Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking ELEVA?
ELEVA contains the active ingredient sertraline hydrochloride. ELEVA is used to treat
depression and conditions called obsessive compulsive disorder (OCD), panic disorder,
social phobia (social anxiety disorder) and premenstrual dysphoric disorder (PMDD).
For more information, see Section
1. Why am I taking ELEVA? in the full CMI.
2. What should I know before I take ELEVA?
Do not take if you have ever had an allergic reaction to sertraline 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 take ELEVA? in the full CMI.
3. What if I am taking other medicines?
4. How do I take ELEVA?
Your doctor will tell you how many tablets you need to take each day. This may depend
on your age, your condition and whether or not you are taking any other medicines. More
instructions can be found in Section
4. How do I take ELEVA? in the full CMI.
5. What should I know while taking ELEVA?
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Things you should do
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Remind any doctor, dentist, pharmacist, surgeon or anaesthetist you visit that you
are taking ELEVA.
Watch carefully for signs of your depressive symptoms getting worse as they may occur
in the first 1 or 2 months of treatment or when the doctor changes your dose.
Tell your doctor immediately or go to the nearest hospital if you have any distressing
thoughts, or if you have any symptoms of serotonin syndrome.
Call your doctor straight away if you become pregnant while taking ELEVA.
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Things you should not do
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Do not stop taking ELEVA, or change the dose, without first checking with your doctor.
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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 ELEVA
affects you.
Children should be careful when riding bicycles or climbing trees.
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Drinking alcohol
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Tell your doctor if you drink alcohol. Avoiding alcohol while you are taking ELEVA
may be suggested.
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Looking after your medicine
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Keep your tablets in their blister pack until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Speak to your doctor or pharmacist if you have: headache, dizziness, shaking or tremors, unusually overactive, muscle stiffness or
weakness, decrease or loss of touch or other senses, sleepiness, drowsiness, impaired
concentration, vision disturbance.
Call your doctor straight away if you have: agitation, nervousness, anxiety, frightening dreams, yawning, abnormal thinking,
teeth grinding, uncontrollable muscle spasms affecting the eyes, head, neck and body,
temporary paralysis or weakness of muscles, lockjaw, painful, swollen joints, difficulty
in breathing, wheezing or coughing, uncontrollable movements of the body.
Tell your doctor immediately or go straight to Emergency at your nearest hospital
if you have: fits or seizures, signs of allergy such as rash or hives, swelling of the face, lips
or tongue, wheezing or difficulty breathing, symptoms of sudden fever with sweating,
fast heartbeat and muscle stiffness, which may lead to loss of consciousness, thoughts
of suicide or self-harm.
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:
sertraline hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ELEVA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking ELEVA.
Where to find information in this leaflet:
1. Why am I taking ELEVA?
ELEVA contains the active ingredient sertraline hydrochloride. ELEVA belongs to a group of medicines called selective serotonin reuptake inhibitors
(SSRIs). They are thought to work by blocking the uptake of a chemical called serotonin
into nerve cells in the brain. Serotonin and other chemicals called amines are involved
in controlling mood.
ELEVA is used to treat depression and conditions called obsessive compulsive disorder
(OCD), panic disorder, social phobia (social anxiety disorder) in adults and premenstrual
dysphoric disorder (PMDD) in women.
PMDD affects some women in the days before their period. PMDD is different from premenstrual
syndrome (PMS). The mood symptoms (anger, sadness, tension, etc) in PMDD are more
severe than in PMS and affect the woman's daily activities and relationships with
others.
ELEVA should not be used in children and adolescents under the age of 18 years for
the treatment of any medical condition other than obsessive compulsive disorder (OCD).
The safety and efficacy of ELEVA for the treatment of medical conditions (other than
OCD) in this age group have not been satisfactorily established.
For the treatment of OCD, ELEVA is not recommended for use in children under the age
of 6, as the safety and efficacy in children of this age group has not been established.
There is no evidence that ELEVA is addictive.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
2. What should I know before I take ELEVA?
Warnings
Do not take ELEVA if:
you are allergic to sertraline, or any of the ingredients listed at the end of this
leaflet.
Some of the 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
rash, itching or hives on the skin.
Always check the ingredients to make sure you can take this medicine.
you have epilepsy not properly controlled by medication.
you are taking another medicine for depression called a monoamine oxidase inhibitor
(MAOI) or have been taking it within the last 14 days. Taking ELEVA with a MAOI (e.g. Aurorix, Eldepryl, Nardil, Parnate) may cause a serious
reaction with a sudden increase in body temperature, extremely high blood pressure
and convulsions (fits).
you are taking:
phentermine, a medicine used to help weight loss
tryptophan, an amino acid which may be found in protein-based foods, some sports and
dietary supplements or multivitamin preparations
methadone, a medicine used to treat drug addiction
medicines used to treat migraine, e.g. sumatriptan (Imigran)
dextromethorphan, a medicine used as a cough suppressant in some cold and flu medications
pimozide, a medicine used to treat disturbances in thinking, feeling and behaviour
medicines used for pain management such as fentanyl, tapentadol (Palexia), tramadol
or pethidine.
These medicines can cause an exaggerated response to ELEVA.Ask your doctor or pharmacist
if you are not sure if you have been taking one of these medicines.
Do not give ELEVA to:
children or adolescents under the age of 18 unless the doctor has prescribed it for
the treatment of OCD.
children under the age of 6 for the treatment of OCD.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should be taking ELEVA, talk to your doctor.
Check with your doctor if you:
have or have had any of the following medical conditions:
any other mental illness
epilepsy or seizures
liver or kidney problems
heart conditions causing irregular heartbeats
a tendency to bleed more than normal
diabetes mellitus
glaucoma, an eye condition
are pregnant or intend to become pregnant
are breastfeeding or wish to breastfeed
take any medicines for any other conditions.
Tell your doctor if you have allergies to any foods, dyes, preservatives or any other
medicines.
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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
There have been reports that babies exposed to ELEVA and other antidepressants during
the third trimester of pregnancy may develop complications immediately after birth.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
ELEVA passes into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of taking ELEVA when pregnant or breastfeeding.
If you have not told your doctor about any of the above, tell them before you start
taking ELEVA.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including all
medicines, vitamins, natural therapies or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Some medicines may interfere with ELEVA and affect how it works.
Tell your doctor or pharmacist if you are taking any of the following medicines:
MAOIs (monoamine oxidase inhibitors), a group of medicines used to treat depression
and the symptoms of Parkinson's disease
Taking ELEVA with a MAOI, or within 14 days of stopping a MAOI may cause a serious
reaction with a sudden increase in body temperature, extremely high blood pressure
and convulsions (fits).
other MAOI drugs such as linezolid, an antibiotic used to treat pneumonia and certain
skin infections
other medicines for depression, panic disorder, social anxiety disorder or obsessive
illnesses (e.g. dosulepin (Dothep), fluoxetine (Prozac), paroxetine (Aropax), citalopram
(Cipramil), venlafaxine (Efexor XR))
lithium (e.g. Lithicarb), a medicine used to treat mood swings
other medicines for PMDD (e.g. Prozac)
tryptophan (contained in protein-based foods or dietary proteins)
phentermine (weight-reducing medicines)
dextromethorphan (used in cold and flu medicines to suppress cough)
medicines for strong pain management such as fentanyl, tapentadol (Palexia), tramadol
or pethidine
methadone, a medicine used to treat drug addiction
other medicines used to relieve pain, swelling and other symptoms of inflammation,
including arthritis (e.g. aspirin or NSAIDs such as ibuprofen or diclofenac)
metamizole, which is an inducer of metabolising enzymes, as this may cause a reduction
in plasma concentrations of sertraline thus efficacy
pimozide, a medicine used to treat disturbances in thinking, feeling and behaviour
St John's wort, a herbal remedy used to treat mood disorders
medicines for treating psychotic illness such as clozapine (e.g. Clozaril) which is
used to treat schizophrenia
flecainide (e.g. Tambocor), a medicine used to treat irregular heartbeats
warfarin (e.g. Marevan, Coumadin) or other medicines used to prevent blood clots
phenytoin (e.g. Dilantin), a medicine used to treat epilepsy
sumatriptan (e.g. Imigran), a medicine used to treat migraine
diazepam or other medicines that act on the brain or nervous system (e.g. Serepax,
Valium)
cimetidine, a medicine used to treat reflux and ulcers
tolbutamide, a medicine used to treat diabetes
dexamphetamine and lisdexamfetamine, medicines used to treat Attention Deficit Hyperactivity
Disorder (ADHD)
antibiotics.
These medicines may be affected by ELEVA or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
You should wait at least 14 days after stopping ELEVA before starting any other medicines
for depression or obsessive illnesses from the MAOI group, such as Aurorix (moclobemide),
Eldepryl (selegiline), Nardil (phenelzine), and Parnate (tranylcypromine).
All of the above precautions are important even after you have stopped taking ELEVA.
The effects of ELEVA may last for some days after you have stopped taking it.
Not all brand names are given for the medicines listed above. Your doctor or pharmacist
has more information on these medicines or other medicines to be careful with or avoid
while taking ELEVA.
If you have not told your doctor or pharmacist about these things, tell them before
you start taking ELEVA.
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 ELEVA.
4. How do I take ELEVA?
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
Your doctor will tell you how many tablets you need to take each day. This may depend
on your age, your condition and whether or not you are taking any other medicines.
Depression - Adults
The usual starting dose is one 50 mg tablet each day. Your doctor may increase the
dose gradually up to 200 mg a day if necessary.
Obsessive Compulsive Disorder - Children (6-12 years)
The usual starting dose is 25 mg each day which is half a 50 mg tablet. Your doctor
may increase the dose to 50 mg per day after one week.
Obsessive Compulsive Disorder - Adults and Adolescents (13-18 years) and Adults
The usual starting dose is one 50 mg tablet each day.
Panic Disorder - Adults
The usual starting dose is 25 mg day each day which is half a 50 mg tablet. Your doctor
may increase the dose to 50 mg per day after one week.
Social Phobia (Social Anxiety Disorder) - Adults
The usual starting dose is 25 mg each day which is half a 50 mg tablet. Your doctor
may increase the dose to 50 mg per day after one week.
Do not take more than 200 mg a day for the conditions listed above.
Premenstrual Dysphoric Disorder (PMDD)
If taking throughout the menstrual cycle
The usual starting dose is one 50 mg tablet a day. This may be increased to a maximum
of 150 mg a day if needed. Increase the dose in a step wise fashion. If you are unclear
how to do this ask your pharmacist or doctor for advice.
If taking ELEVA in the last 14 days of the menstrual cycle
The usual starting dose is one 50 mg tablet a day. This may be increased to a maximum
of 100 mg a day.
Do not take more than the maximum doses recommended above for PMDD.
Follow the instructions provided and take ELEVA until your doctor tells you to stop.
When to take ELEVA
Try to take your tablet 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
remember when to take it.
ELEVA can be taken with or without food.
For women with PMDD, your doctor may ask you to take this medicine only at certain
times of the month.
How to take ELEVA
Swallow the tablets with a glass of water.
How long to take ELEVA
Most medicines for depression and obsessive illnesses take time to work so do not
be discouraged if you do not feel better straight away.
It may take 2 to 4 weeks or even longer to feel the full benefit of ELEVA.
Continue taking your medicine for as long as your doctor tells you to.
Even when you feel well, you may need to take ELEVA for several months or even longer.
If you have PMDD, your doctor may ask you to take this medicine only at certain times
of the month.
Do not stop taking ELEVA, or change the dose, without first checking with your doctor.
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 (i.e. one to two months).
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.
Contact your doctor if you experience any worsening of your depression or other symptoms
at any time during your treatment.
If you forget to take ELEVA
ELEVA should be taken regularly at the same time each day. If you miss your dose at
the usual time and 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 to take your medicine, ask your pharmacist for some
hints.
If you take too much ELEVA
If you think that you or anyone else have taken too much ELEVA, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) 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.
Symptoms of an overdose may include:
feeling drowsy
nausea, diarrhoea, vomiting
fast or irregular heartbeats
tremors
feeling agitated or dizzy.
5. What should I know while taking ELEVA?
Things you should do
Tell your doctor or pharmacist that you are taking ELEVA if you are about to be started
on any new medicines.
Tell the surgeon or anaesthetist that you are taking this medicine if you are going
to have surgery.
It may interact with other medicines used during surgery and cause unwanted side effects.
Keep all of your doctor's appointments so that your progress can be checked.
Tell your doctor that you are taking this medicine if you are about to have any urine
tests. It may interfere with the results of some tests.
Call your doctor straight away if you:
become pregnant while taking ELEVA. Do not stop taking this medicine until you have
spoken to your doctor.
If you are a woman of child-bearing age, you should avoid become pregnant while taking
ELEVA.
have any suicidal thoughts or other mental/mood changes.
A worsening of depressive symptoms including thoughts of suicide or self-harm may
occur in the first one or two months of you taking ELEVA or when the doctor changes
your dose. These symptoms should subside when the full effect of ELEVA takes place.
Children, adolescents or young adults under 24 years of age are more likely to experience
these effects during the first few months of treatment.
Patients and caregivers should be alert and monitor for these effects.
Signs and symptoms of suicide include:
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts of suicide or self-harm
increase in aggressive behaviour, irritability or agitation
worsening of depression.
All mention of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking
ELEVA, contact your doctor or a mental health professional right away.
Children should have regular check-ups with the doctor to monitor growth and development.
Remind any doctor, dentist or pharmacist you visit that you are taking ELEVA.
Things you should not do
Do not suddenly stop taking your medicine, or change the dose, without checking with
your doctor.
Suddenly stopping ELEVA may cause dizziness, light headedness, numbness, unusual tingling
feelings or shakiness.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take ELEVA to treat any other complaints unless your doctor tells you to.
Do not let yourself run out of tablets 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 ELEVA
affects you.
Some medicines for depression may affect your ability to drive or operate machinery
or do anything else that could be dangerous if you are not alert.
Children should be careful when riding bicycles or climbing trees.
Drinking alcohol
Tell your doctor if you drink alcohol.
Although drinking moderate amounts of alcohol is unlikely to affect your response
to ELEVA, your doctor may suggest avoiding alcohol while you are taking ELEVA.
If you are feeling drowsy or are uncoordinated, be careful that you do not fall over.
ELEVA, like other medicines in this class, may increase your risk of bone fracture.
Looking after your medicine
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one and a half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ELEVA.
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.
It can be difficult to tell whether side effects are the result of taking ELEVA, effects
of your condition or side effects of other medicines you may be taking. For this reason
it is important to tell your doctor of any change in your condition.
Do not be alarmed by the list of side effects. You may not experience any of them.
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, dizziness, shaking or tremors, unusually overactive, muscle stiffness or
weakness, decrease or loss of touch or other senses, sleepiness, drowsiness, impaired
concentration
vision disturbance
sleeping difficulties
tiredness, fever, feeling unwell
increased sweating, rash, hives
hot flush, high blood pressure
weight increase or loss
increased or decreased appetite
dry mouth, nausea, feeling sick, indigestion, diarrhoea, vomiting, stomach pain, constipation
inflammation of the colon (causing diarrhoea)
menstrual irregularities in women
sexual problems
sexual dysfunction including impaired sexual function in males
difficulty in passing urine, or increased frequency
persistent noise in the ears
tingling and numbness of hands and feet
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Speak to your doctor or pharmacist 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, nervousness, anxiety, frightening dreams, yawning, abnormal thinking, teeth
grinding, symptoms of agitation, anxiety dizziness, headache, nausea and tingling
or numbness of the hands and feet after stopping ELEVA
uncontrollable muscle spasms affecting the eyes, head, neck and body, temporary paralysis
or weakness of muscles
lockjaw
painful, swollen joints
difficulty in breathing, wheezing or coughing
uncontrollable movements of the body, shuffling walk, unusual weakness,
palpitations, fainting or chest pain
irregular heartbeats
abnormal bleeding including vaginal bleeding,
sudden onset of severe headache
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Call your doctor straight away if you notice any of these serious side effects.
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Very Serious side effects
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Very Serious side effects
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What to do
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fits or seizures
signs of allergy such as rash or hives, swelling of the face, lips or tongue, wheezing
or difficulty breathing
symptoms of sudden fever with sweating, fast heartbeat and muscle stiffness, which
may lead to loss of consciousness
thoughts of suicide or attempting suicide or self-harm.
The following symptoms are signs of side effects named Serotonin Syndrome (SS) or
Neuroleptic Malignant Syndrome (NMS). SS is caused by medications which build up high
levels of serotonin in the body. NMS is a life-threatening emergency associated with
the use of antipsychotic medicines. The risk of SS and NMS with SSRI’s is increased
with combined use of other SSRIs, MAOIs and other antipsychotic medicines.
agitation
hallucinations
coma
fast heartbeat
fluctuating blood pressure readings
high body temperature
twitching and spastic body movements
lack of body co-ordination
nausea
vomiting
diarrhoea
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Tell you doctor immediately or go straight to the Emergency Department at your nearest
hospital if you notice any of these serious side effects.
You may need urgent medical attention or hospitalisation.
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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.
Some of these side effects (e.g., changes in thyroid function, liver function or glucose
control) can only be found when your doctor does tests from time to time to check
your progress.
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 ELEVA contains
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Active ingredient
(main ingredient)
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sertraline 50 mg or 100 mg per tablet
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
calcium hydrogen phosphate
sodium starch glycollate type A
magnesium stearate
purified water
Opadry II Complete film coating system Y-22-7719 white (ARTG PI No: 2578)
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Do not take this medicine if you are allergic to any of these ingredients.
What ELEVA looks like
ELEVA 50: 4.2-4.5 mm x 10.3-10.7 mm, white to off-white, capsule shaped, film-coated
tablets with “ST|50” on one side and "G" on the other side. (AUST R 95581 and AUST
R 95582)
ELEVA 100: 5.2-5.6 mm x 13.0-13.4 mm, white to off-white, capsule shaped, film-coated
tablets with “ST|100” on one side and "G" on the other side. (AUST R 95583 and AUST
R 95584)
Each blister pack contains 30 tablets.
Who distributes ELEVA
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 December 2023.
ELEVA® is a Viatris company trade mark
ELEVA_cmi\Dec23/00