The name of your medicine is APO-Fluvoxamine. It contains the active ingredient maleate.
It is used to treat:
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
Fluvoxamine belongs to a family of medicines known as selective serotonin reuptake inhibitors (SSRIs).
Fluvoxamine is used to treat depression in adults only. It is not recommended for treatment of this condition in children and adolescents as the safety and effectiveness of this medicine, when used for depression in this age group, have not been established.
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 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.
Obsessive compulsive disorder (OCD)
Fluvoxamine is also used to treat a condition known as obsessive compulsive disorder (OCD) in adults and children eight years of age or older.
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.
Both of these conditions are thought to be caused by a chemical imbalance in parts of the brain.
Fluvoxamine corrects this chemical imbalance and may help relieve the symptoms of depression and OCD.
There is no evidence that this medicine is addictive.
There is not enough information to recommend the use of this medicine for treating depression in children and adolescents (under 18 years of age).
There is not enough information to recommend the use of this medicine for treating OCD in children under eight years of age.
Do not take this medicine if you are taking other medicines called Monoamine Oxidase Inhibitors (MAOIs). These may be used for the treatment of depression (phenelzine, tranylcypromine, moclobemide), Parkinson's disease (selegiline), infections (linezolid) or diagnosis of certain conditions/treatment of certain blood disorders (methylene blue).
There may be others so check with your doctor or pharmacist.
Do not take fluvoxamine until 14 days after stopping any irreversible MAOI, and do not take any MAOIs until more than one week after stopping fluvoxamine.
(However you may take fluvoxamine the day after stopping the reversible MAOI called moclobemide).
Taking fluvoxamine 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 if you have been taking any of these medicines.
Do not take this medicine if you are taking a medicine called cisapride, used for treating stomach problems.
Do not take this medicine if you are taking a medicine called tizanidine, used for treating the symptoms of multiple sclerosis or spinal cord injury.
Do not take this medicine if you are taking a medicine called ramelteon, used for helping people get to sleep.
Do not take this medicine if you have or have had any of the following:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You are currently pregnant or you plan to become pregnant.
4. You are currently breast-feeding or you plan to breast-feed.
5. You drink alcohol.
6 .You are planning to have surgery or an anaesthetic or any medical tests or treatments.
7. You are currently receiving or are planning to receive dental treatment.
8. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some combinations of medicines may increase the risk of serious side effects and are potentially life-threatening.
These medicines must not be taken with fluvoxamine. They include:
(see also "When you must not take it").
Some medicines may interact with fluvoxamine. These include:
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with fluvoxamine.
If you smoke the levels of fluvoxamine in your blood may be lower.
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
To treat depression:
Adults: The usual starting dose is 50mg each day, usually in the evening but your doctor may adjust the number of tablets or the strength of the tablets you are taking until the desired response is achieved.
To treat OCD:
Adults: The usual starting dose is 50mg each day, usually in the evening, but your doctor may adjust the number of tablets or the strength of the tablets you are taking until the desired response is achieved.
Children & Adolescents (8 to 17 years): The usual starting dose is 25mg each day, usually at bedtime. The doctor will probably adjust the dose until the desired response is achieved.
If you are elderly and/or have liver or kidney problems your doctor may adjust the dose more slowly.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Swallow the tablet with a full glass of water. Do not chew the tablets.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
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 your tablets for several months or even longer to make sure the benefits are maintained.
Occasionally the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. It is possible that these symptoms may continue or increase until the full anti-depressant effect of your medicine becomes apparent (i.e. one to two months).
You or anyone close to you or caring for you should watch for these symptoms and tell your doctor immediately or go to the nearest hospital if you have any distressing thoughts or experiences during this initial period or at any other time.
Also contact your doctor if you experience any worsening of your depression or other symptoms at any time during your treatment.
This medicine should not be stopped abruptly, especially if you are taking 200 mg or more per day.
If your doctor decides that you should stop treatment, then the dose should be reduced by 100mg every three days.
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
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.
People taking fluvoxamine may be more likely to think about killing themselves or actually try to do so, especially when fluvoxamine 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 fluvoxamine 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 during the first one to two months of taking fluvoxamine until the medicine starts to work completely. 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.
If you or someone you know or care for demonstrates any of the following warning signs of suicide-related behaviour while taking fluvoxamine, contact a doctor immediately, or even go to the nearest hospital for treatment:
Tell your doctor that you are taking this medicine if:
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
If you are under 18 years of age your doctor will monitor your weight and growth carefully.
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.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Be careful when driving or operating machinery until you know how this medicine affects you.
It 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 fluvoxamine, 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, tea) while taking this product.
Large amounts of caffeine may result in side effects such as tremor (shaking), palpitations (fast or irregular heart beat), nausea, restlessness and trouble or inability to sleep.
Older people may become confused when taking this medicine. Families and carers should be aware of this. Special care may be needed.
You should be careful for 1 or 2 weeks after stopping this medicine, because it will still be in your blood stream.
You should be aware that people over 50 years of age who take antidepressants have an increased risk of having a bone fracture.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking fluvoxamine or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.
Other side effects observe 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 you must do").
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to fluvoxamine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 30°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
Fluvoxamine 50mg tablets
Golden, round, scored tablet, film-coated, engraved APO on one side, "F" over bisect "50" on the other side.
Packs of 30 tablets in blisters.
Fluvoxamine 100 mg tablets
Reddish-brown, pillow-shaped scored tablet, film-coated, engraved APO on one side, FLU bisect 100 on the other side.
Packs of 30 tablets in blisters.
Not all strengths may be available.
Each tablet contains 50 mg or 100 mg of fluvoxamine maleate as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Fluvoxamine 50 mg tablets:
AUST R 147380
APO-Fluvoxamine 100 mg tablets:
AUST R 147389