Olzapin

PATIENT INFORMATION LEAFLET

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Enclosed leaflet: information for the user

Olzapin, 15 mg, film-coated tablets

Olzapin, 20 mg, film-coated tablets

Olanzapinum

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Olzapin and what is it used for

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

• Schizophrenia - a disease characterized by the patient 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. The patient may experience depression, anxiety, or tension.
• Moderate to severe manic episodes - disease states whose symptoms include excitement or euphoria. It has been shown that Olzapin prevents the recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Olzapin

When not to take Olzapin

• If the patient is allergic to olanzapine, any of the other ingredients of this medicine (listed in section 6), peanuts, or soy. An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, the doctor should be informed.
• If the patient has eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting Olzapin, the patient should discuss it with their doctor or pharmacist.

• Olzapin is not recommended for use in elderly patients with dementia, as it may cause very serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olzapin, the doctor should be informed.

• Very rarely, these types of medicines cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• Patient's taking Olzapin have been observed to have weight gain. The patient's weight should be checked regularly. If necessary, consideration should be given to consulting a dietitian or seeking help in establishing a diet.
• Patient's taking Olzapin have been observed to have high blood sugar and high lipid levels (triglycerides and cholesterol). Before taking Olzapin and during its use, the doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• The doctor should be informed if the patient or their family has a history of blood clots, as similar medicines have been associated with the formation of blood clots.

If the patient has any of the following conditions, they should immediately inform their doctor:

• Stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• Prostate disorders;
• Bowel obstruction (paralytic ileus);
• Liver or kidney disease;
• Blood disorders;
• Heart disease;
• Diabetes;
• Seizures;
• If the patient knows they may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (diuretic medicines). If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver) should inform the doctor.

As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

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

Olzapin and other medicines

People taking Olzapin may only take other medicines with the doctor's consent. Taking Olzapin in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
The doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be informed about the use of:

• Medicines used to treat Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Olzapin may be necessary.

Taking Olzapin with alcohol

Alcohol should not be consumed after taking Olzapin, as this medicine in combination with alcohol may cause drowsiness.
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Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Olzapin should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Olzapin in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing difficulties, and feeding difficulties. If such symptoms are observed in the patient's child, the doctor should be contacted.

Driving and using machines

Olzapin may cause drowsiness. If drowsiness occurs, the patient should not drive vehicles or operate any machines or mechanical devices. The doctor should be informed.

Olzapin contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Olzapin contains lecithin

The medicine contains soybean lecithin. It should not be taken in case of known hypersensitivity to peanuts or soy.

3. How to take Olzapin

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Adults
The doctor will decide how many tablets and how long to take Olzapin. The daily dose of Olzapin is 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Olzapin unless the doctor decides to do so.
Olzapin tablets should be taken once a day as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food. Olzapin film-coated tablets are taken orally. The tablet should be swallowed whole, washed down with water.

Taking a higher dose of Olzapin than recommended

In patients who have taken a higher dose of Olzapin than recommended, the following symptoms have occurred: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and reduced consciousness. Other symptoms include: severe confusion (disorientation), 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, heart rhythm disorders. The doctor should be contacted immediately or the patient should go to the hospital if any of these symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Olzapin

As soon as the patient remembers, they should take a tablet. A double dose should not be taken to make up for the missed dose.

Stopping Olzapin treatment

In case of improvement, the patient should not stop taking the tablets. It is important to take Olzapin for as long as the doctor recommends.
In case of sudden stop of Olzapin treatment, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. The doctor may recommend gradual reduction of the dose before stopping treatment.
In case of any further doubts about the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Olzapin can cause side effects, although not everybody gets them.
The doctor should be informed immediately if the following occur:

• Abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 patients);
• Blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, medical advice should be sought immediately.
• Simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (which may affect more than 1 in 10 patients) include:
weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a decrease in heart rate) may occur, especially 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 side effects (which may affect up to 1 in 10 patients) include:
changes in the number of certain blood cells, lipid levels in the blood, and transient increases in liver enzyme activity at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, restlessness, tremors, movement disorders (dyskinesias), constipation, dry mouth, rash, weakness, 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 (which may affect up to 1 in 100 patients) 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 rigidity (including eye movements), restless legs syndrome, speech disorders, stuttering, slow heart rate, sensitivity to sunlight, nosebleeds, abdominal bloating, salivation, 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 (which may affect up to 1 in 1000 patients):
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 erection.
Very rare side effects include serious allergic reactions, such as: drug reaction with eosinophilia and systemic symptoms (DRESS), which initially manifests as flu-like symptoms with a rash on the face, and then with widespread rash, high fever, lymph node enlargement, elevated liver enzyme activity in blood tests, and increased eosinophil count in the blood (eosinophilia).
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During olanzapine treatment in elderly patients with dementia, the following may occur:
stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, Olzapin may exacerbate side effects.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olzapin

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
Olzapin should be stored in its original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Olzapin contains

• The active substance is olanzapine. Each film-coated tablet contains 15 mg or 20 mg of the active substance. The specific strength is stated on the packaging of Olzapin.
• The other ingredients (excipients) are: Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, talc, magnesium stearate

Tablet coating Opadry AMB White OY-B-28920 [lecithin (E322), polyvinyl alcohol, talc, xanthan gum (E415), titanium dioxide (E171)].

• In addition:
• Olzapin 15 mg tablets contain the coating Opadry AMB Grey 80W26503 [polyvinyl alcohol, lecithin (E322), talc, xanthan gum (E415), titanium dioxide (E171), indigo carmine, lake (E 132), iron oxide yellow (E172), iron oxide black (E172)].
• Olzapin 20 mg tablets contain the coating Opadry AMB Pink 80W24003 [polyvinyl alcohol, lecithin (E322), talc, xanthan gum (E415), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)].

What Olzapin looks like and contents of the pack

Olzapin 15 mg: light blue, elongated, biconvex film-coated tablets.
Olzapin 20 mg: pink, elongated, biconvex film-coated tablets.
Olzapin is available in packs containing 28 or 56 tablets, packaged in PA/Aluminum/PVC/Aluminum blisters.
The blisters are placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
phone: (+48)(22) 785 27 60
fax: (+48)(22) 785 27 60 ext. 106
Poland

Manufacturer

Pharmathen S.A.
6, Dervenakion Str.
153 51 Pallini, Attiki
Greece
Date of last revision of the leaflet: February 2024
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