TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213726
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213726

TERRY WHITE CHEMISTS ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

6/11/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TERRY WHITE CHEMISTS ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister

Product Type

Single Medicine Product

Effective date

2/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression.

Treatment of obsessive-compulsive disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

48 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. TERRY WHITE CHEMISTS ESCITALOPRAM escitalopram (as oxalate) 20 mg tablet blister

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval, biconvex, film-coated tablet with 'C3' embossed on

one side and a notch break-line on the other side.

Active Ingredients

escitalopram oxalate

25.47 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 10:53:38 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

Terry White Chemists

Escitalopram

Contains the active ingredient, escitalopram (as escitalopram oxalate)

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 escitalopram.

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 Terry

White Chemists Escitalopram. It

contains the active ingredient,

escitalopram (as escitalopram

oxalate).

It is used to treat

depression

obsessive-compulsive disorder.

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

Escitalopram belongs to a group of

medicines called Selective Serotonin

Reuptake Inhibitors (SSRIs).

Escitalopram and other SSRIs are

thought to help by increasing the

amount of serotonin in your brain.

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.

Escitalopram corrects this chemical

imbalance and may help relieve the

symptoms of depression.

There is no evidence that

escitalopram is addictive. However,

if you suddenly stop taking it, you

may get side effects.

Tell your doctor if you get any side

effects after stopping escitalopram.

Use in children

Do not give this medicine to a child

or adolescent.

There is no experience with its use in

children and adolescents under 18

years of age.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are taking the following

other medicines:

pimozide, used to treat disorders

which affect the way you think,

feel or act

monoamine oxidase inhibitors

(MAOIs), used to treat depression

(phenelzine, tranylcypromine,

moclobemide), Parkinson's

Disease (selegiline) or infections

(linezolid).

TERRY WHITE CHEMISTS ESCITALOPRAM

Do not take escitalopram until 14

days after stopping most MAOIs.

The exception is the MAOI,

moclobemide, where you may take

escitalopram one whole day after

finishing taking moclobemide.

Similarly, do not take any MAOI

until at least 14 days after stopping

taking escitalopram.

Taking escitalopram with MAOIs

may cause a serious reaction with

signs such as a sudden increase in

body temperature, very high blood

pressure, rigid muscles, nausea/

vomiting and/or fits (convulsions).

Your doctor will know when it is

safe to start escitalopram after the

MAOI has been stopped.

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.

You have had an allergic

reaction to escitalopram,

citalopram or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include cough, 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 or hayfever-like

symptoms.

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.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

1.

You have allergies to:

any other medicines

any other substances such as

foods, preservatives, lactose or

dyes.

2.

You have or have had any

medical conditions, especially

the following:

mania, hypomania, bipolar

disorder or any other conditions

which affect the way you think,

feel or act

epilepsy or convulsions, fits or

seizures (you should avoid taking

escitalopram if your epilepsy is

not properly controlled; if it is

properly controlled your doctor

will wish to watch you carefully

if you take escitalopram)

heart problems

liver problems

kidney problems

problems with blood clotting or

abnormal bleeding, i.e. a

tendency to bleed or bruise easily

thoughts or actions relating to

self-harm or suicide

diabetes

a decreased level of sodium in

your blood

restlessness and/or a need to

move often (akathisia)

3.

You are currently pregnant or

you plan to become pregnant.

There have been reports that

babies exposed to certain

antidepressants during the third

trimester of pregnancy may

develop complications after birth.

Do not take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

4.

You are currently breast-

feeding or you plan to breast-

feed.

It is not recommended that you

breast-feed while taking this

medicine because escitalopram

passes into breast milk and may

affect your baby.

Do not take this medicine whilst

breast-feeding until you and your

doctor have discussed the risks

and benefits involved.

5.

You are receiving

electroconvulsive therapy

(ECT).

6.

You are planning to have, or

have very recently had, surgery

or an anaesthetic.

7.

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 that are available

from your pharmacy, supermarket

or health food shop.

Some combinations of medicines

may increase the risk of serious

side effects and are potentially life-

threatening.

Therefore some medicines MUST

NOT be taken with escitalopram.

These include:

monoamine oxidase inhibitors,

such as moclobemide, phenelzine,

tranylcypromine, selegiline and

linezolid

pimozide

(see also "When you must not take

it").

Some other medicines may interact

with escitalopram.

These include:

tryptophan, contained in some

multivitamin and herbal

preparations

sumatriptan, used to treat

migraines

tramadol, a strong pain killer

sumatriptan and similar

medicines used to treat migraines

and cluster headaches

St John's Wort (Hypericum

perforatum), a herbal remedy

other medicines used to treat

depression, including SSRIs,

imipramine, clomipramine,

nortriptyline and desipramine

lithium, used to treat mood

swings and some types of

depression

TERRY WHITE CHEMISTS ESCITALOPRAM

any other medicines used to treat

anxiety, obsessive-compulsive

disorder or pre-menstrual

dysphoric disorder.

antipsychotics, medicines used to

treat psychoses, schizophrenia

and other conditions which affect

the way you think, feel or act

(e.g. risperidone, thioridazine and

haloperidol)

any other medicines affecting the

chemicals in the brain

prochlorperazine, used to prevent

or treat severe nausea and

vomiting

bupropion, a medicine helping to

treat nicotine dependence

mefloquine, an anti-malaria

medicine

some heart or blood pressure

medications, e.g. dipyridamole,

flecainide, propafenone,

metoprolol

medicines known to prolong

bleeding e.g. aspirin or other non-

steroidal anti-inflammatory drugs

(NSAIDs) and anti-coagulants

(such as warfarin and ticlopidine),

which are used to prevent blood

clots

medicines used to treat reflux and

ulcers, such as cimetidine,

omeprazole, esomeprazole and

lansoprazole

imipramine and desipramine

types of antidepressants.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with escitalopram.

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 standard dose for this medicine

is 10 mg per day. Your doctor may

increase your dose to 20 mg per day

depending on how you respond to

this medicine.

Elderly people may need smaller

doses. The maximum dose for elderly

people is 10 mg per day.

Patients with liver disease or with a

lack of certain liver enzymes may

receive a lower initial dose of 5 mg

daily for the first two weeks. Your

doctor may increase the dose to 10

mg daily.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow the tablets whole with a

full glass of water.

Do not chew them.

When to take it

Take escitalopram as a single dose,

either in the morning or in the

evening.

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,

even if it takes some time before

you feel any improvement in your

condition.

Make sure you have enough to last

over weekends and holidays.

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 escitalopram.

Your doctor will check your progress

at regular intervals.

The length of treatment may vary for

each individual, but is usually at least

6 months.

In some cases, your doctor may

decide that longer treatment is

necessary.

Occasionally the symptoms of

depression or other psychiatric

conditions may include thoughts of

harming yourself or committing

suicide. It is possible that these

symptoms may continue or increase

until the full anti-depressant effect of

your medicine becomes apparent.

You or anyone close to you or

caring for you should watch for

these symptoms and tell your

doctor immediately or go to the

nearest hospital if you have any

distressing thoughts or experiences

during this initial period or at any

other time.

Also contact your doctor if you

experience any worsening of your

depression or other symptoms at any

time during your treatment.

Stopping Treatment

Do not stop taking this medicine

even if you begin to feel better.

Your doctor may decide that you

should continue to take it for some

time, even when you have overcome

your problem. For best effect, this

medicine must be taken regularly.

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 you suddenly stop taking your

medicine, you may experience mild,

but usually temporary, symptoms

such as dizziness, pins and needles,

electric shock sensations, sleeping

problems (vivid dreams, nightmares,

TERRY WHITE CHEMISTS ESCITALOPRAM

inability to sleep), feeling anxious,

restless 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

escitalopram 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 help

avoid getting side effects.

If you forget to take it

If you missed 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 you are more than 12

hours late, 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 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.

If you take too much escitalopram,

you may get symptoms of

drowsiness, sleepiness, dizziness,

high or low blood pressure, nausea

(feeling sick), vomiting, agitation or

tremor (shaking), fast or slow heart

beat or change in heart rhythm,

dilated pupils or, rarely, temporary

paralysis or weakness of muscles,

convulsions or coma.

A condition called serotonin

syndrome may occur, with high

fever, agitation, confusion, trembling

and abrupt contraction of muscles.

While you are taking

this medicine

Things you must do

People taking escitalopram may be

more likely to think about killing

themselves or actually trying to do

so, especially when escitalopram 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

escitalopram 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.

If you or someone you know or

care for demonstrates any of the

following warning signs of suicide-

related behaviour while taking

escitalopram, contact a doctor

immediately, or even to 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

worsening of depression.

Follow your doctor's instructions.

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 sitting or

standing still.

These symptoms can also occur

during the first weeks of treatment.

Contact your doctor as soon as

possible if you suddenly experience

an episode of mania.

Some people with bipolar disorder

(manic depression) may enter into a

manic phase. Symptoms of mania

include lots of rapidly changing

thoughts or ideas, exaggerated gaiety,

being much more physically active

and much more restless.

Sometimes you may not know that

you are manic, so it may be helpful

to have a friend or relative watch

over you for any possible signs of

change in your behaviour.

Visit your doctor regularly so they

can check on your progress.

Tell your doctor immediately if

you become pregnant. If you are a

woman of child-bearing age, you

should avoid becoming pregnant

while taking escitalopram.

Make sure your midwife and/or

doctor know you are taking

escitalopram. When taken during

pregnancy, particularly in the last 3

months of pregnancy, medicines like

escitalopram 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

TERRY WHITE CHEMISTS ESCITALOPRAM

the baby is born. If this happens to

your baby you should contact your

midwife and/or doctor immediately.

Low Sodium

Some people (especially older people

or those taking diuretics/water

tablets) may experience a lack of

sodium in the blood when taking this

medicine. Tell your doctor if you get

a headache or start to feel sick,

restless, irritated, confused or

fatigued or if you vomit or have fits,

muscle weakness or spasms.

Tell your doctor that you are

taking this medicine if:

you are about to be started on any

new medicine

you are breast-feeding 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.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you

that you take this medicine.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed.

Otherwise your doctor may think that

it was not effective and change your

treatment unnecessarily.

Tell your doctor if you feel this

medicine is not helping your

condition.

If you are being treated for

depression, be sure to discuss with

your doctor any problems you may

have and how you feel, especially

any feelings of severe sadness,

thoughts of suicide, bursts of unusual

energy, anger or aggression, or if you

become particularly agitated or

restless.

Tell your doctor immediately if

you have any suicidal thoughts or

other mental/mood changes.

Make sure you have enough tablets

to last over weekends and holidays.

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 or pharmacist tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

Suddenly stopping escitalopram may

cause unwanted discontinuation

symptoms, such as dizziness,

headache and nausea. Your doctor

will tell you when and how

escitalopram should be discontinued.

You 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 when driving or

operating machinery until you

know how this medicine affects

you.

This medicine may cause nausea,

fatigue, drowsiness, sight problems

or 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 best not to drink alcohol while

you are being treated for depression.

You should be aware that people

over 50 years of age who take

antidepressants have an increased

risk of having a bone fracture.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking escitalopram 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:

feeling tired and weak (fatigued),

hot flushes, fever, feeling unwell,

shaking or tremors, migraine,

headache, or giddiness

muscle, back, bone, nerve or joint

pain, stiffness, weakness or

cramps, decrease or loss of touch

or other senses

increased or decreased sensitivity

to outside stimuli

feeling or being sick, reflux,

diarrhoea or loose bowel motions,

constipation, indigestion, stomach

pain or discomfort, wind,

burping, hiccups, problems

swallowing, sore mouth, tongue

or throat, haemorrhoids (piles)

dry mouth, feeling thirsty

increased saliva, taste disturbance

fatigue, sleepiness or drowsiness,

yawning, ,sleeping difficulties,

strange or terrifying dreams

teeth grinding or clenching

increased or decreased appetite,

weight loss

excessive and/or abnormal

movements

increased muscle tension, muscle

twitching

sexual problems, painful erection,

prostate problems

symptoms of hyperglycaemia

(high blood sugar): feeling

hungry, thirsty and/or frequent or

excessive urination;

problems with eyes or eyesight

TERRY WHITE CHEMISTS ESCITALOPRAM

dizziness when you stand up

suddenly, due to low blood

pressure

unable to tolerate alcohol

menstrual irregularities, period

pain, breast pain, unusual vaginal

bleeding

loss of bladder control unusual

hair loss or thinning

tingling or numbness of the hands

or feet

breast enlargement or unusual

secretion of breast milk in men or

women

mild rash, or itching or prickling

of the skin

acne, eczema, dermatitis, dry

skin, psoriasis or other skin

problem

pain of any type

ringing or other persistent noise

in the ears, problems hearing or

earache

increased or decreased sweating

bruises

osteoporosis

tooth or jaw problems

flu-like symptoms, runny or

blocked nose, sneezing , facial

pressure or pain, coughing or sore

throat

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects.

You may need medical attention.

becoming nervous, confused,

forgetful, unable to concentrate,

agitated, confused, panicky or

anxious

feeling restless or unable to sit

still

stomach pain with nausea and

vomiting of blood, or blood in the

bowel movements

aggression, worsening of

depression

general swelling or swollen

hands, ankles, feet or face or eye

area due to fluid build-up

problems speaking

feelings of not being part of your

body, or in a daze

feeling sick or unwell with weak

muscles or feeling confused

(these symptoms may be signs of

a rare condition as a result of low

levels of sodium in the blood,

which may be caused by

antidepressants and occurs

especially in elderly

women)increased tendency to

bleed, develop bruises or broken

bones

passing more or less urine than

normal, or problems when

urinating, or bladder infection

abnormal liver function tests

(increased amount of liver

enzymes )

flushing, varicose veins

infection in any part of your body

dizziness

agitation, anxiety, feeling tense

and restless, tired, drowsy, lack of

energy, irritable, problems

sleeping, headache, nausea and

tingling or numbness of the hands

and feet after stopping

escitalopram.

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.

You may need urgent medical

attention or hospitalisation.

seizures, tremors, movement

disorders (involuntary

movements of the muscles or

being unco-ordinated).

coma (unconsciousness)

a collection of symptoms

including weight gain (despite

loss of appetite), feeling and

being sick, muscle weakness and

irritability

severe rash, with blisters and/ or

excessive peeling of skin and also

possibly severe blisters and

bleeding in the lips, eyes, mouth,

nose and genitals

a sudden increase in body

temperature, very high blood

pressure, rigid muscles, nausea/

vomiting and/or fits

(convulsions). These symptoms

may be signs of a rare condition

called Serotonin Syndrome.

Neuroleptic Malignant Syndrome

(a serious reaction to some

medicines with a sudden increase

in body temperature, extremely

high blood pressure and severe

convulsions)

fast, slow or irregular heartbeat,

high blood pressure

palpitations, fainting or chest pain

or tightness

abnormal bleeding

kidney pain, difficulty in passing

urine, dark coloured urine or

blood in the urine

a collection of symptoms

including fever, sore throat,

swollen glands, mouth ulcers,

unusual bleeding or bruising

under the skin

mania (mood of excitement, over-

activity and uninhibited

behaviour or aggression),

hallucinations (hearing, seeing or

feeling things that are not there)

jaundice (yellowing of the skin

and/or eyes) , with or without

other signs of hepatitis or liver

problems (loss of appetite,

tiredness, feeling or being sick,

dark urine, stomach pain or

swelling, confusion,

unconsciousness).

feeling paranoid, panicky, or

"high" or having mood swings or

feeling more depressed or in a

trance

thoughts of suicide or attempting

suicide or self-harm

sudden, severe breathing

problems

sudden weakness or numbness of

the face, arms or legs, especially

on one side, slurred speech

Other side effects not listed above

may also occur in some people.

TERRY WHITE CHEMISTS ESCITALOPRAM

Allergic reactions

If you think you are having an

allergic reaction to escitalopram,

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:

cough, 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

hayfever-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 30°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 Terry White Chemists

Escitalopram looks like

Terry White Chemists Escitalopram

tablets are available in the following

strengths:

10 mg tablets: white to off -

white, oval, biconvex, film-

coated tablets with "C4"

embossed on one side and a notch

break-line on the other side.

20 mg tablets: white to off -

white, oval, biconvex, film-

coated tablets with "C3"

embossed on one side and a notch

break-line on the other side.

Blister packs of 28 tablets.

* Not all strengths may be available.

Ingredients

Each tablet contains 10 mg, or 20 mg

of escitalopram (as oxalate) as the

active ingredient.

It also contains the following inactive

ingredients:

microcrystalline cellulose

colloidal anhydrous silica

hypromellose

magnesium stearate

croscarmellose sodium

purified talc

macrogol 400

titanium dioxide.

This medicine is gluten-free, lactose

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Terry White Chemists Escitalopram

10 mg tablets (blister pack): AUST R

213725.

Terry White Chemists Escitalopram

20 mg tablets (blister pack): AUST R

213726.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

January 2017.

TERRY WHITE CHEMISTS ESCITALOPRAM

3-1-2012

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Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

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

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