How does it work?

This medicine contains the active ingredient fluvoxamine maleate, which is a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI). This type of medicine acts on nerve cells in the brain.

In the brain there are numerous different chemical compounds called neurotransmitters. These act as chemical messengers between the nerve cells. Serotonin is one such neurotransmitter and has various functions that we know of.

When serotonin is released from nerve cells in the brain it acts to lighten mood. When it is reabsorbed into the nerve cells, it no longer has an effect on mood. It is thought that when depression occurs, there may be a decreased amount of serotonin released from nerve cells in the brain.

SSRIs work by preventing serotonin from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood lightening effect of any released serotonin. In this way, fluvoxamine helps relieve depression.

Fluvoxamine may also be used in the treatment of obsessive-compulsive disorder.

It must be taken for at least 14 days before the benefits of treatment begin to appear and you start to feel better.

What is it used for?

• Depression.
• A psychiatric disorder in which tasks are excessively repeated (obsessive-compulsive disorder).

Warning!

• This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• Avoid suddenly stopping this medicine. Sudden withdrawal may result in headache, nausea, pins and needles, dizziness and anxiety. When it is time to stop taking this medicine it should be discontinued gradually, following the instructions given by your doctor or pharmacist.
• This medicine may cause low blood sodium levels (hyponatraemia), which can result in drowsiness, confusion or convulsions. Consult your doctor if you develop any of these symptoms while taking this medicine.
• In people with diabetes, treatment with an SSRI antidepressant may alter control of blood sugar, possibly due to an improvement in depressive symptoms. Your dose of insulin or antidiabetic medicine may need to be altered. Seek medical advice from your doctor.
• If you experience seizures (convulsions or fits) while taking this medicine, consult your doctor immediately, as you will need to stop treatment with this medicine. This also applies if you suffer from epilepsy and experience more seizures than normal after starting this medicine.
• This medicine may enhance the effects of alcohol. It is recommended that you avoid drinking alcohol while taking this medicine.
• This medicine is not recommended for the treatment of depression in children under 18 years of age, as there is no information regarding its safety and efficacy for treating depression in this age group. However, this medicine may be used to treat obsessive-compulsive disorder in children aged over eight years.

Use with caution in

• Epilepsy.
• History of bleeding disorders.
• Decreased kidney function.
• Decreased liver function.
• Treatment for severe depression where a convulsion is produced by passing an electric current through the brain (electroconvulsive therapy, ECT).
• Diabetes.
• History of mania or hypomania.

Not to be used in

• People who have taken monoamine-oxidase inhibitor antidepressants (MAOIs) in the last 14 days.
• Manic phase of manic depression.
• Uncontrolled epilepsy.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. Seek medical advice from your doctor.
• This medicine passes into breast milk, however the effect of this on the nursing infant is unknown. For this reason women who need to take this medicine should consider not breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Headache.
• Faster than normal heart beat (tachycardia).
• Difficulty in sleeping (insomnia).
• Dry mouth.
• Confusion.
• Shaking, usually of the hands (tremor).
• Sweating.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Visual disturbances.
• Seizures (convulsions).
• Dizziness.
• Loss of appetite.
• Sleepiness (somnolence).
• Weakness or loss of strength (asthenia).
• Sexual problems.
• Anxiety and agitation.
• A general feeling of being unwell (malaise).

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Fluvoxamine must not be taken at the same time as monoamine oxidase inhibitor antidepressants (MAOIs). It must not be started until 14 days after stopping treatment with an MAOI, and until at least one day after stopping treatment with moclobemide. Treatment with moclobemide or an MAOI should not be started until at least seven days after treatment with fluvoxamine has been discontinued.

Fluvoxamine may increase the blood levels of anti-blood-clotting medicines (anticoagulants) such as warfarin, and this may increase the risk of bleeding. If you are taking an anticoagulant with this medicine, your blood clotting time should be regularly monitored.

As SSRIs have been associated with bleeding abnormalities, the following medicines, which are known to affect the ability of the blood to clot, should be used with caution with fluvoxamine:

• Tricyclic antidepressants.
• Some antipsychotic medicines.
• Some antisickness medicines, eg prochlorperazine.
• Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen.
• Ticlopidine.
• Dipyridamole.

Treatment with this medicine may alter control of blood sugar in people with diabetes, who may need an adjustment in their dose of insulin or antidiabetic tablets.

Fluvoxamine may increase the blood levels of the following medicines, and your doctor may consequently reduce the dose of these if they are taken with fluvoxamine:

• Carbamazepine.
• Phenytoin.
• Some benzodiazepines (eg alprazolam, bromazepam and diazepam).
• Clozapine.
• Theophylline and aminophylline (these medicines should usually be avoided in people taking fluvoxamine).
• Tricyclic antidepressants such as amitriptyline, clomipramine, imipramine, maprotiline (it is recommended that these medicines should not be used with fluvoxamine).

There may be a risk of a severe side effect known as the serotonin syndrome if fluvoxamine is taken with the following:

• Lithium.
• Tryptophan.

There may be an increased risk of side effects if fluvoxamine is taken with the following, which also enhance the activity of serotonin in the brain:

• Sumatriptan.
• Tramadol.

The herbal remedy St John's wort should not be taken with fluvoxamine for the same reason.