Olzapin

Package Leaflet: Information for the User

Olzapin, 5 mg, coated tablets

Olzapin, 10 mg, coated 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, please inform 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 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 are agitation or euphoria.

It has been shown that olanzapine 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 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 such symptoms occur, inform your doctor.
• If you have eye disorders, such as certain types of glaucoma (increased eye pressure).

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.
• 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's taking Olzapin may experience weight gain. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• Patient's taking Olzapin may experience 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 and lipid levels.
• Tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with blood clot formation.

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

• Stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• Prostate disorders;
• Bowel obstruction (paralytic ileus);
• Liver or kidney disease;
• Blood diseases;
• Heart disease;
• Diabetes;
• Seizures;
• If you know that you may have lost electrolytes due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (urine-inducing medicines).

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should inform your doctor.
Routinely, 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 with antidepressant, sedative, or sleeping medicines may cause drowsiness.
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 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

People taking Olzapin should not drink alcohol in any form, as Olzapin, in combination with alcohol, may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Women who are breastfeeding should not take Olzapin, as small amounts of it may pass into breast milk.
In newborns whose mothers took olanzapine in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, difficulty breathing, and feeding difficulties. If you notice such symptoms in your child, contact your doctor.

Driving and using machines

Olzapin may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any machines or mechanical devices. Inform your doctor.

Olzapin contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
The medicine also contains aluminum lake of yellow orange and may cause allergic reactions.

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.
Your doctor will decide how many tablets and how long you should take Olzapin. The daily dose of Olzapin is from 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 more Olzapin than prescribed

In patients who have taken more Olzapin than prescribed, the following symptoms may occur: rapid heartbeat, agitation 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 disturbances.
Contact your doctor immediately or go to the hospital if you experience any of these symptoms. Show the doctor the package with 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 tells you.
If you suddenly stop taking Olzapin, you may experience the following symptoms:
sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Olzapin before stopping treatment.
If you have any further questions about taking Olzapin, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olzapin 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 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 difficulty breathing. 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 determined 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 go away on their own, but if they persist, inform your doctor.
Common side effects (which may affect up to 1 in 10 patients) 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 and urine sugar levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, restlessness, trembling, movement disorders (dyskinesias), constipation, dry mouth, weakness, extreme fatigue, water retention in the body causing swelling of the hands, feet, or ankles, fever, joint pain, 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, rarely 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.
Rarely reported side effects (which may affect up to 1 in 1000 patients):
decreased body temperature, heart rhythm disturbances, 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.
Side effects with unknown frequency:
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, enlarged lymph nodes, elevated liver enzyme levels in blood tests, and an increased number of one type of white blood cell (eosinophilia).
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. In this patient group, several cases of death have also been reported.
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, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 gather more information on the safety of the medicine.

5. How to store Olzapin

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light and moisture.
Do not use Olzapin after the expiry date stated on the carton.
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 of Olzapin is olanzapine. One Olzapin coated tablet contains 5 mg or 10 mg of olanzapine.
The medicine also contains:
in the tablet core:lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium carmellose, magnesium stearate, sodium lauryl sulfate,
in the tablet coating:polyvinyl alcohol, titanium dioxide (E171), soy lecithin, talc, xanthan gum, aluminum lake of quinoline yellow (E104), aluminum lake of orange yellow (E110), yellow iron oxide (E172).

What Olzapin looks like and contents of the pack

Olzapin coated tablets are round, yellow, biconvex, with a smooth surface.
Olzapin coated tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters, and then, along with the patient leaflet, in a cardboard box.
The single pack contains 28, 30, 56, 60, 90, 112, or 120 tablets.

Marketing authorization holder and manufacturer:

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

Date of approval of the leaflet: