Bula do remedy Eufor 20

the package insert of the medicine Eufor 20. Therapeutic class of the anti-Depressants. Active principles Fluoxetine.

what For?

Eufor 20 (hydrochloride fluoxetine) is intended for the treatment of depression.

oral – adult Use

Contraindications

When should I not use?

Hypersensitivity to fluoxetine.

Administration of maoi, concomitant or within 14 days of stopping treatment with fluoxetine, due to the possibility of the emergence of severe reactions and sometimes fatal.

it is Recommended to leave a gap of at least five weeks after discontinuation of fluoxetine and initiation of treatment with Maoi.

Patients experiencing such reactions may benefit from the use of ciproeptadina or dantrolene i. v.

Dosage

How to use?

it is Recommended to start the Eufor 20, with the dose of 20 mg/day in the morning.

it Can be recommended to increase the dose if, after several weeks, is not observed no clinical improvement.

Doses above 20 mg/day should be administered in two taken daily in the morning and at noon-day, and should not be exceeded dose of 80 mg/day.

As with other antidepressants, it can take up to 4 weeks to observe the maximum effect of fluoxetine.

In liver failure or kidney doses must be reduced or administered at longer intervals.

This conduct should also be considered in the elderly and patients with concomitant diseases in the use of other medicines.

As to the duration of treatment Eufor 20, there is no data established and the responsible physician should decide on this already that is accepted by the majority that acute episodes of depression require several months of treatment.

Side Effects

What are the evils that can cause me?

The most common were related to the central nervous system and included: anxiety, nervousness, and insomnia; drowsiness and fatigue or asthenia; tremor, sweating; gastrointestinal complaints, including anorexia, nausea and diarrhea; dizziness or light-headedness.

In approximately 15% of patients had interruption of treatment associated with the adverse effects of fluoxetine.

Among the effects that led to discontinuation of treatment the most common were: source psychiatric (5,3%), primarily nervousness, anxiety and insomnia; digestive (3%), primarily nausea; nervous system (1.6 percent), primarily dizziness; body as a whole (1.5 percent), primarily asthenia and headache; and skin (1.4 percent), primarily rash and pruritus.

in Addition to these, there have been reported reactions considered occurrence more rare (< 1%).

Despite these reactions have occurred during treatment with fluoxetine, they were not necessarily caused by the drug.

The most frequent were: body as a whole: chills, fever, cyst, face edema, feeling of hangover, pain, mandibular, malaise, pain in neck, stiffness in neck, pelvic pain; cardiovascular system: angina pectoris, arrhythmia, hemorrhage, hypertension, hypotension, migraine, postural hypotension, syncope, tachycardia.

digestive System: increased appetite, stomatitis mouth, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossite, liver function tests abnormal, melena, stomatitis, thirst.

the Endocrine System: hypothyroidism.

System hematolinfático: anemia, lymphadenopathy.

Metabolic and nutritional: weight loss, generalized edema, hypoglycemia, peripheral edema, and weight gain.

musculoskeletal System: arthritis, bone pain, bursitis, tenosynovitis, twitching.

nervous System: nightmares, agitation, gait abnormal, syndrome brain acute, akathisia, amnesia, apathy, ataxia, syndrome, oral and glossal, stimulation of the cns, convulsion, delirium, depersonalization, lack of emotional control, euphoria, hallucinations, hostility, hyperkinesia, hiperetesia, lack of coordination, increased libido, reaction, manic, neuralgia, neuropathy, reaction, paranoia, psychosis, vertigo.

respiratory System: bronchitis, rhinitis, yawn, asthma, epistaxis, hiccup, hyperventilation, pneumonia.

Skin and appendages: acne, alopecia, contact dermatitis, dry skin, herpes simplex, rash máculopapular, urticaria.

the Organs of the senses: amblyopia, conjunctivitis, pain in the ear, eye pain, mydriasis, photophobia, Tinitus.

urogenital System: abnormal ejaculation, amenorrhea, pain in the breast, cystitis, dysuria, sinus fibrocístico, impotence, leukorrhea, menopause, menorrhagia, ovarian disorder, urinary incontinence, urgency, failure in urination, vaginitis.

Recently, there have been reported some adverse reactions that may have no causal relationship with the drug: cerebral vascular accident, confusion, dyskinesia, bruising, gastrointestinal bleeding, hyperprolactinemia, pancreatitis, suicidal ideation, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after drug discontinuation and violent behavior.

Warnings and Precautions

what should I know before using?

Was observed in 4% of patients who participated in clinical trials the occurrence of skin rash and /or urticaria, of which 1/3 eve treatment suspended for this reason.

Other signs and related symptoms were fever, leukocytosis, arthralgia, edema, tunnel syndrome carpiano, respiratory disorder, lymphadenopathy, proteinuria and mild elevation of transaminases.

The majority had complete recovery after suspension of the treatment and in some cases it was necessary to the administration of anti-histamines or corticosteroids.

Severe skin disease systemic occurred in 2 patients (vasculitis Leucocitoblástica and vasculitis, or erythema multiforme).

Syndrome systemic suggesting serum sickness has occurred in several other patients.

Reactions to systemic, possibly related to vasculitis, have occurred in patients with rash.

Such reactions are quite rare, but when they occur they can be serious, having been reported the occurrence of death with these reactions systemic.

there have Been reported reactions anaphylactoid (bronchospasm, angioedema, and urticaria).

Reactions lung having dyspnea as the sole symptom are occurring quite rare.

Until the moment it is not known if these reactions systemic and eruptions of the skin have the same cause or are due to the etiology or different processes.

in Case of skin reaction or other allergic reaction with no cause identifiable, Fluoxetine should be discontinued immediately.

Up to the current knowledge there are no elements to evaluate whether the association of rash with other signs and symptoms constitutes a true syndrome related to fluoxetine, or if it constitutes an association occasional frame with different etiology.

Although no patient reported permanent damage, and there is total regression of symptoms after suspension of fluoxetine and in 2/3 of cases there may be continuation of the treatment without any consequence.

physicians should be warned to discontinue the drug in case of occurrence of skin lesions.

Anxiety, nervousness and insomnia – were observed in 10% to 15% of patients treated with fluoxetine, leading to discontinuation in 5% of them.

Change of appetite and weight – can occur weight loss important, which can be especially severe in depressed patients with weight below normal.

In the clinical research it was found an incidence of about 9% of anorexia among patients receiving fluoxetine, which represented about 6 times the observed with the placebo group.

weight Loss above 5% occurred in approximately 13% of the cases treated with fluoxetine, compared to 4% with placebo and 3% with tricyclic antidepressants.

However, despite these observations, it was rarely necessary to stop treatment with fluoxetine because of weight loss.

Activation of mania / hypomania – it was observed in very small number of cases, about 1%, and is reported also with other antidepressants.

Seizures – have been recorded in only 0.2% of treated patients, a rate similar to that of other antidepressants.

either way caution is advised in the administration of fluoxetine to patients with a history of seizure.

Suicide – in depressive patients the possibility of suicide is a component of the framework and may persist until there is remission of the same.

Thus, fluoxetine should be prescribed at the lowest dose possible, to avoid overdose.

the Half-life of elimination is prolonged of fluoxetine and its metabolites because both the original drug and its metabolites have a half-life prolonged (2-3 days for fluoxetine and 7-9 days for its metabolite, the norfluoxetina), the changes of dose are not reflected in plasma for several weeks.

Use in patients with pathologies concomitant – as clinical experience with fluoxetine in patients with systemic diseases concomitant is small, its use should be done with caution in patients with diseases or conditions that could affect metabolism or responses to hemodynamic.

Myocardial infarction recent or heart disease, unstable – there are no data on the use of fluoxetine in these conditions, as patients with these diagnoses were excluded from the studies, but the electrocardiograms performed during the clinical research phase showed no changes.
Cirrhosis of the liver – the clearances of fluoxetine and its metabolite decreased in liver cirrhosis, increasing the half-life in plasma, therefore a lower dose or longer intervals should be used.

As fluoxetine is almost completely metabolized, excretion unchanged in urine is very small, so until an adequate number of patients with kidney failure be treated, fluoxetine should be administered with caution in such patients.

As occurs with many types of drugs administered to diabetic patients, the doses of insulin and /or oral hypoglycemics should be adjusted due to the possibility of the occurrence of hypoglycemia during therapy with fluoxetine or hyperglycemia after discontinuation of the drug.

Interference with cognitive performance and motor – as with any psychoactive drug, can be no compromise of performance and, therefore, patients should be advised to not drive vehicles or operate machinery.

Toxicology animal – in mice, rats and dogs was observed accumulation of phospholipids in some tissues, after prolonged use, the effect of this reversible with the interruption of fluoxetine.

Its significance in humans is unknown.
Carcinogenesis, mutagênese and damage to the fertility – fluoxetine showed no change in these areas.

In rats and mice, the long-term management, for about 2 years, doses of 7.5 to 9.0 times greater than the maximum dose to the man it has not produced any evidence of carcinogenicity.

The mutation assays the bacterial assay of repair of dna in cultures of hepatocytes from rats, the test of lymphoma in mouse and in the testing of exchange of cromátides sisters in vivo on bone marrow cells of hamsters have not shown genotoxic effects.

In two studies of fertility in rats, with doses 5 and 9 times higher than the maximum indicated human beings, there was no adverse effect of fluoxetine on fertility.

it Was observed a slight reduction in the survival of neonatal, perhaps associated with a decrease in food consumption by the mother and the consequent reduction of weight.

Eufor in Pregnancy – the studies in rats and rabbits, doses that are quite high (9 to 11 times the maximum dose for human beings) did not reveal changes in the offspring.

However, as there are no available studies in women, fluoxetine should not be administered to pregnant patients unless it is absolutely necessary, getting at the physician’s discretion to assess the risks versus benefits.

Lactation – as you know, many drugs are excreted into breast milk.

In a sample of human milk, the concentration of Fluoxetine /norfluoxetina was 70,4 ng/ml.

was Not reported adverse reactions in the nursing infant.

His administration to women who are breastfeeding should be done with care.

children – have not been established efficacy and safety in children.

Use geriatric – several elderly patients were treated with Fluoxetine in the clinical research phase and have not been observed adverse reactions associated with aging.

However, the number of cases is small, and therefore fluoxetine should be used with caution in the elderly, especially if they have concomitant diseases that require treatment with other drugs.

Hyponatraemia – has been observed in several cases and seems reversible with the discontinuation of fluoxetine.

Despite being raised several theories as to its etiology, it seems that in some cases there was secretion of inappropriate antidiuretic hormone.

The greater part of the cases occurred in the elderly and patients who took diuretics or had a depletion of liquids.

Function platelet – changes the function of platelet and /or abnormal results from laboratory studies have been observed in rare cases, not being clear causal relationship with fluoxetine.

At the beginning of treatment should be greater attention when treating patients with suicidal tendencies.

Drug Interactions

The concurrent use with tryptophan in some patients led to the appearance of adverse reactions such as agitation, restlessness and gastrointestinal disturbances.

Inhibitors of the monoaminooxidase – see contra-indications.

The administration with other antidepressants has led to an increase in plasma levels stable them in about two times.

it Can occur increase or decrease in plasma levels of Lithium when of concomitant administration of fluoxetine.

Due to the reporting of cases of toxicity with lithium, plasma levels of this drug must be monitored.

In some patients the simultaneous administration with diazepam provoked an increase of the half-life of this.

When it makes simultaneous use of fluoxetine with other drugs with high protein binding (for example, warfarin, digitoxina) there may be a displacement of this connection and, consequently, change of the plasma concentration, which can result in effect potentially greater and possible adverse reaction.

This can occur both with Fluoxetine as with another drug.

there are Still no sufficient data on the simultaneous use of fluoxetine with other drugs active on the central nervous system, therefore the use of these associations should be avoided and, if strictly necessary, their use should be supervised carefully.

there is Also no sufficient data on the concurrent Use of fluoxetine and the treatment eletroconvulsivo, not being, therefore, established the benefit of this association.

Storage

Where how and for how long can I save?

The product must be kept protected from light, moisture and avoid excessive heat.

Displays a period of validity of 2 years, which must be checked on the external packaging.

Overdose

what to do if someone use a larger amount than is recommended?

With the use greater than the indicated amount of Eufor 20, can occur gastrointestinal symptoms important as nausea and vomiting, and in the area of the central nervous system, agitation, restlessness, and hypomania.

it was Also reported the onset of seizures grand mal type, which ceased spontaneously.

Were registered 2 cases of death associated with excessive dose of fluoxetine, one of them in association with maprotiline and another with codeine and temazepam.

In almost all reported cases of overdosage acute with fluoxetine had combination with other drugs and/or alcohol.

In only one case the death was attributed to overdose only for fluoxetine.