Oilatum Emollient                                       

Fluoxetine Alacan

Compostion

Each tablet contains: Fluoxetine (hydrochloride) 20mg

Capsules

Packages of 14 or 28 capsules

Fluoxetine Alacan is indicated for the treatment of depression and anxiety related as well as for bulimia nervosa and treatment of obsessive-compulsive disorders.

Known history of hypersensitivity to fluoxetine.

Fluoxetine should not be administered in combination with Monoqamine Oxidase Inhibitor (MAOI) or with a minimum of 14 days of discontinuing therapy with an MAOI.

At least 5 weeks should be allowed after stopping Fluoxetine before starting an MAOI

Activation of mania/hypomania has been reported in a little proportion of patients treated with Fluoxetine.

Systemic events, possibly related to vasculitis have developed in patients with rash. Although, these events are rare, death have been reported to occur in association with these systemic events. Upon the appearance of rash or other possibly allergic phenomena for which an alternative aetiology cannot be identified Fluoxetine hydrochloride should be discontinued.

Safety has not been established for pregnant women. Fluoxetine should be administered only if potential benefit justifies potential risk to the foetus.
Fluoxetine is excreted in human milk, therefore it should be administered with caution to nursing mothers.

Patients should be cautioned when managing hazardous machinery including cars until there is evidence that pharmacological treatment does not adversely affect

Safety and effectiveness in pediatric patients have not been established.

This medicine has been prescribed specially to you and your own process, therefore you should not modify doses and usage without previous advice of your physician.

Fluoxetine is orally administered.

Depression: 20 mg/day is recommended as initial dose administered in the morning.

If no clinical improvement is observed after several weeks, a dose increase may be considered by your doctor. This will be done from 20 to 20mg in two times, for instance morning and noon. 

Nervous bulimia: For treatment of nervous bulimia, recommended dose is 60mg per day.

Obsessive-compulsive disorder: For treatment of obsessive-compulsive disorders, a dose range of 20 to 60 mg/day is recommended.

In any treatment, maximum dose will never exceed 80m/day.

Usage in elderly: a daily dose of 20mg is recommended.

Liver impairment: lower doses or less frequent

Renal impairment: In case of severe renal impairment, it is recommended lower doses or less frequent.

All modifications and control should be done under medical criteria.

Signs and symptoms: Nausea and vomiting are the predominant symptoms. Also marked CNS excitement like agitation and convulsions.

Since its launch, death cases associated with overdose with fluoxetine reported have been extremely rare.

Treatment: It is recommended symptomatic and supportive care. Use of activated charcoal with sorbitol can be as effective asx emesis or gastric lavage and should be considered. Convulsions induced by fluoxetine no solved spontaneously can respond to diazepam.

Take special care in case of fluoxetine overdose associated with other antidepressants.

In case of overdose or accidental intake, consult local poisob control center.

Most observed side reactions observed in association with fluoxetine includes anxiety, nervousness, insomnia, somnolence, tiredness, tremor, sweatiness, anorexia, nauseous, diarrhoea and dizziness.

Less frequent reactions include migraine, dry mouth, dyspepsia and vomiting.  Also other less frequent severe reactions have been reported: syncope, heart arrhythmia, abnormalities in hepatic function tests, hypo and hyper thyroidism, haemorrhage time increased, acute brain syndrome and convulsions.

Store at room temperature

This product must not be used beyond the expiry date that appears on the packaging.