APO-Citalopram

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Contains the active ingredient citalopram (as citalopram hydrobromide)
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What this medicine is used for

APO-Citalopram contains the active ingredient citalopram (as citalopram hydrobromide).
It is used to treat depression.
Citalopram belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Citalopram 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 over nothing.
Citalopram corrects this chemical imbalance and may help relieve the symptoms of depression.
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.
There is no evidence that this medicine is addictive.
However, if you suddenly stop taking it, you may get side effects.
This medicine is available only with a doctor's prescription.
Do not give this medicine to a child or adolescent.
The benefit and safety of citalopram use in children and adolescents below 18 years of age has not been proven.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
any medicine containing citalopram
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
Do not take this medicine if you are taking 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 citalopram until 14 days after stopping most MAOIs. The exception is the MAOI, moclobemide, where you may take citalopram one whole day after finishing taking moclobemide.
Taking citalopram 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 citalopram after the MAOI has been stopped.
linezolid, used in some serious bacterial infections
Do not take this medicine if you have or have had any of the following medical conditions:
Congenital Long QT Syndrome, where your heart beats unusually, and you may feel short of breath, dizzy or faint. Your doctor will tell you if you have this.
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.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
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 citalopram if your epilepsy is not properly controlled; if it is properly controlled your doctor will wish to watch you carefully if you take citalopram)
heart problems
liver problems
kidney problems
problems with blood clotting or abnormal bleeding, or bruise easily
thoughts or actions relating to self-harm or suicide
diabetes
lactose or galactose intolerance, Lapp lactase insufficiency, glucose or galactose malabsorption
(These tablets contain lactose)
a decreased level of sodium or potassium in your blood, which may be due to certain medicines (e.g. certain diuretics [water tablets] and antibiotics), or to certain medical conditions (e.g. kidney problems, dehydration, excess sweating or vomiting or diarrhoea). Your doctor will test you for this before you start taking citalopram.
restlessness and/or a need to move often (akathisia)
raised intraocular pressure (fluid pressure in the eye), or if you are at risk of angle-closure glaucoma
Tell your doctor if you are pregnant or plan to become pregnant.
There have been reports that babies exposed to certain 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.
Citalopram has also been shown to reduce the quality of sperm in animal studies, which may affect fertility. If you are intending to start a family, ask your doctor for advice.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not recommended that you breast-feed while taking this medicine because citalopram 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.
Tell your doctor if you are receiving electroconvulsive treatment (ECT).
If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription 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 citalopram. These include:
monoamine oxidase inhibitors, such as moclobemide, phenelzine, tranylcypromine, selegiline and linezolid
pimozide
Some other medicines may interact with citalopram. These include:
tryptophan, contained in some multivitamin and herbal preparations
tramadol, a strong pain killer
sumatriptan and similar medicines used to treat migraines and cluster headaches
St John's Wort (Hypericum perforatum), a herbal remedy
other medicines used to treat depression
lithium, used to treat mood swings and some types of depression
any other medicines used to treat anxiety, obsessive-compulsive disorder or pre-menstrual dysphoric disorder.
antipsychotics, medicines used to treat psychoses, schizophrenia and other conditions which affect the way you think, feel or act (e.g. olanzapine, risperidone)
prochlorperazine, used to prevent or treat severe nausea and vomiting
antiarrhythmics, medicines used to treat an irregular heart beat e.g. dipyridamole
medicines known to prolong bleeding e.g. aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) and anti-coagulants (such as warfarin and ticlopidine), which can thin the blood
beta-blockers such as metoprolol, used to treat high blood pressure and other heart problems
fluconazole, ketoconazole and itraconazole, medicines used to treat fungal infections
macrolide antibiotics, such as erythromycin and clarithromycin
certain other antibiotics which may lower your potassium or magnesium levels (e.g. penicillin)
carbamazepine and other medicines used to control epilepsy (fits).
cimetidine and medicines called proton pump inhibitors (e.g. omeprazole) used to treat reflux and stomach ulcers
certain diuretics (water tablets)
If you are taking any of these you may need a different dose or you may need to take different medicines.
If you take medicines which affect the heart rhythm whilst taking citalopram then your doctor will do regular tests on your heart (ECG). Citalopram may also cause changes to your heart rhythm.
Other medicines not listed above may also interact with citalopram.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

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 directions, ask your doctor or pharmacist for help.

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.
The usual starting dose for adults is 20 mg per day.
Your doctor may increase your dose slowly in stages of 10 mg depending on how you respond to this medicine. The maximum dose is 40 mg a day.
Elderly people have a starting dose of 10 mg per day, which may be increased slowly to a maximum dose of 20 mg a day.
People who take cimetidine or other medicines which affect the blood levels of citalopram (called CYP 2C19 inhibitors), or people who have liver problems should not take more than 20 mg of citalopram per day.
Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow the tablets whole with a full glass of water. Do not chew them.

When to take it

Take it as a single dose, either in the morning or in the evening, at about 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, even if it takes some time before you feel any improvement in your condition.
Make sure you have enough to last over weekends and holidays.
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 this medicine.
Your doctor will check your progress at regular intervals.
The length of treatment may vary for each individual, but is usually at least 6 months.
In some cases your doctor may decide that longer treatment is necessary.
The underlying illness may last for a long time and if you stop your medicine too soon, your symptoms may return.
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.
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.

Stopping 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.
Do not stop taking your medicine suddenly.
If you suddenly stop taking your medicine, you may experience mild, but usually temporary, symptoms such as dizziness, feelings like pins and needles, sleeping problems (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), vomiting, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, or fast or irregular heartbeats.
When you have completed your course of treatment, it is better that your dose 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 help avoid getting any unwanted effects.

If you forget to take it

If you are less than 12 hours late in taking your dose, take the missed dose as soon as you remember and then go back to taking your dose as you normally would.
If you are more than 12 hours late, then 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 missed doses.
This may increase the chance of you experiencing side effects.
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 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 nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much citalopram you may get symptoms of nausea (feeling sick), vomiting, dizziness, fast or slow heart beat or change in heart rhythm, decreased or increased blood pressure, tremor (shaking), agitation, dilated pupils of the eyes, drowsiness or sleepiness. Convulsions, coma, and rarely, temporary paralysis or weakness of muscles may occur.
A condition called serotonin syndrome may occur, with high fever, agitation, confusion, trembling and abrupt contraction of muscles.

While you are taking this medicine

Things you must do

Persons taking citalopram may be more likely to think about killing themselves or actually trying to do so, especially when citalopram 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 citalopram 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.
If you or someone you know or care for is showing any of the following warning signs of suicide-related behaviour while taking this medicine, contact your doctor 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
worsening of depression.
Follow your doctor's instructions. Do not stop taking this medicine or change the dose without consulting your doctor, even if you experience increased anxiety at the beginning of treatment.
At the beginning of treatment certain patients may experience increased anxiety, which will disappear during continued treatment.
Tell your doctor immediately if you experience symptoms such as restlessness or difficulty in sitting or standing still.
These symptoms can also occur during the first weeks of treatment.
Contact your doctor immediately if you suddenly experience an episode of mania.
Some people with manic depression (bipolar disorder) may enter a manic phase. Symptoms of mania include lots of rapidly changing thoughts or ideas, exaggerated gaiety, being much more physically active and much more restless.
Sometimes you may not know that you are manic, so it may be helpful to have a friend or relative watch over you for any possible signs of change in your behaviour.
Visit your doctor regularly so they can check on your progress.
Tell your doctor immediately if you become pregnant.
If you are a woman of child-bearing age, you should avoid becoming pregnant while taking citalopram.
Make sure your midwife and/or doctor know you are taking citalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like citalopram 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 immediately.
Low Potassium or Sodium
Some people (especially older people or those taking diuretics/water tablets or people who are dehydrated, have diarrhoea or vomiting or take certain antibiotics) may experience a lack of sodium or potassium in the blood when taking this medicine. Tell your doctor if you get a headache or start to feel dizzy, confused, forgetful, weak or fatigued, unsteady or unable to concentrate or if you get muscle weakness or spasms or abnormal heart beats or have problems breathing.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
If you start to breastfeed or are planning to breastfeed while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. If you are taking certain other medicines or have heart problems you doctor will monitor you closely.
Keep all your doctor's appointments so that your progress can be checked.
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 this medicine is 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 your heart beats unusually, and/or you feel short of breath, dizzy or faint.
Make sure you have enough tablets to last over weekends and holidays.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen, or you may have unwanted side effects.
Your doctor will tell you how to gradually reduce the dose of your medicine. This is usually done slowly, over 1 to 2 weeks, before stopping completely.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
This medicine may cause nausea, fatigue, dizziness, visual disturbances or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Avoid alcohol while you are taking this medicine.
It is best not to drink alcohol while you are being treated for depression.
You should be aware that people over 50 years of age who take antidepressants have an increased risk of having a bone fracture.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.
All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
feeling tired and weak (fatigued), hot flushes, fever, feeling unwell, shaking or tremors, migraine, headache, dizziness or giddiness
muscle, back, bone, nerve or joint pain, stiffness, weakness or cramps, decrease or loss of touch or other senses
increased or decreased sensitivity to outside stimuli
feeling or being sick, reflux, diarrhoea or loose bowel motions, constipation, indigestion, stomach pain or discomfort, wind
increased saliva or dry mouth, taste disturbance
feeling thirsty
burping, hiccups, problems swallowing, sore mouth, tongue or throat, haemorrhoids (piles)
sleepiness, drowsiness, sleeping difficulties, strange dreams
sexual disturbances (decreased sexual drive, problems with orgasm; problems with ejaculation or erection)
frightening or unusual dreams, yawning, teeth grinding or clenching, increased or decreased appetite, impaired concentration
excessive and/or abnormal movements
increased muscle tension, muscle twitching
problems with eyes or eyesight
feeling faint or dizzy when you stand up due to low blood pressure
unable to tolerate alcohol
menstrual irregularities, breast pain, unusual vaginal bleeding
loss of bladder control
unusual hair loss or thinning
tingling or numbness of the hands or feet
drooping eyelid
breast enlargement or the unusual secretion of breast milk in men or women
increased sensitivity of the skin to sun
mild rash, or itching or prickling of the skin
acne, eczema, dermatitis, dry skin, psoriasis or other skin problem
ringing or other persistent noise in the ears
increased or decreased sweating
bruises or skin discolouration
weight decrease or weight increase
flu-like symptoms, runny or blocked nose, sneezing, facial pressure or pain, coughing or sore throat
a sense of indifference to everything.
Some of these side effects may occur within the first two weeks of treatment and disappear after a short period of time.
Tell your doctor as soon as possible if you notice any of the following:
nervousness, confusion, problems with concentration, loss of memory
feeling restless or unable to sit still
stomach pain with nausea and vomiting of blood, or blood in the bowel movements
anxiety, agitation, aggression, worsening of depression
general swelling or swollen hands, ankles, feet or face or eye area due to fluid build-up
blurred vision
problems speaking
feelings of not being part of your body, or in a daze
feeling sick or unwell with weak muscles or feeling confused (these symptoms may be signs of a rare condition as a result of low levels of sodium in the blood, which may be caused by antidepressants, especially in elderly female patients)
feeling fatigued with muscle weakness or spasms or abnormal heart beats or problems breathing. This may be due to low potassium levels in your blood.
increased tendency to develop bruises or broken bones
passing more or less urine than normal, or problems when urinating
agitation, anxiety, 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 citalopram.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
convulsions (fits or seizures)
coma (unconsciousness)
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
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
abnormal bleeding
kidney 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
sudden, severe breathing problems
feeling paranoid, panicky, or "high" or having mood swings or feeling more depressed or in a trance
tremors, movement disorders such as involuntary movements of the muscles or being uncoordinated
jaundice (yellowing of the skin and/or eyes) , with or without other signs of hepatitis or liver problems (loss of appetite, tiredness, feeling or being sick, dark urine, stomach pain or swelling, confusion, unconsciousness).
sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech
symptoms of an allergic reaction including 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
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.

Storage and disposal

Storage

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.

New formulation

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 windowsill 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.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Citalopram look like

APO-Citalopram 20 mg Tablets
White to off-white, oval, biconvex, film-coated tablets, with BL embossed on one side and '20' on the other. AUST R 226578. AUST R 233166.
APO-Citalopram 40 mg Tablets
White to off-white, oval, biconvex, film coated tablets with '40' embossed on one and 'BL' embossed on the other side. AUST R 226579. AUST R 233165.
Available in bottles or blister packs of 28 tablets.
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 20 mg or 40 mg of citalopram (as citalopram hydrobromide) as the active ingredient.
It also contains the following inactive ingredients:
lactose
maize starch
microcrystalline cellulose
croscarmellose sodium
magnesium stearate
hypromellose
titanium dioxide
purified talc
macrogol 400
purified water
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue,
Macquarie Park NSW 2113
 
APO is registered trademarks of Apotex Inc.
 
This leaflet was last updated in July 2020.