Olanzaran

Package Leaflet: Information for the User

Olanzaran, 10 mg, Oral Disintegrating Tablets

Olanzapine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Olanzaran and what is it used for
• 2. Important information before taking Olanzaran
• 3. How to take Olanzaran
• 4. Possible side effects
• 5. How to store Olanzaran
• 6. Contents of the pack and other information

1. What is Olanzaran and what is it used for

Olanzaran contains the active substance olanzapine. Olanzaran belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disease characterized by hearing, seeing, or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious, and withdrawing from contact with others. Patients with this disease may also experience depression, anxiety, or tension;
• Moderate to severe manic episodes, i.e., a state in which the patient feels excited or euphoric.

In patients with bipolar disorder, who had manic episodes that disappeared after taking Olanzaran, the use of the medicine also prevented their recurrence.

2. Important information before taking Olanzaran

When not to take Olanzaran:

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or shortness of breath. If an allergic reaction occurs, tell your doctor;
• If you have previously been diagnosed with eye diseases, including certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting to take Olanzaran, discuss it with your doctor or pharmacist.

• Olanzaran is not recommended for use in elderly patients with dementia, as the medicine may have serious side effects in this group of patients.
• Medicines of this type may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olanzaran, tell your doctor.
• Medicines of this type can very rarely cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, contact your doctor immediately.
• In patients taking Olanzaran, an increase in body weight has been observed. Therefore, when taking Olanzaran, body weight should be regularly monitored. Consider visiting a dietitian or using a diet if necessary.
• In patients taking olanzapine, an increase in glucose and fat (triglycerides and cholesterol) levels in the blood has been observed. Your doctor will recommend a blood test to monitor glucose levels and certain fats before starting treatment and regularly during treatment with Olanzaran.
• Tell your doctor if you or a family member have had blood clots, as taking this type of medicine has been associated with the formation of blood clots.

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

• stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• prostate disorders
• intestinal obstruction (paralytic ileus)
• liver or kidney disease
• blood diseases
• heart disease
• diabetes
• seizures
• if you know that you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (i.e., water pills).

If you have dementia and have ever had a stroke or "mini" stroke, you or your caregiver should tell your doctor.
In people over 65 years of age, the doctor may monitor blood pressure as a routine precaution.

Children and Adolescents

Olanzaran is not intended for use in patients under 18 years of age.

Olanzaran and other medicines

When taking Olanzaran, other medicines can only be used with the doctor's consent. You may feel drowsy when Olanzaran is used in combination with antidepressants or medicines used in anxiety disorders, or medicines that help you fall asleep (sedatives).
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking:

• medicines for Parkinson's disease;
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as a dose adjustment of Olanzaran may be necessary.

Taking Olanzaran with alcohol

When taking Olanzaran, do not drink alcohol, as olanzapine in combination with alcohol can cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Do not take the medicine during breastfeeding, as small amounts of olanzapine may pass into breast milk.
In newborns whose mothers took Olanzaran in the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) muscle weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If any of these side effects occur, the patient should contact their doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzaran. If this happens, do not drive or operate tools or machines. Tell your doctor.

Olanzaran contains aspartame

Patients who cannot take phenylalanine should be aware that Olanzaran contains aspartame, which is a source of phenylalanine. It may be harmful to patients with phenylketonuria.

3. How to take Olanzaran

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Your doctor will decide how many Olanzaran oral disintegrating tablets to take and for how long. The daily dose of Olanzaran is 5 mg to 20 mg. If symptoms recur, consult your doctor, but do not stop taking Olanzaran unless your doctor tells you to.
Take Olanzaran once a day, as directed by your doctor. If possible, take the tablets at the same time every day. The tablets can be taken with or without food.
Take Olanzaran orally.
Place the Olanzaran tablet in your mouth, where it will dissolve in contact with saliva and can be easily swallowed. Removing an intact tablet from the mouth is very difficult. After removing the tablet from the packaging, swallow it immediately, as it is very fragile. The medicine can also be dissolved in a glass of water or other liquid (orange juice, apple juice, milk, or coffee) just before taking. With some drinks, the mixture may change color and become cloudy. Drink the liquid immediately after dissolving the medicine.
Olanzaran oral disintegrating tablets dissolve easily, so handle them carefully. Do not take the tablets with wet hands, as they may dissolve.

Use in special patient groups

Use in children and adolescents

Olanzaran is not recommended for use in children and adolescents under 18 years of age.

Use in elderly patients

Elderly patients may require dose adjustment.
Before starting to take Olanzaran, discuss it with your doctor.

Use in patients with kidney and/or liver disorders

Patients with kidney and/or liver disorders may require dose adjustment.
Before starting to take Olanzaran, discuss it with your doctor.

Smokers

Smokers may require dose adjustment.
Before starting to take Olanzaran, discuss it with your doctor.

Taking more than the recommended dose of Olanzaran

In patients who took more than the recommended dose of Olanzaran, the following symptoms occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, abnormal movements (especially of the face or tongue), and reduced consciousness. Other possible symptoms include: acute confusion, impaired consciousness, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, and heart rhythm disorders. If any of these symptoms occur, contact your doctor immediately or go to the hospital. Show your doctor the package of tablets.

Missing a dose of Olanzaran

If you miss a dose, take it as soon as you remember. Do not take two doses in one day.

Stopping treatment with Olanzaran

Do not stop taking the tablets due to improved well-being. It is important to continue taking Olanzaran for as long as your doctor has prescribed.
If you suddenly stop taking Olanzaran, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may recommend gradually reducing the dose before ending therapy.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzaran can cause side effects, although not everybody gets them.
Tell your doctor immediatelyif you experience any of the following symptoms:

• abnormal movements, especially of the face or tongue (a common side effect that may affect up to 1 in 10 people);
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs and cause chest pain and difficulty breathing (an uncommon side effect that may affect up to 1 in 100 people). If you notice such symptoms, contact your doctor as soon as possible;
• a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (frequency cannot be estimated from the available data).

Very common side effects(may affect more than 1 in 10 people) include:
weight gain, drowsiness, and increased prolactin levels in the blood.
At the beginning of treatment, some patients may experience dizziness or fainting (with a decrease in heart rate), especially when getting up from a lying or sitting position.
These symptoms usually go away on their own, but if they persist, tell your doctor.
Common side effects(may affect up to 1 in 10 people) include:
changes in the number of certain blood cells, changes in lipid levels in the blood, and transient increases in liver enzyme activity at the beginning of treatment, increased glucose levels in the blood and urine, increased uric acid levels and creatine phosphokinase activity in the blood, increased appetite, dizziness, restlessness, tremors, movement disorders (dyskinesias), constipation, dry mouth, rash, loss of strength, extreme fatigue, water retention in the body causing swelling of the hands, feet, or ankles, fever, joint pain, and sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects(may affect up to 1 in 100 people) include:
hypersensitivity (e.g., swelling in the mouth and throat, itching, rash), diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma, seizures, usually in patients who have had seizures (epilepsy) before, muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, slow heart rate, blood clots with embolism, sensitivity to sunlight, nosebleeds, abdominal bloating, drooling, increased bilirubin levels, memory loss or lack of memory, urinary incontinence, difficulty urinating, hair loss, absence or decrease of menstrual periods, changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rare side effects(may affect up to 1 in 1,000 people) include:
decreased body temperature, heart rhythm disorders, sudden death from an unknown cause, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease characterized by a change in skin and white eye color to yellow, muscle disease characterized by unexplained muscle pain and weakness, prolonged and (or) painful erections.
Very rare side effects(may affect up to 1 in 10,000 people) include:
severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high fever, swollen lymph nodes, elevated liver enzyme activity in blood tests, and increased levels of a specific type of white blood cell (eosinophilia).
During treatment with olanzapine in elderly patients with dementia, the following have been reported: stroke, pneumonia (often), urinary incontinence (often), falls (very often), extreme fatigue, visual hallucinations (often), elevated body temperature (often), redness of the skin, and walking disorders (very often). In this patient group, several cases of death have been reported.
In patients with Parkinson's disease, taking Olanzaran may worsen the symptoms of the disease.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzaran

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
The medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olanzaran contains

• -The active substance of Olanzaran is olanzapine. Each oral disintegrating tablet contains 10 mg of the active substance.
• -The other ingredients are: mannitol, crospovidone (Type B), aspartame, talc, and magnesium stearate.

What Olanzaran looks like and contents of the pack

Olanzaran, 10 mg oral disintegrating tablets: yellow or light yellow tablets, slightly speckled, round, with the inscription "OV2" on one side and smooth on the other.
Olanzaran is available in packs of 28 tablets.

Marketing authorization holder:

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania
For more detailed information on this medicine, contact the marketing authorization holder.
Date of last revision of the leaflet:April 2020