Consumer medicine information

CITALOPRAM GENERICHEALTH

citalopram (as hydrobromide salt)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Citalopram generichealth.

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 using Citalopram generichealth against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Citalopram generichealth is used for

Citalopram generichealth is used to treat depression.

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

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.

This medicine is only available with a doctor’s prescription.

Citalopram generichealth is not addictive. However, if you suddenly stop taking it, you may get side effects.

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

Before you take Citalopram generichealth

When you must not take it

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

Do not take Citalopram generichealth at the same time as the following other medicines:

  • pimozide, a medicine used to treat mental disorders
  • monoamine oxidase inhibitors (MAOIs), which are also used for the treatment of depression.

Do not take Citalopram generichealth when you are taking a MAOI or when you have been taking a MAOI within the last 14 days.

Taking Citalopram generichealth 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 Citalopram generichealth after the MAOI has been stopped.

Do not take it after the expiry date printed on the pack. If you take it after the expiry date has passed, it may not work as well. The expiry date refers to the last day of the month.

Do not take it if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if:

  • you have allergies to any other substances such as foods, preservatives or dyes.
  • you are pregnant or intend to become pregnant.
    Do not take Citalopram generichealth if you are pregnant unless you and your doctor have discussed the risks and benefits involved. The general condition of your newborn baby might be affected by medicines like Citalopram generichealth. If you take a medicine from this group of medicines (antidepressants) during the last three months of pregnancy and until your baby is born, the following effects may be seen in your new born: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately
  • you are breast-feeding or planning to breast-feed.
    Do not take Citalopram generichealth if you are breast-feeding unless you and your doctor have discussed the risks and benefits involved.It is not recommended that you breast-feed while taking Citalopram generichealth as it is excreted in breast milk.
  • you have, or have had, the following medical conditions:

– bleeding disorder
– diabetes
– heart disease
– kidney disease
– liver disease
– bipolar disorder (manic depression)
– a history of seizures or fits.
– a decreased level of sodium in your blood
– restlessness and/or a need to move often (akathisia)

  • you are receiving electroconvulsive therapy

Use in children

Do not give Citalopram generichealth to a child or adolescent

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

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

If you have not told your doctor about any of the above, tell them before you use Citalopram generichealth.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Citalopram generichealth may interfere with each other. These include:

  • ketoconazole and itraconazole, medicines used to treat fungal infections
  • macrolide antibiotics, e.g. erythromycin and clarithromycin
  • medicines used to treat reflux and ulcers, such as cimetidine and omeprazole
  • medicines known to prolong bleeding, e.g. aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • warfarin, a medicine used to prevent blood clots
  • sumatriptan, used to treat migraines
  • tramadol, used to relieve pain
  • carbamazepine, a medicine used to treat convulsions
  • some heart medications, such as beta-blockers (e.g. metoprolol) or antiarrhythmics
  • selegiline, a medicine used to treat Parkinson’s disease
  • tryptophan, an amino-acid
  • lithium, used to treat mood swings and some types of depression
  • antipsychotics, a class of medicines used to treat certain mental and emotional conditions
  • tricyclic antidepressants, e.g. imipramine, desipramine
  • St John’s Wort (Hypericum perforatum), a herbal remedy
  • any other medicines for depression, anxiety, obsessive-compulsive disorder or pre-menstrual dysphoric disorder.

These medicines may be affected by Citalopram generichealth, 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.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Citalopram generichealth.

How to take Citalopram generichealth

How much to take

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

The standard dose for adults of Citalopram generichealth is between 20 mg and 60 mg (one to three tablets) per day.

The recommended dose in elderly patients is 20 mg to 40 mg (one to two tablets) per day.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you. If you take the wrong dose, Citalopram generichealth may not work as well and your condition may not improve.

How to take it

Swallow the tablets whole with a full glass of water.

Do not chew them.

When to take it

Take Citalopram generichealth as a single dose either in the morning or in the evening.

Take Citalopram generichealth with or without food.

How long to take it

Continue to take Citalopram generichealth 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 Citalopram generichealth. 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 the medicine is stopped suddenly you may experience mild, but usually temporary, symptoms such as dizziness, feelings like pins and needles, sleep disturbances (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, fluttering or pounding heartbeat (palpitations).

When you have completed your course of treatment it is therefore advised that the dose of Citalopram generichealth is gradually reduced over a couple of weeks rather than stopped abruptly.

Your doctor will tell you how to reduce the dosage gradually so that you do not get these unwanted effects.

If you forget to take it

If you miss a dose and remember in less than 12 hours, take it straight away, and then go back to taking it as you would normally.

Otherwise, if it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Do not take a double dose to make up for the dose you have 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 take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (Tel: 13 11 26 for Australia in New Zealand, Tel: 0800 POISON or 0800 764 766) for advice, or go to Casualty or the Accident and Emergency department at your nearest hospital if you think that you or anyone else may have taken too much Citalopram generichealth. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include nausea (feeling sick), dizziness, fast or slow heart beat, or change in heart rhythm, decreased or increased blood pressure,,tremor (shaking), agitation, dilated pupiils of the eyes,drowsiness and sleepiness. Convulsions 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 Citalopram generichealth

Things you must do

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

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

If you become pregnant while taking Citalopram generichealth, tell your doctor immediately.

Persons taking Citalopram generichealth may be more likely to think about killing themselves or actually try to do so, especially when Citalopram generichealth 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 generichealth who talks about or shows signs of wanting to kill 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, ie under 30 years of age and you have not used antidepressive medicines before.

If you or someone you know demonstrates any of the following warning signs of suicide-related behaviour while taking Citalopram generichealth, contact a health care provider immediately, 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.

Follow your doctor’s orders and do not stop the treatment or change the dose without consulting your doctor even if you experience increased anxiety at the beginning of treatment. In the beginning of the 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 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.

Things you must not do

Do not give the tablets to anyone else even if they have the same condition as you.

Do not take Citalopram generichealth to treat any other complaints unless your doctor tells you to.

Do not stop taking Citalopram generichealth, or lower the dosage, without checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays. Suddenly stopping Citalopram generichealth may cause unwanted discontinuation symptoms such as dizziness, headache and nausea. Your doctor will tell you when and how Citalopram generichealth 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.

Things to be careful of

Be careful driving or operating machinery until you know how Citalopram generichealth affects you. It may cause 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.

Avoid alcohol while you are taking this medicine. It is not advisable to drink alcohol while you are being treated for depression.

Side Effects

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits he/she expects it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Citalopram generichealth. It helps most people with depression, but it may have unwanted side effects in a few people.

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

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

  • itching or prickling of the skin
  • ringing or other persistent noise in the ears
  • aching muscles or joint pain
  • flu-like symptoms, pain in muscles or joints, fever, runny or blocked nose, sneezing, facial pressure or pain, coughing or sore throat
  • increased sweating
  • increased saliva or dry mouth, taste disturbance
  • loss of appetite or increased appetite, weight decrease or weight increase
  • diarrhoea, constipation, flatulence, indigestion, stomach pain or discomfort
  • dizziness
  • nausea (feeling sick) or vomiting
  • migraine, headache
  • sleepiness or drowsiness,
  • fatigue, yawning or sleeplessness
  • a sense of indifference to everything
  • sexual disturbances (decreased sexual drive, problems with orgasm; problems with ejaculation or erection)
  • problems with menstrual periods.

Tell your doctor as soon as possible if you notice any of the following:

  • chest pain
  • fast heart rate or decrease in heart rate
  • dizziness when you stand up due to low blood pressure
  • blurred vision
  • increased tendency to develop bruises
  • unusual bleeds including bleeding from the stomach or bowel
  • passing more urine than normal or problems when urinating
  • tingling or numbness of the hands or feet
  • nervousness, confusion, problems with concentration, loss of memory
  • agitation, anxiety, worsening of depression.

These may be serious side effects of Citalopram generichealth. You may need urgent medical attention.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

  • thoughts of suicide
  • serious allergic reaction (symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, or hives)
  • high fever, agitation, confusion, trembling and abrupt contractions of muscles (these symptoms may be signs of a rare condition called serotonin syndrome which has been reported with the combined use of antidepressants)
  • tremors, movement disorders (involuntary movements of the muscles).
  • feeling sick or unwell with weak muscles or feeling confused (these 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)

These are very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Citalopram generichealth

Storage

Keep your Citalopram generichealth in a cool dry place where the temperature stays below 25ºC.

Keep Citalopram generichealth in the blister pack/bottle until it is time to take them. If you take the tablets out of the container, they may not keep well.

Do not leave it in the car

Keep Citalopram generichealth away from direct sunlight.

Do not store Citalopram generichealth, or any other medicine, in the bathroom or near a sink or stove, or on a window sill. Heat, light and dampness can destroy some medicines.

Keep Citalopram generichealth where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Dispose of the tablets where children cannot reach them.

Ask your pharmacist what to do with any Citalopram generichealth 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.

Citalopram generichealth description

What Citalopram generichealth looks like

Citalopram generichealth is presented as 20 mg tablets.

The tablets are white, oval, film-coated tablets containing 20 mg citalopram (as hydrobromide), marked C, scoreline, A on one side and plain on the other: Blister pack of 28.

Citalopram generichealth is available in cartons of 28.

Ingredients

Each Citalopram generichealth 20mg tablet contains 20 mg citalopram (as hydrobromide salt).

The tablets also contain:

  • lactose
  • microcrystalline cellulose
  • maize starch
  • povidone
  • crospovidone
  • magnesium stearate
  • Opadry White OY-LS-28908.
  • The tablets do not contain gluten, sucrose, tartrazine or any azo dyes.

Sponsor

Australian sponsor:
Bellwether Pharma Limited
Suite 1, Level 1
1175 Toorak Road
Camberwell VIC 3124

Australian Registration Number
Citalopram generichealth:
AUST R 161004

This leaflet was prepared in May 2009

Published by MIMS December 2009