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Fluvoxamine maleate

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pate it on to others. It may harm them, even if their symptoms are the same as yours.

Round, biconvex, scored, white film coated tablet for oral administration, containing 50 mg or 100 mg of fluvoxamine maleate.

Excipients: mannitol, maize starch, pregelatinised starch, sodium stearyl fumarate, colloidal anhydrous silica, hypromellose, polyethyleneglycol 6000, talc, titaniumdioxyde (E171).


  - Major depressive episode.

  - Obsessive Compulsive Disorder (OCD).


Dosage and administration


The recommended starting dose is 50 or 100 mg, given as a single dose in the evening. It is recommended to increase the dose gradually until an effective dose is reached. The usual effective dose is 100 mg per day and should be adjusted on individual patient response. Doses of up to 300 mg per day have been given. Dosages above 150 mg should be given in divided doses. In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6 months after recovery from a depressive episode.


Luvox at a fixed single daily dose of 100 mg is the recommended dose for the prevention of recurrence of depression.


Obsessive compulsive disorder

The recommended starting dose is 50 mg per day for 3 - 4 days. The effective dosage usually lies between 100 mg and 300 mg per day. The dosage should be increased gradually until the effective dosage is achieved, with a maximum of 300 mg per day for adults and 200 mg per day for children from 8 years on/adolescents. Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. If no improvement is observed within 10 weeks, treatment with Luvox should be reconsidered. While there are no systematic studies to answer the question of how long to continue Luvox treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose.


The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioral psychotherapy for patients who have done well on pharmacotherapy.


Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.


Luvox tablets should be swallowed with water and without chewing.



Luvox tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs).


Treatment with Luvox can be initiated:

  - two weeks after discontinuation of an irreversible MAOI, or

  - the following day after discontinuation of a reversible MAOI (e.g. moclobemide).


At least one week should elapse between discontinuation of Luvox and initiation of therapy with any MAOI. Hypersensitivity to the active substance or to any of the excipients.


Warnings and special precautions for use

Depression is associated with an increased risk of suicidal thoughts, suicidal attempts and suicide. The risk persists until significant remission occurs. It is general clinical experience that the risk of suicide-related behavior is highest shortly after presentation and may increase again in the early stages of recovery. Therefore patients should be carefully monitored especially at the beginning of antidepressant therapy or at any time of dosage adjustments until improvement is noticed.


Obsessive compulsive disorders may also be associated with an increased risk of suicide-related events. The same precautions should therefore be observed for these patients.


Patients with a history of suicide-related events and those exhibiting a significant degree of suicidal ideation prior to commencement of treatment may be at a greater risk of suicidal thoughts or suicide attempts. Patients (and their caregivers) should be informed about the need to monitor for the emergence of suicide-related behavior and to seek medical advice immediately if these symptoms occur.


Luvox should not be used in the treatment of children and adolescents under the age of 18 years except for patients with OCD. Suicide-related behaviors (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressant compared to those treated with placebo. If based on clinical need, a decision to treat is taken, the patient should be carefully monitored for the appearance of suicidal symptoms.


In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive behavioral development are lacking.


Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.


Treatment with Luvox has rarely been associated with an increase in hepatic enzymes, generally accompanied by clinical symptoms. In such cases treatment should be discontinued. Glycaemic control may be disturbed, especially in the early stages of treatment. The dosage of anti-diabetic drugs may need to be adjusted.


Although in animal studies Luvox has no pro-convulsive properties, caution is recommended when the drug is administered to patients with a history of convulsive disorders.


Luvox should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Treatment with Luvox should be discontinued if seizures occur or if seizure frequency increases.


On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with treatment of Luvox, particularly when given in combination with other serotonergic and/or neuroleptic drugs. As these syndromes may result in potentially life-threatening conditions, treatment with Luvox should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated. As with other SSRIs, hyponatremia has been rarely reported, and appears to be reversible, when Luvox is discontinued. Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion. The majority of reports were associated with older patients.


There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura as well as haemorrhagic manifestations e.g. gastrointestinal bleeding with SSRIs. Caution is advised in patients taking SSRIs, particularly in elderly patients and in patients who concomitantly use drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most TCAs, acetylsalicylic acid, NSAIDs) or drugs that increase risk of bleeding as well as in patients with a history of bleeding disorders and in those with predisposing conditions (e.g. thrombocytopenia).


When combined with Luvox plasma concentrations of terfenadine, astemizole or cisapride may be increased resulting in an increased risk for QT prolongation/ Torsade de Pointes.


Therefore, Luvox should not be coadministered with these drugs.


Data in elderly subjects give no indication of clinically significant differences in normal daily dosages compared to younger subjects. However upward dose titration should be done slower in the elderly, and dosing should always be done with caution. Luvox may cause an insignificant decrease in heartbeat (2-6 beats per minute). Due to lack of clinical experience the use of Luvox in children for the treatment of depression cannot be recommended.


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