Contains the active ingredient sertraline (as sertraline hydrochloride)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about sertraline. It does not contain all the available information. It does not
take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine
may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they
expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Sertraline. It contains the active ingredient sertraline (as sertraline hydrochloride).
It is used to treat:
social anxiety disorder or social phobia
Pre-Menstrual Dysphoric Disorder (PMDD)
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed
this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Sertraline belongs to a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs). Serotonin is one of the
chemicals in your brain which helps control your mood. Sertraline and other SSRIs are thought to help by increasing the amount
of serotonin in your brain.
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
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 relationship
There is no evidence that this medicine is addictive.
Clinical experience has shown that sertraline should not affect the ability to drive or operate machinery. However, make sure
you know how sertraline affects you before driving or operating machinery, as it can make some people drowsy or dizzy or affect
Use in children
This medicine should not be used in children.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You are taking any of the following medicines:
Pimozide (used to treat disorders which affect the way you think, feel or act)
Monoamine Oxidase Inhibitors (MAOIs), used to treat depression (phenelzine, tranylcypromine, moclobemide), Parkinson's Disease
(selegiline) or infections (linezolid).
Do not take sertraline until 14 days after stopping any MAOI, and do not take MAOIs until 14 days after stopping sertraline.
Taking sertraline with MAOIs may cause a serious reaction with signs such as a sudden increase in body temperature, very high
blood pressure, rigid muscles, nausea/vomiting and/or fits (convulsions). Your doctor will know when it is safe to start sertraline
after the MAOI has been stopped.
You have had an allergic reaction to sertraline or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the
face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately
or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
mania, hypomania, bipolar disorder or any other conditions which affect the way you think, feel or act
epilepsy or convulsions, fits or seizures (you should avoid taking sertraline if your epilepsy is not properly controlled;
if it is properly controlled your doctor will wish to watch you carefully if you take sertraline)
problems with blood clotting or abnormal bleeding
thoughts or actions relating to self-harm or suicide.
3.You are currently pregnant or you plan to become pregnant. It is not recommended that you take this medicine whilst pregnant.
The effects of sertraline on the developing baby are not yet known. There have been reports that babies exposed to sertraline
and other antidepressants during the third trimester of pregnancy may develop complications after birth. Do not take this
medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
4.You are currently breast-feeding or you plan to breast-feed. Sertraline passes into breast milk and may affect your baby.
Do not take this medicine whilst breast-feeding until you and your doctor have discussed the risks and benefits involved.
5.You are planning to have, or have recently had, surgery or an anaesthetic.
6.You are currently receiving or are planning to receive dental treatment.
7.You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from
your pharmacy, supermarket or health food shop.
Some combinations of medicines may increase the risk of serious side effects and are potentially life-threatening. Therefore
some medicines must not be taken with sertraline. These include:
monoamine oxidase inhibitors, such as moclobemide, phenelzine, tranylcypromine, selegiline and linezolid
Some other medicines may interact with sertraline. These include:
phentermine, a weight loss medicine
tryptophan, contained in some multivitamin and herbal preparations
tramadol, a strong pain-killer
sumatriptan, naratriptan and zolmitriptan, used for treating migraines
St John's Wort (Hypericum perforatum ) , a herbal remedy for mood disorders
other SSRIs (e.g. fluoxetine, citalopram, paroxetine, fluvoxamine)
other medicines for depression, mood disorders or social anxiety disorder, such as dothiepin, desipramine, amitriptyline,
lithium and venlafaxine
medicines called antipsychotics, used to treat psychoses, schizophrenia and other conditions which affect the way you think,
feel or act
prochlorperazine, used to prevent or treat severe nausea and vomiting
phenytoin, used to control epilepsy or fits
medicines used to treat heart conditions, such as flecainide and propafenone
medicines called diuretics, used to get rid of excess fluid from the body, and to treat high blood pressure
medicines known to prolong bleeding, e.g. aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) and anti-coagulants
(such as warfarin), which can thin the blood
cimetidine, used to treat stomach ulcers or reflux
methadone, a medicine used to treat drug addiction
diazepam, a medicine used to treat anxiety disorders
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with sertraline.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information
in this leaflet.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and
whether you are taking any other medicines.
Adults (18 years and older)
The usual starting dose for sertraline is one 50 mg tablet each day. The dose can be increased gradually up to 200 mg a day
For Social Phobia (Social Anxiety Disorder)
The usual starting dose for sertraline is 25 mg per day (half a 50 mg tablet), increasing to 50 mg per day after one week.
The maximum recommended dose of sertraline for the treatment of social phobia is 200 mg per day.
For Pre-Menstrual Dysphoric Disorder (PMDD)
The usual starting dose for sertraline is one 50 mg tablet each day, either throughout the menstrual cycle (to a maximum of
150 mg daily) or for the last 14 days before the start of your period (to a maximum of 100 mg daily).
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Swallow the tablets with a glass of water.
When to take it
Take your tablets once a day, either in the morning or in the evening.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also
help you remember when to take it.
It does not matter if you take it before, with or after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Most antidepressants take time to work, so don't be discouraged if you don't feel better right away. Some of your symptoms
may improve in 1 or 2 weeks but it can take up to 4 to 6 weeks to feel any real improvement. Even when you feel well, you
will usually have to take sertraline for several months or even longer to make sure the benefits will last.
Make sure you have enough to last over weekends and holidays.
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.
Also contact your doctor if you experience any worsening of your depression or other symptoms at any time during your treatment.
Do not stop taking this medicine even if you begin to feel better.
Your doctor may decide that you should continue to take it for some time, even when you have overcome your problem. For best
effect, this medicine must be taken regularly.
Your doctor will tell you when and how this medicine should be discontinued. Your doctor will usually recommend that you stop
treatment by slowly reducing the dosage over a period of several weeks. When you stop treatment with this medicine especially
if this is done suddenly, you may experience unwanted side effects such as headache, feeling dizzy, sick, irritable, agitated,
lethargic or anxious; sweating; pins and needles or electric shock feelings, changing moods or emotions, or disturbed sleep
if sertraline is stopped, particularly if stopped suddenly.
If you forget to take it
Do not take an extra dose. Wait until the next day and take your normal dose then.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons
Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much sertraline, you may have some of the following symptoms: sedation, nausea, diarrhoea, vomiting, fast
heartbeat, tremor, agitation, dizziness and unconsciousness.
While you are taking this medicine
Things you must do
People taking sertraline may be more likely to think about killing themselves or actually try to do so, especially when sertraline
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 sertraline 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 during the first one to two months of taking sertraline until the medicine starts to work completely.
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
If you or someone you know or care for demonstrates any of the following warning signs of suicide-related behaviour while
taking sertraline, contact a doctor immediately, or even go to the nearest hospital for treatment:
thoughts or talk of death or suicide
thoughts of 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.
Tell your doctor immediately if you become pregnant.
If you are a woman of child-bearing age, you should avoid becoming pregnant while taking sertraline.
Make sure your midwife and/or doctor know you are taking sertraline. When taken during pregnancy, particularly in the last
3 months of pregnancy, medicines like sertraline 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 midwife and/or doctor
Some people (especially older people or those taking diuretics/water tablets) may experience a lack of sodium in the blood
when taking this medicine. Tell your doctor if you get a headache or start to feel dizzy, confused, forgetful, weak, unsteady
or unable to concentrate.
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are breast-feeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor
regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets are not helping your condition.
If you are being treated for depression, be sure to discuss with your doctor any problems you may have and how you feel, especially
any feelings of severe sadness, thoughts of suicide, bursts of unusual energy, anger or aggression, or if you become particularly
agitated or restless.
Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes.
Make sure you have enough tablets to last over weekends and holidays.
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor. If you stop taking it suddenly,
your condition may worsen or you may have unwanted side effects (see "Things to be careful of").
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause dizziness, drowsiness or impaired concentration in some people. If you have any of these symptoms,
do not drive, operate machinery, or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking sertraline.
If you drink alcohol, dizziness, drowsiness or impaired concentration may be worse.
Although drinking moderate amounts of alcohol is unlikely to affect your response to this medicine, your doctor may suggest
avoiding alcohol while you are being treated with this medicine.
You should wait at least 14 days after stopping sertraline before starting any medicines known as monoamine oxidase inhibitors
(MAOIs), such as selegiline, phenelzine, tranylcypromine, moclobemide and linezolid.
The effects of sertraline may last for some days after you have stopped taking it.
When your doctor decides that you should stop taking this medicine, the dose may be reduced slowly or the time between the
doses increased over 1 to 2 weeks.
Some people may have symptoms such as such as headache, feeling dizzy, sick, irritable, agitated, lethargic or anxious; sweating;
pins and needles or electric shock feelings, changing moods or emotions, or disturbed sleep if sertraline is stopped, particularly
if stopped suddenly.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking sertraline or if you have
any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side
effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
feeling tired and weak (fatigued), hot flushes, fever, feeling unwell, shaking or tremors, headache, dizziness
muscle pain, stiffness, weakness or cramps, decrease or loss of touch or other senses
dry mouth, increased sweating, feeling or being sick, diarrhoea or loose bowel motions, constipation, indigestion, stomach
tiredness, sleepiness, sleeping difficulties
weight increase or decrease
sexual problems, painful erection
frightening dreams, yawning, teeth grinding, increased or decreased appetite, impaired concentration
excessive and/or abnormal movements
increased muscle tension, muscle twitching
vision disturbance, dilated pupils or eye pain
menstrual irregularities, unusual vaginal bleeding
loss of bladder control
unusual hair loss or thinning
tingling or numbness of the hands or feet
breast enlargement in men or the unusual secretion of breast milk in men or women
increased sensitivity of the skin to sun
mild rash, itchy skin
ringing or other persistent noise in the ears
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
agitation, nervousness, anxiety, worsening of depression
abnormal or suspicious thinking
general swelling or swollen hands, ankles, feet or face or eye area due to fluid build-up
severe stomach or abdominal pain
symptoms of hyperglycaemia (high blood sugar): feeling hungry, thirsty and/or frequent or excessive urination
agitation, anxiety, dizziness, feeling tense and restless, tired, drowsy, lack of energy, irritable, problems sleeping, headache,
nausea and tingling or numbness of the hands and feet after stopping sertraline.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident
and Emergency department at your nearest hospital.
These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.
Convulsions (fits or seizures)
a collection of symptoms including weight gain (despite loss of appetite), feeling and being sick, muscle weakness and irritability
severe rash, with blisters and/ or excessive peeling of skin
skin rash combined with inflamed blood vessels
a sudden increase in body temperature, very high blood pressure, rigid muscles, nausea/vomiting and/or fits (convulsions).
These symptoms may be signs of a rare condition called Serotonin Syndrome.
Neuroleptic Malignant Syndrome (a serious reaction to some medicines with a sudden increase in body temperature, extremely
high blood pressure and severe convulsions)
fast, slow or irregular heartbeat, high blood pressure
palpitations, fainting or chest pain
difficulty in passing urine or blood in the urine
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
fever, sore throat, swollen glands, mouth ulcers, unusual bleeding or bruising under the skin
mood of excitement, over-activity and uninhibited behaviour or aggression
hearing, seeing or feeling things that are not there (hallucinations)
thoughts of suicide or attempting suicide or self-harm
jaundice (yellowing of the skin and/or eyes) , with or without other signs of hepatitis or liver failure (loss of appetite,
tiredness, feeling or being sick, dark urine, stomach pain or swelling, confusion, unconsciousness).
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to sertraline, do not take any more of this medicine and tell your doctor
immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing.
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in
the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist
can dispose of the remaining medicine safely.
What APO-Sertraline looks like
50 mg tablets:
White to off white, capsule shaped, biconvex, film coated tablets with breakline on one side and '50' and 'BL' embossed on
either side of the breakline.
100 mg tablets:
White to off white, capsule shaped, biconvex, film coated tablets with '100' and 'BL' embossed on one side.
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 50 mg or 100 mg of sertraline as the active ingredient.
It also contains the following inactive ingredients:
Calcium hydrogen phosphate anhydrous
cellulose - microcrystalline
Sodium starch glycollate type A
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Sertraline 50 mg tablets:
PVC/Al Blister packs of 30
AUST R 213177.
APO-Sertraline 100 mg tablets:
PVC/Al Blister packs of 30
AUST R 213180.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in: