OLANZAPINE VIATRIS 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Flas Viatris 15 mg orodispersible tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Olanzapine Flas Viatris is and what it is used for
2. What you need to know before taking Olanzapine Flas Viatris
3. How to take Olanzapine Flas Viatris
4. Possible side effects
5. Storage of Olanzapine Flas Viatris
6. Package contents and additional information

1. What Olanzapine Flas Viatris is and what it is used for

Olanzapine Flas Viatris contains the active substance olanzapine, which belongs to a group of medications called antipsychotics.

Olanzapine Flas Viatris is used to treat schizophrenia, a disease with symptoms such as perceiving sounds, images, or sensations that do not exist, the appearance of mistaken beliefs, unusual suspicions, and withdrawal. People with this disease may also feel depressed, anxious, or tense.

Olanzapine Flas Viatris is used to treat moderate to severe manic episodes, a disease with symptoms such as feelings of euphoria, excessive energy, reduced need for sleep, rapid speech, accelerated thoughts, and occasionally, great irritability. It is also a mood stabilizer, which prevents the recurrence of extreme and disabling mood swings of euphoria and depression associated with this condition.

2. What you need to know before taking Olanzapine Flas Viatris

Do not take Olanzapine Flas Viatris:

• If you are allergic to olanzapine or any of the other components of this medication (listed in section 6). An allergic reaction can be recognized by the appearance of rashes, itching, or swelling in the face, lips, tongue, or throat, difficulty breathing. If this happens, inform your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapine Flas Viatris.

• If you or a family member have a history of blood clots, as medications of this type have been associated with the formation of blood clots.
• If you are an elderly person with dementia, as you may experience severe side effects.

• If you have diabetes.
• If you have heart disease.
• If you have been told you have imbalances in blood salts (especially low potassium or magnesium levels).
• If you were born with a prolonged QT interval (see ECG, electrocardiogram record).
• If you have liver or kidney problems.
• If you have Parkinson's disease.
• If you have a history of seizures or convulsions (epilepsy).
• If you have an enlarged prostate.
• If you have intestinal obstruction (paralytic ileus).
• If you have a low white blood cell count (which can be caused by some medications, radiation therapy, chemotherapy, or bone marrow disease).
• If you have been told you have increased white blood cell counts in the blood or have a bone marrow disease in which blood cells are produced excessively, called myeloproliferative disease.
• If you have had a stroke or "mini" stroke (temporary stroke symptoms).
• If you are a smoker (as it may be necessary to adjust the dose of olanzapine).

During treatment

If you experience a combination of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness, talk to your doctor, as you may need to stop taking olanzapine.

If you experience uncontrolled movements of the face or tongue, talk to your doctor, as they may weigh reducing the dose of olanzapine or interrupting treatment.

Weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. Consider consulting a dietitian or adopting a diet plan if necessary.

High blood sugar levels and high lipid levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor may want to perform blood tests to check blood sugar and lipid levels before starting this medication.

If you are over 65 years old, your doctor will monitor your blood pressure as a precautionary measure.

Children and adolescents

The use of olanzapine is not recommended in patients under 18 years of age.

Other medications and Olanzapine Flas Viatris

Inform your doctor or pharmacist if you are using, have used, or may need to use any other medication. Especially, inform your doctor if you are taking any of the following:

• Medications for Parkinson's disease.
• Antidepressants or other medications for anxiety or to help you sleep (tranquilizers), as you may feel drowsy.
• Carbamazepine (used as an antiepileptic or mood stabilizer).
• Fluvoxamine (an antidepressant).
• Ciprofloxacin (an antibiotic), as you may need a dose adjustment of olanzapine.
• Medications that can alter heart rhythm, such as antiarrhythmics (like amiodarone, sotalol, quinidine, disopyramide), antibiotics (belonging to the macrolide group), tricyclic antidepressants.
• Activated charcoal (a chemical substance used to bind to other medications), which should be taken at least 2 hours before or after taking olanzapine, as it may interfere with its absorption.

Taking Olanzapine Flas Viatris with alcohol

Do not drink alcohol if you are taking olanzapine, as the combination of both can cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. You should not take this medication during breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in breastfed babies or in mothers who have taken olanzapine in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby experiences any of these symptoms, contact your doctor.

Driving and using machines

Do not drive, as there is a risk of drowsiness or dizziness during treatment with olanzapine. If this happens, do not drive or operate tools or machines. Consult your doctor.

Olanzapine Flas Viatris contains aspartame and sodium

Each 5 mg orodispersible tablet of Olanzapine Flas Viatris contains 1.975 mg of aspartame.

Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Olanzapine Flas Viatris contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered sodium-free.

3. How to take Olanzapine Flas Viatris

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how to take the olanzapine tablets and for how long you should take them. The recommended daily dose of olanzapine is between 5 and 20 mg. Consult your doctor if your symptoms recur, but do not stop taking this medication unless your doctor tells you to.

You should take olanzapine once a day and follow your doctor's instructions. Try to take the tablets at the same time each day. It does not matter if you take them with or without food. Olanzapine is administered orally.

The olanzapine tablets break easily, so they should be handled with care. The tablets should be handled with dry hands; otherwise, they may dissolve.

1. In the case of blister packs with perforated lines, hold the blister strip by the edges and separate one cell from the rest of the strip by gently cutting along the perforated lines surrounding it.
2. Carefully peel off the backing.
3. Then, carefully push the tablet out.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, so you can swallow it easily.

You can also place the tablet in a glass of water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change color and become cloudy. Drink it immediately.

If you take more Olanzapine Flas Viatris than you should

Contact your doctor or the nearest hospital. Show your doctor the package of tablets. Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and partial loss of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or somnolence, slower breathing, inhalation of liquids into the trachea and lungs (aspiration), hypertension or hypotension, abnormal heart rhythms.

If you forget to take Olanzapine Flas Viatris

Take the tablet as soon as you remember. Do not take a double dose to make up for forgotten doses. Do not take two doses on the same day.

If you stop taking Olanzapine Flas Viatris

Do not stop taking the tablets, even if you feel better. It is important that you take olanzapine for the time indicated by your doctor.

If you stop taking olanzapine suddenly, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety, or feelings of discomfort (nausea) and discomfort (vomiting). Your doctor may advise you to gradually reduce the dose before finishing treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Frequent(may affect 1 in 10 people)

• An increase in the number of infections that are contracted and cause sore throat, mouth ulcers, intense chills, or fever. These signs could be indicative of a reduction in the number of white blood cells that help fight infections (leukopenia, neutropenia).

Infrequent(may affect 1 in 100 people)

• Severe allergic reactions, such as skin rashes, itching, swelling of the face, lips, mouth, or throat, which can make breathing or swallowing difficult.
• Unusual or uncontrolled movement of the mouth, tongue, cheeks, or jaw, which can spread to the arms and legs (tardive dyskinesia).
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing.
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) that causes loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain, or a feeling of weakness, fatigue, or discomfort, or coma.
• Abnormal heart rhythm that can be observed in an electrocardiogram (ECG).
• Seizures, most often related to a history of seizures (epilepsy).
• Difficulty urinating or emptying the bladder.

Rare(may affect 1 in 1,000 people)

• Unexplained bruising or bleeding that lasts longer than usual. These signs could be indicative of a low concentration of platelets in the blood.
• A combination of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness (neuroleptic malignant syndrome).
• Yellowing of the skin or sclera, dark urine, pale stools, itching, feeling of drowsiness or fatigue, fever, nausea, weakness, and abdominal pain (these signs could be indicative of liver problems).
• Dangerous or unusual rapid heart rhythm (ventricular fibrillation/tachycardia).
• Pancreatitis that causes severe stomach pain, which can spread to the back.
• Drop in body temperature that causes shivering, coldness, or pale skin.
• Muscle rupture that causes muscle pain, weakness, or soreness accompanied by dark urine (rhabdomyolysis).
• Prolonged and/or painful erection.

Frequency Not Known(cannot be estimated from the available data)

• Symptoms similar to those of the flu, with a rash on the face that spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia). These signs could be indicative of drug reaction with eosinophilia and systemic symptoms (DRESS).

Other Possible Adverse Effects

Very Frequent(may affect more than 1 in 10 people)

• Weight gain.
• Drowsiness.
• Increased prolactin concentration, which can be observed in a blood test.
• In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This feeling usually disappears on its own, but if it does not, consult your doctor.

Frequent(may affect up to 1 in 10 people)

• Increased concentration of white blood cells (blood cells) and circulating fatty acids, and temporary increases in liver enzymes at the start of treatment, which can be observed in a blood test.
• Increased glucose concentration in blood and urine, which can be observed in a blood or urine test.
• Increased levels of uric acid, alkaline phosphatase, and creatine phosphokinase in the blood, which can be observed in a blood test.
• Increased feeling of hunger.
• Dizziness.
• Restlessness or difficulty staying seated.
• Tremors, rigid posture, slow movements, and unsteady gait (parkinsonism).
• Unusual movements (dyskinesias).
• Constipation.
• Dry mouth.
• Rashes.
• Lack of energy.
• Extreme fatigue.
• Fluid retention that causes swelling in hands, ankles, or feet.
• Fever, joint pain.
• Sexual problems such as decreased sexual desire in men and women or difficulty achieving or maintaining an erection in men.

Infrequent(may affect up to 1 in 100 people)

• Uncontrollable muscle stiffness or spasms that affect the head (including eye movements), neck, and body.
• Restless legs syndrome.
• Speech problems.
• Stuttering.
• Slow heart rate.
• Hypersensitivity to sunlight.
• Nosebleeds.
• Feeling of being bloated (abdominal distension).
• Excessive salivation.
• Memory loss or forgetfulness.
• Inability to control urination, difficulty starting to urinate, or maintaining the flow.
• Hair loss.
• Absence of menstruation or decreased menstrual periods.
• Change in breast size in women and men.
• Abnormal milk production in women.

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

• Sudden death of unknown cause.
• Withdrawal symptoms, such as sweating, difficulty sleeping, tremors, anxiety, or a feeling of discomfort (nausea) or discomfort (vomiting).

Frequency Not Known(cannot be estimated from the available data)

• Withdrawal symptoms in newborns, such as skin spots, diarrhea, excessive sucking or crying, poor feeding, slow weight gain, or sneezing.

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations (seeing things that do not exist), increased body temperature, skin redness, and walking difficulties. Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson's disease, olanzapine may worsen symptoms and cause hallucinations (seeing, hearing, or feeling things that do not exist).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Olanzapina Flas Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the carton, blister pack, or label of the bottle, after CAD or EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Store in the original packaging to protect it from light and moisture.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Olanzapina Flas Viatris

Olanzapina Flas Viatris 15 mg contains 15 mg of olanzapine as the active ingredient.

The other components are: mannitol (E-421), microcrystalline cellulose (E-460), guar gum (E-412), crospovidone (E-1202), magnesium stearate (E-470), anhydrous colloidal silica (E-551), aspartame (E-951), and sodium lauryl sulfate (E-487) (see "Olanzapina Flas Viatris contains aspartame and sodium").

Appearance of the Product and Package Contents

Tablets of a yellowish to yellow color, between smooth and speckled, round, with flat faces and beveled edges, marked with "M" on one face and "OE3" on the other.

The packages contain non-perforated blisters of 7, 10, 14, 28, 30, 35, 56, 60, 70, 98, and 100 orodispersible tablets, perforated unit-dose blisters of 7, 10, 14, 28, 30, 35, 56, 60, 70, 98, and 100 orodispersible tablets, and bottles with 7, 10, 14, 28, 30, 56, 98, 100, 250, and 500 orodispersible tablets. The bottles also contain a desiccant. Do not ingest the desiccant.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan út.1

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Olanzapina Flas Viatris 15 mg orodispersible tablets EFG

Date of the Last Revision of this Prospectus:April 2020

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es