APO-ESCITALOPRAM

APO-ESCITALOPRAM

Active ingredient(s): escitalopram oxalate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-ESCITALOPRAM. 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 APO-ESCITALOPRAM.

Where to find information in this leaflet:

1. Why am I using APO-ESCITALOPRAM?
2. What should I know before I use APO-ESCITALOPRAM?
3. What if I am taking other medicines?
4. How do I use APO-ESCITALOPRAM?
5. What should I know while using APO-ESCITALOPRAM?
6. Are there any side effects?
7. Product details

1. Why am I using APO-ESCITALOPRAM?

APO-ESCITALOPRAM contains the active ingredient escitalopram oxalate. APO-ESCITALOPRAM 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.

APO-ESCITALOPRAM 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.

APO-ESCITALOPRAM corrects this chemical imbalance and may help relieve the symptoms of depression.

APO-ESCITALOPRAM may also be used to treat patients who may avoid and/or are fearful of social situations.

APO-ESCITALOPRAM may also be used to treat patients who have excessive anxiety and worry.

APO-ESCITALOPRAM may also be used to treat irrational fears or obsessional behaviour (obsessive-compulsive disorder). Obsessive-compulsive disorder involves having both obsessions and compulsions. Obsessions are unwanted thoughts that occur over and over again. Compulsions are the ongoing need to repeat certain actions as a result of these thoughts.

Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

2. What should I know before I use APO-ESCITALOPRAM?

Warnings

Do not use APO-ESCITALOPRAM 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 or are breastfeeding
• have any other medical conditions
• take any medicines for any other condition

If you have, or have had any of the following conditions, tell your doctor before starting APO-ESCITALOPRAM:

• 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 (akathisia)
• raised intraocular pressure (fluid pressure in the eye), or if you are at risk of angle-closure glaucoma.
• thoughts or actions relating to self-harm or suicide
• a decreased level of sodium in your blood
• you are receiving electroconvulsive therapy

Medicines like APO-ESCITALOPRAM so called (SSRIs) may cause symptoms of sexual dysfunction (See Section 6. Are there any side effects?). In some cases, these symptoms have continued after stopping treatment.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Do not take APO-ESCITALOPRAM at the same time as the following other medicines:

• pimozide, a medicine used to treat mental disorders.
• monoamine oxidase inhibitors (MAOIs), such as phenelzine, tranylcypromine and moclobemide which are also used for the treatment of depression.
• monoamine oxidase inhibitors such as linezolid which is an antibiotic and selegiline which is used in the treatment of Parkinson’s Disease.

One day must elapse after you have finished taking moclobemide before you start taking APO-ESCITALOPRAM. If you have taken any other MAOI you will need to wait 14 days. After stopping APO-ESCITALOPRAM you must allow 14 days before taking any MAOI including moclobemide.

Taking APO-ESCITALOPRAM 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 APO-ESCITALOPRAM after the MAOI has been stopped.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Medicines like APO-ESCITALOPRAM have been shown to reduce the quality of sperm in animal studies, which theoretically could affect fertility. If you are intending to start a family, ask your doctor for advice.

When taken during pregnancy, particularly in the last three months of pregnancy, medicines like APO-ESCITALOPRAM 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 APO-ESCITALOPRAM 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 APO-ESCITALOPRAM so they can advise you.

If used during pregnancy APO-ESCITALOPRAM should never be stopped abruptly.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take APO-ESCITALOPRAM if you are breast-feeding unless you and your doctor have discussed the risks and benefits. It passes into breast milk and therefore there is a possibility that your baby may be affected.

APO-ESCITALOPRAM use in children and adolescents

Do not give APO-ESCITALOPRAM to a child or adolescent.

There is no experience with its use in children or adolescents under 18 years old.

APO-ESCITALOPRAM use in the elderly

APO-ESCITALOPRAM can be given to elderly patients over 65 years of age with a reduced dose.

The effects of APO-ESCITALOPRAM 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 APO-ESCITALOPRAM and affect how it works. These include:

• Medicines used to treat nicotine dependence (e.g., bupropion)
• Medicines used to treat reflux and ulcers such as, cimetidine, omeprazole, esomeprazole, and lansoprazole
• Non-steroidal anti-inflammatory drugs (NSAIDs), known to prolong bleeding (e.g., aspirin and other NSAIDs)
• Medicines used to prevent blood clots such as ticlopidine and warfarin
• Anti-fungal medicines (e.g., fluconazole)
• Anti-malaria medicines (e.g., mefloquine)
• Medicines used to treat migraines (e.g., sumatriptan)
• Medicines used to relieve pain (e.g., tramadol and similar medicines)
• Medicines affecting chemicals in the brain
• Some heart medicines such as flecainide, propafenone, metoprolol
• Amino acids (e.g., tryptophan)
• Medicines used to treat mood swings and some types of depression (e.g., lithium)
• Antipsychotics, a class of medicines use to treat certain mental and emotional disorders such as risperidone, thioridazine, haloperidol
• Tricyclic anti-depressants such as imipramine and desipramine
• St John’s Wort (Hypericum perforatum), an herbal remedy
• Any other medicines for depression, anxiety obsessive-compulsive disorder or pre-menstrual dysphoric disorder.

These medicines may be affected by APO-ESCITALOPRAM 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 APO-ESCITALOPRAM.

4. How do I use APO-ESCITALOPRAM?

How much to take / use

• 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 APO-ESCITALOPRAM until your doctor tells you to stop.

When to take / use APO-ESCITALOPRAM

• APO-ESCITALOPRAM should be taken as a single dose either in the morning or the evening.
• Take APO-ESCITALOPRAM with or without food.

How to take APO-ESCITALOPRAM

• Swallow the tablets whole with a full glass of water
• Do not chew APO-ESCITALOPRAM tablets

How long to take APO-ESCITALOPRAM

Continue to take APO-ESCITALOPRAM 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 APO-ESCITALOPRAM.

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 APO-ESCITALOPRAM 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 APO-ESCITALOPRAM 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 APO-ESCITALOPRAM

APO-ESCITALOPRAM 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 APO-ESCITALOPRAM

If you think that you have used too much APO-ESCITALOPRAM, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much escitalopram, you may get symptoms of drowsiness, sleepiness, dizziness, high or low blood pressure, nausea (feeling sick), vomiting, agitation or tremor (shaking), fast or slow heart beat or change in heart rhythm, dilated pupils or, rarely, temporary paralysis or weakness of muscles, convulsions or coma.

A condition called serotonin syndrome may occur, with high fever, agitation, confusion, trembling and abrupt contraction of muscles.

5. What should I know while using APO-ESCITALOPRAM?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking APO-ESCITALOPRAM.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking APO-ESCITALOPRAM, tell your doctor immediately.

Persons taking APO-ESCITALOPRAM may be more likely to think about killing themselves or actually trying to do so, especially when APO-ESCITALOPRAM 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 escitalopram 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 APO-ESCITALOPRAM. Tell your doctor immediately, or even go to the nearest hospital for treatment:

• thoughts or talk of death or suicide
• thoughts or talk of self-harm or harm to others
• any recent attempts of self-harm
• increase in aggressive behaviour, irritability, or agitation
• worsening of depression.

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 APO-ESCITALOPRAM
• have thoughts about killing yourself or if you are close to or care for someone using APO-ESCITALOPRAM 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 APO-ESCITALOPRAM.

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 APO-ESCITALOPRAM to treat any other complaints unless your doctor tells you to.
• Do not let yourself run out of medicine over the weekend or on holidays.

At the beginning of treatment, some patients may experience increased anxiety which will disappear during continued treatment.

Suddenly stopping APO-ESCITALOPRAM may cause unwanted discontinuation symptoms such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, visual disturbances, and nausea. Your doctor will tell you when and how APO-ESCITALOPRAM 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 APO-ESCITALOPRAM affects you.

APO-ESCITALOPRAM may cause visual disturbance (such as blurred vision), nausea, fatigue, and dizziness in some people, especially early in the treatment. If you have any of these symptoms, do not drive, operate machinery, or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

It is not advisable to drink alcohol while you are being treated for depression.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Keep your tablets in the original pack until it is time to take them. If you take your tablets out of the pack, they may not keep well.

Store it in a cool dry place below 30°C away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on 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 APO-ESCITALOPRAM.

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 APO-ESCITALOPRAM 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

Less serious side effects

What to do

feeling tired and weak (fatigued), hot flushes, fever, feeling unwell, shaking or tremors, migraine, headache, 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, burping, hiccups, problems swallowing, sore mouth, tongue or throat, haemorrhoids (piles) dry mouth, feeling thirsty increased saliva, taste disturbance fatigue, sleepiness or drowsiness, yawning, sleeping difficulties, strange or terrifying dreams teeth grinding or clenching increased or decreased appetite, weight loss excessive and/or abnormal movements increased muscle tension, muscle twitching sexual disturbances (decreased sexual drive; problems with ejaculation or erection; women may experience difficulties achieving orgasm) or prostate problems symptoms of hyperglycaemia (high blood sugar) – feeling hungry, thirsty and/or frequent or excessive urination problems with eyes or eyesight dizziness when you stand up suddenly, due to low blood pressure unable to tolerate alcohol menstrual irregularities, period pain, breast pain, unusual vaginal bleeding loss of bladder control unusual hair loss or thinning tingling or numbness of the hands or feet breast enlargement or unusual secretion of breast milk in men or women mild rash, or itching or prickling of the skin acne, eczema, dermatitis, dry skin, psoriasis or other skin problem pain of any type ringing or other persistent noise in the ears, problems hearing or earache increased or decreased sweating bruises osteoporosis tooth or jaw problems flu-like symptoms, runny or blocked nose, sneezing, facial pressure or pain, coughing or sore throat

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

becoming nervous, confused, forgetful, unable to concentrate, agitated, confused, panicky or anxious feeling restless or unable to sit still stomach pain with nausea and vomiting of blood, or blood in the bowel movements aggression, worsening of depression general swelling or swollen hands, ankles, feet or face or eye area due to fluid build-up 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 and occurs especially in elderly women) increased tendency to bleed, develop bruises or broken bones passing more or less urine than normal, or problems when urinating, or bladder infection abnormal liver function tests (increased amount of liver enzymes) flushing, varicose veins infection in any part of your body dizziness 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 escitalopram seizures, tremors, movement disorders (involuntary movements of the muscles or being unco-ordinated). 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 and also possibly severe blisters and bleeding in the lips, eyes, mouth, nose and genitals 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 or tightness abnormal bleeding kidney pain, difficulty in passing urine, dark coloured urine or blood in the urine a collection of symptoms including fever, sore throat, swollen glands, mouth ulcers, unusual bleeding or bruising under the skin mania (mood of excitement, over-activity and uninhibited behaviour or aggression), hallucinations (hearing, seeing or feeling things that are not there) 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) feeling paranoid, panicky, or “high” or having mood swings or feeling more depressed or in a trance thoughts of suicide or attempting suicide or self-harm sudden, severe breathing problems 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.

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.

The above list includes serious side effects that may require urgent medical attention or hospitalisation. Serious side effects are rare.

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 APO-ESCITALOPRAM contains

Active ingredient (main ingredient)	APO-ESCITALOPRAM 10 mg tablets: 10 mg escitalopram (as oxalate) per tablet APO-ESCITALOPRAM 20 mg tablets: 20 mg escitalopram (as oxalate) per tablet
Other ingredients (inactive ingredients)	microcrystalline cellulose colloidal anhydrous silica hypromellose magnesium stearate croscarmellose sodium purified talc macrogol 400 titanium dioxide.
Potential allergens	This medicine is gluten-free, lactose free, sucrose-free, tartrazine-free and free of other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What APO-ESCITALOPRAM looks like

• 10 mg tablet – white to off -white, oval, biconvex, film-coated tablets with “C4” debossed on one side and a notch break-line on the other side.
  AUST R 213721.
• 20 mg tablet – white to off -white, oval, biconvex, film-coated tablets with “C3” debossed on one side and a notch break-line on the other side.
  AUST R 213722.

Blister packs of 28 tablets.

* Not all strengths may be available.

Who distributes APO-ESCITALOPRAM

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was last updated in November 2023.