LEXAPRO

Escitalopram oxalate

Consumer Medicine Information

What is in this leaflet

This leaflet answers 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 risks of you taking LEXAPRO against the benefits he/she expects it will have for you.

If you have any concerns about taking 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 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 and/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.

Ask your doctor if you have any questions about why LEXAPRO has been prescribed for you.
Your doctor, may have prescribed LEXAPRO for another reason.

Before you take LEXAPRO

When you must not take it.

Do not take LEXAPRO if you have ever had an allergic reaction to LEXAPRO or citalopram or any of the ingredients listed at the end of this leaflet.

If you have an allergic reaction you may get a skin rash, have difficulty in breathing, get symptoms of hayfever or feel faint.

LEXAPRO should not be taken at the same time as taking medication known as 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.

The herbal remedy St John`s wort (Hypericum perforatum) should not be taken at the same time as this medicine.

LEXAPRO should not be taken at the same time as the medication pimozide.

Do not take LEXAPRO after the expiry date (EXP) printed on the pack.

It may have no effect at all or, an entirely unexpected effect if you take it after the expiry date.

Do not take LEXAPRO if the packaging is torn or shows signs of having been tampered with.

Do not take LEXAPRO to treat any other complaints unless your doctor has instructed you to do so.

Before you start to take it

Your doctor must know about all the following before you start to take LEXAPRO.

You must tell your doctor if:

1.you are allergic to any other medicines or any foods, dyes or preservatives.

2.you have or have had any of the following medical conditions:

heart disease

epilepsy

liver disease

kidney disease

diabetes

manic depression

bleeding tendency

Your doctor will take the necessary precautions to ensure safe use of LEXAPRO if you have any of these medical conditions.

3.you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some of the medicines in common use that may interfere with LEXAPRO include:

bupropion,

cimetidine,

sumatriptan,

tricyclic antidepressants eg. imipramine, desipramine,

mefloquine,

omeprazole,

medicines known to prolong bleeding eg. aspirin,

some heart medications,

medicines to treat mental disorders such as lithium, risperidone, thioridazine and haloperidol,

sleeping tablets,

pain relievers eg. tramadol,

tryptophan,

any other medications for depression, anxiety, obsessive compulsive disorder or premenstrual dysphoric disorder.

You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist can tell you what to do if you are taking this or any other medicines.

4.you are pregnant or plan to become pregnant.

Do not take LEXAPRO if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

The general condition of your newborn baby might be affected by the use of this group of medicines.
It is not recommended that you do breastfeed while taking LEXAPRO as it is excreted in breast milk.

If you have not told your doctor about any of these things, tell him/her before you take LEXAPRO.

5.you have heart disease.

LEXAPRO may decrease your heart rate.

Use in children

Do not give LEXAPRO to children and adolescents.

LEXAPRO should not be given to children and adolescents under 18 years of age as the safety and efficacy of LEXAPRO in this age group has not been established.

Use in elderly

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 that in other patients.

How to take LEXAPRO

How much to take

Your doctor will tell you how much LEXAPRO to take. Take the amount your doctor tells you to.

The usual dose is 10 mg (one 10 mg tablet or 1 mL of the oral solution) per day. This may be increased by your doctor. The recommended maximum dose is 20 mg (one 20 mg tablet or 2 mL of the oral solution) per day.

The recommended maximum dose in elderly patients is 10 mg (one 10 mg tablet or 1 mL of the oral solution) 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.

How to take it

Take LEXAPRO as a single dose either in the morning or in the evening. LEXAPRO may be taken with or without food.

It is best if the tablet is swallowed whole with a drink of water. Do not chew the tablets.

The oral solution can be mixed with water, orange juice or apple juice.

What to expect

As with other medicines for the treatment of depression or anxiety it may take a few weeks before you feel any improvement.

Therefore you should continue to take LEXAPRO even if it takes some time before you feel any improvement in your condition.

Individuals will vary greatly in their response to LEXAPRO. Your doctor will check your progress at regular intervals.

How long to take it

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. You should continue to take the tablets or oral solution for as long as your doctor recommends, 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.

When finishing a course

Abrupt cessation of this kind of medication may cause discontinuation symptoms such as dizziness, nausea and headache.

When you have completed your course of treatment it is therefore advised that the dose of LEXAPRO is gradually reduced over a couple of weeks.

If you forget to take it

If you miss a dose and remember in less than 12 hours, take it straight away, then continue as normal the next day. Otherwise, skip that day`s dose but be sure to take the next day`s dose when it is due.

Do not try to make up for missed doses by taking more than one dose at a time.

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 (telephone 13 11 26) for advice, or go to the Accident and Emergency or Casualty department at your nearest hospital, if you think that you or anyone else may have taken too much LEXAPRO. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers for these places handy.

Symptoms of overdosage may include:

nausea (feeling sick)

vomiting

sweating

drowsiness

blue discolouration of the skin

convulsions

unconsciousness

fast heart beats

tremor

While you are taking LEXAPRO

Things you must do

Take LEXAPRO exactly as your doctor has prescribed.

If you do not follow your doctor`s instructions, you may not get relief from your condition.

Try not to miss any doses and continue to take the medicine even if you feel well.

Tell your doctor immediately if you become pregnant while taking LEXAPRO.

Tell all doctors, dentists and pharmacists who are treating you that you are using LEXAPRO, especially if you are being started on any new medicines.

Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes.

All mentions of suicide or violence must be taken seriously. If you or someone you know demonstrates any of the following warning signs of suicide-related behaviour while taking LEXAPRO, then it is important to contact a health care provider right away 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

Episodes of mania

Some patients with manic-depressive illness may enter into a manic phase.

This is characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. In such cases, it is important to contact your doctor.

Things you must not do

Do not give this medicine to anyone else even if their symptoms seem similar to yours.

Do not stop taking LEXAPRO, or lower the dose, 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 usually recommend that you stop treatment by slowly reducing the dosage over a period of one to two weeks.

Things to be careful of

As with any new medicine, make sure you know how you react to LEXAPRO before you drive or operate machinery.

It is not recommended that LEXAPRO be taken with alcohol.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LEXAPRO.

LEXAPRO helps most people with depression, social anxiety disorder (social phobia) and generalised anxiety disorder, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

The side effects of LEXAPRO are, in general, mild and disappear after a short period of time.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

Nausea

Difficulties falling asleep

Feeling sleepy

Fatigue

Diarrhoea

Dry mouth

Increased sweating

Dizziness

Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties getting orgasm)

Decreased appetite

Yawning

Agitation

Fever

In addition a number of rare side effects are known to occur with medicines that work in a similar way to LEXAPRO. These are:

Dizziness when you stand up due to low blood pressure

Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)

Blurring of vision

Vomiting

Abnormal liver function test (increased amounts of liver enzymes in the blood)

Pains in muscles and joints

High fever, agitation, confusion, trembling and abrupt contractions of muscles may be signs of a rare condition called serotonin syndrome

Seizures, tremors, movement disorders (involuntary movements of the muscles)

Hallucinations, mania, confusion, panic attacks, depersonalisation, anxiety, nervousness,

Difficulties urinating

Flow of milk in women that are not breastfeeding

Rash, increased tendency to develop bruises, itchings, patches of circumscribed swellings

Tell your doctor if you notice anything else that is making you feel unwell.

Some people may get other side effects while using LEXAPRO.

There is no evidence that LEXAPRO is addictive, however, if you suddenly stop taking LEXAPRO, you may get side effects.

Tell your doctor if you get any side effects after stopping LEXAPRO.

After taking LEXAPRO

Storage

Tablets:
Keep LEXAPRO tablets in a cool place where the temperature stays below 30 degrees C.

Keep LEXAPRO tablets in the blister pack until it is time to take them.

Oral solution:
Keep LEXAPRO oral solution in a cool place where the temperature stays below 25 degrees C.

Once LEXAPRO oral solution has been opened, store below 25 degrees C. Discard after 3 months.

Do not freeze LEXAPRO.

Do not leave LEXAPRO in the car on hot days.

Keep LEXAPRO away from direct sunlight.

Do not store LEXAPRO or any other medicine in the bathroom or near a sink or stove.

Heat, light and dampness can destroy some medicines.

Keep LEXAPRO where young children cannot reach it.

A locked cupboard at least one-and-a-half a metre above ground is a good place to store medicines.

Disposal

Dispose of the tablets or oral solution where children cannot reach them.

Ask your pharmacist what to do with any LEXAPRO tablets or oral solution you may have left over if your doctor tells you to stop using it, or you find that the tablets or oral solution has passed the expiry date.

LEXAPRO description

What LEXAPRO tablets look like

LEXAPRO tablets are presented as 10 mg & 20 mg tablets and are available in packs of 28 tablets.

The tablets are described below.

10 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “L” on each side of the score on one side of the tablet.

20 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “N” on each side of the score on one side of the tablet.

What LEXAPRO oral solution looks like

LEXAPRO oral solution is clear, nearly colourless to yellowish solution.

Active Ingredients

Tablets:

Each LEXAPRO tablet contains either 10mg or 20mg escitalopram (as oxalate salt).

Oral solution:

LEXAPRO oral solution contains 10 mg escitalopram (as oxalate salt) per mL.

Other Ingredients

LEXAPRO tablets also contain:

cellulose – microcrystalline

silica – colloidal anhydrous

talc – purified

croscarmellose sodium

magnesium stearate

hypromellose

macrogol 400

titanium dioxide

LEXAPRO oral solution also contains:

sodium hydroxide

purified water

Manufacturer

LEXAPRO is made in Denmark and supplied in Australia by:

Lundbeck Australia Pty Ltd.

1/10 Inglewood Place

Baulkham Hills NSW 2153

Ph: +61 2 9836 1655

This leaflet was prepared on

20 September 2005

Australian Registration Numbers are: