Risperon 2 mg 30 tablets — Made in Bulgaria — Free Delivery

Product description

Risperon® tablets are used for the following indications:

• treatment of schizophrenia and other mental disorders, including supportive care in patients who have responded to therapy, in order to prevent recurrence of the disease;
• treatment of manic episodes in bipolar disorders (adjuvant therapy in combination with normotimics as initial treatment or as monotherapy for a period of up to 12 weeks);
• short-term treatment of severe aggression or severe mental symptoms in patients with dementia when there is a threat of harm to themselves or others;
• symptomatic treatment of impudent oppositional disorders or other disorders of social behavior in children, adolescents and adults with intellectual development below average or mental retardation, who have manifestations of destructive behavior (impulsivity, autoaggression);
• symptomatic treatment of autistic disorders in children aged 5 years and older, whose symptoms range from hyperactivity to irritability (including aggression, self-harm, anxiety and pathological cyclic actions).

Compound

The active ingredient is risperidone (one coated tablet contains 2 mg risperidone).

Excipients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose 6, macrogol 6000, titanium dioxide (E 171).

Contraindications

hypersensitivity to the active ingredient or to any excipient of the preparation;

dementia and symptoms of Parkinson's disease (stiffness, bradykinesia and parkinsonian postural disorders);

dementia and suspected Lewy body dementia (except for dementia symptoms, less than two of the following symptoms: parkinsonism, visual hallucinations, unsteadiness of gait).

Mode of application

The usual dose

The preparation can be used 1 or 2 times a day. Doses over 8 mg should be divided into 2 doses (morning and evening). Food intake does not affect the absorption of Risperon®.

A gradual discontinuation of treatment is recommended. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia, were very rare after abrupt cessation of high-dose antipsychotic preparations. Recurrence of psychotic symptoms may also occur, and involuntary movements (eg, akathisia, dystonia, and dyskinesia) have been reported.

To achieve a dose of 0.25-2.5 mg, risperidone is recommended as an oral solution.

Schizophrenia

Adults. The preparation can be administered 1 or 2 times a day.

You should start taking with 2 mg of the preparation per day, on the second day the dose can be increased to 4 mg. Thereafter, the dose can be maintained unchanged or, if necessary, individually adjusted. For most patients, the recommended dose is 4-6 mg per day. In some patients, a gradual dose increase or a lower initial dose may be indicated.

Doses that exceed 10 mg per day have not been shown to be highly effective compared to lower doses, but they can cause extrapyramidal symptoms. Since the safety of doses exceeding 16 mg per day has not been studied, such doses cannot be used.

If additional sedation is needed, benzodiazepine can be used concurrently.

Manic episodes in bipolar disorder

Adults. The recommended initial dose of the preparation is 2 mg once a day in the evening. The dose can be individually increased by adding one mg / day no more often than every 24 hours. The recommended dose range is from 2 to 6 mg per day. As with other types of symptomatic treatment, with long-term use of the preparation "Risperon®" it is necessary to periodically review the doses and adjust them during the entire therapy. There is no data on the effectiveness of the preparation "Risperon®" in the treatment of acute bipolar mania lasting more than 12 weeks. If the preparation "Risperon®" is used in combination with normotimics, therapy can be stopped earlier, since the beginning of the effect of treatment can be expected in the first weeks of therapy. Even after the appearance of a response to treatment, one should take into account the possibility of recurrence of symptoms of depression due to the peculiarities of the course of the disease and adverse reactions of the preparations used for treatment, including the preparation "Risperon®".

Children over the age of 10. The recommended starting dose is 0.5 mg once a day, in the morning or in the evening. The dose can be individually increased by adding from 0.5 to one mg / day no more often than every 24 hours until the recommended dose of 2.5 mg / day is reached. The effectiveness of treatment was demonstrated in the dose range from 0.5 to 6 mg / day, doses above 6 mg / day have not been studied.

For patients with drowsiness, dividing the daily dose into 2 doses may be recommended.

As with other types of symptomatic treatment, with long-term use of the preparation "Risperon®" it is necessary to periodically review the doses and adjust them during the entire therapy.

There is no experience of using the preparation "Risperon®" for the treatment of manic episodes in bipolar disorders in children under 10 years of age.

Short-term therapy for severe aggression or severe psychiatric symptoms in patients with dementia

The recommended starting dose is 0.25 mg 2 times a day. If necessary, the dose can be increased by increasing the dose by 0.25 mg 2 times a day, no more often than every other day. For most patients, the optimal dose is 0.5 mg 2 times a day. However, for some patients, the effective dose can be increased to one mg twice daily. Once the optimal dose has been reached, consideration may be given to taking the daily dose once a day. As with other types of symptomatic treatment, with long-term use of the preparation "Risperon®" it is necessary to periodically review the doses and adjust them during the entire therapy.

Cancellation of treatment with this preparation should take place no later than 3 months after the start of therapy, therapy can be resumed only if behavioral disorders reappear.

Symptomatic treatment for social behavior disorders or aggressive behavior

Patients weighing ≥ 50 kg. The recommended starting dose is 0.5 mg once a day. If necessary, the dose should be adjusted by adding 0.5 mg once a day, no more often than every other day. The optimal dose for most patients is 1 mg once a day. However, for some patients, no more than 0.5 mg once a day is sufficient to achieve a positive effect, while others may require 1.5 mg once a day.

Patients weighing <50 kg. The recommended starting dose is 0.25 mg once a day. If necessary, the dose can be adjusted by adding 0.25 mg once a day, no more often than every other day. The optimal dose for most patients is 0.5 mg once a day. However, for some patients, no more than 0.25 mg once a day is enough to achieve a positive effect, while others may require 0.75 mg once a day.

As with other types of symptomatic treatment, long-term use of Risperon® should be periodically reviewed and adjusted throughout therapy.

There is no experience of using the preparation "Risperon®" for the symptomatic treatment of disorders of social behavior or aggressive behavior in children under the age of 5 years.

Autism (children from 5 years old)

The dose should be selected individually, depending on the patient's condition and clinical response.

Patients weighing <50 kg. The recommended starting dose is 0.25 mg once a day. From the 4th day, the dose can be increased by 0.25 mg. The dose should be maintained at 0.5 mg and the clinical response should be assessed on day 14. Dose increases of 0.25 mg two weeks apart should be considered only for patients with insufficient clinical response.

Patients weighing ≥ 50 kg. The recommended starting dose is 0.5 mg once a day. From the 4th day, the dose can be increased by 0.5 mg. The 1 mg dose should be maintained and the clinical response evaluated on day 14. A dose increase of 0.5 mg every two weeks should be considered only for patients with insufficient clinical response.

The preparation can be used 1 or 2 times a day.

For patients who develop drowsiness after taking the preparation, it is better to use the daily dose of the preparation "Risperon®" before bedtime or in two doses. During clinical studies, approximately two-thirds of children with autism complained of weakness, especially during the initial phase of treatment.

Once an adequate clinical response has been achieved, gradual dose reduction should be considered to achieve an optimal clinical efficacy-safety relationship.

There is insufficient information from controlled clinical trials to determine the recommended duration of treatment with Risperon® in autistic patients. Therefore, an experienced specialist should carefully monitor the patient's condition.

If serious adverse reactions occur (for example, extrapyramidal disorders, tardive dyskinesia, or uncontrolled weight gain), reduce the dose of this preparation or stop treatment.

There is no experience of using the preparation "Risperon®" for the symptomatic treatment of autism in children under 5 years of age.

To achieve a dose of 0.25-1 mg, risperidone is recommended as an oral solution.

Application features

Pregnant

No controlled studies have been conducted in pregnant women. Although no teratogenic effects were found in animal studies, there was an indirect effect on prolactin levels.

In newborns whose mothers have used antipsychotics (including risperidone) during the last trimester of pregnancy, there is a risk of recurrent extrapyramidal symptoms and / or preparation withdrawal. These symptoms include agitation, unusually increased or decreased muscle tone, tremors, drowsiness, trouble breathing, or feeding problems. These complications can vary in severity. In some cases, they themselves disappeared after a certain period of time, in some it was necessary to monitor the condition of the infants in the intensive care unit or long-term hospitalization.

"Risperon®" is not recommended for use during pregnancy, except in cases of vital necessity. If it is necessary to stop treatment with Risperon® during pregnancy, you should not do it suddenly.

In animal studies, risperidone and 9-hydroxyrisperidone were absorbed into milk. There are observations that risperidone and 9-hydroxyrisperidone can also pass into human breast milk. In some cases, 4.3% of the dose that the mother used in the form of an active antipsychotic fraction of the active substance was determined in breast milk. If necessary, taking the preparation, breastfeeding should be discontinued.

Children

Risperidone is used to treat disorders of social behavior or aggressive behavior, as well as autistic disorders in children over the age of 5 years; for the treatment of manic episodes in bipolar disorders in children over the age of 10 years.

Drivers

The preparation can affect the reaction rate when performing work requiring special attention. Therefore, it is recommended to refrain from driving or operating other mechanisms.

Overdose

Symptoms

Signs and symptoms of overdose that have been observed are known side effects of the preparation, which are manifested in an intensified form: drowsiness and sedation, tachycardia and arterial hypotension, as well as extrapyramidal symptoms. In overdose, QT interval prolongation and seizures have been reported. Flicker-flutter associated with an overdose of Risperon® in combination with paroxetine has been reported.

Treatment

A clear airway should be provided and maintained to ensure adequate ventilation and oxygenation. Consideration should be given to gastric lavage (after intubation, if the patient is unconscious) and the appointment of activated charcoal along with a laxative no later than 1 hour after taking the preparation. Shows monitoring of cardiovascular activity, including continuous recording of ECG to identify possible arrhythmias. Risperidone has no specific antidote. Therefore, appropriate supportive measures should be taken. In case of acute overdose, the possibility of interaction between several preparations should be analyzed. Arterial hypotension and vascular collapse should be treated with measures such as intravenous fluids and / or sympathomimetic preparations. If acute extrapyramidal symptoms develop, anticholinergic preparations should be prescribed. Continuous medical supervision should be continued until the patient is fully recovered.

Side effects

The most common reported adverse reactions (frequency ≥ 10%) are parkinsonism, sedation / drowsiness, headache, and insomnia. Parkinsonism and akathisia are dose-dependent adverse reactions.

Storage conditions

Store in its original packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 3 years.