Genofinex 20 Mg Capsules

GENOFINEX is indicated for the treatment of major depressive episodes: i.e. single episode and recurrent depression with associated anxiety. GENOFINEX is used in the treatment of Bulimia nervosa where it has been shown to significantly decrease binge-eating and purging activity. GENOFINEX is used in the treatment of Obsessive-compulsive disorder. The obsessions or compulsions must be experienced as intrusive, markedly distressing, time consuming or interfering significantly with the person's social or occupational functioning.

Posology
A major depressive episode
Adults and elderly: A dose of 20 mg/day is recommended, preferably in the morning.
Bulimia nervosa
A dose of 60 mg/day is recommended.
Obsessive-compulsive disorder
A dose of 20 to 60 mg/day is the recommended dose for the treatment of obsessive-compulsive disorder. The recommended dose may be increased or decreased. Doses above 80 mg/day are not recommended for any indication. Upward dose titration is advised at intervals of several weeks due to the kinetic properties of GENOFINEX (see section 5.2).
Elderly
GENOFINEX should be used with caution in all elderly patients, particularly if they have systemic illness or are receiving multiple medications for concomitant diseases. Dosages over 20 mg per day are not recommended (see section 5.2).
Concurrent disease
A lower or less frequent dose should be considered in patients with hepatic impairment and concurrent diseases.
Discontinuation of fluoxetine
Discontinuation of GENOFINEX may lead to withdrawal symptoms, including dizziness, paraesthesia, headache, insomnia, tremor, confusion, sensory disturbances, agitation, anxiety and nausea (see sections 4.4 and 4.8). Abrupt discontinuation should be avoided. When stopping treatment with fluoxetine, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4.4 and section 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the medical practitioner may continue decreasing the dose, but at a more gradual rate.
Method of administration
GENOFINEX may be administered with or without food. The capsules may be swallowed whole or be dispersed in approximately 100 ml water.

GENOFINEX is contraindicated:
u2022 In patients with hypersensitivity to fluoxetine or to any excipients in GENOFINEX (see section 6.1).
u2022 In children under the age of 18 years, as the safety and efficacy of GENOFINEX has not been established.
u2022 And should not be administered to patients with severe renal failure (GFR <10 ml/min) because accumulation may occur in these patients during chronic treatment.
u2022 In concomitant use with Monoamine oxidase inhibitors (see section 4.5).
u2022 In concomitant use with Thioridazine (see section 4.5).

Patients with major depressive disorder, both adults and children, may experience worsening of their depression and/or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medicines. This risk may persist until significant remission occurs. The safety and efficacy of GENOFINEX have not been established in children under the age of 18 years. In clinical trials in Major Depressive Disorder, there were increased reports of hostility and suicide-related adverse events such as suicidal ideation and self-harm. (See (see section 4.3)
Suicide
Isolated cases of suicidal ideation and suicidal behaviours have been reported during GENOFINEX therapy or early after treatment discontinuation. Although a causal role for GENOFINEX alone in inducing such behaviours has not been established, pooled analyses from studies of some other antidepressants in psychiatric conditions indicate a potential increased risk for suicidal ideation and suicidal behaviours in paediatric patients compared to placebo. Patients being treated with GENOFINEX should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of therapy or at any time of dose changes, either increases or decreases. Medical Practitioners should encourage patients of all ages to report any distressing thoughts or feelings at any time.
Because of the possibility of comorbidity between major depressive disorder and other psychiatric and non-psychiatric disorders, the same precautions should be observed when treating patients with major depressive disorder when treating patients with other psychiatric and non-psychiatric disorders. The following symptoms have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania and mania. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing GENOFINEX in patients for whom such symptoms are severe, abrupt in onset or were not part of the patientu2019s presenting symptoms. If the decision is made to discontinue treatment, GENOFINEX should be tapered (see section 4.2)
Serotonin syndrome
A serotonin syndrome, which may be confused with neuroleptic malignant syndrome, may occur with the use of GENOFINEX. This syndrome is characterised by the clustering of clinical features of changes in mental state (confusion, disorientation, agitation) and neuromuscular activity (myoclonus, hyper-reflexia, tremor, rigidity, inco-ordination), in combination with auto-immune dysfunction (especially fever, sweating, diarrhoea). The serotonin syndrome has been seen in temporal association with the use of monoamine oxidase inhibitors and with other serotonergic medication, but may occur in the absence of any concomitant medication. GENOFINEX should be stopped immediately as serious morbidity and death may follow the serotonin syndrome.
Rash and possibly allergic events
Rash, anaphylactoid events and progressive systemic events, sometimes serious and involving skin, kidney, liver or lung, have been reported in patients taking GENOFINEX. Upon the appearance of rash or of other possibly allergic phenomena, GENOFINEX should be discontinued.
Seizures
GENOFINEX should be introduced cautiously in patients who have a history of seizures. GENOFINEX should be discontinued in any patient who develops seizures. GENOFINEX should be avoided in patients with unstable epilepsy; patients with controlled epilepsy should be carefully monitored. There have been reports of prolonged seizures in patients on GENOFINEX receiving ECT treatment (see section 4.5)

Pregnancy
GENOFINEX is not recommended to be used in pregnancy, due to the potential risk to the foetus. After administration of fluoxetine late in pregnancy, the following effects have been reported in neonates: irritability, tremor, hypotonia, persistent crying, and difficulty in sucking or in sleeping. These symptoms may indicate either serotonergic effects or a withdrawal syndrome. Epidemiological data have suggested that the use of SSRIs in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Abrupt discontinuation of therapy should be avoided during pregnancy (see Section 4.2).
Lactation
The safety of GENOFINEX has not been established in breastfeeding women.
Fertility
Animal data have shown that fluoxetine may affect sperm quality. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.

Although GENOFINEX has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive medicine may impair judgement, thinking or motor skills. Therefore, patients should be advised to avoid driving a car or operating hazardous machinery until they are certain that their performance is not affected.

a. Summary of the safety profile
The most commonly reported adverse reaction are chest pain, chills, haemorrhage, hypertension and palpitations. Adverse reactions affecting the digestive system include increased appetite, nausea and vomiting. Weight gain is also a commonly reported adverse reaction. Common adverse reaction affecting the nervous system include agitation, amnesia, confusion, emotional lability and sleep disorder. Ear pain, taste perversion and tinnitus were common reported adverse reaction affecting the senses. Increase in urinary frequency has also been reported.
b. Tabulated list of adverse reactions
System organ class Frequent (u22651/100 to <1/10) Less frequent (u22651/1000 to <1/100)

Symptoms
Symptoms of overdose included nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic dysrhythmias to cardiac arrest, pulmonary dysfunction and signs of altered CNS status ranging from excitation to coma.
Treatment
Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. There are no specific antidotes for GENOFINEX. Due to the large volume of distribution of GENOFINEX, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit. In managing overdosage, the possibility of multiple drug involvement should be considered.