Zyzapin (Olanzapine) Tablets

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, do not give it to others.

• When using this medicine, tell your doctor or doctor if you go to the hospital.

• We sleep exactly as written in this instruction. Do not use high or low doses other than the recommended dose for the medication.

In this Instructions for Use:

1. What is ZYZAPIN and what is it used for?
2. Things to watch out for before using ZYZAPIN
3. How to use ZYZAPIN
4. What are the possible side effects?
5. Storage of ZYZAPIN

Their headlines are in place.

What is ZYZAPIN and what is it used for?

ZYZAPINE is a film-coated tablet presented in a 28 tablet blister package containing 2.5 mg olanzapine. White colored, round, bikonveks, both sides flat film tablets.

ZYZAPINE belongs to the drug group called antipsychotics.

ZYZAPIN is used in the treatment of a disease that is accompanied by symptoms such as hearing, seeing or feeling things that do not really exist, false beliefs, abnormal skepticism, In addition, patients suffering from this disease may feel depressed, anxious or nervous.

ZYZAPIN is used to treat a condition accompanied by symptoms such as enthusiastic and overly cognitive, requiring much less sleep than normal, suggesting chaotic ideas, very fast speech and sometimes excessive nervousness. It is also a balancing act that can be accompanied by this dream, which prevents the outburst of depression and its outflow.

3. How to use ZYZAPIN
Instructions for proper use and dose / application frequency

Always use ZYZAPIN as your doctor tells you. Your doctor or pharmacist is okay if you are not sure.

Your doctor will decide how many ZYZAPINE tablets you will use and how long you should continue. The daily dose of ZYZAPINE is between 5 and 20 mg. Consult your doctor if your symptoms recur, but do not stop using ZYZAPIN unless you tell your doctor.

ZYZAPINE is taken once a day on your doctor's recommendation,

Take your tablets at the same time each day. It does not matter whether you take the tablet with meals or alone.

Application path and method

ZYZAPIN is taken orally.

Different age groups

Use in children

ZYZAPINE is not suitable for patients under the age of 18 years.

Use in the elderly

There is no need for an age-related dose adjustment.

Special use cases

It has no special use.

If you have an impression that the effect of ZYZAPIN is too strong or weak, talk to your doctor or pharmacist.

If you use more ZYZAPIN than you need

If you use more ZYZAPIN than you need

If you use ZYZAPIN, you should talk to a doctor or pharmacist.

If you forgot to use ZYZAPIN

Take your tablet when you remember.

Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment with ZYZAPINE is terminated:

Do not stop using tablets when you feel better. It is important that you continue to take ZYZAPIN as long as your doctor tells you.

ZYZAPIN If you stop using Ti suddenly, sweating, sleeplessness, trembling, excitement or nausea and vomiting may occur. Your doctor may recommend a gradual dose reduction before treatment is cured.

If you have any additional questions about the use of this product, please contact your doctor and pharmacist

4.What are the side effects?

As with all medicines, there may be side effects in people susceptible to substances in the context of ZYZAPIN.

If any of the following occur, stop using ZYZAPIN and report it to your doctor or contact your nearest hospital emergency department:

• Allergic reaction (eg mouth and throat swelling, pruritus, rash)

■ Dysrhythmia in the heart

■ worsening of diabetes or diabetes associated with coma or ketoacidosis (blood and urinary ketones)

These are all very serious side effects

If any of these exist in you, then you have a serious allergy against ZYZAPINE. You may need to be admitted to an emergency medical intervention or hospital.

If you notice any of the following, tell your doctor immediately or contact the emergency department of your nearest hospital:

• Feeling stupor or fainting (with low heart rate) when getting up from a sitting or sitting position early in the treatment period,

• Liver disease (caused by skinning in the skin and white areas of the eye)

• Low heart rate

• Prolonged and / or painful stiffness (erection)

• Difficulty in urinating

• Seizures (epilepsy) usually in those with seizure history

• Pancreatitis causing severe abdominal pain, fever and nausea / vomiting

• Decrease in body temperature

All these are serious side effects. Immediate medical intervention may be required Serious side effects are rare.

Very common side effects

• Weight gain

■ Sleepiness

■ fever, rapid breathing, sweating, muscle stiffness and drowsiness or drowsiness combination

• Increased levels of prolactin (hormone stimulating milk secretion)

Common side effects

■ Changes in the amount of fat in some blood cells and in the blood

• Increase in sugar levels in blood and urine

• Increased feeling of hunger

• dizziness

• Restlessness

• Flicker

• Muscle stiffness or spasm (including eye movements)

• Problem in speaking

• Abnormal movement (especially on the face or on the underside)

• Constipation

• Oral establishment

• Deride rash

• Power loss

• Excessive fatigue

• Water retention, as evidenced by swelling in the hands, wrists or feet

Uncommon side effects

■ Sensitivity to daylight

• Hair loss

Rare side effects

• Breast growth in men or women

Other side effects (incidence rates can not be estimated from available data)

• Eye spasms that cause circular movement of the eye

• unexplained sudden death

• lobar vein occlusion (deep vein thrombosis) or pulmonary embolism (sudden breathlessness without a specific cause, pain in the palate, feeling of faintness, coughing bloody sputum production, accelerated pulse)

• Muscular disease manifested by unexplained pain and soreness

Elderly patients with dementia complain of stroke, urinary incontinence, falls, excessive fatigue, hallucinations, increase in body temperature, redness of skin and difficulty walking. Some deaths have also been reported in patients in this particular group.

In patients with Parkinson's disease, ZYZAPINE may worsen the indication,

These types of medicines have been infrequently started to come in milk for a long period of time, menstrual periods and irregular menstrual periods. If this is persistent, tell your doctor immediately. In the last period of pregnancy (last 3 months), the feeling of trembling, drowsiness and dizziness in infants of women using ZYZAPIN can be seen very rarely.

These are minor side effects of ZYZAPIN.

2. Things to watch out for before using ZYZAPIN
DO NOT USE ZYZAPIN in the following situations

• If you are allergic to any of the olanzapine or other ingredients of ZYZAPIN (if you have hypersensitivity). An allergic reaction can be recognized in the form of rash, itching, swelling on the face, swelling on the lips, or shortness of breath. If any of these happen, consult your doctor.

• If you already have recognized eye problems such as narrow-angle glaucoma.
Use ZYZAPIN CAREFULLY in the following situations

• This type of medication can cause abnormal movements mainly on the face and the undersurface. If you live after ZYZAPIN is given, tell your doctor.

• This type of medication rarely causes symptoms such as fever, faster breathing, sweating, muscle stiffness, drowsiness or drowsiness. If this happens, contact your doctor immediately.

• The use of ZYZAPIN in elderly patients with dementia (dementia) is not recommended because it can lead to serious side effects.

If you have any of the following diseases, you should contact your doctor as soon as possible:

• Diabetes (diabetes)

• Heart disease

• Liver or kidney disease

• Parkinson's disease

• Epilepsy (epilepsy)

• Prostate problems

• Intestinal obstruction (paralytic ileus)

• Blood diseases

• Stroke or "minor" stroke (transient indication of stroke)

If you have dementia (dementia), you or your caregiver should say to your doctor that you have not had a stroke or "minor" stroke.

ZYZAPINE is not suitable for patients under 18 years old.

If you are over 65 years old, your doctor may follow your blood pressure as a routine precaution.

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

Use of ZYZAPIN with food and drink

Alcohol should not be taken with ZYZAPINE because taking ZYZAPINE with alcohol may cause sleepiness.

Pregnancy

Consult your doctor or pharmacist before using this medication.

You should not use ZYZAPIN during pregnancy without consulting your doctor.

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.

Since ZYZAPIN is passed on to mother in small amount, this drug should not be used during breastfeeding period.

Vehicle and machine use

ZYZAPIN has the risk of causing sleep. In such a case, do not use tools and machinery. Ask your doctor.

Important information about some auxiliary substances in the content of ZYZAPIN

ZYZAPINE contains lactose. If you are already told by your doctor that you are sensitive to certain sugars, you should consult your doctor before taking this medicinal product.

Use with other medicines

When using ZYZAPINE, only other medications that your doctor allows are taken.

The use of ZYZAPIN in combination with medicines used in the treatment of restlessness, sleeping medications (sedatives) and medicines (antidepressants) against psychological depression may cause you to feel drowsy.

Tell your doctor if you use fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) because you may need to change your ZYZAPINE dosage.

If you are taking medication for Parkinson's disease, tell your doctor specifically.

4.1. Therapeutic indications

Adults and adolescents from 13 to 17 vas:

Olanzapine, a group of schizophrenia, is indicated for the treatment of psychotic disorders.

Olanzapine is effective in providing clinical remediation in the treatment of idiopathic patients responding to initial treatment.

Olanzapine in bipolar disorder is indicated in the treatment of moderate to severe manic episodes and in the prevention of recurrences in bipolar disorder.
4.2. Posology and application form

Posology / application frequency and duration:

Adults:

Schizophrenia: The recommended initial dose of olanzapine is 10 mg per day.

Manic episode: Initial dose, monotherapy is usually 15 mg administered daily or 10 mg daily in combination therapy (see section 5.1).

Prevention of recurrence in bipolar disorder: The recommended initial dose is 10 mg / day. Treatment with olanzapine for manic episode treatment should be continued at the same dose to prevent recurrence. If there is a new manic, mixed or depressive episode, olanzapine treatment should be continued with additional treatment for mood symptoms as dose adjustment and clinically indicated as needed.

During the treatment of schizophrenia, manic episodes and recurrence prevention in bipolar disorder, the daily dose can be adjusted from 5 to 20 mg per day, depending on the individual clinical situation. A dose greater than the recommended initial dose should be bypassed and increased only after a clinically appropriate reassessment, with dose intervals not shorter than 24 hours. The absorption of olanzapine can be given to the hungry or full-blown cam as it is not affected by the food. When the use of olanzapine is discontinued, gradual dose reduction should be undertaken.

13-17 wow eres

Schizophrenia: The recommended initial dose of olanzapine is 2.5 mg or 5 mg once daily, as the target dose is 10 mg / day. Since the absorption of olanzapine is not adversely affected, it can be given to the hungry or full-blown cam. In patients with schizophrenia, efficacy has been demonstrated in clinical trials with the most common average dose of 12.5 mg / day (mean dose 11.1 mg / day) in the flexible dosing range of 2.5 to 20 mg / day. When dose adjustment is required, a dose increase or reduction of 2.5 mg or 5 mg is recommended.

The safety and efficacy of doses above 20 mg / day have not been evaluated in clinical trials.

Admission therapy: The efficacy of olanzapine in the treatment of schizophrenia in adolescent idiopathic patients has not been systematically assessed; however, the efficacy of idiopathic treatment from the data of adult patients can be estimated, as well as the comparison of olanzapine with pharmacokinetic parameters in adult and adolescent patients. For this reason, it is generally recommended that patients responding to treatment should continue treatment at the lowest dose required to reduce remission, other than in the acute response. Patients should be reassessed periodically to determine whether to continue with the treatment of the admission.

Bipolar disorder (manic or mixed periods): Oral olanzapine is the recommended initial dose, 2.5 mg or 5 mg once daily, as the target dose is 10 mg / day. Since the absorption of olanzapine is not affected by foods, it can be given to a hungry or full mate. In adolescents with bipolar I disorder (manic or mixed periods), efficacy has been demonstrated in clinical trials with the most common average dose of 10.7 mg / day (mean dose 8.9 mg / day) in the flexible dosing range of 2.5 to 20 mg / day. When dose adjustment is required, a dose increase or reduction of 2.5 mg or 5 mg is recommended.

The safety and efficacy of doses above 20 mg / day have not been evaluated in clinical trials.

Admission therapy: The efficacy of olanzapine has not been systematically assessed in the treatment of bipolar disorder (manic or mixed periods) in adult patients; however, the efficacy of idiopathic treatment can be estimated from the data of adult patients, with the comparison of the pharmacokinetic parameters of olanzapine in adult and adolescent patients. For this reason, it is generally recommended that patients responding to treatment should continue treatment at the lowest dose required to reduce remission, other than in the acute response. Patients should be reassessed periodically to determine whether to continue with the treatment of the admission.

Method of Application:

The tablets are taken orally as a whole, together with a glass of water.

Additional information on special populations

Kidney / liver failure: A lower initial dose (5 mg) should be considered in such patients. In patients with moderate hepatic insufficiency (cirrhosis, Child-Pugh, class A or B), the initial dose should be 5 mg and the dose should be increased with caution.

Pediatric population: The use of olanzapine in children under the age of 13 is not recommended due to insufficient data on safety and efficacy.
4.2. Posology and application form

4.2). Compared to patients in clinical trials in adults, more weight gain and sedation were observed in adult patients, and total cholesterol, triglycerides, LDL cholesterol, prolactin and liver aminotransferase

(see sections 4.4, 4.8, 5.1 and 5.2) .Respiratory population: Routine lower initial doses (5 mg / day) are not indicative, but should be considered at 65 years of age and over when clinical characteristics are required. Section 4.4) .Considence: It is not necessary to routinely change the initial dose and dose interval in female patients compared to male patients. Smoking patients: When the smokers are compared to the non-smokers, the initial dose and dose interval need not be routinely changed. Contraindications Contraindicated in patients with hypersensitivity to any of the substance or the ancillary substances and in patients known to have a narrow-angle glaucoma risk.

4.4. Special use warnings and precautions

The clinical improvement of the patient during antipsychotic treatment may last for several days to several weeks. During this time, patients should be closely monitored.

Dementia-related psychosis and / or behavioral disorders

Mortality is high in elderly patients with psychosis due to dementia treated with antipsychotic medications. Olanzapine has not been approved for the treatment of dementia-related psychosis and / or behavioral disorders and is not recommended for use in this group of patients due to an increased risk of mortality and cerebrovascular events. In placebo-controlled clinical trials conducted in elderly patients with dementia-related psychosis and / or behavioral disturbances (mean age 78 years) (6 to 12 weeks), the incidence of death in patients treated with oral olanzapine was 2-fold higher than in placebo patients (3.5% and 1.5%). The increase in death incidence is not associated with olanzapine dose (average daily dose 4.4 mg) or duration of treatment. The underlying risk factors for an increased patient mortality with olanzapine include over 65 years of age, dysphagia, sedation, malnutrition and dehydration, the presence of pulmonary problems (eg aspirated or aspirated pneumonia) or the use of benzodiazepines together. However, the incidence of death is higher than patients receiving placebo in olanzapine-treated patients, regardless of these risk factors.

Cerebrovascular adverse reactions (CVAE eg stroke, transient ischemic attack) have been reported in the same clinical trials, including death. In cerebrovascular adverse reactions, patients treated with oral olanzapine had a 3-fold increase in CVAE compared to patients receiving placebo (0.4% versus 1.3%, respectively). All patients with cerebrovascular adverse effects, oral olanzapine and placebo have pre-existing risk factors. Over 75 years of age and vascular / mixed type dementia were defined as risk factors for cerebrovascular adverse events associated with olanzapine treatment. In these studies, the efficacy of olanzapine has not been proven.

Parkinson's disease

The use of olanzapine in the treatment of psychosis caused by dopamine agonists in Parkinson's disease is not recommended. In clinical trials, worsening Parkinson's symptoms and hallucinations were reported more frequently and more frequently in olanzapine-treated patients than in placebo users (see 4.8), and olanzapine was not found to be more effective in the treatment of psychotic symptoms. In these studies, patients are initially required to remain stable at the lowest effective dose of anti-parkinson drugs and remain in the same antiparkinsonian (dose-agonist) and dose throughout the study. Olanzapine was titrated up to a maximum of 15 mg / day according to the investigator's decision, beginning with 2.5 mg / day.

Neuroleptic Mal i sn Syndrome (NMS)

NMS is a potentially life-threatening condition associated with antipsychotic drug treatment. Nancy casein associated with olanzapine has also been reported infrequently. Clinical manifestations of NMS include hyperpyrexia, muscle stiffness, change in mental status, and autonomic instability (irregular heartbeat or blood pressure, tachycardia, diaphragm and cardiac dysrhythmia). Additional symptoms include increased creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. All antipsychotic drugs including olanzapine should be discontinued if the patient exhibits signs and symptoms of NMS or if unexplained high fever occurs without additional clinical signs of NMS.

Hyperglycaemia and diabetes

The use of oral olanzapine, including some fatal cases, has been reported occasionally with hyperglycemia and / or diabetes mellitus exacerbation or development associated with ketoacidosis or coma (see section 4.8). It has been reported that in some cases pre-weight gain may be a facilitating factor. Appropriate clinical monitoring may be recommended in accordance with the antipsychotic guidelines used. Patients treated with any antipsychotic agent, including ZYZAPIN®, should be monitored regularly for signs and symptoms of hyperglycaemia (polydipsia, polyuria, polyphagia and weakness) and for patients with diabetes mellitus or diabetes mellitus risk factors for worsening glucose control. Weight should be regularly monitored. Lipid changes

Undesirable changes in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials (see section 4.8). Especially in patients with dyslipidemic disease and those at risk of developing lipid disorders, lipid changes should be controlled as clinically appropriate. Patients treated with any antipsychotic agent, including ZYZAPIN®, should be monitored regularly in terms of lipids in accordance with the antipsychotic guidelines used.

Anticholinergic activity

Olanzapine, in vitro
it has been reported that the incidence of related events is low during clinical trials when showing anticholinergic activity. However,

Thromboembolism İz

Rarely may cause a venous thromboembolic event (VTE). There was no causal relationship between olanzapine treatment and venous thromboembolism. However, since patients with schizophrenia often have venous thromboembolism risk factors, all VTE-related risk factors, such as patient inactivity, should be identified and preventive measures should be taken.

General FAQ effect

Olanzapine should be used with caution in conjunction with other centrally acting drugs and alcohol, as well as with the effects of the central nervous system (CNS). In vitro
, olanzapine can antagonize the action of direct and indirect dopamine agonists.

seizures

Olanzapine should be used with caution in patients with seizure history or in patients with factors that may reduce seizure threshold. Seizures are rarely reported in patients treated with olanzapine. The majority of these cases have been reported to have risk factors for seizure onset or seizure formation.

Tardive dyskinesia

In a year or less of comparative studies, the incidence of treatment-related dyskinesia associated with olanzapine is statistically significantly lower. Although the risk of tardive dyskinesia increases over long periods of exposure, dose reduction or drug withdrawal should be considered if symptoms and symptoms of tardive dyskinesia occur in patients receiving olanzapine. These symptoms may worsen temporarily and may even occur even after the treatment is discontinued.

Postural hypotension

Postural hypotension has been rarely seen in clinical trials involving the use of olanzapine in the elderly. As with other antipsychotics, it is recommended that blood pressure is measured in patients over 65 years of age.

Sudden cardiac death

Post-marketing reports of olanzapine reported cases of sudden cardiac death in patients receiving olanzapine. In a retrospective observational cohort study, the estimated risk of sudden cardiac death in patients treated with olanzapine was found to be about twice as high as in patients without antipsychotic use. In the study, the risk of olanzapine can be compared to the risk with atypical antipsychotics in the collective analysis.

Pediatric population

Olanzapine is not intended for use in the treatment of children under the age of 13 years. Studies in patients aged 13-17 showed several adverse effects, including weight gain, changes in metabolic parameters, and increases in prolactin levels. Long-term outcomes associated with these effects have not been studied and are currently unknown (see sections 4.8 and 5.1).

Lactose

ZYZAPIN® tablets contain lactose. Patients with rare hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicine.
4.5. Interactions with other medicinal products and other forms of interaction

Interaction work was done only in adults.

Potential interactions affecting olanzapine

Since olanzapine is metabolised by CYP1A2, this isoenzymia can affect the pharmacokinetics of olanzapine, which is a particularly inducing or inhibiting agent.

Induction of CYPIA2

Olanzapine metabolism may lead to smoking and decreased carbamazepine-induced olanzapine concentrations. Only slightly to moderate increases in olanzapine clearance have been observed. Monitoring is recommended with limited clinical outcomes, and an increase in olanzapine dose may be considered if necessary (see 4.2).

Inhibition of CYP1A2

Fluoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine. The average increase in maximum concentration of olanzapine following fluvoxamine was 54% in non-smokers and 77% in smokers. The increase in the area under the mean curve (OAA) of olanzapine was 52% and 108%, respectively. A lower olanzapine initial dose should be considered when using any CYP1A2 inhibitor such as fluvoxamine or ciprofloxacin. If treatment with a CYP1A2 inhibitor is initiated, a reduction in olanzapine dose should be considered.

Decreased bioavailability

Activated charcoal oral olanzapine should be taken at least 2 hours before or after olanzapine as it reduces the bioavailability by 50-60%.

Fluoxetine (CYP2D6 inhibitor), a single dose of antacid (aluminum, magnesium) or cimetidine has been found not to significantly affect the pharmacokinetics of olanzapine. Olanzapine has potential to affect other drugs

Olanzapine may antagonize the direct and indirect effects of dopamine agonists.

Olanzapine, in vitro
(e.g., 1A2, 2D6, 2C9, 2C19, 3A4) as the parent CYP450 Isoenzymes. Thus, in vivo
As confirmed in studies, no specific interaction is anticipated as there is no inhibition of metabolism in the indicated active substances: tricyclic antidepressant (mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19). When administered together with lithium or biperiden, olanzapine did not show any interaction. Therapeutic monitoring of valproate plasma levels has shown that valproate dose need not be adjusted after initiation of concurrent olanzapine use.

4.9. Overdose and treatment

Symptoms and symptoms:

Very common symptoms of overdose (> 10% incidence); tachycardia,

agitation / aggression, speech impairment, various extrapyramidal symptoms, and decreased consciousness ranging from sedation to coma.

There are delirium, convulsions, coma, possible neuroleptic malign syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmia (<2% of overdose cases) and cardiac arrest among the significant dose limits in medical care. Although fatal results have been reported in cases of low acute overdose of 450 mg,
2nd
g oral olanzapine has been reported following the use of olanzapine.

Dose age therapy

There is no specific antidote for olanzapine. Vomiting is not recommended. Standard procedures for overdose treatment may be suggested (eg gastric lavage, activated charcoal application). Oral bioavailability of olanzapine has been reduced by 50-60% with active carmeal co-administration.

Symptomatic treatment should be performed according to the clinical picture and vital organ functions should be monitored, including collapse therapy and support for respiratory function caused by hypotension and circulatory insufficiency. Since beta stimulation may aggravate hypotension, other sympathomimetic drugs with epinephrine, dopamine or beta agonist activity should not be used. Cardiovascular monitoring is necessary to detect possible arrhythmias. Medical observation and monitoring should continue as soon as the patient heals.