The package insert of the medicine Relaxil

the package insert of the medicine Relaxil.

what For?



When should I not use?

it should Not be administered to: patients with hypersensitivity to benzodiazepines, or any component of the product; during the first trimester of pregnancy; during prolonged treatment in women with risk of pregnancy; lactating women; people with closed angle glaucoma.


How to use?

average Dose to non-hospitalised patients: 1.5 to 3 mg, up to 3 times a day. Severe cases, especially in hospitalized patients: 6 to 12 mg, 2 or 3 times a day. These doses should be considered as general recommendations, and the dose of each patient to be established individually. The treatment of non-hospitalised patients should be started with low doses, gradually increased until reaching the optimum dose. After a few weeks, and, at the latest. 3 months, according to the result of the treatment, you should try to discontinue the medication. A treatment period of 3 months or less does not cause, in general, any problem. If it is necessary to continue the treatment for more than 3 months, the withdrawal of the medication should be gradual. Instructions dosing: elderly patients and feeble and need smaller doses than those recommended, due to variations in individual sensitivity and the pharmacokinetics of bromazepam. – Overdose: clinical picture: the overdosage is manifested by a confusional state, deep sleep, muscle relaxation, hiporreflexia, and amnesia. It is recommended gastric lavage, monitoring, and conventional treatment of the changes of respiratory and cardiovascular disease. Treatment: in cases of intoxication severe for any of the benzodiazepines (sedation, severe or coma) recommends the use of the antagonist, flumazenil, in an initial dose of 0.3 mg E. V. with increment from 0.3 mg to 60-second intervals, until the reversal of the coma. In the case of benzodiazepines of long half-life can be resedação; therefore, it is recommended the use of flumazenil for infusion intravenous 0.1 – 0.4 mg/hour, a drop in glucose 5% or sodium chloride 0,9%, together with the other processes of reanimation, since that flumazenil does not reverse the respiratory depression.

Side Effects

What are the evils that can cause me?

In therapeutic doses, the bromazepam is well tolerated. Tiredness, drowsiness and, in rare cases, muscle relaxation, can occur when using high doses. These symptoms disappear with dose reduction. Although there is no evidence of toxic effects hematologic, or that affect the function of the liver or kidney, it is recommended in prolonged treatments, control of blood count and liver function.

Warnings and Precautions

what should I know before using?

General: muscular hypotonia. Respiratory failure decompensated. Use in pediatrics: safety and efficacy anxiolytic are not defined in patients up to 18 years. Use in elderly: elderly patients require smaller doses than those recommended, due to variations in individual sensitivity and the pharmacokinetics of bromazepam. Use in pregnancy: as with other benzodiazepines, should not be refused the possibility of fetal harm. Therefore, it should not be used in the first three months of pregnancy, except in cases of extreme necessity, where the benefits justify the potential risks to the fetus. Use in lactation: it is not recommended its use in lactating women because of the possibility of passing to the breast milk can’t be taken away. Dependence and withdrawal: can occur dependency when therapy with benzodiazepines. The risk is more evident in patients with long-term use, high doses, and, particularly, in patients predisposed with a history of drug abuse, alcoholism or other psychiatric disorders severe. In order to minimize the risk of addiction, and the bromazepam should only be prescribed after careful assessment as to the indication, and must be administered for a period of time as short as possible. The prolonged duration of the treatment is only justified after careful assessment of risks and benefits. The onset of withdrawal symptoms is variable, lasting from a few hours to a week or more. In more severe cases, the symptoms of the withdrawal may be limited to tremor, agitation, insomnia, anxiety, headache, sweating, spasms, muscle and abdominal and, more rarely, delirium and convulsions. On the occurrence of withdrawal symptoms, it is necessary for a medical follow-up as well next to and support for the patient. Abrupt cessation should be avoided, by adopting a scheme of gradual withdrawal. Surveillance and driving: in the first 4 to 6 hours after the administration of Relaxil, patients should avoid driving vehicles or operating dangerous machinery due to the possibility, depending on the dose and individual sensitivity, of medicine to modify the reactions of the patient. Warnings: extreme caution should be taken when administering the bromazepam to patients with myasthenia gravis (due to muscle relaxation, preexisting), and patients with porfiríase, kidney dysfunctions, and severe hepatic. Drug interactions: as with any psychoactive substance, the effect of bromazepam may be enhanced by alcohol. Its concomitant use with other drugs action on the central, such as neuroleptics, tranquilizers, antidepressants, hypnotics, analgesics and anesthetics, can enhance its sedative effect. The concurrent use with levodopa may decrease the therapeutic effect of levodopa. It is not recommended to use concomitantly with: oral contraceptives containing estrogens; disulfiram; doxycycline; rifampicin; isoniazid, and zidovudine.