the package insert of the medicine Sonebon 5 mg. Therapeutic class of Anxiolytics. Active principlesNitrazepam.
Sonebon is indicated for the treatment of insomnia, whatever its etiology.
When should I not use?
The nitrazepam is contraindicated to patients with known hypersensitivity to benzodiazepines or to any other component of the formula. Should be
avoided in patients with glaucoma acute angle, miastenias gravis and dependent use of other drugs, including alcohol. Respiratory failure due to the depressant effect of benzodiazepines. The aggravation of hypoxia can, itself, trigger a anxiety that
would refer the patient to intensive care.
How to use?
Adults: 1 to 2 tablets at bedtime;
Elderly: ½ to 1 tablet at bedtime;
If the desired effect is achieved, one must decrease the dosage, for example, to a half. A dosage less can be sufficient.
What are the evils that can cause me?
The adverse reactions are related to dose and individual susceptibility. Sleepiness (which is subject to age), muscular hypotonia, and a feeling of intoxication can be described as adverse reactions. Some individuals may exhibit irritability, aggressiveness, superexcitação and syndrome of confusion, dreamlike. Linked to individual sensitivity, can we have a rash of type maculopápula itchy. Adverse effects commonly cited and that in general are related to the administered dose are: drowsiness, fatigue, and muscle relaxation. Adverse reactions less frequent: constipation, diarrhea, nausea, vomiting, urinary incontinence, increased or decreased libido, blurred vision, dry mouth, euphoria, skin rash, urinary retention, tremor, headache, tachycardia, muscle spasms, palpitations, increased secretion bronquial. Reactions paradoxical as states of acute hyperarousal, anxiety,
hallucinations, increased spasticity, muscle, insomnia, irritability, sleep disturbances, have been described. When the latter occur, the treatment should be stopped. Abrupt cessation can cause reactions that range from irritability, anxiety, myalgia, tremors, relapse of insomnia and vomiting, even convulsions isolated, and the states of evil mioclônico.
Warnings and Precautions
what should I know before using?
Benzodiazepines should be used with caution in patients with a history of alcoholism or drug addiction. The dosage must be adjusted for patients with renal and/or hepatic compromised, and for elderly patients. The consumption of alcoholic beverages should be avoided during the treatment. Tolerance: May occur some reduction in the response to the effects of benzodiazepines after repeated use of Sonebon for a prolonged period.
Dependence: The use of benzodiazepines may lead to the development of physical or psychological dependence. The risk of dependence increases with dose and duration of treatment. It is higher also in patients predisposed with a history of abuse of drugs or alcohol.
Anxiety rebound: A syndrome transient with symptoms that led to treatment with a benzodiazepine recurs, with greater intensity. May be accompanied by other reactions including mood changes, anxiety, and restlessness. As the risk of abstinence and rebound is higher when the
treatment discontinuation is abrupt, it is recommended that the dosage be reduced gradually.
Amnesia: it Should be borne in mind that benzodiazepines may induce amnesia anteróloga. This can occur with the use of therapeutic doses, with increasing risk at higher doses. Amnesic effects may be associated with inappropriate behavior.
Reactions psychiatric and “inconsistent”: Reactions psychiatric as restlessness, agitation, irritability, aggressiveness, delusion, rage, nightmares,
hallucinations, psychoses, inappropriate behaviour and other behavioural effects may occur with the use of benzodiazepines. When this
occurs, one should discontinue the use of the drug. These effects are more likely in children and the elderly.
Sedation, amnesia, decreased concentration, and alteration of muscle function may adversely affect the ability to drive and operate machinery.
The phenomenon of Withdrawal: the abrupt suppression of the medication can precipitate the abstinence syndrome, especially after prolonged treatment and,
especially in high doses. To avoid this phenomenon, it is recommended to gradually reduce the doses. If you need to stop abruptly, the medication, the physician must be attentive to the reactions of the patient.
Pregnancy and lactation: teratogenic effects have not yet been well elucidated, so it is not recommended the use of Sonebon in the first three months of pregnancy. It is inadvisable to prescribe high doses in the quarter to the end of the pregnancy because of the risk of hypotonia, hypothermia and complications
breathing in the newborn. The use of benzodiazepines during the Model of the Bull period of lactation is not recommended as the nitrazepam and its metabolites cross the placental barrier and are excreted in breast milk.
what to do if someone use a larger amount than is recommended?
The ingestion of quantities above the recommended dosages, can cause deep sleep or coma. It is recommended to suspend immediately the medicine. In this case, the measures to be taken include gastric lavage, followed by the general care and support, monitoring of the signals and observation of the patient.