Package leaflet: Information for the user

Olanzaran, 10 mg, orodispersible tablets
Olanzapine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Olanzaran is and what it is used for
What you need to know before taking Olanzaran
How to take Olanzaran
Possible side effects
How to store Olanzaran
Contents of the pack and other information

1. What Olanzaran is and what it is 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 condition in which patients hear, see or feel things that do not exist in reality, have beliefs that are not based on reality, are excessively suspicious and withdraw from contact with other people. Patients with this condition may also experience depression, anxiety or tension;
moderate to severe manic episodes, which is a state in which the patient feels excited or euphoric.

In patients with bipolar disorder whose manic episodes have subsided after treatment with Olanzaran, continued treatment with this medicine helped prevent recurrence of such episodes.

2. Important information before using Olanzaran

When not to use Olanzaran:

if the patient is allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial swelling, lip swelling, or shortness of breath. If an allergic reaction occurs, contact a doctor immediately;
if the patient has previously been diagnosed with eye disorders, including certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzaran, discuss this with your doctor or pharmacist.

Use of Olanzaran is not recommended in elderly patients with dementia, as the medicine may cause serious adverse effects in this patient group.
Medicines of this type may cause abnormal movements, particularly affecting the face or tongue. If such symptoms occur after taking Olanzaran, inform your doctor immediately.
Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy. If these symptoms occur, contact your doctor immediately.
Weight gain has been observed in patients taking Olanzaran. Therefore, body weight should be monitored regularly during treatment. Consider consulting a dietitian or starting a diet if necessary.
Increased blood glucose and lipid levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor will recommend blood tests to monitor glucose and certain lipid levels before starting and regularly during treatment with Olanzaran.
Inform your doctor if the patient or their family has a history of blood clots, as use of this type of medicine has been associated with thrombosis.

If the patient has any of the following conditions, inform the doctor as soon as possible:

stroke or "mini" stroke (transient ischemic attack)
Parkinson's disease
prostate gland disorders
intestinal obstruction (paralytic ileus)
liver or kidney disease
blood disorders
heart disease
diabetes
seizures
if the patient knows they may have lost body salts due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or use of diuretics (water pills).

If the patient has dementia and has ever had a stroke or "mini" stroke, the patient or their caregiver/relative should inform the doctor.
For patients 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 with other medicines
Other medicines should only be taken during treatment with Olanzaran under the advice of a doctor. The patient may feel drowsy when Olanzaran is used in combination with antidepressants, anti-anxiety medicines, or sleep aids (sedatives).
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking:

medicines used for Parkinson's disease;
carbamazepine (an anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as the dose of Olanzaran may need to be adjusted.

Use of Olanzaran with alcohol
Do not drink alcohol while taking Olanzaran, as olanzapine combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Do not take Olanzaran while breastfeeding, as small amounts of olanzapine may pass into breast milk.
Newborns whose mothers took Olanzaran during the third trimester of pregnancy (last three months) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If any of these adverse effects occur, the patient should contact her doctor.

Driving and operating machinery
There is a risk of drowsiness during treatment with Olanzaran. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olanzaran contains aspartame
Patients who cannot tolerate phenylalanine should be aware that Olanzaran contains aspartame, a source of phenylalanine. It may be harmful for patients with phenylketonuria.

3. How to use Olanzaran

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide how many orally disintegrating tablets of Olanzaran you should take and for how long. The daily dose of Olanzaran ranges from 5 mg to 20 mg. If symptoms recur, consult your doctor, but do not stop taking Olanzaran unless instructed by your doctor.
Olanzaran should be taken once daily, as directed by your doctor. Tablets should be taken at approximately the same time each day, if possible. The tablets may be taken with food or independently of meals.
Olanzaran is taken by mouth.
The Olanzaran tablet should be placed in the mouth, where it will disintegrate upon contact with saliva and can be easily swallowed. Removing an intact tablet from the mouth is very difficult. The tablet should be taken immediately after removal from the packaging, as it is very fragile. The medicine may also be dissolved just before administration in a glass of water or another liquid (orange juice, apple juice, milk, or coffee). With certain beverages, the mixture may change colour and become cloudy. The drink should be consumed immediately after dissolving the medicine.
The orally disintegrating tablets of Olanzaran disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

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. Discuss this with your doctor before starting Olanzaran.

Use in patients with renal and/or hepatic impairment
Patients with impaired kidney and/or liver function may require dose adjustment. Discuss this with your doctor before starting Olanzaran.

Smokers
Smokers may require dose adjustment. Discuss this with your doctor before starting Olanzaran.

Overdose of Olanzaran
In patients who have taken more than the recommended dose of Olanzaran, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behaviour, difficulty speaking, unusual movements (especially of the facial muscles or tongue), and reduced consciousness. Other possible symptoms include: acute confusion, disturbances of consciousness, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sedation, decreased respiratory rate, choking, high or low blood pressure, and cardiac arrhythmias. Seek immediate medical attention or go to the hospital if any of these symptoms occur. Show the doctor the medicine packaging.

Missed dose of Olanzaran
If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose.

Stopping Olanzaran
Do not stop taking the tablets because you feel better. It is important to continue taking Olanzaran for as long as your doctor has instructed.
If Olanzaran is stopped abruptly, symptoms such as sweating, insomnia, tremors, anxiety, nausea, and vomiting may occur. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Immediately inform your doctor if any of the following symptoms occur:

unusual movements, especially of the face or tongue (a common adverse effect which may affect up to 1 in 10 patients);
blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs and cause chest pain and breathing difficulties (an uncommon adverse effect which may affect up to 1 in 100 patients). If a patient notices such symptoms, they should contact their doctor as soon as possible;
a group of symptoms including fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness (frequency cannot be determined from available data).

Very common adverse effects (may affect more than 1 in 10 patients)
include:
weight gain, drowsiness and increased blood prolactin levels.
At the beginning of treatment, some patients may experience dizziness or fainting (with slowed heart rate), particularly when standing up from a lying or sitting position. These symptoms usually resolve on their own, but if they persist, the doctor should be informed.
Common adverse effects (may affect up to 1 in 10 patients)
include:
changes in the number of certain blood cells, changes in blood lipid levels, transient increase in liver enzyme activity at the beginning of treatment, increased blood and urine glucose levels, increased blood uric acid and creatine phosphokinase activity, increased appetite, dizziness, restlessness, tremor, movement disorders (dyskinesias), constipation, dryness of the oral mucosa, rash, weakness, extreme fatigue, fluid retention 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 adverse effects (may affect up to 1 in 100 patients) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash), diabetes or worsening of existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma, seizures, usually in patients who previously had seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, slowed heart rate, thromboembolism, photosensitivity, nosebleeds, abdominal distension, salivation, increased bilirubin levels, memory loss or amnesia, urinary incontinence, difficulty urinating, hair loss, absence or reduction of menstruation, breast changes in men and women such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rare adverse effects (may affect up to 1 in 1,000 patients)
include:
lowering of normal body temperature, heart rhythm disturbances, sudden unexplained death, pancreatitis causing severe abdominal pain, fever and nausea, liver disease manifesting as yellowing of the skin and whites of the eyes, muscle disease manifesting as unexplained muscle aches and pain, prolonged and/or painful erection.
Very rare adverse effects (may affect up to 1 in 10,000 patients)
include:
severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms resemble influenza with facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and elevated levels of a specific type of white blood cells (eosinophilia).
During treatment with olanzapine in elderly patients with dementia, stroke, pneumonia (common), urinary incontinence (common), falls (very common), extreme fatigue, visual hallucinations (common), elevated body temperature (common), skin redness and walking difficulties (very common) may occur. In this patient group, several cases of death have been reported.
In patients with Parkinson's disease, treatment with Olanzaran may worsen symptoms of the disease.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Olanzaran

Keep this medicine out of 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 stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Olanzaran contains

The active substance is olanzapine. Each orodispersible 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 orodispersible tablets 10 mg: light yellow or yellow, slightly speckled, round tablets, with the imprint "OV2" on one side and plain on the other side.
Olanzaran is available in packs containing 28 tablets.
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania
For further information about this medicinal product, please contact the Marketing Authorisation Holder.