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 LOXALATE?
LOXALATE contains the active ingredient escitalopram. LOXALATE is used to treat depression.
2. What should I know before I use LOXALATE?
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.
For more information, see Section
2. What should I know before I use LOXALATE? in the full CMI.
3. What if I am taking other medicines?
4. How do I use LOXALATE?
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 LOXALATE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using LOXALATE.
If you become pregnant while taking LOXALATE, tell your doctor immediately.
Tell your doctor immediately if you have thoughts about killing yourself.
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Things you should not do
|
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.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how LOXALATE
affects you.
LOXALATE 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
|
Store it in a cool dry place below 25°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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
escitalopram oxalate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using LOXALATE. 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 LOXALATE.
Where to find information in this leaflet:
1. Why am I using LOXALATE?
LOXALATE contains the active ingredient escitalopram oxalate. LOXALATE 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.
LOXALATE 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.
LOXALATE corrects this chemical imbalance and may help relieve the symptoms of depression.
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 LOXALATE?
Warnings
Do not use LOXALATE 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 conditions.
If you have, or have had any of the following conditions, tell your doctor before
starting LOXALATE:
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.
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 LOXALATE at the same time as the following other medicines:
pimozide, a medicine used to treat mental disorders.
monoamine oxidase inhibitors (MAOIs), such as phenelzine (Nardil), tranylcypromine
(Parnate) and moclobemide (e.g. Aurorix) which are also used for the treatment of
depression.
monoamine oxidase inhibitors such as linezolid which is an antibiotic and selegiline
(e.g. Eldepryl) which is used in the treatment of Parkinson's Disease.
One day must elapse after you have finished taking moclobemide before you start taking
LOXALATE. If you have taken any other MAOI you will need to wait 14 days. After stopping
LOXALATE you must allow 14 days before taking any MAOI including moclobemide.
Taking LOXALATE 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 LOXALATE after the MAOI has been stopped.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Medicines like LOXALATE 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 LOXALATE if you are pregnant unless you and your doctor have discussed
the risks and benefits involved.
When taken during pregnancy, particularly in the last three months of pregnancy, medicines
like LOXALATE 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 LOXALATE 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 LOXALATE
so they can advise you.
If used during pregnancy LOXALATE should never be stopped abruptly. You should not
stop taking your tablets until you have spoken to your doctor. Your doctor will discuss
the possible risks and benefits of taking LOXALATE during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take
LOXALATE if you are breastfeeding 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.
LOXALATE use in children and adolescents
Do not give LOXALATE to a child or adolescent
There is no experience with its use in children or adolescents under 18 years old.
LOXALATE use in the elderly
LOXALATE can be given to elderly patients over 65 years of age with a reduced dose.
The effects of LOXALATE 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 LOXALATE 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)
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 LOXALATE 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 LOXALATE.
4. How do I use LOXALATE?
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 LOXALATE until your doctor tells you to stop.
When to take LOXALATE
Take LOXALATE at about the same time each day. Taking it at the same time each day
will have the best effect. It will also help you to remember when to take it.
LOXALATE should be taken as a single dose either in the morning or the evening.
Take LOXALATE with or without food.
How to take LOXALATE
Swallow the tablets whole with a full glass of water.
Do not chew LOXALATE tablets.
LOXALATE 10 mg and 20 mg tablets can be divided in half if advised by your doctor
or pharmacist.
How long to take LOXALATE
Continue to take LOXALATE 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 LOXALATE. 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 LOXALATE 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 LOXALATE 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 LOXALATE
LOXALATE 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 LOXALATE
If you think that you have used too much LOXALATE, 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
(Australia telephone 13 11 26); New Zealand telephone 0800 POISON or 0800 764 766
for advice, 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 LOXALATE?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking LOXALATE.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
Keep all your doctor's appointments so that your progress can be checked.
If you become pregnant while taking LOXALATE, tell your doctor immediately.
Persons taking LOXALATE may be more likely to think about killing themselves or actually
trying to do so, especially when LOXALATE is first started (generally the first one
to two months), 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 LOXALATE 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 LOXALATE. Tell your doctor immediately,
or even go to the nearest hospital for treatment:
Worsening of symptoms
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, or any other unusual
changes in behaviour or mood.
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 LOXALATE
have thoughts about killing yourself or if you are close to or care for someone using
LOXALATE 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 LOXALATE.
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 LOXALATE 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.
Suddenly stopping LOXALATE 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 (feeling sick). Your doctor will tell you when and
how LOXALATE 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 LOXALATE
affects you.
LOXALATE may cause visual disturbance (such as blurred vision), nausea, fatigue, drowsiness
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 25°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 window sills.
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 LOXALATE.
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 LOXALATE 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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headache
clogged or runny nose, sore throat
flu-like symptoms
decreased appetite or loss of appetite
dry mouth
diarrhoea
nausea (feeling sick), vomiting
constipation
abdominal pain, indigestion, flatulence
back pain, joint pain
sleeplessness
fatigue, sleepiness or drowsiness, yawning
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*, abnormal dreams
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)*
dark stools with stomach pain
difficulties urinating*
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 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 LOXALATE.
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 LOXALATE contains
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Active ingredient
(main ingredient)
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LOXALATE 10 mg tablets:
10 mg escitalopram (as oxalate) per tablet
LOXALATE 20 mg tablets:
20 mg escitalopram (as oxalate) per tablet
|
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Other ingredients
(inactive ingredients)
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colloidal anhydrous silica
croscarmellose sodium
magnesium stearate
microcrystalline cellulose
Opadry White OY-LS-28908 (ARTG PI No: 2596)
purified talc
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Potential allergens
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Soya bean products, lactose and traces of sulfites.
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Do not take this medicine if you are allergic to any of these ingredients.
What LOXALATE looks like
LOXALATE 10 mg is 9.5 mm x 5.5 mm oblong normal convex white film-coated tablet debossed
"EC|10" on one side and "G" on the other (AUST R 119964).
LOXALATE 20 mg is 12.5 mm x 7 mm oblong normal convex white film-coated tablet debossed
"EC|20" on one side and "G" on the other (AUST R 119966).
Who distributes LOXALATE
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in April 2024.
LOXALATE® is a Viatris company trade mark
LOXALATE_cmi\Apr24/00