 days. After

stopping LEXAPRO you must

allow 14 days before taking any

MAOI including moclobemide.

Taking LEXAPRO with MAOIs

may cause a serious reaction with

a sudden increase in body

temperature, extremely high

blood pressure and severe

convulsions. Your doctor will

know when it is safe to start

LEXAPRO

LEXAPRO after the MAOI has

been stopped.

Do not take it after the expiry date

printed on the pack.

If you take it after the expiry date has

passed, it may not work as well. The

expiry date refers to the last day of

the month.

Do not take it if the packaging is

torn or shows signs of tampering

Before you start to take it

Tell your doctor if:

you have allergies to any other

substances such as foods,

preservatives or dyes.

you are pregnant or intend to

become pregnant.

Medicines like Lexapro have

been shown to reduce the quality

of sperm in animal studies, which

theoretically could affect fertility.

If you are intending to start a

family, ask your doctor for

advice.

Do not take LEXAPRO if you

are pregnant unless you and

your doctor have discussed the

risks and benefits involved.

Make sure your doctor and/or

midwife know you are on

LEXAPRO.

When taken during pregnancy,

particularly in the last three

months of pregnancy, medicines

like LEXAPRO may affect the

general condition of your

newborn baby and may increase

the risk of a serious condition in

babies, called persistent

pulmonary hypertension of the

newborn (PPHN), making the

baby breathe faster and appear

bluish. These symptoms usually

begin during the first 24 hours

after the baby is born. If this

happens to your baby you should

contact your doctor and/or

midwife immediately.

If used during pregnancy

LEXAPRO should never be

stopped abruptly.

you are breast-feeding or

planning to breast-feed.

Do not take LEXAPRO if you

are breast-feeding unless you

and your doctor have discussed

the risks and benefits involved.

It is not recommended that you

breast-feed while taking

LEXAPRO as it is excreted in

breast milk.

you have, or have had, the

following medical conditions:

a tendency to bleed or bruise

easily

diabetes

heart disease

kidney disease

liver disease

bipolar disorder (manic

depression)

a history of seizures or fits

restlessness and/or a need to

move often

you are receiving

electroconvulsive therapy.

Do not give LEXAPRO to a child

or adolescent.

There is no experience with its use in

children or adolescents under 18

years old.

LEXAPRO can be given to elderly

patients over 65 years of age with a

reduced dose.

The effects of LEXAPRO in elderly

patients are similar to those in other

patients.

If you have not told your doctor

about any of the above, tell them

before you use LEXAPRO.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and LEXAPRO may

interfere with each other. These

include:

bupropion, a medicine helping to

treat nicotine dependence

medicines used to treat reflux and

ulcers, such as cimetidine,

omeprazole, esomeprazole and

lansoprazole

medicines known to prolong

bleeding, e.g. aspirin or other

non-steroidal anti-inflammatory

drugs (NSAIDs)

ticlopidine and warfarin,

medicines used to prevent blood

clots

mefloquine, an anti-malaria

medicine

sumatriptan, used to treat

migraines

tramadol, used to relieve pain

medicines affecting the chemicals

in the brain

some heart medications, e.g.

flecainide, propafenone,

metoprolol

tryptophan, an amino-acid

lithium, used to treat mood

swings and some types of

depression

antipsychotics, a class of

medicines used to treat certain

mental and emotional conditions,

e.g. risperidone, thioridazine and

haloperidol

tricyclic antidepressants, e.g.

imipramine, desipramine

St John's Wort (Hypericum

perforatum), a herbal remedy

any other medicines for

depression, anxiety, obsessive-

compulsive disorder or pre-

menstrual dysphoric disorder

These medicines may be affected by

LEXAPRO, or may affect how well

it works. You may need to use

different amounts of your medicines,

or take different medicines. Your

doctor will advise you.

Some combinations of medicines

may increase the risk of serious side

effects and are potentially life

threatening.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

LEXAPRO.

LEXAPRO

How to take it

How much to take

Your doctor will decide what dose

you will receive.

The standard dose for this medicine

is 10 mg per day. This may be

increased by your doctor to 20 mg

per day.

The recommended maximum dose in

elderly patients is 10 mg per day.

It is recommended that patients with

liver disease receive an initial dose of

5 mg daily for the first two weeks.

Your doctor may increase the dose to

10 mg daily.

A 5 mg dose can be delivered by

measuring 0.5 mL of LEXAPRO oral

solution 10 mg/mL or 5 drops of

LEXAPRO oral solution 20 mg/mL.

A 10 mg dose can be delivered by

measuring 1 mL of LEXAPRO oral

solution 10 mg/mL or 10 drops of

LEXAPRO oral solution 20 mg/mL.

A 20 mg dose can be delivered by

measuring 2 mL of LEXAPRO oral

solution 10 mg/mL or 20 drops of

LEXAPRO oral solution 20 mg/mL.

Your doctor may have prescribed a

different dose.

Ask your doctor or pharmacist if

you are unsure of the correct dose

for you.

They will tell you exactly how much

to take.

Follow the instructions they give

you.

If you take the wrong dose,

LEXAPRO may not work as well

and your condition may not improve.

How to take it

Oral solution 10 mg/mL: To assist

with the dosing, a syringe is provided

in the pack with a scale ranging from

1 mg to 10 mg, in 1 mg increments.

Dispense the required volume of

solution into your drink (water,

orange juice or apple juice), stir

briefly then drink all of it.

Oral solution 20 mg/mL: Count the

required number of drops into your

drink (water, orange juice or apple

juice), stir it briefly and then drink all

of it.

Do not mix the LEXAPRO oral

solution with other liquids and do not

mix them with other medicinal

products.

When to take it

Take LEXAPRO as a single dose

either in the morning or in the

evening.

Take LEXAPRO with or without

food.

How long to take it

Continue to take LEXAPRO even

if it takes some time before you feel

any improvement in your

condition.

As with other medicines for the

treatment of these conditions it may

take a few weeks before you feel any

improvement.

Individuals will vary greatly in their

response to LEXAPRO. Your doctor

will check your progress at regular

intervals.

The duration of treatment may vary

for each individual, but is usually at

least 6 months.

In some cases the doctor may decide

that longer treatment is necessary.

Continue taking your medicine for

as long as your doctor tells you,

even if you begin to feel better.

The underlying illness may persist

for a long time and if you stop your

treatment too soon, your symptoms

may return.

Do not stop taking this medicine

suddenly.

If LEXAPRO is stopped suddenly

you may experience mild, but usually

temporary, symptoms such as

dizziness, pins and needles, electric

shock sensations, sleep disturbances

(vivid dreams, inability to sleep),

feeling anxious or agitated,

headaches, feeling sick (nausea),

vomiting, sweating, tremor (shaking),

feeling confused, feeling emotional

or irritable, diarrhoea, visual

disturbances, or fast or irregular

heartbeats.

When you have completed your

course of treatment, the dose of

LEXAPRO is gradually reduced over

a couple of weeks rather than stopped

abruptly.

Your doctor will tell you how to

reduce the dosage so that you do not

get these unwanted effects.

If you forget to take it

If you miss a dose and remember

in less than 12 hours, take it

straight away, and then go back to

taking it as you would normally.

Otherwise, if it is almost time for

your next dose, skip the dose you

missed and take the next dose

when you are meant to.

Do not take a double dose to make

up for the dose you have missed.

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 hints.

If you take too much

(overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre (Tel: 13 11 26), or go to

Accident and Emergency at your

nearest hospital, if you think you

or anyone else may have taken too

much LEXAPRO.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include dizziness, low blood

pressure, nausea (feeling sick),

vomiting, agitation, tremor (shaking)

and rarely convulsions and coma.

LEXAPRO

While you are taking it

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking LEXAPRO.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you become pregnant while

taking LEXAPRO, tell your doctor

immediately.

Persons taking LEXAPRO may be

more likely to think about killing

themselves or actually trying to do

so, especially when LEXAPRO is

first started or the dose is changed.

Tell your doctor immediately if

you have thoughts about killing

yourself or if you are close to or

care for someone using LEXAPRO

who talks about or shows signs of

killing him or herself.

All mentions of suicide or violence

must be taken seriously.

Occasionally, the symptoms of

depression may include thoughts of

suicide or self-harm. It is possible

that these symptoms continue or get

worse until the full antidepressant

effect of the medicine becomes

apparent. This is more likely to occur

if you are a young adult, i.e. 18 to 24

years of age, and you have not used

antidepressant medicines before.

Patients and care givers should pay

attention for any of the following

warning signs of suicide-related

behaviour while taking

LEXAPRO. Tell your doctor

immediately, or even go to the

nearest hospital for treatment:

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 agitation

Do not stop taking this medicine or

change the dose without consulting

your doctor, even if you experience

increased anxiety at the beginning

of treatment.

At the beginning of treatment, some

patients may experience increased

anxiety which will disappear during

continued treatment.

Tell your doctor immediately if

you experience symptoms such as

restlessness or difficulty in sitting

or standing still.

These symptoms can occur during

the first weeks of treatment.

Contact your doctor as soon as

possible if you suddenly experience

an episode of mania.

Some patients with bipolar disorder

(manic depression) may enter into a

manic phase. This is characterised by

profuse and rapidly changing ideas,

exaggerated gaiety and excessive

physical activity.

Sometimes you may be unaware of

the above-mentioned symptoms and

therefore you may find it helpful to

ask a friend or relative to help you to

observe the possible signs of change

in your behaviour.

Things you must not do

Do not give the oral solution to

anyone else, even if they have the

same condition as you.

Do not take LEXAPRO to treat

any other complaints unless your

doctor tells you to.

Do not stop taking LEXAPRO, or

lower the dosage, without checking

with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

Suddenly stopping LEXAPRO may

cause unwanted discontinuation

symptoms such as dizziness,

headache and nausea. Your doctor

will tell you when and how

LEXAPRO should be discontinued.

Your doctor will gradually reduce the

amount you are using, usually over a

period of one to two weeks, before

stopping completely.

Things to be careful of

Be careful driving or operating

machinery until you know how

LEXAPRO affects you.

It may cause nausea, fatigue and

dizziness in some people, especially

early in the treatment. If you have

any of these symptoms, do not drive,

operate machinery, or do anything

else that could be dangerous.

Avoid alcohol while you are taking

this medicine.

It is not advisable to drink alcohol

while you are being treated for

depression.

Side effects

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time

they are not. Your doctor has

weighed the risks of using this

medicine against the benefits he/she

expects it will have for you.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

LEXAPRO.

It helps most people with depression,

social anxiety disorder (social

phobia), generalised anxiety disorder

and obsessive-compulsive disorder,

but it may have unwanted side effects

in a few people.

The side effects of LEXAPRO are, in

general, mild and disappear after a

short period of time.

Tell your doctor if you notice any

of the following and they worry

you:

decreased appetite or loss of

appetite

dry mouth

diarrhoea

nausea (feeling sick)

sleeplessness

fatigue, sleepiness or drowsiness,

yawning

increased sweating

LEXAPRO

sexual disturbances (decreased

sexual drive; problems with

ejaculation or erection; women

may experience difficulties

achieving orgasm)

*The side effects marked with an

asterisk (*) are a number of rare side

effects that are known to occur with

medicines that work in a similar way

to LEXAPRO.

Tell your doctor as soon as possible

if you notice any of the following:

agitation, confusion, panic

attacks*, anxiety, restlessness*

dizziness

dizziness when you stand up due

to low blood pressure*

fast heart rate or decrease in heart

rate or irregular heart beat

low sodium levels in the blood

(the symptoms are feeling sick

and unwell with weak muscles or

feeling confused)*

abnormal liver function tests

(increased amounts of liver

enzymes in the blood)*

difficulties urinating*

unusual secretion of breast milk*

bleeding disorders including skin

and mucous bleeding (e.g.

bruising*) and a low level of

blood platelets*

rash, itching, patches of

circumscribed swellings

an increased risk of bone

fractures has been observed in

patients taking this type of

medicine*

These may be serious side effects of

LEXAPRO. You may need urgent

medical attention.

Tell your doctor immediately, or

go to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

thoughts of harming yourself or

thoughts of suicide*, see also

section "Things you must do"

serious allergic reaction

(symptoms of an allergic reaction

may include swelling of the face,

lips, mouth or throat which may

cause difficulty in swallowing or

breathing, or hives)

high fever, agitation, confusion,

trembling and abrupt contractions

of muscles

(these symptoms may be signs of

a rare condition called serotonin

syndrome)*

mania (i.e.: elevated mood and

associated symptoms)*

hallucinations

seizures, tremors, movement

disorders (involuntary

movements of the muscles)*

fast, irregular heart beat with

feelings of dizziness or difficulty

breathing

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

Tell your doctor if you notice

anything else that is making you feel

unwell.

Other side effects not listed above

may occur in some people.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After taking it

Storage

Keep LEXAPRO oral solution in a

cool dry place where the

temperature stays below 25°C.

Discard LEXAPRO oral solution

10 mg/mL 3 months after first

opening.

Discard LEXAPRO oral solution

20 mg/mL 2 months after first

opening.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a window-sill.

Do not leave it in the car.

Heat and damp 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 LEXAPRO, or the medicine

has passed its expiry date, ask your

pharmacist what to do with any

that is left over.

Return any unused medicine to

your pharmacist.

Product description

What it looks like

LEXAPRO oral solution is a clear,

nearly colourless to yellowish

solution.

LEXAPRO 10 mg/mL oral solution:

28 mL in a brown glass bottle. A

measuring syringe is also included in

the pack.

LEXAPRO 20 mg/mL oral solution:

15 mL in a brown glass bottle with a

dropper applicator and childproof

screw cap.

Ingredients

Active ingredient(s):

LEXAPRO oral solution 10 mg/

mL: Each mL contains 10 mg

escitalopram (as oxalate).

LEXAPRO oral solution 20 mg/

mL: Each mL (20 drops) contains

20 mg escitalopram (as oxalate).

One drop contains 1 mg

escitalopram (as oxalate).

Inactive ingredients (oral solution

10 mg/mL):

sodium hydroxide

purified water

Inactive ingredients (oral solution

20 mg/mL):

propyl gallate

anhydrous citric acid

ethanol/alcohol

sodium hydroxide

LEXAPRO

purified water

LEXAPRO oral solution does not

contain lactose, gluten, sucrose,

tartrazine or any other azo dyes.

Manufacturer/Sponsor

LEXAPRO is made by H. Lundbeck

A/S, Denmark.

Distributed in Australia by:

Lundbeck Australia Pty Ltd

Ground Floor, 1 Innovation Road

North Ryde NSW 2113

Ph: +61 2 8669 1000

This leaflet was prepared on

25 August 2014

Australian Registration Numbers:

LEXAPRO oral solution

10 mg/mL - AUST R 99369

20 mg/mL - AUST R 209721

"Lexapro" is the registered trade

mark of H. Lundbeck A/S.

AU-659701-CMI

LEXAPRO

3-1-2012

Danish Pharmacovigilance Update, 15 December 2011

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Danish Medicines Agency

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

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