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.

Contents of the package 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 excitement 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 be manifested by a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, you should inform your doctor.
• If you have eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting treatment with Olzapin, you should 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 you experience such a symptom after taking Olzapin, you should 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, you should contact your doctor immediately.
• Patient taking Olzapin may experience weight gain. You should regularly check your weight. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• Patient taking Olzapin may experience high blood sugar and high lipid levels (triglycerides and cholesterol). Before taking Olzapin and during treatment, your doctor should perform blood tests to determine blood sugar levels and levels of certain lipids.
• You should tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

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

• 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 and vomiting) or the use of diuretics (urinary 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, your doctor may check your blood pressure in people over 65 years of age.

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.
You should 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, you should 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, excitement, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, you should contact your doctor.

Driving and using machines

Olzapin may cause drowsiness. If drowsiness occurs, you should not drive vehicles or operate any machines and devices. You should inform your doctor.

Olzapin contains lactose

If you have been diagnosed with an intolerance to some sugars, you should 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

This medicine should always be taken as directed by your doctor. If you are unsure, you should 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, you should inform your doctor. However, you should not stop taking Olzapin unless your doctor decides to do so.
Olzapin tablets should be taken once a day as directed by your doctor. You should 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. The tablet should be swallowed whole with water.

Taking more Olzapin than prescribed

In patients who have taken more Olzapin than prescribed, the following symptoms may occur: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and decreased 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.
You should contact your doctor immediately or go to the hospital if any of these symptoms occur. You should show your doctor the package with the tablets.

Missing a dose of Olzapin

As soon as you remember, you should take a tablet. You should not take a double dose to make up for the missed dose.

Stopping treatment with Olzapin

In case of improvement, you should not stop taking the tablets. It is important to take Olzapin for as long as your doctor recommends.
If you suddenly stop taking Olzapin, you may experience the following symptoms:
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 Olzapin, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately inform your doctor 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 breathing difficulties. If you notice any of these symptoms, you should 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, you should 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 beginning of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase activity in the blood, increased appetite, dizziness, anxiety, trembling, movement disorders (dyskinesia), 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, 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 spasms (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 normal 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 erection.
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, lymph node enlargement, elevated liver enzyme levels in blood tests, and an increase in the number of one type of white blood cell (eosinophilia).
During treatment with olanzapine 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 group of patients, several cases of death have also been reported.
In patients with Parkinson's disease, Olzapin may worsen side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

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. You should 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.
A single pack contains 28, 30, 56, 60, 90, 112, or 120 tablets.

Marketing authorization holder and manufacturer:

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

Date of approval of the leaflet: