OLANZAPINA 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Olanzapina Viatris, 5 mg, orodispersible tablets
3. Olanzapina Viatris, 10 mg, orodispersible tablets
4. Olanzapina Viatris, 15 mg, orodispersible tablets
5. Olanzapina Viatris, 20 mg, orodispersible tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
6. What is Olanzapina Viatris and what is it used for
7. Important information before taking Olanzapina Viatris
   1. When not to take Olanzapina Viatris:
   2. Warnings and precautions
   3. During treatment
   4. Children and adolescents
   5. Olanzapina Viatris and other medicines
   6. Taking Olanzapina Viatris with alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Aspartame content
   10. Sodium content
8. How to take Olanzapina Viatris
   1. Overdose of Olanzapina Viatris
   2. Missed dose of Olanzapina Viatris
   3. Stopping treatment with Olanzapina Viatris
9. Possible side effects
   1. If you experience any of the following side effects, contact your doctor immediately:
   2. Very common (may affect more than 1 in 10 people):
   3. Common (may affect up to 1 in 10 people):
   4. Uncommon (may affect up to 1 in 100 people):
   5. Rare (may affect up to 1 in 1,000 people):
   6. Frequency not known (frequency cannot be estimated from the available data):
   7. Reporting side effects
10. How to store Olanzapina Viatris
11. Contents of the pack and other information
    1. What Olanzapina Viatris contains
    2. What Olanzapina Viatris looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer / Importer
    5. Viatris Healthcare Sp. z o. o.

Package Leaflet: Information for the User

Olanzapina Viatris, 5 mg, orodispersible tablets

Olanzapina Viatris, 10 mg, orodispersible tablets

Olanzapina Viatris, 15 mg, orodispersible tablets

Olanzapina Viatris, 20 mg, orodispersible tablets

Olanzapinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 Olanzapina Viatris and what is it used for
• 2. Important information before taking Olanzapina Viatris
• 3. How to take Olanzapina Viatris
• 4. Possible side effects
• 5. How to store Olanzapina Viatris
• 6. Contents of the pack and other information

1. What is Olanzapina Viatris and what is it used for

Olanzapina Viatris contains the active substance olanzapine, which belongs to a group of medicines called antipsychotics.
Olanzapina Viatris is used to treat schizophrenia, a disease characterized by hearing, seeing, or feeling things that do not exist in reality, having beliefs that are not true, being overly suspicious, and withdrawing from social contacts.
Patients may experience depression, anxiety, or tension.
Olanzapina Viatris is used to treat moderate to severe manic episodes, a condition in which patients have extremely good mood, excessive energy, need much less sleep than usual, talk very quickly, and have racing thoughts. This condition is sometimes characterized by extreme irritability. This medicine is also a mood stabilizer, preventing the recurrence of extreme mood swings - elevated and lowered mood (depression) - associated with this disease.

2. Important information before taking Olanzapina Viatris

When not to take Olanzapina Viatris:

Warnings and precautions

Before starting treatment with Olanzapina Viatris, discuss it with your doctor or pharmacist:

During treatment

If you experience the following symptoms: very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness, consult your doctor, as the doctor may decide to discontinue treatment with Olanzapina Viatris.
If you experience uncontrolled movements of the face or tongue, consult your doctor, as the doctor may decide to reduce the dose or discontinue treatment with Olanzapina Viatris.
Weight gain has been observed in patients taking olanzapine. Regularly check the patient's weight. Consider a visit to a dietitian or help with meal planning if necessary.
In patients taking olanzapine, increased blood sugar and fat levels (triglycerides and cholesterol) have been observed. The doctor may recommend blood tests to check blood sugar and certain fat levels before starting treatment with Olanzapina Viatris.
As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

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

Olanzapina Viatris and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. In particular, tell your doctor about taking any of the following medicines:

• medicines used to treat Parkinson's disease
• antidepressants or medicines taken for anxiety or to help you sleep (sedatives) as you may feel drowsy
• carbamazepine (an antiepileptic and mood stabilizer)
• fluvoxamine (an antidepressant)
• ciprofloxacin (an antibiotic)
• medicines that can change heart rhythm, such as antiarrhythmic medicines (like amiodarone, sotalol, quinidine, disopyramide), antibiotics (which belong to the group of macrolides), tricyclic antidepressants
• activated charcoal (a chemical substance used to bind other medicines), should be taken at least 2 hours before or after taking Olanzapina Viatris, as it may interfere with the absorption of olanzapine.

Taking Olanzapina Viatris with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
This medicine should not be taken by women who are breastfeeding, as small amounts of olanzapine may pass into breast milk.
In newborn babies of mothers taking olanzapine in the third trimester (last three months of pregnancy), the following symptoms may occur: trembling, stiffness, and/or muscle weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If your child experiences any of these side effects, contact your doctor.

Driving and using machines

Olanzapina Viatris may cause drowsiness or dizziness. If these occur, do not drive or operate any machinery or equipment. Inform your doctor.

Aspartame content

Olanzapina Viatris 5 mg orodispersible tablets contain 1.975 mg of aspartame in each tablet.
Olanzapina Viatris 10 mg orodispersible tablets contain 3.950 mg of aspartame in each tablet.
Olanzapina Viatris 15 mg orodispersible tablets contain 5.950 mg of aspartame in each tablet.
Olanzapina Viatris 20 mg orodispersible tablets contain 7.900 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU).
This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Sodium content

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Olanzapina Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The doctor will decide how many tablets and how long to take Olanzapina Viatris. The recommended daily dose of Olanzapina Viatris is 5 to 20 mg. If symptoms of the disease recur, inform your doctor. However, do not stop taking this medicine unless your doctor tells you to.
Take Olanzapina Viatris 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. Olanzapina Viatris orodispersible tablets are for oral use.
Olanzapina Viatris tablets are fragile, so handle them carefully. Do not handle the tablets with wet hands, as they may disintegrate.

• 1. Holding the blister by the edges, separate one tablet from the rest. Tear off carefully along the perforation.
• 2. Carefully peel off the rear foil.
• 3. Gently push the tablet out of the blister.
• 4. Place the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easy to swallow.

Non-perforated blisters:

• 1. Carefully peel off the rear foil, being careful not to peel off the foil from adjacent tablets.
• 2. Gently slide the tablet out.
• 3. Place the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easy to swallow.

The tablet can also be placed in a full glass of water, orange juice, apple juice, milk, or coffee and then stirred. Some beverages may change color or become cloudy when the tablet is added and stirred. The resulting liquid should be drunk immediately.

Overdose of Olanzapina Viatris

Contact your doctor or go to the hospital immediately. Show the doctor the package of tablets. In patients who have taken more than the recommended dose of olanzapine, the following symptoms have occurred: rapid heartbeat, agitation and/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 high fever, rapid breathing, sweating, mood changes, muscle stiffness, and drowsiness or excessive sleepiness, decreased breathing rate, inhalation of fluid into the trachea and lungs (aspiration), high or low blood pressure, heart rhythm disturbances.

Missed dose of Olanzapina Viatris

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

Stopping treatment with Olanzapina Viatris

Do not stop taking the tablets even if you feel better. It is important to take Olanzapina Viatris for as long as your doctor recommends.
If you suddenly stop taking Olanzapina Viatris, you may experience the following symptoms: sweating, difficulty sleeping, trembling, anxiety, feeling sick (nausea) or vomiting. Your doctor may recommend gradually reducing the dose of Olanzapina Viatris 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.

If you experience any of the following side effects, contact your doctor immediately:

Very common (may affect more than 1 in 10 people):

• increased number of infections causing sore throat, mouth ulcers, or fever. These may be symptoms of a decrease in the number of white blood cells, which help fight infections (leukopenia, neutropenia)

Common (may affect up to 1 in 10 people):

• allergic reactions, such as rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing
• diabetes or worsening of its course, occasionally associated with diabetic ketoacidosis (presence of ketone bodies in the blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain or feeling of weakness, fatigue, or discomfort)
• heart rhythm disturbances
• seizures, usually related to a history of seizures (e.g., epilepsy)
• uncontrolled movements of the mouth, tongue, cheeks, and jaws, which may extend to the arms and legs (tardive dyskinesia)
• difficulty urinating or emptying the bladder

Uncommon (may affect up to 1 in 100 people):

• yellowing of the skin or whites of the eyes, dark urine, pale stools, itching, feeling drowsy or tired, fever, nausea, weakness, and stomach pain (may be symptoms of liver problems)
• simultaneous occurrence of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness or sleepiness (neuroleptic malignant syndrome)
• abnormal or dangerously fast heartbeat (ventricular tachycardia/ventricular fibrillation)
• pancreatitis causing severe stomach pain radiating to the back
• decreased body temperature causing shivering, feeling cold, or pale skin
• muscle fiber damage causing muscle pain, weakness, or tenderness, accompanied by dark urine (rhabdomyolysis)
• prolonged and/or painful erection

Rare (may affect up to 1 in 1,000 people):

• symptoms similar to flu with a rash on the face, which spreads to other areas of the body, high fever, enlarged lymph nodes, increased liver enzyme activity visible in blood tests, and increased eosinophils (a type of white blood cell) in the blood. These may be symptoms of a drug reaction with eosinophilia and systemic symptoms (DRESS)

Frequency not known (frequency cannot be estimated from the available data):

• symptoms of withdrawal in newborns, such as skin spots, diarrhea, excessive sucking or crying, poor feeding, slow weight gain, hiccups

During treatment with olanzapine, the following have been observed in elderly patients with dementia: stroke, pneumonia, incontinence, falls, extreme fatigue, visual hallucinations (seeing things that do not exist), elevated body temperature, skin redness, and walking difficulties. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, taking olanzapine may worsen symptoms of the disease and cause hallucinations (seeing, hearing, or feeling things that do not exist).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapina Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or bottle, after EXP.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olanzapina Viatris contains

Each orodispersible tablet contains 5 mg of olanzapine as the active substance.
Each orodispersible tablet contains 10 mg of olanzapine as the active substance.
Each orodispersible tablet contains 15 mg of olanzapine as the active substance.
Each orodispersible tablet contains 20 mg of olanzapine as the active substance.
The other ingredients are: mannitol, microcrystalline cellulose, and guar gum (Avicel CE 15), crospovidone, magnesium stearate, anhydrous colloidal silica, aspartame (E 951, see section 2 "Aspartame content"), sodium lauryl sulfate.

What Olanzapina Viatris looks like and contents of the pack

Olanzapina Viatris, 5 mg, are light yellow to yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE1" on the other side.
Olanzapina Viatris, 10 mg, are light yellow to yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE2" on the other side.
Olanzapina Viatris, 15 mg, are light yellow to yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE3" on the other side.
Olanzapina Viatris, 20 mg, are light yellow to yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE4" on the other side.
Olanzapina Viatris orodispersible tablets are available in blisters and cardboard boxes of 28 and 30 tablets or in perforated blisters for single doses and cardboard boxes of (28 and 30) x 1 tablets, and in bottles containing 28, 30, 56, 250, or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer / Importer

Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o. o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:December 2024