Bula do remedy Semap

the package insert of the medicine Semap. Therapeutic class of Antipsychotics. Active principles Penfluridol.

what For?

In the psychotic symptoms productive (hallucinations, delusions, mannerism, and stereotypies) in autism, and apathy.


When should I not use?

Semap should not be used in depressive disorders and Parkinson. Semap is contraindicated in depression of the CNS and in the states comatosos. Should not be used in patients with a known hypersensitivity to any of the components of the formula or any derivative difenilbutilpiperidínico.


How to use?

Semap is administered orally one time per week. In patients who are already receiving medication neuroléptica, suggests a gradual reduction of the existing therapy, while the initial dose of Semap 20 mg is gradually increased according to the results obtained. Initial Dose: in patients who have not yet received any medication neuroléptica, 20 to 40 mg of Semap are administered as an initial dose, and adapted to the measurement of other psychotropic sedatives, if it is necessary to combat the psychomotor agitation, anxiety and insomnia. These psychotropic drugs can be progressively reduced and possibly stopped. Maintenance Dose: the dose weekly single maintenance varies between 20 and 60 mg (1 to 3 tablets), oral. Such a dose should be tateada during a treatment period of between 4 and 8 weeks, starting with 10 mg in the first week, being increased gradually. Some patients may require doses greater than 60 mg and in these cases, to get to reach 100 mg, no adverse effects. In psychoses chronic mild and stabilized, or in a borderline case (borderline), doses weekly of 10 mg may be satisfactory. In the replacement therapy of neuroleptics sedative, the dose should be gradually reduced, replaced by doses weekly growing penfluridol, from 10 mg. Occasionally, some patients may require a greater or lesser need for medication sedative additional (such as, for example, administration in the evening) during treatment with Semap. Overdose: symptoms: after a superdose, the known adverse effects are the same as in a usual dosage, only the most prominent. However, some patients have a good tolerability with doses weekly from 160 to 200 mg, and even with daily doses of 120 mg. The side effects the most important observed in such patients were: extrapyramidal effects, hypotension and light sedation. Treatment: in the case of a superdose, supportive treatment and symptomatic have been recommended. There is no specific antidote. One should keep in mind the long duration of action of Semap. The measures suggested are: washing the gi-tract, establishment of the airway and, if necessary, if breathing is mechanically assisted. Hypotension and circulatory collapse may be treated with supportive measures, such as intravenous administration of fluids, plasma or albumin concentrated and with vasopressores, such as dopamine or dobutamine. Extrapyramidal symptoms should be treated with a antiparkinsoniano type anticholinergic.

Side Effects

What are the evils that can cause me?

The side effects are rare and generally mild. Neurological effects: appear about 4-6 hours after the administration of the weekly dose and are more pronounced on the following day. Usually subside in 48 hours and tend to disappear spontaneously within 3 to 6 weeks as the treatment and continued. Extrapyramidal symptoms, which occur due to blocking dopaminergic, rarely appear at doses lower than 10 mg of Semap for the week. With doses above 10 mg per week, the occurrence increases proportionately with the dose. The clinical manifestations the most common of these symptoms are: parkinsonism: bradykinesia, muscular rigidity, difficulty walking, lack of facial expression, tremor, micrograph. Dystonia, acute dyskinesia: stiff neck, trismus, seizures oculógiras. Akathisia: inability to sit still. The effects most frequently reported are: agitation and dyskinesia. The parkinsonian symptoms are decreased with the administration of anticholinergic or, if possible, with the reduction of the dose. Tardive dyskinesia. Hormonal effects include hyperprolactinemia, which in some cases can lead to galactorrhea or amenorrhea. Syndrome neuroléptica evil: as with other neuroleptics, rare cases have been reported this type of syndrome to the Semap. This syndrome constitutes a response idiossincrásica developed rapidly, characterized by hyperthermia, muscle rigidity, instability of autonomic, alteration of consciousness, coma, and increased levels of CPK. Signs of instability of autonomic, such as, tachycardia, labile blood pressure and sweating may precede hyperthermia, and act as warning signs. Treatment antipsychotic should be discontinued immediately and instituted therapy appropriate support and careful monitoring of the patient. The dantrolene and bromocriptine have been shown to be effective in the treatment of the syndrome neuroléptica malignant. Other effects: side effects autonomic, such as visual disturbances and hypotension, gastrointestinal symptoms, including nausea and vomiting, may occur mainly at the beginning of the treatment. However, such symptoms are rare. Fatigue, hipersalivação or excessive sweating may occur on the day following the administration of the weekly dose of Semap. Other observations include dizziness, drowsiness, headache, skin reactions and weight gain. Depression has occasionally been reported. In most cases, the causal relationship with Semap is not known. Have been reported isolated cases of changes in liver function and tachycardia benign after the administration of neuroleptics.

Warnings and Precautions

what should I know before using?

As the Semap is not a sedative powerful, it must be used in combination with psychotropic drugs sedatives, when it is used in patients who are agitated or aggressive. Semap should be used with caution in patients with hepatic dysfunction. It is believed that the neuroleptics can lower the seizure threshold and should, therefore, be used with caution in epileptic patients. If necessary, the doses of anticonvulsants should be adapted in these patients. Elderly patients may be particularly sensitive, particularly to extrapyramidal effects is recommended to reduce initial doses in half. The security of Semap in children under 12 years has not been established. Tardive dyskinesia: as every agent neuroléptico can observe tardive dyskinesia in some patients undergoing prolonged therapy or after discontinuation of the drug. The risk of developing increases with age and with dose, especially in women. The manifestations may be permanent in some patients. This syndrome is mainly characterized by involuntary movements, rhythmic tongue, face, mouth or jaw. There is no effective treatment known. Agents antiparkinsonianos usually do not relieve the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear, especially in patients over the age of 50 years. The syndrome may be masked when treatment is reintroduced, when the dose is increased or when it is made an exchange for another antipsychotic drug. It has been reported that movements compact thin tongue may be an early sign of tardive dyskinesia and that the syndrome full may not develop if medication is stopped in time. Interactions: as with all neuroleptics, the Semap can intensify the depression of the CNS produced by other CNS depressants, including alcohol, hypnotics, sedatives or powerful painkillers. In the same way, although the Semap does not have a depressant effect on the respiration, it may potentiate the respiratory depression caused by morfinomiméticos. When administered concomitantly with anti-hypertensive drugs, Semap may intensify the orthostatic hypotension. When drugs inducing enzyme (such as, phenobarbital, carbamazepine or phenytoin) is administered concomitantly, the dose of Semap should be increased. Semap inhibits the action of agonists dopamine, such as L-dopa or bromocriptine. Have not been reported incompatibilities with other psychotropic drugs. Pregnancy and lactation: although no effect teratogenic or embriotóxico has been observed in animals, there are not sufficient data to evaluate their safety in humans, therefore, Semap should only be used during pregnancy if the benefits exceed the possible risks. If the use of Semap is considered essential, the benefits of breastfeeding should be weighed before of the potential risks involved. Effects on ability to drive or operate machinery: patients who want to drive or operate machinery should be warned about the possibility of drowsiness and losses on a state of alert, especially during the first day of the treatment.