Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this
medicine, speak to your doctor or pharmacist.
1. Why am I using ESIPRAM?
ESIPRAM contains the active ingredient escitalopram. ESIPRAM is used to treat depression.
2. What should I know before I use ESIPRAM?
Do not use if you have ever had an allergic reaction to escitalopram or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ESIPRAM and affect how it works.
4. How do I use ESIPRAM?
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.
5. What should I know while using ESIPRAM?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are using ESIPRAM.
If you become pregnant while taking ESIPRAM, tell your doctor immediately.
Tell your doctor immediately if you have thoughts about killing yourself.
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Things you should not do
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Do not stop using this medicine suddenly or lower the dosage without telling your
doctor.
Do not give the tablets to anyone else, even if they have the same condition as you.
Do not let yourself run out of medicine over the weekend or on holidays
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how ESIPRAM
affects you.
ESIPRAM may cause visual disturbance (such as blurred vision), 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.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
It is not advisable to drink alcohol while you are being treated for depression.
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Looking after your medicine
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Store it in a cool dry place below 30°C, away from moisture, heat, or sunlight.
Keep your tablets in the original packaging, in a safe place, away from children
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6. Are there any side effects?
Tell your doctor if you notice any of the following and they worry you: decreased appetite or loss of appetite, dry mouth diarrhoea, nausea, sleeplessness,
fatigue, sleepiness or drowsiness, yawning, increased sweating, sexual disturbances.
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, serious allergic reaction, high
fever, agitation, confusion, trembling and abrupt contractions of muscles, mania,
hallucinations, seizures, tremors, movement disorders, fast, irregular heartbeat.
Active ingredient: escitalopram oxalate (ES-sigh-talo-pram OX-a-late)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ESIPRAM. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ESIPRAM.
Where to find information in this leaflet:
1. Why am I using ESIPRAM?
ESIPRAM contains the active ingredient escitalopram oxalate. ESIPRAM 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.
ESIPRAM is used to treat depression.
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.
ESIPRAM corrects this chemical imbalance and may help relieve the symptoms of depression.
ESIPRAM may also be used to treat patients who may avoid and/or are fearful of social
situations.
ESIPRAM may also be used to treat patients who have excessive anxiety and worry.
ESIPRAM 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.
2. What should I know before I use ESIPRAM?
Warnings
Do not use ESIPRAM if:
you are allergic to escitalopram oxalate, citalopram, or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
The packaging is torn or shows signs of tampering.
Check with your doctor if you:
have allergies to any other substances such as foods, preservatives or dye.
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.
are pregnant or intend to become pregnant.
have any other medical conditions
take any medicines for any other condition
If you have, or have had any of the following conditions, tell your doctor before
starting ESIPRAM:
a tendency to bleed or bruise easily, or if you are pregnant (see ‘Pregnancy and breastfeeding’)
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
raised intraocular pressure (fluid pressure in the eye), or if you are at risk of
angle-closure glaucoma.
you are receiving electroconvulsive therapy
Medicines like LEXAPRO (so called SSRIs) may cause symptoms of sexual dysfunction
(see
Section 6. Are there any side effects?). In some cases, these symptoms have continued after stopping treatment.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Do not take ESIPRAM 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.
monoamine oxidase inhibitors such as linezolid which is an antibiotic and selegiline
which is used in the treatment of Parkinson's Disease.
One day must elapse after you have finished taking moclobemide before you start taking
ESIPRAM. If you have taken any other MAOI you will need to wait 14 days. After stopping
ESIPRAM you must allow 14 days before taking any MAOI including moclobemide.
Taking ESIPRAM 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 ESIPRAM after the MAOI has been stopped.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Medicines like ESIPRAM 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.
When taken during pregnancy, particularly in the last three months of pregnancy, medicines
like ESIPRAM 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 you take ESIPRAM near the end of your pregnancy there may be an increased risk
of heavy vaginal bleeding shortly after birth, especially if you have a history of
bleeding disorders. Your doctor or midwife should be aware that you are taking ESIPRAM
so they can advise you.
If used during pregnancy ESIPRAM should never be stopped abruptly.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take
ESIPRAM if you are breast-feeding unless you and your doctor have discussed the risks
and benefits. It passes into breast milk and therefore there is a possibility that
your baby may be affected.
ESIPRAM use in children and adolescents
Do not give ESIPRAM to a child or adolescent.
There is no experience with its use in children or adolescents under 18 years old.
ESIPRAM use in the elderly
ESIPRAM can be given to elderly patients over 65 years of age with a reduced dose.
The effects of ESIPRAM in elderly patients are similar to those in other patients.
The recommended maximum dose in elderly patients is 10 mg per day.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with ESIPRAM and affect how it works. These include
Medicines used to treat nicotine dependence
(e.g., bupropion)
Medicines used to treat reflux and ulcers such as, cimetidine, omeprazole, esomeprazole,
and lansoprazole
Non-steroidal anti-inflammatory drugs (NSAIDs), known to prolong bleeding (e.g., aspirin
and other NSAIDs)
Medicines used to prevent blood clots such as ticlopidine and warfarin
Anti-fungal medicines (e.g., fluconazole)
Anti-malaria medicines (e.g., mefloquine)
Medicines used to treat migraines (e.g., sumatriptan)
Medicines used to relieve pain (e.g., tramadol and similar medicines)
Medicines affecting chemicals in the brain
Some heart medicines such as flecainide, propafenone, metoprolol
Amino acids (e.g., tryptophan)
Medicines used to treat mood swings and some types of depression (e.g., lithium)
Antipsychotics, a class of medicines use to treat certain mental and emotional disorders
such as risperidone, thioridazine, haloperidol
Tricyclic anti-depressants such as imipramine and desipramine
St John’s Wort (Hypericum perforatum), an herbal remedy
Any other medicines for depression, anxiety obsessive-compulsive disorder or pre-menstrual
dysphoric disorder.
These medicines may be affected by ESIPRAM 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ESIPRAM.
4. How do I use ESIPRAM?
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.
Your doctor may have prescribed a different dose
Follow the instructions provided and use ESIPRAM until your doctor tells you to stop.
If necessary, you can divide the 10 and 20 mg tablets by firstly placing the tablet
on a flat surface with the score facing upwards. The tablets may then be broken by
pressing down on each end of the tablet, using both forefingers.
The 10 and 20 mg tablets can be divided into equal doses.
When to take ESIPRAM
ESIPRAM should be taken as a single dose either in the morning or the evening.
Take ESIPRAM with or without food.
How to take ESIPRAM
Swallow the tablets whole with a full glass of water
Do not chew ESIPRAM tablets
How long to take ESIPRAM
Continue to take ESIPRAM 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 ESIPRAM. 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 ESIPRAM 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 ESIPRAM 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 use ESIPRAM
ESIPRAM should be used regularly at the same time each day. If you miss your dose
at the usual time, and remember in less than 12 hours, take it straight away, and
then go back to taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you 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 use too much ESIPRAM
If you think that you have used too much ESIPRAM, 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.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using ESIPRAM?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ESIPRAM.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you become pregnant while taking ESIPRAM, tell your doctor immediately.
Persons taking ESIPRAM may be more likely to think about killing themselves or actually
trying to do so, especially when ESIPRAM 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 ESIPRAM 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 ESIPRAM. 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
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.
Call your doctor straight away if you:
difficulties urinating
seizures (fits)
yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis
become pregnant while taking ESIPRAM
have thoughts about killing yourself or if you are close to or care for someone using
ESIPRAM who talks about or shows signs of killing him or herself
experience symptoms such as restlessness or difficulty in sitting or standing still
suddenly experience an episode of mania
Remind any doctor, dentist, or pharmacist you visit that you are using ESIPRAM.
Things you should not do
Do not stop using this medicine suddenly, or lower the dosage without checking with
your doctor
Do not give the tablets to anyone else, even if they have the same condition as you.
Do not take ESIPRAM to treat any other complaints unless your doctor tells you to.
Do not let yourself run out of medicine over the weekend or on holidays.
At the beginning of treatment, some patients may experience increased anxiety which
will disappear during continued treatment.
Suddenly stopping ESIPRAM may cause unwanted discontinuation symptoms such as dizziness,
sensory disturbances, sleep disturbances, agitation or anxiety tremor, confusion,
sweating, headache, diarrhoea, palpitations, emotional instability, irritability,
visual disturbances, and nausea. Your doctor will tell you when and how ESIPRAM 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ESIPRAM
affects you.
ESIPRAM may cause visual disturbance (such as blurred vision), 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
It is not advisable to drink alcohol while you are being treated for depression.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the original pack until it is time to take them. If you take
your tablets out of the pack, they may not keep well.
Store it in a cool dry place below 30°C away from moisture, heat, or sunlight; for
example, do not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ESIPRAM.
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 ESIPRAM are, in general, mild and disappear after a short period
of time.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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decreased appetite or loss of appetite
dry mouth
diarrhoea
nausea (feeling sick)
sleeplessness
fatigue, sleepiness or drowsiness, yawning nausea (feeling sick)
increased sweating
sexual disturbances (decreased sexual drive; problems with ejaculation or erection;
women may experience difficulties achieving orgasm)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
|
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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 heartbeat
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*
Increased blood levels of the hormone prolactin*
unusual secretion of breast milk*
bleeding disorders including skin and mucous bleeding (e.g., bruising*) and a low
level of blood platelets*
heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see ‘Pregnancy
and breastfeeding' in section 2 for more information
rash, itching, patches of circumscribed swellings
an increased risk of bone fractures has been observed in patients taking this type
of medicine*
thoughts of harming yourself or thoughts of suicide*
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 heartbeat with feelings of dizziness or difficulty breathing
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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*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 ESIPRAM.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ESIPRAM contains
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Active ingredient
(main ingredient)
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ESIPRAM 10 mg tablets:
10 mg escitalopram (as oxalate) per tablet
ESIPRAM 20 mg tablets:
20 mg escitalopram (as oxalate) per tablets
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
croscarmellose sodium
opadry OY-S28849 PI (4748) (contains: hypromellose, macrogol 400, titanium dioxide).
magnesium stearate
colloidal anhydrous silica
purified talc
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Potential allergens
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ESIPRAM does not contain lactose, gluten, sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What ESIPRAM looks like
ESIPRAM tablets are presented in blister strips containing 14 film-coated tablets.
The blisters are packed in a carton, with each carton of ESIPRAM film-coated tablets
containing 2 blister strips, 28 tablets in total.
ESIPRAM tablets are available in two strengths.
ESIPRAM 10 mg film-coated tablets (AUST R 92051) are oval in shape and white in colour, scored and marked with “E”
and “L” on each side of the score on one side of the tablet
ESIPRAM 20 mg film-coated tables (AUST R 92053) are oval in shape and white in colour, scored and marked with “E”
and “N” on each side of the score on one side of the tablet.
Who distributes ESIPRAM
ESIPRAM is made by H. Lundbeck A/S, Denmark.
Distributed in Australia by:
CNS Pharma Pty Ltd
Level 5, Deutsche Bank Place
126 Philip Street
Sydney NSW 2000
Tel: +61 2 8669 1068
This leaflet was prepared in November 2023.