Olzapin

PATIENT INFORMATION LEAFLET

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Enclosed leaflet: information for the user

Olzapin, 15 mg, coated tablets

Olzapin, 20 mg, coated tablets

Olanzapinum

Read the 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.

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 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 - conditions 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 you are 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, inform your doctor.
• if you have eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting Olzapin, discuss it with your 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, inform your doctor.

of the face or tongue.

• 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, contact your doctor immediately.
• Patient weight gain has been observed in patients taking Olzapin. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• High blood sugar and high lipid levels (triglycerides and cholesterol) have been observed in patients taking Olzapin. Before taking Olzapin and during its use, the doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• Tell your doctor if you or a family member have had blood clots, as similar medicines have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor immediately:

• stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• prostate disorders;
• intestinal obstruction (paralytic);
• liver or kidney disease;
• blood diseases;
• heart disease;
• diabetes;
• seizures;
• if you know you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (diuretic medicines). If you have dementia and have had a stroke or "mini" stroke, you or your caregiver should inform your doctor.

As a precaution, in people over 65 years of age, the doctor may check 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 consent of their doctor. Taking Olzapin in combination with antidepressant, sedative or sleeping medicines may cause drowsiness.
Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, tell your doctor about taking:

• 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

Do not drink alcohol after taking Olzapin, as this medicine in combination with alcohol may cause drowsiness.
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Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. Women who are breastfeeding should not take Olzapin, 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 problems. If you notice such symptoms in your child, contact your doctor.

Driving and operating machinery

Olzapin may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any machinery and equipment. Inform your doctor.

Olzapin contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

Olzapin contains lecithin

The medicine contains soybean lecithin. Do not use if you are hypersensitive to peanuts or soy.

3. How to take Olzapin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Adults
Your doctor will decide how many tablets and how long you should take Olzapin. The daily dose of Olzapin is 5 mg to 20 mg. If the symptoms of the disease recur, inform your doctor. However, do not stop taking Olzapin unless your doctor tells you to.
Take Olzapin tablets once a day as directed by your doctor. Try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food. Olzapin coated tablets are taken orally. Swallow the tablet whole 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: acute 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. Contact your doctor or go to the hospital immediately if you experience any of these symptoms. Show the doctor the packaging of the tablets.

Missing a dose of Olzapin

Take the tablet as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping Olzapin treatment

Do not stop taking the tablets even if you feel better. It is important to take Olzapin for as long as your doctor recommends.
If you suddenly stop taking Olzapin, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea or vomiting. Your doctor may recommend gradually reducingthe dose of Olzapin before stopping treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience:

• abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 people);
• blood clots in the veins (a not very common side effect that may affect up to 1 in 100 people), 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 you notice any of these symptoms, seek medical attention 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 people) include:
weight gain, drowsiness and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with slowed heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, inform your doctor.
Common side effects (which may affect up to 1 in 10 people) include:
changes in the number of certain blood cells, blood lipid levels 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, trembling, 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 people) include:
allergic reactions (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 spasm (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed 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 people):
decreased body temperature, heart rhythm disorders, sudden unexplained death, 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 pain, 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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In elderly patients with dementia treated with olanzapine, the following have been reported:
stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness and walking problems. 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. 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 this medicine.

5. How to store Olzapin

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

6. Contents of the pack and other information

What Olzapin contains

• The active substance is olanzapine. Each 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 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 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)].

aluminum, 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 coated tablets.
Olzapin 20 mg: pink, elongated, biconvex 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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