Chemmart Escitalopram 10mg Tablets (Pack Of 28)

Esipram

Escitalopram oxalate
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Esipram. It does not contain all the information that is known about Esipram. 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 Esipram against the benefits he/she expects 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 Esipram is used for

Esipram 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.

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.

Esipram corrects this chemical imbalance and may help relieve the symptoms of depression.

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

Esipram may also be used to treat patients who have excessive anxiety and worry.

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

Your doctor, may have prescribed Esipram for another reason.

Before you take Esipram

When you must not take it

Do not take Esipram if you have ever had an allergic reaction to Esipram or citalopram or any of the ingredients listed at the end of this leaflet.

If you have an allergic reaction you may get a skin rash, have difficulty in breathing, get symptoms of hayfever or feel faint.

Esipram should not be taken at the same time as taking medication known as monoamine oxidase inhibitors (MAOIs), such as phenelzine, tranylcypromine and moclobemide which are also used for the treatment of depression.

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

    The herbal remedy St John`s Wort (Hypericum perforatum) should not be taken at the same time as this medicine.

    Esipram should not be taken at the same time as the medication pimozide.

    Do not take Esipram after the expiry date (EXP) printed on the pack.

    It may have no effect at all or, an entirely unexpected effect if you take it after the expiry date.

    Do not take Esipram if the packaging is torn or shows signs of having been tampered with.

    Do not take Esipram to treat any other complaints unless your doctor has instructed you to do so.

    Before you start to take it

    Your doctor must know about all the following before you start to take Esipram.

    You must tell your doctor if:

  • 1.you are allergic to any other medicines or any foods, dyes or preservatives.
  • 2.you have or have had any of the following medical conditions:
  • heart disease
  • epilepsy
  • liver disease
  • kidney disease
  • diabetes
  • manic depression
  • bleeding tendency
  • Your doctor will take the necessary precautions to ensure safe use of Esipram if you have any of these medical conditions.

  • 3.you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
  • Some of the medicines in common use that may interfere with Esipram include:

  • bupropion,
  • cimetidine,
  • sumatriptan,
  • tricyclic antidepressants eg. imipramine, desipramine,
  • mefloquine,
  • omeprazole,
  • medicines known to prolong bleeding eg. aspirin,
  • some heart medications,
  • medicines to treat mental disorders such as lithium, risperidone, thioridazine and haloperidol,
  • sleeping tablets,
  • pain relievers eg. tramadol,
  • tryptophan,
  • any other medications for depression, anxiety, obsessive compulsive disorder or premenstrual dysphoric disorder.
  • You may need different amounts of your medicines, or you may need to take different medicines.

    Your doctor or pharmacist can tell you what to do if you are taking this or any other medicines.

  • 4.you are pregnant or plan to become pregnant.
  • Do not take Esipram if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.
  • The general condition of your newborn baby might be affected by the use of this group of medicines.

    It is not recommended that you do breastfeed while taking Esipram as it is excreted in breast milk.

    If you have not told your doctor about any of these things, tell him/her before you take Esipram.

  • 5.you have heart disease.
  • Esipram may decrease your heart rate.

    Use in children

    Do not give Esipram to children and adolescents.

    Esipram should not be given to children and adolescents under 18 years of age as the safety and efficacy of Esipram in this age group has not been established.

    Use in elderly

    Esipram can be given to elderly patients over 65 years of age with a reduced dose. The effects of Esipram in elderly patients are similar to that in other patients.

    How to take Esipram

    How much to take

    Your doctor will tell you how much Esipram to take. Take the amount your doctor tells you to.

    The usual dose is 10 mg (one 10 mg tablet) per day. This may be increased by your doctor. The recommended maximum dose is 20 mg (one 20 mg tablet) per day.

    The recommended maximum dose in elderly patients is 10 mg (one 10 mg tablet) 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.

    How to take it

    Take Esipram as a single dose either in the morning or in the evening. Esipram may be taken with or without food.

    It is best if the tablet is swallowed whole with a drink of water. Do not chew the tablets.

    What to expect

    As with other medicines for the treatment of depression or anxiety it may take a few weeks before you feel any improvement.

    Therefore you should continue to take Esipram even if it takes some time before you feel any improvement in your condition.

    Individuals will vary greatly in their response to Esipram. Your doctor will check your progress at regular intervals.

    How long to take it

    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. You should continue to take the tablets for as long as your doctor recommends, 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.

    When finishing a course

    Abrupt cessation of this kind of medication may cause discontinuation symptoms such as dizziness, nausea and headache.

    When you have completed your course of treatment it is therefore advised that the dose of Esipram is gradually reduced over a couple of weeks.

    If you forget to take it

    If you miss a dose and remember in less than 12 hours, take it straight away, then continue as normal the next day. Otherwise, skip that day`s dose but be sure to take the next day`s dose when it is due.

    Do not try to make up for missed doses by taking more than one dose at a time.

    If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

    If you take too much (Overdose)

    Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to the Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Esipram. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers for these places handy.

    Symptoms of overdosage may include:

  • nausea (feeling sick)
  • vomiting
  • sweating
  • drowsiness
  • blue discolouration of the skin
  • convulsions
  • unconsciousness
  • fast heart beats
  • tremor
  • While you are taking Esipram

    Things you must do

    Take Esipram exactly as your doctor has prescribed.

    If you do not follow your doctor`s instructions, you may not get relief from your condition.

  • Try not to miss any doses and continue to take the medicine even if you feel well.

    Tell your doctor immediately if you become pregnant while taking Esipram.

    Tell all doctors, dentists and pharmacists who are treating you that you are using Esipram, especially if you are being started on any new medicines.

    Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes.

    All mentions of suicide or violence must be taken seriously. If you or someone you know demonstrates any of the following warning signs of suicide-related behaviour while taking Esipram, then it is important to contact a health care provider right away or even to 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
  • Episodes of mania

    Some patients with manic-depressive illness may enter into a manic phase.

    This is characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. In such cases, it is important to contact your doctor.

    Things you must not do

    Do not give this medicine to anyone else even if their symptoms seem similar to yours.

    Do not stop taking Esipram, or lower the dose, without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.

    Suddenly stopping Esipram may cause unwanted discontinuation symptoms such as dizziness, headache and nausea. Your doctor will tell you when and how Esipram should be discontinued. Your doctor will usually recommend that you stop treatment by slowly reducing the dosage over a period of one to two weeks.

    Things to be careful of

    As with any new medicine, make sure you know how you react to Esipram before you drive or operate machinery.

    It is not recommended that Esipram be taken with alcohol.

    Side effects

    Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Esipram.

    Esipram helps most people with depression, social anxiety disorder (social phobia) and generalised anxiety disorder, but it may have unwanted side effects in some people.

    All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

    Ask your doctor or pharmacist to answer any questions you may have.

    The side effects of Esipram are, in general, mild and disappear after a short period of time.

    Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Nausea
  • Difficulties falling asleep
  • Feeling sleepy
  • Fatigue
  • Diarrhoea
  • Dry mouth
  • Increased sweating
  • Dizziness
  • Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties getting orgasm)
  • Decreased appetite
  • Yawning
  • Agitation
  • Fever
  • In addition a number of rare side effects are known to occur with medicines that work in a similar way to Esipram. These are:

  • Dizziness when you stand up due to low blood pressure
  • Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)
  • Blurring of vision
  • Vomiting
  • Abnormal liver function test (increased amounts of liver enzymes in the blood)
  • Pains in muscles and joints
  • High fever, agitation, confusion, trembling and abrupt contractions of muscles may be signs of a rare condition called serotonin syndrome
  • Seizures, tremors, movement disorders (involuntary movements of the muscles)
  • Hallucinations, mania, confusion, panic attacks, depersonalisation, anxiety, nervousness,
  • Difficulties urinating
  • Flow of milk in women that are not breastfeeding
  • Rash, increased tendency to develop bruises, itchings, patches of circumscribed swellings
  • Tell your doctor if you notice anything else that is making you feel unwell.

    Some people may get other side effects while using Esipram.

    There is no evidence that Esipram is addictive, however, if you suddenly stop taking Esipram, you may get side effects.

    Tell your doctor if you get any side effects after stopping Esipram.

    After taking Esipram

    Storage

    Keep Esipram tablets in a cool place where the temperature stays below 30 degrees C.

    Keep Esipram tablets in the blister pack until it is time to take them.

    Do not freeze Esipram.

    Do not leave Esipram in the car on hot days.

    Keep Esipram away from direct sunlight.

    Do not store Esipram or any other medicine in the bathroom or near a sink or stove.

    Heat, light and dampness can destroy some medicines.

    Keep Esipram where young children cannot reach it.

    A locked cupboard at least one-and-a-half a metre above ground is a good place to store medicines.

    Disposal

  • Dispose of the tablets where children cannot reach them.
  • Ask your pharmacist what to do with any Esipram tablets you may have left over if your doctor tells you to stop using it, or you find that the tablets have passed the expiry date.
  • Esipram description

    What Esipram tablets look like

  • Esipram tablets are presented as 10 mg and 20 mg tablets and are available in packs of 28 tablets.
  • The tablets are described below.
  • 10 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “L” on each side of the score on one side of the tablet.
  • 20 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “N” on each side of the score on one side of the tablet.

    Active Ingredients

    Each Esipram tablet contains either 10 mg or 20 mg escitalopram (as oxalate salt).

    Other Ingredients

    Esipram tablets also contain:

  • cellulose – microcrystalline
  • silica – colloidal anhydrous
  • talc – purified
  • croscarmellose sodium
  • magnesium stearate
  • hypromellose
  • macrogol 400
  • titanium dioxide
  • Manufacturer

  • Esipram is supplied in Australia by:
  • CNS Pharma Pty Ltd
  • Level 4
  • Deutsche Bank Place
  • Corner Hunter and Phillip Streets
  • Sydney NSW 2000
  • Tel: +61 2 9629 0638
  • This leaflet was prepared in August 2006.
  • Australian Registration Numbers are:
  • Esipram 10mg AUST R 128781
  • Esipram 20mg AUST R 128783
  • ENQUIRE

    1800 200 736