LUVOX (TM) Tablets
Fluvoxamine Maleate
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about LUVOX.
It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
Please read this leaflet before you start taking LUVOX.
If you are helping someone else take LUVOX, please read this leaflet before you give the first dose.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking LUVOX against the benefits they expect it will have for you.
If you have any concerns about taking LUVOX, ask your doctor or pharmacist.
Your doctor and pharmacist have more information.
Keep this leaflet with your LUVOX.
You may need to read it again.
WHAT LUVOX IS USED FOR
LUVOX belongs to a family of medicines known as selective serotonin reuptake inhibitors (SSRIs).
LUVOX 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. LUVOX 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. Check with your doctor if you need more information.
LUVOX is approved for the uses listed above. However, your doctor may prescribe this medicine for another use. If you would like more information, ask your doctor.
LUVOX is not recommended for use in children (under the age of 8), as the safety and effectiveness of LUVOX in this age group have not been established.
This medicine is available only with a doctor`s prescription.
BEFORE YOU TAKE LUVOX
When you must not take it
Do not take LUVOX if:
Examples of these medicines are NARDIL(TM) (phenelzine) and PARNATE(TM) (tranylcypromine).
Taking LUVOX with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
If you have taken a “reversible monoamine oxidase inhibitor” such as AURORIX(TM) (moclobemide), it is all right to start taking LUVOX the next day.
Like many other medicines, LUVOX can pass into breast milk and may affect your baby.
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 LUVOX, contact your doctor.
Before you start to take it
You must tell your doctor if:
Your doctor will discuss with you the risks and benefits of taking LUVOX when pregnant.
Your doctor will discuss the risks and benefits of taking LUVOX when breastfeeding.
You should avoid drinking alcohol while taking LUVOX.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with LUVOX. These include: aspirin, NSAID medicines, 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.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking LUVOX.
These medicines may be affected by LUVOX or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.
Your doctor or pharmacist may have more information on medicines to avoid while taking LUVOX.
HOW TO TAKE LUVOX
LUVOX contains fluvoxamine.
Take LUVOX exactly as your doctor has prescribed.
How much to take
Adults: Your doctor will normally tell you to start taking 50 mg each day, but will probably adjust the number of tablets or the strength of the tablets you are taking until the medicine is effective.
Children & Adolescents: The usual starting dose is 25 mg each day. The doctor will probably adjust the dose until the medicine is effective.
You may experience some nausea (feeling sick) at first, but this usually disappears after the first 2 weeks of treatment. Make sure you tell your doctor if you feel sick or notice any other symptoms while you are taking LUVOX.
Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes.
Warning signs of suicide
If you or someone you know is demonstrating any of the following warning signs of suicide, contact your doctor or a mental health professional right away or go to the nearest hospital for treatment:
All mentions of suicide or violence must be taken seriously. If you intend or have a plan to commit suicide, go to the nearest hospital for immediate treatment.
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How to take it
Swallow LUVOX with a full glass of water. Do not chew the tablets.
How long to take it
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 LUVOX for several months or even longer to make sure the benefits will last. Continue taking your tablets until your doctor tells you to stop.
If your doctor tells you to stop taking LUVOX and if you are taking a dose of two tablets (200 mg) or more per day do not stop treatment abruptly. You should reduce the dose by one tablet (100 mg) every three days.
Do not stop using it unless your doctor tells you to – even if you feel better.
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 Australia or 0800 764 766 NZ) for advice, or go to casualty at your nearest hospital if you think you or anyone else may have taken too much LUVOX, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy. Take the pack of tablets with you to the doctor or hospital.
The most common symptoms are nausea (feeling sick), vomiting and diarrhoea. You could also experience drowsiness and dizziness, or feel faint.
If you are not sure what to do, contact your doctor or pharmacist.
Instructions for doctor: Symptomatic treatment should be employed.
WHILE YOU ARE USING LUVOX
Things you must do
Tell your doctor immediately if you become pregnant while taking LUVOX.
If you are about to be started on any new medicines, tell your doctor or pharmacist that you are taking LUVOX.
Do not take any other medicines, whether they require a prescription or not, without first telling your doctor.
Tell all doctors, dentists and pharmacists who are treating you that you are taking LUVOX.
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 you must not do
Do not stop taking LUVOX 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 LUVOX 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 LUVOX to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how LUVOX affects you.
LUVOX may cause drowsiness, dizziness or sleepiness in some people and affect alertness.
Make sure you know how you react to LUVOX before you drive or operate machinery .
Although drinking moderate amounts of alcohol is unlikely to affect your response to LUVOX, your doctor may suggest avoiding alcohol while you are being treated for depression.
If you drink large amounts of caffeine-containing beverages (eg. coffee, tea), you should minimise your intake of these beverages while taking LUVOX. Drinking large amounts of caffeine while taking LUVOX may increase the amount of caffeine in your body and 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 LUVOX. Families and carers should be aware of this. Special care may be needed.
After you have stopped taking LUVOX, you should still be careful for 1 or 2 weeks because some of the medicine will still be in your blood stream.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LUVOX.
Like other medicines, LUVOX 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.
Ask your doctor or pharmacist any questions you may have.
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.
Contact your doctor immediately, or go to Accident & Emergency at your nearest hospital if any of the following occur:
swelling of limbs, face, eyes, inside the nose, mouth or throat, shortness of breath, breathing or swallowing difficulties. These are very serious side effects and may indicate a serious allergic reaction. These side effects are rare.
Other side effects observed more frequently in children are: abnormal thoughts or behaviour, cough, increased period pain, nose bleeds, increased restlessness, infection and sinusitis.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you don`t understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
AFTER USING LUVOX
Storage
Keep your tablets in their container until it is time to take them.
If you take the tablets out of their container they may not keep well.
Keep LUVOX in a cool, dry place where it stays below 25 degrees C. Do not store it, 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.
Disposal
If your doctor tells you to stop taking LUVOX, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over tablets.
PRODUCT DESCRIPTION
What it looks like
LUVOX 50 mg 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.
AUST R 57632
LUVOX 100 mg 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.
AUST R 57633
Ingredients
Each LUVOX Tablet contains 50 mg or 100mg of the active ingredient fluvoxamine maleate. The tablet also contains mannitol, maize starch, pregelatinised potato starch, sodium stearyl fumarate, colloidal anhydrous silica, hypromellose, macrogol 6000, talc and titanium dioxide.
LUVOX does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Sponsor
LUVOX is manufactured in The Netherlands for: