Olanzapine

Package leaflet: Information for the user

Olanzaran, 5 mg, tablets
Olanzaran, 10 mg, tablets
Olanzapinum
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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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, please tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Olanzaran is and what it is used for
2. What you need to know 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 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 disorder in which patients hear, see, or sense things that do not exist in reality, have beliefs that are not in accordance with reality, are excessively suspicious, and withdraw from contact with other people. Patients with this disorder may also experience depression, anxiety, or tension;
• moderate to severe manic episodes, which is a state in which the patient feels overexcited or euphoric.

In patients with bipolar disorder who have had manic episodes that resolved after treatment with Olanzaran, continued treatment with the medicine helped prevent recurrence of these 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, inform the 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 it with your doctor or pharmacist.

• Olanzaran is not recommended for elderly patients with dementia, as the medicine may cause serious adverse effects in this patient group.
• Medicines of this type may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Olanzaran, inform your doctor.
• Medicines of this type very rarely cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy. If such symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzaran. Therefore, body weight should be monitored regularly during treatment with Olanzaran. A visit to a dietitian or initiation of a diet may be considered if necessary.
• Increased blood levels of glucose and lipids (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 treatment and regularly during treatment with Olanzaran.
• Inform your doctor if the patient has a history of blood clots, or if there is a family history of thrombosis, as use of this type of medicine has been associated with blood clot formation.

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

• stroke or "mini" stroke (transient ischaemic 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 diarrhoea and vomiting (nausea with vomiting) or use of diuretics (water tablets).

If the patient has dementia and has ever had a stroke or "mini" stroke, the patient or their caregiver/relative should inform the doctor.
As a routine precaution, the doctor may monitor blood pressure in patients aged over 65 years.

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 if approved by a doctor. The patient may feel drowsy when Olanzaran is taken together with antidepressants, medicines used for anxiety or medicines that help sleep (sedatives).
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
In particular, inform your doctor if the patient is taking:

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

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Do not take this medicine during 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 of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or muscle 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 lactose
Olanzaran contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Olanzaran

This medicine should always be taken as directed by the doctor. If in doubt, consult
the doctor or pharmacist.
The doctor will decide how many Olanzaran tablets to take and for how long they should be used.
The daily dose of Olanzaran ranges from 5 mg to 20 mg. If symptoms recur, consult the doctor, but
do not stop taking Olanzaran unless instructed by the doctor.
Olanzaran should be taken once daily, as directed by the doctor. Tablets should be taken at the
same time each day, if possible. Tablets may be taken with food or independently of meals.
Olanzaran is taken orally. Tablets should be swallowed whole with water.

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 the 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 the doctor before starting Olanzaran.

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

Taking more Olanzaran than recommended
In patients who have taken more than the recommended dose of Olanzaran, the following
symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking,
abnormal 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
sleepiness, reduced breathing rate, choking, high or low blood pressure, and heart rhythm disturbances.
Seek immediate medical attention or go to a hospital if any of the above symptoms occur. Show the
doctor the tablet packaging.

Missed dose of Olanzaran
If a dose is missed, take it as soon as remembered. Do not take two doses on the same day.

Stopping Olanzaran treatment
Do not stop taking the tablets due to feeling better. It is important to continue taking Olanzaran for
as long as directed by the doctor.
If Olanzaran is stopped abruptly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea
and vomiting may occur. The doctor may advise gradually reducing the dose before ending treatment.
If there are any further doubts about using this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 reaction, which may affect up to 1 in 10 patients);
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs and cause chest pain and breathing difficulties (an uncommon adverse reaction, 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 lethargy or drowsiness (frequency cannot be determined from available data).

Very common adverse reactions (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 rising from a lying or sitting position. These symptoms usually resolve spontaneously, but if they persist, the doctor should be informed.

Common adverse reactions (may affect up to 1 in 10 patients)
include:
changes in the count 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 reactions (may affect up to 1 in 100 patients)
include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash), diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone compounds in blood and urine) or coma, seizures, usually in patients with a previous history of 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 galactorrhea (milk secretion outside the breastfeeding period) or unusual breast enlargement.

Rare adverse reactions (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 reactions (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 influenza-like symptoms with facial rash occur, 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, the following may occur: 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). In this patient group, several fatal cases have been reported.

In patients with Parkinson's disease, treatment with Olanzaran may worsen the symptoms of this disease.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions 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 should 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 package and other information

What Olanzaran contains

• The active substance is olanzapine. Each tablet contains 5 mg or 10 mg of the active substance.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate.

What Olanzaran looks like and contents of the pack
Olanzaran 5 mg: light yellow or yellow, slightly mottled, round, biconvex tablets, embossed with the code "O5" on one side and smooth on the other.
Olanzaran 10 mg: light yellow or yellow, slightly mottled, round, biconvex tablets, embossed with the code "O7" on one side and smooth on the other.
Olanzaran is available in packs containing 28 tablets.

Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Poland

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 more detailed information about this medicine, please contact the marketing authorisation holder.