Rileptid 2mg Egis Pharma drugs treat acute and chronic schizophrenia (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Risperidone

Ingredient

Composition information	Content
Risperidone	2mg

Uses

indications

Rileptid Egis drug is indicated in the following cases:

Treatment of schizophrenia treatment. Rileptid is used to treat sensitive goods that are severe in bipolar disorders.

Rileptid is indicated in short -term treatment (up to 6 weeks) of prolonged aggression in patients with dementia has just been severe due to Alzheimer's disease without responding to non -drug -free measures and when there is a risk of harm to themselves or others.

Rileptid is used to treat symptoms in a short time (up to 6 weeks) of prolonged aggression when there are behavioral disorders in children 5 years of age and older and in young people with intelligence operating below average or mental development retarded according to DSM-IV standards, who are the people where the severity of other aggressive or other disorders require drugs.

Medication treatment must be an inexplicable part of a more comprehensive treatment regimen, including social and educational intervention.

Risperidone should be indicated by a pediatric nerve expert and children's psychology or young people or by experienced physicians in the treatment of behavioral disorders in children and young people.

Pharmacokology

Group of pharmacological effects, other anti -psychotropic drugs.

ATC code: n05a xos

Pharmacological pharmacology: Risperidone is a selective dopaminergic antagonist with specific characteristics. The drug has high affinity for serotonin 5-HT2 and Dopamine D2.

Risperidone is also attached to the alpha-adrenergic receptor and has lower affinity with H1 histamine receptors and alpha1-adrenergic receptors. Risperidone has no affinity for the Cholinergic receptors. Although Risperidone is a strong antagonist with D2, which is considered to improve the positive symptoms of schizophrenia, the drug is less inhibited in exercise and is less likely to keep the anti -psychotic drugs.

The balanced antagonistic between serotonin and central dopamine may reduce the risk of extrasicide sub -effects and expand the treatment activity to negative symptoms and emotional symptoms of schizophrenia.

Dynamic pharmacokinetics

Risperidone is converted into 9-hydroxy-risperidone, which is a pharmacological activity similar to Risperidone.

Risperidone is completely absorbed after drinking, reaching the peak concentration of plasma within 1 to 2 hours.

absolutely used when drinking Risperidone is 70% (CV = 25%). Relative bioavailability when taking Risperidone tablets is 94% (CV = 10%) compared to the solution.

The absorption is not affected by food and therefore can drink Risperidone with food or not. Risperidone's dynamic balance state is achieved within 1 day in most patients. The dynamic equilibrium of 9-hydroxyrisperidone is achieved within 4-5 days of taking the drug.

Risperidone is quickly distributed. The distribution volume is 1-2 l/kg. In plasma, Risperidone is attached to albumin and alpha1-acid glycoprotein. The ratio of risperidone binding to plasma proteins is 90%, of 9-Hydroxy-Risperidon is 77%.

Risperidone is converted by CYP 2D6 to 9-hydroxy-risperidone, which is a pharmacological activity similar to Risperidone. Risperidone, along with 9-Hydroxy-Risperidone, creates an anti-psychotic activity. Strong CYP 2D6 chemicals will quickly convert Risperidone into 9-hydroxy-risperidone, while weak CYP 2D6 metabolites are the opposite.

Strong metabolites produce lower Risperidone concentrations and 9-hydroxy-risperidone concentration higher than weak metabolites, but the combined pharmacokinetics of Risperidone and 9-Hydroxy-Rperidone (meaning that the component has anti-psychotic activity), after unique doses and repeated doses, similarly in powerful and weak metabolites 206.

Another metabolic path of Risperidone is the reduction of Alkyl. In human in vitro studies, the liver mini has shown that Risperidone at the appropriate clinical concentration does not inhibit the metabolism of drugs metabolized by cytochrome P450 ISoenzyme, including CYP 1A2, CYP 2A6, CYP 208/9/10, CYP 206, CYP 2E1, CYP 3A4, and CYP 3A5. A week after taking the medication, 70% of the dose is discharged in urine and 14% in feces. In urine, risperidone along with 9-hydroxy-risperidone corresponds to 35-45% of the drug.

The rest are non -activity metabolites. After mental patients take medicine, Risperidone is eliminated with a half -life. The half-life of 9-hydroxy-risperidone and the drug ingredient with anti-psychotic activity is 24 hours.

The plasma concentration of Risperidone ratio is proportional to the dose within the treatment dose range.

A single -dose study in the elderly shows that the average concentration in the blood of the anti -psychotic activity is 43%higher, the half -life of cancellation is longer than 38%and the elimination of the anti -psychotic activity has decreased by 30%.

In patients with renal failure, plasma concentrations of components have higher anti -psychotic activity and the elimination of components with anti -psychotic activity decreases than 60%on average. Plasma risperidone concentrations are normal in patients with liver failure, but the average free risperidone component in plasma increases about 35%.

The pharmacokinetics of Risperidone, 9-Hydroxy-Risperidone and the ingredients with anti-psychotic activity in children are similar to adults.

A population dynamic analysis shows no clear impact of gender, race or smoking habits on Risperidone's pharmacokinetics or anti -psychotic activity.

Before taking Rileptid 2mg Egis Pharma drugs treat acute and chronic schizophrenia (6 blisters x 10 tablets)

How to use

Rileptid is used for drinking. Food does not affect the absorption of Rileptid.

Dosage

schizophrenia

Adults

Can take Rileptid once a day or twice a day. Must start with the dose of Risperidone 2 mg/day.

On the second day, the dose may be increased to 4 mg. The dose can then be then adjusted by individuals if needed. The majority of patients take daily doses of 4 and 6 mg.

A slower dosage exploration stage and lower starting and maintenance dose may be more suitable for some patients.

The dose of over 10 mg/day does not show more efficiency than lower doses and may increase the symptoms of foreign tower. Not evaluating the safety of doses higher than 16 mg/day, and thus should not use these doses.

Elderly

Should start the starting dose of 0.5 mg oral twice a day. This dose can be adjusted by individuals up to 1-2 mg twice a day, each increase 0.5 mg twice a day.

Children

Do not use Risperidone for children under 18 years of age with schizophrenia because there is a lack of data on effectiveness.

The attacks in bipolar disorders

Adults

Must use Rileptid once a day, starting with 2 mg risperidone dose. If the dose adjustment is needed, the adjustment distance must not be shorter than 24 hours and with an increase of 1 mg each time. Risperidone can be used at a dose of about 1 - 6 mg daily to optimize the effectiveness and tolerance of the patient. No more than 6 mg daily dose per day in patients with manic attacks.

Like all other symptomatic treatments, the long -term use of Rileptid must be continuously evaluated.

Elderly

Should start the starting dose of 0.5 mg twice a day. This dose can be adjusted by individuals up to 1 - 2 mg twice a day, with each increase of 0.5 mg twice a day. Because clinical experience in the elderly is limited, it is necessary to be cautious.

Children

Do not use Risperidone for children under 18 years old with a manicular attack due to bipolar disorder due to lack of data on efficiency.

prolonged aggression in patients with dementia has just come severe due to Alzheimer's disease

Should start the starting dose of 0.25 mg twice a day. If necessary, the dose can be adjusted by individuals with each increase of 0.25 mg twice a day, but not usually more than every two days. The optimal dose for most patients is 0.5 mg twice a day. However, some patients may need a dose of 1 mg twice a day.

Do not use Rileptid for more than 6 weeks in patients with continuous aggression due to the illness of the Alzheimer intelligence. While treatment must evaluate patients regularly and regularly, and the need to prolong the treatment must be re -evaluated.

behavioral disorders

Children and young people from 5 to 18 years old

Should use the starting dose of 0.5 mg once a day if there is a weight or over 50 kg. If necessary, the dose can be adjusted by individuals with each increase of 0.5 mg once a day, but not usually more than every two days.

The optimal dose for most patients is 1 mg once a day. However, some patients may only need 0.5 mg once a day while others may need 1.5 mg once a day.

For patients weighing less than 50 kg, the starting dose should start 0.25 mg once a day. If needed, the dose can be adjusted by individuals with each increase every 0.25 mg once a day, but not usually two days better than termites. The optimal dose for most patients is 0.5 mg once a day.

However, some patients may only need 0.25 mg once a day while others may need 0.75 mg once a day. Like all other symptomatic treatments, the long -term use of Rileptid must be continuously evaluated.

Do not use Rileptid for children under 5 years old because they have no experience in children under 5 years old with this disease.

kidney failure and liver failure

Patients with renal impairment are capable of eliminating drugs with less anti -psychotic activity than adults with normal kidney function. Patients with liver function impaired with free risperidone component in plasma increases.

Regardless of whatever treatment indications, the starting dose and the next dose must be reduced by half, and the exploration of the dose must be conducted slower in patients with kidney failure or liver failure.

Be cautious when using Rileptid for these patients. When stopping the drug, the dose should be slowly reduced. Symptoms of acute cessation, including nausea, vomiting, sweating and insomnia are rarely reported after the sudden stopping of anti -psychotic drugs used in high doses (see the side effects).

can also relapse mental symptoms, and there are reports of incontinence disorders (such as sitting, restless, muscular dysplasia and dysplasia).

Transfer from other anti -psychotic drugs: When appropriate, at the beginning of using Rileptid, it should be slowly stopped previously treated. Also, if appropriate, when transferred from anti -psychotic drugs that have a long -lasting effect, should start the treatment with Rileptid at the time of the next injection. The need to continue the medications of Parkinson's being used periodically to be re -evaluated.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Symptoms

In general, signs and symptoms are reported by excessive increase in the known pharmacological effects of Risperidone. Including chicken and sedation, tachycardia and low blood pressure, and extrasic symptoms. When the overdose, the extended QT interval and the convulsions have been reported. The peak twisted symptoms have been reported in the case of overdose of risperidone and paroxetine.

In case of acute overdose, it is necessary to consider the possibility of being involved in many drugs.

Handling

Set and maintain a smooth air and ensure adequate oxygen and ventilation.

Only consider gastric lavage (after placing the trachea if the patient is in a coma and using activated carbon with a laxative when taking the drug occurs less than an hour earlier). Heart monitoring must be started immediately and must include continuous monitoring of electrocardiograms to detect percentage may occur.

There is no specific antidote for Rileptid. Therefore, appropriate support measures must be taken. Hypotension and circulation must be treated with appropriate measures such as intravenous infusion and/or using sympathetic nerve stimulants.

In the case of severe foreign symptoms, a cholin anti -secretion. Must continue monitoring and monitoring until the patient recovers.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Rileptide 2 mg Egis, you may experience unwanted effects (ADR).

The most commonly reported adverse drug reactions (≥ 10%ratio) are Parkinson's syndrome, headache and insomnia.

The following are all adverse reactions due to drugs reported in clinical trials and during after -sales. The following terms and ratios are applied: Very common (≥ 1/10), common (≥ 1/100 to

In each group of incisions, unwanted effects are presented in the order of severity.

The adverse reactions caused by drugs by each agency and the rate of occurrence.

Infections and parasites

Common: pneumonia, influenza, bronchitis, upper respiratory tract infection, urinary tract infection.

Not common: sinusitis, viral infection, ear infections, tonsillitis, cellular inflammation, otitis media, eye infections, localized infections, ticks caused by ticks, respiratory infections, cystitis, nail fungal disease.

Rare: Chronic otitis media.

Blood and lymphatic system

Not common: Anemia, thrombocytopenia.

Unknown: loss of granulocytes.

The immune system

Not common: hypersensitivity.

Rare: Hypersensitivity to the drug.

Unknown: Anaphylaxis reaction.

Endocrine

Rare: The anti -hormone secretion syndrome is inappropriate.

Metabolism and nutrition

Common: Increasing appetite, reducing appetite.

Not common: anorexia, a lot of thirst.

is very rare: acidosis is caused by diabetes.

Unknown: Water poisoning.

Mental

Very common: insomnia.

Common: anxiety, excitement, sleep disorders.

Not common: Mixed, revealing, reducing libido, indifferent, stress.

Nervous system

Very common: Parkinson's syndrome, headache.

Common: Sitting, restless, dizzy, trembling limbs, muscular disorders, sleeping, sedation, sleeping, movement. Speaking, abnormal in coordination, reducing sensation.

Rare: Malignant neuroleptic syndrome, Diabetes coma, cerebral vascular disorders, ischemia in the brain, dynamic disorders.

Common: blurred vision.

Not common: conjunctivitis, congestion, eyes with secretions, swelling, dry eyes, increased tears, fear of light.

Rare: Reduction of vision, eye stir, glaucoma.

ears and mesmerizing

Not common: ear aches, tinnitus.

heart

Common: tachycardia.

Blood vessels

Not common: Low blood pressure, hypotension, vertical posture, flushing.

unknown: There have been reports of venous thrombosis, including pulmonary and thrombosis in the vein after using anti -psychotic drugs.

Respiratory, chest and mediastinum

Common: Difficulty breathing, nosebleeds, cough, stuffy nose, sore throat-laryngeal.

Rare: Sleep apnea syndrome, ventilation.

Digestive

Common: vomiting, diarrhea, constipation, nausea, abdominal pain, indigestion, uncomfortable dry mouth in the stomach.

Rare: intestinal obstruction, pancreas inflammation, swelling of the lips, inflammation.

Liver

Rare: jaundice.

Skin and subcutaneous tissue

Common: ban, erythema.

Rare: scalp scales.

Bone muscle and connective tissue

Common: joint pain, back pain, pain in the limbs.

Not common: muscle weakness, muscle aches, neck pain, joint swelling, abnormal posture, stiffness, muscle aches in the chest.

Rare: Mechanical pilot.

Kidney and urinary tract

Common: bedwetting.

Not common: urination, incontinence, urination.

pregnancy, postpartum and chu sinh

Unknown: The cessation syndrome in newborns (see caution).

Reproduction and breast system

Not common: amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorders, secretion of milk, breast enlargement in men, menstrual disorders, white blood.

unknown: Penis pain.

Systemic side effects and at the place of medicine

Common: fever, fatigue, peripheral edema, weakness, chest pain.

Not common: edema, disordered gait, feeling abnormal, drowsiness, disease like flu, thirst, discomfort in the chest, chills.

Rare: Comprehensive edema, lower body temperature, cessation syndrome, peripheral cold.

Testing

Common: increased blood prolactin, weight gain.

Not common: Qt lasts on the electrocardiogram, abnormal electrocardiograms, hyperglycemia, transaminase increased, reducing the number of white blood cells, increasing body temperature, hypernagus, hemoglobin, increased creatinine phosphokinase in blood.

Rare: Reduce body temperature.

In some cases, increased prolactin in the blood can lead to breast enlargement in men, menstrual disorders, amenorrhea, dairy secretion.

There may be a percentage disorder: Parkinson's syndrome (increased salivation, stiff muscle muscle, Parkinson's syndrome, drooling, muscle hardened like serrated wheels, slow movement, reduced exercise function, face like masking, muscular muscles, stiff muscles, stiff muscles, hard muscles, Parkinson's body, abnormal nasal root) vacuum in the seat), tremor of hands and feet, dysplasia (convulsive muscles, dancing, dancing, and muscle vibration), muscle muscle disorders.

Muscle disorder includes muscle disorders, twitching muscles, increasing tone, crooked neck, unauthorized muscles, spasms, eyelid spasms, longan, paralysis, facial convulsions, laryngeal seizures, muscle tone, bent -to -mouth -to -mouth convulsions, side spasms, tongue convulsions, and jaw tightness. Run includes tremor of limbs and Parkinson's tremor when resting. Note that there are more than the symptoms that have been listed but not necessarily due to the source of the pagoda.

The following is a list of other adverse reactions because Risperidone has been determined to be an adverse reaction because the drug is seen in clinical trials with the injection risperidone that has a long -lasting effect, but these reactions are not considered a disadvantage due to drugs in clinical trials with oral Risperidone. This table regardless of the adverse reactions due to the typical drug for the form of preparation for injection when using the injection risperidone has a long -lasting effect.

The adverse drug reactions caused by other drugs are reported when using Risperidone injected in the form of prolonged effects but not seen when taking Risperidone, arranged by each organ.

Testing: weight loss, gamma-glutamyltransferase, liver enzyme.

Heart: Slow heart rate.

Blood and lymph: neutropenia.

Nervous system: Perception, convulsions.

face: eyelid spasm.

In and mesmerizing: dizziness.

Digestive: toothache, tongue spasm.

Skin and subcutaneous tissue: eczema.

Bone muscle, connective tissue and bone: butt pain.

infection and parasitic infection: lower respiratory tract infections, infections, intestinal inflammation, abscess under the skin.

Trauma and poisoning: falling.

blood vessels: hypertension.

General and at the place of medicine: Pain.

Mental: depression.

The effect of the drug group

As well as other anti -psychotic drugs, it is rare for prolonged QT interval to be reported in the after -sales stage of Risperidone. Other heart effects, related to the drug group, seen with anti -psychotic drugs that extend the QT range including ventricular arrhythmia, cancer, fastest, sudden death, cardiac arrest and torsion.

weight gain

The percentage of adult patients with schizophrenia is treated with risperidone and placebo with a 27%increase in body weight compared to a collection of places with a place of fatal control that lasts 6 to 8 weeks, showing that the weight gain rate in the Risperidone group is larger in a significant way (18%) compared to the placebo group (9%).

Through a set of 3 -week fat control studies in adult patients with acute mania, the rate of weight gain in the 27%increased milestone is equivalent to the Risperidone group (2.5%) and the placebo group (2.4%), and slightly higher in the control group (3.5%).

In long -lasting studies in groups of children and young people with behavioral disorders and other aggressive disorders, with an average weight gain of 1.3 kg after 12 months of treatment.

The level of weight gain is expected to be normal from 5-12 years old is 3 to 5 kg per year. From 12-16 years old, an increase of 3 to 5 kg per year mentioned above is maintained in girls, while in male children is about 5 kg per year.

More information about special patient groups

Medicine adverse reactions, which are reported to occur more in elderly patients with dementia or children compared to adult groups, described below:

Elderly patients with dementia: In the elderly patients with dementia, fleeting brain anemia and stroke are adverse reactions due to drugs seen in clinical trials at a rate of 1.4% and 1.5% respectively. In addition, the following adverse drug reactions are reported at a rate of 25% in elderly patients with dementia and at least twice as much as possible in other adult groups: urinary tract infections, peripheral edema, sleep, and cough.

Children's patients: The following adverse reactions are reported at 25% in children's patients (5 to 17 years old) and at least twice as much in clinical trials in adults: Sleep/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory infections, stuffy nose, abdominal pain, dizziness, pulse, pun

Notify the doctor with unwanted effects when using the drug.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Rileptid Egis drugs are contraindicated in cases of hypersensitivity to active ingredients or any excipients of the drug.

Precautions when using

Hypotenary pressure posture

Due to Risperidone's alpha blockers, hypotension (vertical posture) can occur, especially in the early stages when exploring the dose. Clinical significant hypotension has been seen during the post -marketing period when using Risperidone at the same time with hypertension. Be cautious when using Rileptid for those who are known to have cardiovascular disease (such as heart failure, myocardial infarction, abnormal transmission, dehydration, blood volume, or cerebrovascular disease), and the dosage must be slowly explored as recommended (see the dose and usage). The dose reduction must be considered if there is a hypotension.

Venous thrombosis

There have been reports of venous thrombosis when taking anti -psychotic drugs. Because patients treated with anti -psychotic drugs often suffer from risk factors for venous thrombosis, before and while using Rileptid must identify all risks of venous thrombosis and must apply preventive measures.

Late dysfunction/Symptoms of extracurricular symptoms

The drugs with dopamine receptor antagonistic properties are associated with the causing late dysplasia with the characteristics of the non -autonomous, mainly self -reliant movements of the tongue and/or face.

The emergence of outsider symptoms is a risk factor for late dysplasia. If the signs and symptoms of late dysplasia appear, it is necessary to consider stopping all anti -psychotic drugs.

Malignant neuropular syndrome

Malignant neuroleptic syndrome, characterized by high fever, muscle, nerves, instability, changing consciousness and increasing the level of creatine in serum has been reported to occur with anti -psychotic drugs. Other signs may include Myoglobin-Nurt (muscle fiber) and acute renal failure. In this case, all anti -psychotic drugs must be stopped, including Rileptid.

Parkinson's disease and dementia can be lewy

Doctors must consider gums and harm when prescribing anti -psychotic drugs, including risperidone, for patients with Parkinson's disease or dementia may be lewy. Parkinson's disease may worsen if using Risperidone. Both groups of patients may increase the risk of malignant neuroleptics as well as increase sensitivity to anti -psychotic drugs; These patients were not accepted into clinical trials. The manifestations of increased sensitivity may include mixed, inanimate, unstable posture with many falls, in addition to the symptoms of the pupils.

Hyperglycemia

Hyperglycemia or diabetes are worse has been reported in a very rare number of cases of risperidone. There should be appropriate clinical monitoring in patients with diabetes or in patients with risk factors for developing diabetes.

Hyperlactin in the blood

Tissue studies show that the growth of cells in breast tumors in humans can be stimulated by prolactin. Although it has not been proven to be clearly related to the use of anti -psychotic drugs in clinical and epidemiological studies, but should be cautious when taking drugs for patients with relevant history. Be cautious when taking Rileptide for patients who are increasing the blood prolactin and patients may have tumors depending on the prolactin.

extended qt

Prolonged QT is rarely reported during after -sales. As with other anti -psychotic drugs, it is necessary to be cautious when prescribing Risperidone for patients with cardiovascular disease, in the family with prolonged QT history, slow heart rate, or electrolyte disorders (hypokalemia, blood magnesium decreased), because there may be an increase in risk of arrhythmia, and when combined with drugs that extend QT.

convulsions

Be cautious when taking Rileptid for patients with convulsions or other diseases that can lower the seizure threshold.

Penis pain

There may be penis pain when using Rileptide due to the sympathetic receptor of the drug's alpha.

Air conditioner

Anti -psychotic drugs are said to cause the body to lose the ability to reduce the central body temperature. It is necessary to have appropriate care when ordering Rileptid for patients who may experience situations that contribute to the increase in central body temperature, such as very hot movement, very hot environment, using drugs that have anti -cholin activity, or dehydration.

excipients

Rileptid contains lactose. Do not use this medication if the patient has rare genetic conditions that do not tolerate galactose, lactase lactase deficiency.

Use drugs for children and adolescents

Before appointing Risperidone for children or teenagers with behavioral disorders, these patients must be fully assessed for the real or social causes of aggression such as pain or inappropriate need from the environment.

Must monitor the sedative effect of Risperidone in this patient group because there may be consequences on the ability to learn. A change in the time of using Risperidone can improve the impact of sedation on the attention of children and teenagers.

Risperidone increases the average weight and mass index (BMI). Changes in height in long -term opening studies are in the expected standard for each age. The effect of long -term treatment with Risperidone on sexual maturity and height has not been fully studied.

Because the effects of prolactin prolonged prolactin prolonged the development and sexual growth in children and young people, it is necessary to consider regular clinical assessment of endocrine status, including height, weight, sexual maturity, menstrual monitoring, and other effects may be due to prolactin.

While treating with Risperidone, regular examination must be examined to find foreign symptoms and other movement disorders.

Regarding specific doses recommended for children and teenagers, see the dosage and usage.

Take medicine for the elderly: Elderly people have dementia. In general mortality: Elderly people have dementia when using non -typical anti -psychotic drugs with increased mortality rate compared to the placebo group, when analyzing the synthetic analysis of 17 tests with non -typical anti -psychotic drugs, including Risperidone. In risperidone's place of control control in this patient group, the mortality rate is 4.0% in the Risperidone group compared to 3.1% in the placebo group. The difference ratio (95%accurate confidence interval) is 1.21 (0.7-2.1). The average age (about age) of patients died is 86 years old (about 67-100 years old).

Data from two large -scale observation studies shows that in the elderly people who are demented and treated with conventional anti -psychotic drugs also have an increase in the risk of death when compared to those who are not treated. There is no adequate data to firmly estimate the accuracy of this risk and do not know the cause of increased risk. If considering some patient characteristics, the degree may be attributed to psychotic drugs in increasing the risk of death in described studies.

Rileptid is not allowed to treat behavioral disorders due to intellectual decline.

Simultaneously used with Furosemide: In Risperidone's place-to-off control tests in the elderly, there is a higher mortality rate in the group using Furosemide along with Risperidone (7.3%; Average age 89, about 75-97 years old) when compared to the risperidone group alone (3.1%; Average age 84, about 70-96) or Furosemide group. (4.1%; average age 80, about 67-90 years old). The increase from death in patients using Furosemide along with Risperidone is noticed in two of the four clinical trials. The use of Risperidone at the same time with other diuretics (mainly low -dose thiazide diuretics) does not show similar results.

It is not known which pathophysiological mechanism can explain this finding, and there is no pattern about the cause of death. However, before deciding to use the drug, it is necessary to be careful and to consider gums and harm when coordinating or taking use at the same time with strong diuretics. When used at the same time Risperidone with other diuretics does not see increased mortality rate. Regardless of any treatment, dehydration is a general risk factor for death and therefore need to be cautious to avoid the elderly patients with dementia.

Disadvantage in cerebral vascular: In the place of fatal control in elderly patients with dementia, there is a significant higher ratio (about 3 times) on the adverse event in the brain vessel, such as a stroke (including death) and brain anemia in patients using Risperidone compared to the placebo group (average age 85, about age 85). The figures combined from six fat control studies, mainly in elderly patients (greater than 65 years old), have dementia, showing adverse events in brain blood vessels (including severe and non -severe) occurring at 3.3% (33/1009) patients using Risperidone and at 1.2% (8/712) patients use placebo. The difference rate (accurate confidence interval of 95%) is 2.96 (1.34, 7.50). It is unknown the mechanism of this risk increased. It is impossible to rule out an increase in risk for other anti -psychotic drugs or in other patients.

Be cautious when using Rileptid for patients with risk factors for stroke. The risk of disadvantage of cerebrovascular disadvantage is significantly higher in patients with intellectual dementia in a combination or type of blood vessels when compared to Alzheimer intellectual decline, so patients with intellectual decline in other types with Alzheimer's disease do not use Risperidone.

Doctors need to evaluate benefits and harm when taking Rileptid for elderly patients with dementia, paying attention to the elements of predicting the risk of stroke for each patient. Patients/caregivers must pay attention to immediately report the signs and symptoms of the disadvantage of the may have, such as suddenly seeing weak people who are numb in the face, arm or leg, or have difficulty in speaking or looking. It must be considered not to delay in all treatment options, including the suspension of Risperidone.

Only use Rileptid with a short time in prolonged aggression in patients with dementia has just been severe due to Alzheimer's disease to supplement non -drug -free measures when these measures are not effective or only limited and when there is a risk of patients who harm themselves or others. Must re -evaluate patients regularly, and re -evaluate long -lasting demand.

The ability to drive and operate machinery

Rileptid may have a slight or moderate effect on the ability to drive and operate machinery due to its ability to act on the nervous and visual system (see items of unwanted effects).

Therefore recommends that patients should not drive or operate machines until they know the sensitivity of each individual.

Pregnancy

infants exposed to anti -psychotic drugs (including risperidone) in the last three months of pregnancy are at risk of adverse reactions including symptoms of pagoda and/or quitting drugs, which the severity and prolonged time of these symptoms may change after birth.

There have been reports of excitement, increasing tone, reducing tone, tremor of hands and feet, sleeping, respiratory failure, or eating disorders. Therefore, careful monitoring of babies must be monitored.

Do not use Rileptid when pregnant unless really necessary. If you need to stop the drug during pregnancy, you should not stop suddenly.

Lactation period

In animal studies, Risperidone and 9-Hydroxy-Risperidone are secreted into breast milk. It has proven that Risperidone and 9-Hydroxy-Risperidone are also secreted into human breast milk in small amounts.

There are no data on adverse reactions that occur in breastfed babies. Therefore, it is necessary to consider the benefits of breastfeeding with the risk of a child.

Interactive drug

as well as with other anti -psychotic drugs, so be careful when prescribing Risperidone along with drugs that are known to extend QT interval, such as La anti -arrhythmia (such as Quinidine, Dysopiramide, Procainamide), anti -arrhythmic drugs III (such as Amiodarone, Sotalol), Three -Route Anti -Damage Drugs (such as Amitride). Four-round antidepressants (such as Mappotiline), several antihistamine drugs, other anti-psychotic drugs, some malaria medications (such as Chinice and Mefloquine), and with drugs that cause electrolyte imbalance (potassium-lowered, magnership), bradycardia, or inhibitors inhibit the metabolism of risperidone in the liver. This list is only listed but incomplete.

The ability to rileptid affects other drugs

Be cautious when coordinating Risperidone with central effects, including alcohol, opium, antihistamine and benzodiazepine drugs due to increased risk of sleep.

Rileptid may be opposed to the effects of levodopa and other dopamine owners. If considering this combination is necessary, especially Parkinson's disease in the final stage, it must be used with the lowest doses and still effective.

Clinical hypotension has been seen in after -sales monitoring when using Risperidone at the same time with hypertension medication.

There is no clinical significant Rileptid on pharmacokinetics of lithium, valproate, digoxin or topiramate.

The possibility of other drugs affects Rileptid

It has noticed that carbamazepine has reduced the plasma concentration of risperidone anti -dysplasia components. The same effects can be seen with rifampicin, phenytoin and phenobarbital are drugs that cause CYP 3A4 liver enzymes as well as p-glycoprotein.

When starting or stopping carbamazepine or other drugs that induce CYP 3A4/P-Glycoprotein (P-GP), the physician must re-evaluate the dosage of Rileptid.

fluoxetine and paroxetine, CYP 2D6 inhibitors increase the plasma concentration of risperidone, and less for ingredients that have anti -psychotic activity.

It is thought that other CYP 2D6 inhibitors, such as Quinidine, can affect the plasma concentration of risperidone in the same way. When the coordination with fluoxetine or paroxetine is started or stopped, the physician must re -evaluate the dosage of Rileptid.

Verapamil, a CYP 3A4 and P-GP inhibitors, increases the risperidone levels in plasma.

Galantamine and Donepezil do not show clinical effects on Risperidone's pharmacokinetics and on the ingredient with anti -psychotic activity.

Phenothiazine, three -round antidepressants and some beta blockers can increase the plasma concentration of risperidone but for ingredients that are anti -psychotic activity.

Amitriptyline does not affect the dynamics of Risperidone or of the ingredient with anti -psychotic activity. Cimetidine and ranitidine increase the bioavailability of risperidone, but for ingredients with anti -psychotic activity, it increases very little.

erythromycin, a CYP 3A4 inhibitor, does not change the kinetics of Risperidone or of the ingredient with anti -psychotic activity.

The combination of mental stimulants (such as methylphenidate) with Rileptid in children and adolescents does not change the dynamics or effectiveness of Rileptid.

About increasing death in the elderly, dementia when used simultaneously with Furosemide, see the cautious part.

Do not simultaneously use oral rileptid with paliperidone because caliperidone is a metabolic substance that is active of risperidone and the combination of these two drugs can lead to an increase in exposure to an anti -psychotic activity.

Children: Studies on interaction are only conducted on adults.

Storage

Store drugs at temperatures below 30 ° C in the original packaging. To be out of reach of children.

Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.

Other drugs

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