Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about Voxam.
It does not contain all of 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 Voxam 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 Voxam is used for
Voxam contains fluvoxamine. It belongs to a family of medicines known as selective serotonin reuptake inhibitors (SSRIs).
Voxam is used to treat depression in adults and a condition known as "Obsessive Compulsive Disorder" (OCD) in adults and children eight years of age or older. Both of these conditions are thought to be caused by a chemical imbalance in parts of the brain. Voxam corrects this chemical imbalance and may help relieve the symptoms of depression and OCD.
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. Depression caused by a chemical imbalance in the brain can affect 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 for no reason.
People with OCD can have two types of symptoms – obsessions and compulsions. Obsessions are unwanted repeated thoughts or feelings, which are ongoing. Compulsions are the need to repeat actions over and over. The symptoms of OCD can vary from patient to patient.
Voxam is approved for the uses listed above. However, your doctor may prescribe this medicine for another use. Ask your doctor if you have any questions about why it was prescribed for you.
Voxam is not recommended for use in children (under the age of 8), as the safety and effectiveness of Voxam in this age group have not been established.
There is no evidence that Voxam is addictive.
This medicine is available only with a doctor's prescription.
Before you take Voxam
When you must not take it
Do not take this medicine if:
you have an allergy to fluvoxamine or any of the ingredients listed at the end of this leaflet
you are taking another anti-depressant medicine called an irreversible monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days. Taking Voxam with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
Ask your doctor or pharmacist if you are not sure you have been taking one of these medicines.
you are taking cisapride
the packaging is torn or shows signs of tampering or if the tablets do not look right
the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work (as well).
If you are not sure whether you should start taking Voxam, contact your doctor.
Before you start to take it
Tell your doctor if you have allergies:
to any other medicines
any other substances, including foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
a history of bleeding disorders
Tell your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss with you the risks and benefits of taking Voxam when pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will discuss the risks and benefits of taking Voxam when breastfeeding.
Tell your doctor if you drink alcohol. You should avoid drinking alcohol while taking Voxam.
Taking other medicines
Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Voxam may interfere with each other. These include:
aspirin, NSAID, or any medications used to treat depression, obsessive compulsive disorder, anxiety disorders or other psychoses.
You should also tell your doctor if you are taking tryptophan, sumatriptan, phentermine, tramadol, lithium, any herbal products containing St. John’s Wort, warfarin, clomipramine, amitriptyline, imipramine, clozapine, olanzapine, tacrine, theophylline, methadone, mexiletine, thioridazine, propranolol, cisapride, alprazolam, triazolam, midazolam, diazepam, haloperidol, cyclosporin, carbamazepine or phenytoin. These medicines may be affected by Voxam, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Some combinations of medicines (including herbal and other remedies) can interact with Voxam and increase the risk of side effects, some of which can be potentially life-threatening.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Voxam.
Your doctor or pharmacist may have more information on medicines to avoid while taking Voxam.
How to take Voxam
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
How much to take
Your doctor will tell you how many tablets you will need to take each day. These will be printed on the pharmacy label on the container.
Adults: Your doctor will normally tell you to start taking 50mg each day, but may adjust the number of tablets or the strength of the tablets you are taking until the desired response is achieved.
Children (8 years & above) & Adolescents: The usual starting dose is 25mg each day. The doctor will probably adjust the dose until the desired response is achieved.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How to take it
Swallow Voxam tablets with a full glass of water. Do not chew the tablets.
Take Voxam with or without food.
If you have any concerns about how to take this medicine, ask your doctor or pharmacist.
How long to take it
Even if you feel better, continue taking your medicine for as long as your doctor tells you.
The length of treatment will depend on how quickly your symptoms improve. 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 or 6 weeks to feel any real improvement. Even when you feel well, you will usually have to take Voxam for several months or even longer to make sure the benefits are maintained.
If your doctor tells you to stop taking VOXAM do not stop abruptly, especially if you are taking 200mg or more per day. You should reduce the dose by one tablet (100mg) every three days.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accidents and Emergency at your nearest hospital if you think you or anyone else may have taken too much Voxam. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
The most common symptoms are nausea (feeling sick), vomiting and diarrhoea. You could also experience drowsiness and dizziness, or feel faint.
If possible show the doctor the pack of tablets.
While you are taking Voxam
Things you must do
Always follow your doctor’s instructions carefully.
Tell your doctor immediately if you become pregnant while taking Voxam.
If you are about to start or stop any medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop, tell your doctor or pharmacist that you are taking Voxam.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Voxam.
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 or bursts of unusual energy or anger. This will help your doctor to determine the best treatment for you.
Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor may want to take some blood tests and check your heart and blood pressure from time to time. This helps prevent unwanted side effects.
Things to be careful of
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.
Immediately contact your doctor or go to the nearest hospital for help if you or someone you are is being treated for depression (or for any other condition) and are demonstrating any of the warning signs of suicide. Families and caregivers of children and adolescents who are taking Voxam should be especially watchful of the warning signs associated with suicide listed below.
The warning signs include:
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
mood changes such as an increase in aggressive or unusual behaviour, irritability, agitation or worsening of depressive symptoms.
Be especially careful of any suicidal thoughts or other mental /mood changes in the first few months of taking Voxam or when the dose is changed.
These effects are more likely to occur in people aged less than 24 years including those not being treated for depression.
Be careful driving or operating machinery until you know how Voxam affects you. Voxam may cause drowsiness, dizziness or sleepiness in some people and affect alertness.
Although drinking moderate amounts of alcohol is unlikely to affect your response to Voxam, your doctor may suggest avoiding alcohol while you are being treated for depression.
You should minimise your intake of caffeine-containing beverages (e.g. coffee and tea) while taking Voxam. Large amounts of caffeine may result in side effects such as tremor (shaking), palpitations (fast or irregular heat beat), nausea (feeling sick), insomnia (trouble or inability to sleep) or restlessness.
Older people may become confused when taking Voxam. Families and carers should be aware of this. Special care may be needed.
After you have stopped taking Voxam, you should still be careful for 1 or 2 weeks because some of the medicine will still be in your blood stream.
Things you must not do
Do not stop taking VOXAM or lower the dose, without first checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays. Suddenly stopping Voxam may cause headache, nausea, dizziness and anxious feelings.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.
Do not use Voxam to treat any other complaints unless your doctor tells you to.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Voxam. Like other medicines, Voxam can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you: nausea, vomiting, drowsiness, difficulty sleeping, dizziness, nervousness, feeling anxious, dry mouth, stomach pain, constipation, diarrhoea, heart burn, loss of appetite, muscle weakness, pins and needles, abnormal taste, headache, faster heart beat, sweating, weight gain, weight loss or unusual bruising.
Tell your doctor immediately if you notice any of the following:
muscle spasms or twitches.
Stop taking Voxam and tell your doctor immediately, or go to Accident & Emergency at your nearest hospital if any of the following occur:
allergic reaction including swelling of limbs, face, lips, mouth or throat which may cause difficulty breathing or swallowing
sudden onset of prolonged muscular spasm, affecting the eyes, head, neck and body
sudden increase in body temperature, severe convulsions
fast heart beat, sweating, racing thoughts and restlessness.
These are very serious though rare side effects.
Other side effects observed more frequently in children are: abnormal thoughts or behaviour, cough, increased period pain, nose bleeds, increased restlessness, infection and sinusitis.
Tell your doctor if you notice anything else that is making you feel unwell including any suicidal thoughts or other mental/mood changes (see ‘Things to be careful of’). Other side effects not listed above may also occur in some patients.
Ask your doctor or pharmacist to answer any questions you may have.
After taking Voxam
Keep your tablets in their original pack until it is time to take them. If you take the tablets out of their container they may not keep well.
Keep the pack in a cool, dry place where it stays below 25°C. Do not store Voxam, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep this medicine 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.
If your doctor tells you to stop taking Voxam, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over tablets.
What it looks like
Voxam 50mg tablets are white, round, biconvex tablets marked “S” on one side and “291” on the other, with a line in the middle, making them easy to break in half if necessary. Packs of 30 tablets.
Voxam 100mg tablets are white, oval shaped tablets marked "S" on one side and "313” on the other side, with a line through the middle, making them easy to break in half if necessary. Packs of 30 tablets.
Each Voxam 50mg tablet contains 50mg fluvoxamine maleate.
Each Voxam 100mg tablet contains 100mg fluvoxamine maleate.
pregelatinised potato starch
sodium stearyl fumarate
colloidal anhydrous silica
Voxam does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Voxam is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris Street
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
This leaflet was prepared in January 2009.
Australian Registration Numbers
Voxam 50 mg tablet: AUST R 111781
Voxam 100 mg tablet: AUST R 111782
Published by MIMS/myDr September 2009
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