INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo A-LENNON FLUOXETINE (capsule)

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

A-LENNON FLUOXETINE (capsule)

COMPOSITION:
Each capsule contains fluoxetine hydrochloride equivalent to
fluoxetine 20 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 1.2 Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
Fluoxetine inhibits the neuronal uptake of serotonin into the central nervous system.
Pharmacokinetics:
Fluoxetine is readily absorbed from the gastro-intestinal tract with peak plasma concentrations appearing about 6 to 8 hours after administration. Fluoxetine is widely distributed throughout the body and is extensively bound to plasma proteins.
Fluoxetine has a long elimination half-life of 2 to 3 days and 7 to 9 days for its major active metabolite, Norfluoxetine; changes in dose will not be fully reflected in plasma far several weeks (approximately 4 half-lives). This must be taken into account when doses are titrated or when treatment is stopped.

INDICATIONS:
Major depressive episodes,
i.e. single episode and recurrent depression with associated anxiety. Bulimia nervosa; A-LENNON FLUOXETINE has been shown to significantly decrease binge-eating and purging activity.
Obsessive-compulsive disorder:A-LENNON FLUOXETINE is indicated far 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.

CONTRA-INDICATIONS:
Hypersensitivity to fluoxetine or other serotonin re-uptake inhibitors. Severe renal failure (glomerular filtration rate <10 mL per minute).
Mono-amine oxidase inhibitors: A-LENNON FLUOXETINE should not be used concomitantly with mono-amine oxidase inhibitors. There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with a mono-amine oxidase inhibitor (MAOI) and in patients who have recently discontinued fluoxetine and are then started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore fluoxetine should not be used in combination with . a MAOI, or within 14 days of discontinuing treatment with a MAO]. Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI.
Safety in pregnancy and lactation has not been established.
Safety and efficacy in children have not been established.

WARNINGS:
Rash and possibly allergic events
: A-LENNON FLUOXETINE should be discontinued in patients who develop a rash since systemic effects, involving the lungs, kidneys or liver, possibly related to vasculitis, have occurred in such patients.

DOSAGE AND DIRECTIONS FOR USE:
For oral administration to adults only.
Major Depressive Episode:
A dose of 20 mg/day is recommended, preferably in the morning. Doses above 80 mg/day are not recommended.
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.
A-LENNON FLUOXETINE may be administered with or without food.
Usage in the elderly:
The effects of age upon the metabolism of fluoxetine have not been fully explored. Thus fluoxetine should be used with caution in the elderly, particularly if they have systemic illness or are receiving multiple medications for concomitant diseases.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Body as a whole: Asthenia, fever, palpitations, vision disturbances.
Digestive system: Nausea, diarrhoea, dry mouth, appetite loss, dyspepsia, vomiting.
Nervous system: Headache, nervousness, insomnia, drowsiness, anxiety, tremor, dizziness, fatigue, decreased libido, seizures (see "Precautions"). Hypo mania or mania occurred in approximately 1% of fluoxetine treated patients. Abnormal dreams, agitation.
Respiratory system: Dyspnoea. Pulmonary events (including inflammatory processes of varying histopathology and/or fibrosis) have been reported. Dyspnoea may be the only preceding symptom.
Skin and appendages: A small percentage developed rash and/or uticaria (see "WARNINGS"). Serious systemic events, possibly related to vasculitis, have developed in patients with rash and less frequently death has been reported. Excessive sweating, serum sickness and anaphylactoid reactions have also been reported.
Urogenital system: Sexual dysfunction (delayed or inhibited orgasm).
Endocrine system: Hypothyroidism
Hyponatraemia (including serum sodium lower than 110 mmol/L) has been reported. The hyponatraemia appeared to be reversible when Fluoxetine was discontinued. Although these cases were complex with varying possible aetiologies, some were possibly due to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The majority of these occurrences have been in older patients and in patients taking diuretics or who were otherwise volume depleted.
Elevated serum transaminase values have occurred.
The following have been reported in association with fluoxetine, but no causal relationship has been established: Aplastic anaemia, cerebral vascular accident, confusion, dyskinesia (including, for example, a case of buccallingual-masticatory syndrome, which resolved following medicine discontinuation), ecchymoses, eosinophilic pneumonia, gastro-intestinal haemorrhage, hyper-prolactinaemia, movement disorders developing in patients with risk factors (including medicines associated with such events) and worsening of pre-existing movement disorders, neuroleptic malignant syndrome-like events, pancreatitis, suicidal ideation, pancytopenia, immune related haemolytic anaemia, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after withdrawal of the medication and violent behaviour.
Precautions:
Abrupt discontinuation of A-LENNON FLUOXETINE may lead to withdrawal symptoms, which include dizziness, sweating, nausea, insomnia, tremor, confusion, sensory disturbances, agitation and anxiety.
A-LENNON FLUOXETINE should be discontinued in any patient who develops seizures. A-LENNON, FLUOXETINE 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 fluoxetine receiving ECT treatment.
A-LENNON FLUOXETINE is extensively metabolised by the liver and excreted by the kidneys. A lower dose, e.g. alternate day dosing, is recommended in patients with significant hepatic dysfunction or mild to moderate renal failure (GFR 10 - 50 mL/min).
Clinical experience in acute cardiac disease is limited; therefore caution is advisable.
Fluoxetine may cause loss of mass, which could be undesirable in undermass depressed patients. In patients with diabetes, fluoxetine may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
There have been reports of altered platelet function and/or abnormal results from laboratory studies in patients taking fluoxetine. While there have been reports of abnormal bleeding in several patients taking fluoxetine, it is unclear whether fluoxetine had a causative role. Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive agent may impair judgement or skills. Therefore patients should be cautioned that their ability to perform potentially hazardous tasks (e.g. driving a motor vehicle or operating machinery) might be impaired.
As improvement may not occur during the first two or more weeks of treatment, patients should be closely monitored during this period. Due to the risk of suicide in major depressive episodes, close supervision of high risk patients should accompany medication therapy.
Because of well-established co-morbidity between obsessive-compulsive disorder and depression, the same precautions observed when treating patients with depression should be observed when treating patients with obsessive-compulsive disorder.
There have been reports of extrapyramidal symptoms associated with the use of A-LENNON FLUOXETINE and of aggravation of Parkinson's disease in patients taking A-LENNON FLUOXETINE. A-LENNON FLUOXETINE should therefore be avoided in patients with extrapyramidal disorders.
Interactions:
A-LENNON FLUOXETINE should not be used concomitantly with monoamine oxidase inhibitors (see "CONTRA-INDICATIONS").
Caution is advised if the concomitant administration of A-LENNON FLUOXETINE and central nervous system active agents, including lithium, is required. There have been reports of both increased and decreased lithium levels when used concomitantly with fluoxetine. Lithium levels should be monitored. There have been greater than 2-foid increases of previously stable plasma levels of other antidepressants when fluoxetine has been administered in combination with these agents. Patients receiving fluoxetine in combination with tryptophan have been reported to experience adverse reactions, including agitation, restlessness and gastro-intestinal distress.
The long elimination half-lives of fluoxetine and its active metabolite should be borne in mind (see "Pharmacokinetics") when considering pharmacodynamic or pharmacokinetic drug interactions. The half-life of concurrently administered diazepam may be prolonged. Fluoxetine is bound to plasma protein and concurrent administration may alter plasma concentrations of other plasma protein bound drugs, e.g. warfarin, digitoxin, phenytoin, or conversely, fluoxetine binding may be changed by other agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In overdosage, nausea, vomiting and excitation of the central nervous system occur. Death has been reported. Treatment involves induction of emesis or gastric lavage followed by symptomatic and supportive therapy.

IDENTIFICATION:
A hard gelatin capsule with an ivory opaque body and a light green opaque cap, containing a white to slightly off-white powder.

PRESENTATION:
Securitainers of 28 and 250 capsules.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25ºC). Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/1.2/0575

NAME AND ADDRESS OF THE APPLICANT:
Pharmacare Ltd
7 Fairclough Rd
Korsten
Port Elizabeth

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 August 1998

Approved 07 Mar 2003
New addition to this site: March 2010
Source: Pharmaceutical Industry

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