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Things to watch out for before using ABIZOL
Do NOT use ABIZOL in the following situations

Do not use if you have allergy (hypersensitivity) to any of the Aripiprazole or ABIZOL.

USE BENEFICIAL OF ABIZOL in the following situations

If one of the following applies to you, tell your doctor before your ABIZOL treatment.

If;

• If your blood sugar is high or if you have diabetes in your family,

• If you have a seizure,

• If you have particularly involuntary and repetitive muscle movements,

• If you or your family has a history of cardiovascular disease, stroke, mini-stroke, abnormal blood pressure,

• Because antipsychotic use is associated with blood clot formation, if you or your family has a blood clot,

If you notice that you have gained weight, please tell your doctor if you have any strength or allergic symptoms in the swallow.

An elderly patient with a disability (memory or other loss of mental skills) should say to your doctor if you are unemployed or if you / your caregiver have had any stroke or mini-stroke in the past.

Immediately tell your doctor if you have any thoughts or feelings of hurting yourself. Suicidal thoughts and behaviors were reported during the treatment of aripiprazole.

Please consult your doctor if these warnings apply to you, even at any time in the past.

Use of ABIZOL with food and beverage

You can get ABIZOL independently of the food.

Do not drink alcohol while using ABIZOL.

Pregnancy

Consult your doctor or pharmacist before using this medication.

ABIZOL should not be used during pregnancy unless it is necessary.

If you are pregnant or think that you are pregnant, be sure to tell your doctor immediately.

Newborns exposed to antipsychotic drugs in the last three months of pregnancy are at risk for abnormal muscle movements and / or discontinuation of medication, which may change in severity following birth. Consult your doctor for detailed information about these symptoms.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breast-feeding

Consult your doctor or pharmacist before using this medication.

Breast-feeding

Vehicle and machine use

Do not use hazardous machinery, including motor vehicles, until you are sure that ABIZOL does not affect you negatively.

Important information about some auxiliary substances in the content of ABIZOL

ABIZOL contains 78.60 mg of mannitol per tablet. No adverse effects due to mannitol are expected at this dose.

Use with other medicines

If,

If you are taking medicines that lower your blood pressure: ABIZOL may increase the effectiveness of blood pressure-lowering drugs. Tell your doctor that you take medication to keep your blood pressure under control.

Use of ABIZOL with certain medications can cause your ABIZOL dose to change. It is very important for your doctor to specify the following medicines in particular:

• Medications that regulate your heart rate

• Psychiatric depression (anxiety) or depressive medication or phytotherapy

• Fungicides

• Some drugs used to treat HIV infection

4. CLINICAL CHARACTERISTICS
4.1. Therapeutic indications

ABIZOL is indicated in adults and adolescents (13-17 years) in the treatment of schizophrenia (in the treatment of episodes of acute schizophrenia and in the continuity of clinical remedy during admission treatment).

ABIZOL is indicated in the treatment of acute manic episodes associated with Bipolar I Disorder in adults and in the prevention of recurrence and stabilization in bipolar I patients whose last episode is manic or mixed.
4.2. Posology and application form

Posology / application frequency and duration Adults

schizophrenia

ABIZOL is 10 or 15 mg / day given in a single dose daily, regardless of the time of the initial dose of the recommended dose. The daily intake of ABIZOL is 15 mg per day. Clinical trials have shown that aripiprazole is effective at doses ranging from 10-30 mg / day. The maximum daily dose should not exceed 30 mg.

Bipolar mania

ABIZOL should be given in a single dose daily, regardless of the time of the meals, the starting dose is usually 15 or 30 mg per day. If necessary, dosing should not be done in less than 24 hours. Antimanic efficacy (3-12 weeks) has been demonstrated in clinical trials for a dose range of 15-30 mg / day. The safety of doses above 30 mg / day is not evaluated by clinical trials.

Prevention of new manic episodes in Bipolar I Disorder

To prevent the recurrence of manic episodes in patients using aripiprazole, the treatment should be continued at the same dose. In daily dose adjustments, including dose reduction, the clinical situation must be considered.

Pediatric population

Schizophrenia in adolescents (13-17 years)

The recommended dose is 10 mg / day as a single dose per day regardless of the time of the meals. Treatment should be initiated with a 2 mg dose for the first 2 days and titrated to Smg for the next 2 days to reach the recommended daily dose of 10 mg. Where appropriate, consecutive dose increments should be administered at doses of 5 mg, such that the maximum daily dose does not exceed 30 mg.

ABIZOL is effective at a dose range of 10-30 mg / day. The activity in doses exceeding 10 mg per day has not been studied in adolescents, but some patients may benefit from high doses.

Method of Application:

It is taken by mouth.

ABIZOL tablet is taken with enough water (eg a glass of water) into the hungry or thigh cam.

Additional information on special populations:

Kidney failure:

Dose adjustment is not necessary for patients with renal insufficiency.

Liver failure:

Dosage adjustment is not recommended for patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the available data are insufficient to recommend. In these patients, dosing should be carefully regulated. In addition, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).

Pediatric population:

Aripiprazole is not recommended for use in children under 13 years of age because safety and efficacy have not been established.

Geriatric population:

The effectiveness of aripiprazole in schizophrenia and Bipolar I disorder treatment has not been established in patients aged 65 years or older. Due to the high sensitivity of this population, lower initial doses should be considered when clinical factors are appropriate (see section 4.4).

Gender:

Female patients do not need a different dose setting than male patients.
4.5. Interactions with other medicinal products and other forms of interaction

Dosage adjustment in patients receiving aripiprazole concurrent with potent CYP3A4 or CYP2D6 inhibitors:
If aripiprazole is administered concurrently with a potent CYP3A4 or CYP2D6 inhibitor, aripiprazole must be reduced to half the usual dose of doxorhea. When combined treatment with a CYP3A4 or CYP2D6 inhibitor is discontinued, aripiprazole should be augmented again (see section 4.5).

Dosage adjustment in patients using potent CYP3A4 inducers:
When a strong CYP3A4 inducer is added to treatment with aripiprazole, aripiprazole should be taken to twice the dose. Additional dose increments of aripiprazole should be done in the context of clinical evaluation. When the CYP3A4 inducer is withdrawn from combination therapy, aripiprazole should be reduced to the dose recommended (see section 4.5).

It is important to consider reducing the daily dose to 25% of the normal dose in patients treated concurrently with a large number of drugs that inhibit CYP3A4 and CYP2D6 enzymes.

In patients known to be unable to metabolize CYP2D6, aripiprazole should be adjusted so that the dose is initially reduced to half the normal dose (50%), then a good clinical response is obtained. Aripiprazole should be as much as the normal dose (25%) dose in patients without a good CYP3A4 inhibitor.
4.3. contraindications

Contraindicated in those who have allergy to aripiprazole or other components.
4.4. Special use warnings and precautions

During antipsychotic treatment, improvement of the clinical condition of the patient may take several days to several weeks. Patients should be closely monitored during this period.

Significant adverse drug reactions:

Suicide:
It is natural that there is a suicidal tendency in psychotic illnesses and mood disorders, and in some cases suicidal tendency is reported immediately after the start of antipsychotic treatment including aripiprazole or discontinuation of treatment (see section 4.8). Close monitoring of patients at high risk should be accompanied by antipsychotic treatment. The results of epidemiologic studies have shown that patients with bipolar disorder and schizophrenia do not have a higher risk of suicide with aripiprazole when compared to other antipsychotics. Aripiprazole should be prescribed in the lowest amount to reduce the risk of overdose, as it is compatible with good patient practice.

Tardive dyskinesia:
In clinical trials with 1 year or less duration, there were rare reports of dyskinesia occurring suddenly during treatment with aripiprazole. Since the risk of tardive dyskinesia increases when antipsychotic treatment is prolonged, patients should be considered to reduce doses or discontinue medication if symptoms and signs of tardive dyskinesia occur in patients taking ABIZOL. These findings may worsen temporarily or even occur after treatment has ceased (see section 4.8).

Neuroleptic malignant syndrome (NMS):

NMS is a potentially lethal detection complex associated with antipsychotic medicinal products. In clinical trials, rare NMS cases have been reported during treatment with aripiprazole. Clinical manifestations of NMS are hyperpyrexia, muscle tension, changes in mental status, and signs of autonomic instability (irregular heartbeat or blood pressure, tachycardia, excessive sweating, and cardiac dysrhythmias). In addition, although not strictly related to NMS, an increase in creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure may also be seen. If a patient develops signs and symptoms of NMS or high fever occurs that is not explained by other clinical indications of NMS, all antipsychotic Drugs should be discontinued, including ABISOL (see section 4.8).

Watch:

In clinical trials, rare seizures have been reported during treatment with aripiprazole. For this reason, it should be used with caution in patients with seizure disorders or relapses associated with seizures (see section 4.8).

Psychosis associated with dementia in elderly patients:
_______ _

Conventional and atypical antipsychotic drugs cause an increased risk of death when used in the treatment of elderly patients with dementia-related psychosis.
_

Increase in mortality;
Compared with placebo, the risk of death was higher in patients treated with aripiprazole in three placebo-controlled aripiprazole trials (n = 938; mean age: 82.4; range, 56-99 years) in elderly patients with psychosis associated with Alzheimer's disease. The mortality rate of patients treated with aripiprazole was 3.5% when compared with the placebo group with 1.7%. Along with a variety of causes of death, a large proportion of deaths have been found to be due to cardiovascular (eg heart failure, sudden death) or infection (eg pneumonia).

Cerebrovascular adverse events.
In the same studies, patients were reported with cerebrovascular adverse events (eg stroke, transient ischemic attack), including Death (mean age: 84 years; range: 78-88 years). In total, cerebrovascular adverse events were reported in 1.3% of patients treated with aripiprazole versus 0.6% of patients treated with placebo during these trials. This difference is not statistically significant. However, there is a statistically significant dose-response relationship for cerebrovascular adverse events seen in patients treated with aripiprazole in a fixed-dose study, one of these studies. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis,

Hyperglycaemia and diabetes mellitus:

Hyperglycaemia and diabetes have been reported in patients treated with atypical antipsychotics, including aripiprazole, in some cases hyperglycemia has been reported to be overdose and associated with ketoacidosis, hyperosmolar coma or death.

Risk factors that may cause the tendency of patients to severe complications include obesity and patients with a family history of diabetes. Clinical trials with aripiprazole did not reveal any significant differences in incidence rates of hyperglycaemia-associated adverse events (including diabetes) or in abnormal glycemic laboratory values ​​compared with placebo. Patients treated with aripiprazole or other atypical antipsychotic agents do not have exact risk estimates that would allow direct comparison for hyperglycemic-associated adverse events. Patients treated with other atypical antipsychotics, including ABIZOL, should be regularly monitored for signs of hyperglycemia, signs of disease (polydipsia, polyuria, polyphagia and weakness) and diabetes mellitus, or patients with diabetes mellitus risk factors worsening of glucose control.

Weight gain:

Weight gain is usually seen in schizophrenic and bipolar manic patients due to the use of antipsychotics known to cause weight gain in co-morbidities, irregular lifestyle and may cause severe complications. Post-marketing weight gain has been reported in patients treated with aripiprazole. When detected, it is usually patients with high risk factors such as diabetes mellitus, thyroid disorder, or pituitary adenoma. Aripiprazole has not been shown to cause clinically significant weight gain in clinical trials (see section 5.1).

Cardiovascular adverse events:
Aripiprazole is a known hypertension, including known cardiovascular disease (myocardial infarction or ischemic heart disease, cardiac insufficiency or conduction abnormalities), cerebrovascular disease or hypotension (dehydration, treatment with hypovolemia and antihypertensive drugs) should be used with caution in well-known patients.

Venous thromboembolism (VTE) cases have been reported with antipsychotic medications. Since VTE risk may occur in patients treated with antipsychotics, all possible risk factors for VTE should be determined during and before treatment with ABIZOL and preventive measures should be taken.

Transmission anomalies:

In clinical trials of aripiprazole, the incidence of QT prolongation was found to be comparable to placebo. As with other antipsychotics, aripiprazole should be used with caution in patients with family history of QT prolongation.

Orthostatic hypotension:

Due to potentially a-adrenergic receptor antagonist activity, aripiprazole may be associated with orthostatic hypotension. The incidence of adverse events associated with orthostatic hypotension in placebo-controlled short-term studies in adult patients (n-2467) is as follows: orthostatic hypotension (placebo 0.3%; aripiprazole, 1%); orthostatic drowsiness (placebo, 0.3%, aripiprazole, 0.5%) and syncope (placebo, 0.4%, aripiprazole, 0.5%). Incidence of adverse events associated with orthostatic hypotension in pediatric patients aged 13-17 (n = 202); orthostatic hypotension (placebo, 0%; aripiprazole, 1.5%); (placebo, 0% aripiprazole, 1%) and syncope (placebo, 0% aripiprazole, 0.5%). Orthostatic hypotension was observed in 0.8% (112 / 13,543) of patients treated with oral aripiprazole in clinical trials.

Body temperature setting:
It is thought that antipsychotic medications, including aripiprazole, disrupt the body's ability to lower the internal body temperature. Aripiprazole should be prescribed with due care in patients who may be exposed to excessive exercise, exposure to drugs with anticholinergic activity, or exposure to dehydration, which may result in an increase in internal body temperature.

Dysphagia:
Antipsychotic drug use has been associated with esophageal dysmotility and aspiration. Aripiprazole and other antipsychotic drugs should be used with caution in patients at risk of aspiration pneumonia.

mannitol:

ABIZOL contains 78.60 mg of mannitol per tablet. No adverse effects due to mannitol are expected at this dose.

Hypersensitivity:

Hypersensitivity reactions characterized by allergic symptoms may occur with aripiprazole as well as with other drugs (see section 4.8).

Aripiprazole causes adverse effects such as sedation on the central nervous system (see section 4.8)
When considering primary effects, care should be taken when taking ABIZOL with other central medicines or alcohol. Aripiprazole has the potential to enhance the efficacy of certain antihypertensive compounds due to its CTI-adrenergic receptor antagonist activity.

If aripiprazole is used with medications known to cause QT prolongation or impaired electrolyte balance, it should be used with caution.

impact of drugs on ABIZOL:

Gastric acid blocker and H2
antagonist famotidine decreases the absorption rate of aripiprazole, but this effect is not considered clinically relevant.

Aripiprazole is independent of the CYP1A enzyme, but is metabolized in multiple ways under the responsibility of the CYP2D6 and CYP3A4 enzymes. For this reason, dosage adjustment is not necessary for smokers.

In a clinical trial conducted in healthy volunteers, the potent CYP2D6 inhibitor (quinidine) increased Aripiprazole EAA by 107% while Cmax remained unchanged. The EAA and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%, respectively. If administered together with quinidine, ABIZOL dose should be reduced to about half of the normal dose. Other potent CYP2D6 (quinidine) inhibitors, such as fluoxetine and paroxetine, are expected to have similar effects and therefore a similar dose reduction should be applied.

In a clinical trial in healthy volunteers, the potent CYP3A4 (ketoconazole) inhibitor increased the aripiprazole EAA and Cmax'1111 by 63% and 37%, respectively. The EAA of dehydro-aripiprazole and Cmax
decreased by 77% and 43%, respectively. Slow CYP2D6 metabolizers, when administered in combination with a potent CYP3A4 inhibitor, result in higher plasma concentrations of aripiprazole compared to fast CYP2D6 metabolizers. Given that ABTZOL is administered together with ketoconazole or other potent CYP3A4 inhibitors, the potential benefit to the patient should be greater than the potential risks. In the case of co-administration with ketoconazole, ABIZOL dose should be reduced to approximately half of the normal dose. Other potent CYP3A4 inhibitors, such as itraconazole and HIV protease inhibitors, are expected to exhibit similar effects and therefore a similar dose reduction should be administered.

When CYP2D6 or 3A4 inhibitors are withdrawn from combination therapy, the ABIZOL dose should be increased to the previous level before concurrent treatment begins.

When a weak CYP3A4 (eg, diltiazem or escitalopram) or CYP2D6 inhibitors are administered in combination with ABIZOL, a slight increase in aripiprazole concentrations may be expected
.

The geometric center of aripiprazole Cmax and EAA is 68% and 73% lower, respectively, when combined with carbamazepine, a potent CYP3A4 inducer, compared to aripiprazole alone (30 mg). Similarly, the geometric mean of the dehydro-aripiprazole CMAX and EAA after co-administration with carbamazepine is 69% and 71% lower, respectively, than those treated with aripiprazole alone.

When ABIZOL is used in combination with carbamazepine, ABIZOL Dose should be subtracted by two folds. Other potent CYP3A4 inducers (such as rifampicin, rubabutin, fentin, phenobarbital, primidone, efavirenz, nevirafin, and St. John's Wort) are expected to have similar effects and therefore a similar dose escalation should be administered. When strong CYP3A4 inducers are withdrawn from treatment, ABIZOL should be reduced to the recommended dose.

Famotidine, valproate or lithium did not have a clinically significant effect on the pharmacokinetics of aripiprazole.

The impact of ABIZOL on other drugs:

Clinical trials have shown no significant effect on the metabolism of aripiprazole, CYP2D6 (dextromethorphan), CYP2C9 (warfarin), CYP2C19 (omeprazole, warfarin), and CYP3A4 (dextromethorphan) substrates at doses of 10-30 mg / day. In addition, aripiprazole and dehydro-aripiprazole can inhibit the metabolism mediated by CYP2A2 in vitro
has not shown a potential to change. For this reason, it is unlikely that these enzymes mediate an interaction with a clinically important medicinal product of aripiprazole.

When used in combination with aripiprazole valproate, lithium or lamotrigine, there has been no clinically significant change in valproate, lithium, or lamotrigine concentrations.

When aripiprazole was administered concomitantly with escitalopram or venlafaxine, there were no clinically significant changes in plasma concentrations of escitalopram or venlafaxine.

Alcohol: As with many psychoac- tive treatments, patients should be advised to avoid alcohol intake during the use of ABIZOL.

4.6. Pregnancy and lactation

General advice

Pregnancy Category: C

Women with childbearing potential / Contraception (Contraception);

Patients should notify their doctor if they are pregnant during aripiprazole treatment, or if they plan to become pregnant. Because of limited experience in humans, ABIZOL should only be used in pregnancy more than potential damage to the fetus if the expected benefit is.

Pregnancy period:

There are no adequate and well-controlled studies of the use of aripiprazole in pregnant women. Congenital anomalies have been reported, but no causal relationship with aripiprazole has been detected. Studies on animals are also insufficient in terms of effects on pregnancy, embryonal / fetal development, labor, or postnatal development. The potential risk for humans is unknown.

Newborns exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for abnormal muscle movements (extrapyramidal signs / extrapyramidal symptoms) and / or drug withdrawal symptoms that change after birth. These symptoms include agitation, hypertension, hypothyroidism, tremor, somnolence, respiratory distress, or malnutrition. These complications have been observed at different severities, in some cases the symptoms have improved spontaneously and in some cases newborns have had to be hospitalized intensively. These events have been reported very rarely due to exposure to aripiprazole.

Lactation period:

Studies on rats show that aripiprazole is injected into the milk. Two individual case reports of aripiprazole super transit have been published in humans. Of these, aripiprazole was found to be undetectable and in the other approximately 20% of the maternal plasma concentration. When deciding whether or not to stop breastfeeding or stopping ABIZOL treatment, it should be considered that breastfeeding is beneficial for the child and that ABIZOL treatment is beneficial for breastfeeding mothers.

Reproduction ability / Fertility:

Aripiprazole did not reduce fertility in reproductive toxicity studies in animals (see section

5.3 preclinical safety data).
4.7. Effects on vehicle and machine use

As with other antipsychotic medications, it should be warranted to use dangerous machinery, including motor vehicles, until they are sure that aripiprazole does not adversely affect them.
8.4. Undesirable effects

Commonly reported adverse reactions in placebo-controlled trials; akathisia and nausea: more than 3% of patients treated with oral aripiprazole each.

The following frequency groups are used:

Very common (> 1/10); common (> 1/100 to 1/10); uncommon (> 1 / 1,000 to <1/100); rare (> 1 / 10,000 to <1 / 1,000); very uncommon (<1 / 10,000), unknown (unpredictable on the basis of available data)

The following side effects are more frequent (> 1/100) or medically side effects (*) than placebo.

Nervous system diseases

Common: Extrapyramidal disorder, akathisia, tremor, dizziness, sleepiness, sedation, headache

Eye diseases

Common: Blurred vision

Cardiac diseases

Uncommon: Tachycardia *

Vascular diseases

Uncommon: Orthostatic hypotension *

Gastrointestinal diseases

Prevalence: Dyspepsia, nausea, vomiting, constipation, indigestion, excessive saliva secretion

General disorders and application zone diseases

Common: Fatigue

Psychiatric diseases

Uncommon: Insomnia, anxiety Uncommon: Depression *

The following side effects are more frequent (> 1/100) or medically adverse side effects (*) in patients receiving additional treatment with aripiprazole antidepressants than placebo.

Nervous system diseases

Prevalence: Akathisia, sleepiness carpet, sedation, dizziness, distraction, extrapyramidal disorder

Respiratory, thoracic disorders and mediastinal disorders

Common: Dispne

Eye disease

Typical: Blurred vision

Vascular diseases

Uncommon: Orthostatic hypotension *

Gastrointestinal diseases

Common: Constipation, dyspepsia

General disorders and application zone diseases

Common: Fatigue, irritability

Psychiatric diseases

Common: Restlessness, insomnia

Extrapyramidal findings (EPS):

Schizophrenia-long
In a controlled 52-week study, aripiprazole-treated patients had a lower mean EPS (25.8%) than haloperidol-treated patients (57.3%), including Parkinson's, akathisia, dystonia and dyskinesia. For a 26-week, long-term controlled trial, the incidence of EPS was 19% for patients treated with aripiprazole and 13.1% for patients treated with placebo. In another 26-week long controlled study, the frequency of EPS was 14.8% for patients treated with aripiprazole and 15.1% for olanzapine-treated patients.

Bipolar
Manic Episodes in Disorder-YI
The frequency of EPS was 23.5% for patients treated with aripiprazole and 53.3% for patients treated with haloperidol in a weekly controlled trial. For another 12-week controlled study, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for patients treated with lithium. In the placebo-controlled study of the long-term 26-week maintenance phase, the incidence of EPS was 18.2% for patients treated with aripiprazole and 15.7% for patients treated with placebo.

In placebo-controlled trials, the incidence of akathisia in patients with bipolar disorder treated with aripiprazole was found to be 12.1% and 3.2% for patients with bipolar disorder treated with placebo. In schizophrenic patients, the incidence of akathisia is 6.2% for those treated with aripiprazole and 3.0% for those treated with placebo.

Distoni: Class Effect: In individuals who are prone to the first days of treatment; symptoms of dystonia, stretching abnormal contraction of the muscle group may occur. Dystonic symptoms: spasm in neck muscles, constriction in th