Olanzapine Flas Viatris 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olanzapina Flas Viatris 10 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Olanzapina Flas Viatris is and what it is used for
2. What you need to know before taking Olanzapina Flas Viatris
3. How to take Olanzapina Flas Viatris
4. Possible side effects
5. How to store Olanzapina Flas Viatris
6. Contents of the pack and other information

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

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

Olanzapina Flas Viatris is used to treat schizophrenia, a condition characterized by symptoms such as hearing, seeing, or sensing things that do not exist, having false beliefs, unusual suspicions, and social withdrawal. People with this illness may also feel depressed, anxious, or tense.

Olanzapina Flas Viatris is used to treat moderate to severe manic episodes, a condition marked by symptoms such as feelings of euphoria, excessive energy, reduced need for sleep, rapid speech, racing thoughts, and occasionally, marked irritability. It also acts as a mood stabilizer, preventing the recurrence of extreme and disabling mood states of euphoria and depression associated with this disorder.

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

Do not take Olanzapina Flas Viatris:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olanzapina Flas Viatris.

• If you or a family member have a history of blood clots, as this type of medicine has been associated with blood clot formation.

• If you are an elderly patient with dementia, as you may experience serious adverse effects.

• If you have diabetes.

• If you have a heart condition.

• If you have been told you have imbalances in blood electrolytes (especially low levels of potassium or magnesium).

• If you were born with a prolonged QT interval (seen on ECG, an electrocardiogram recording).

• If you have liver or kidney problems.

• If you have Parkinson's disease.

• If you have a history of seizures or fits (epilepsy).

• If you have benign prostatic hyperplasia (enlarged prostate).

• If you have intestinal obstruction (paralytic ileus).

• If you have a low white blood cell count (which may be caused by certain medications, radiation therapy, chemotherapy, or bone marrow disease).

• If you have been told that your white blood cell count is elevated or you have a bone marrow disorder in which blood cells are overproduced, called myeloproliferative disease.

• If you have had a stroke or "mini" stroke (transient stroke symptoms).

• If you are a smoker (as it may be necessary to adjust the olanzapine dose).

During treatment

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

If you experience uncontrolled movements of the face or tongue, speak to your doctor, as they may consider reducing the dose of olanzapine or stopping treatment.

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

High blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor may wish to perform blood tests to check your blood sugar and certain lipid levels before starting this medicine.

If you are over 65 years of age, your doctor will monitor your blood pressure as a routine precaution.

Children and adolescents

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

Other medicines and Olanzapina Flas Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking any of the following:

• Medicines for Parkinson's disease.
• Antidepressants or other medicines 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.
• Medicines that may affect heart rhythm, such as antiarrhythmics (e.g., amiodarone, sotalol, quinidine, disopyramide), antibiotics (belonging to the macrolide group), tricyclic antidepressants.
• Activated charcoal (a chemical used to bind other medicines), which should be taken at least 2 hours before or after taking olanzapine, as it may interfere with its absorption.

Taking Olanzapina Flas Viatris with alcohol

Do not drink alcohol while taking olanzapine, as combining both may 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 medicine. You should not take this medicine during breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in breastfed infants or in mothers who took olanzapine during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows 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 occurs, do not drive or operate tools or machinery. Consult your doctor.

Olanzapina Flas Viatris contains aspartame and sodium

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

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

Olanzapina Flas Viatris contains less than 1 mmol of sodium (23 mg) per tablet and is therefore considered essentially "sodium-free".

3. How to take Olanzapina Flas Viatris

Follow exactly the instructions for use of this medicine as given 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 return, but do not stop taking this medicine unless instructed by your doctor.

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

Olanzapine tablets break easily and should therefore be handled with care. The tablets should be handled with dry hands, otherwise they may dissolve.

1. For 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 back the backing. For blister packs without perforated lines, take care not to peel back the backing of adjacent tablets.
3. Then, carefully push the tablet out.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, allowing you to swallow it easily.

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

If you take more Olanzapina Flas Viatris than you should

Contact your doctor or the nearest hospital. Show the doctor your medicine packaging. 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 rigidity, and lethargy or drowsiness, slowed breathing, inhalation of fluids into the trachea and lungs (aspiration), hypertension or hypotension, and abnormal heart rhythms.

If you forget to take Olanzapina 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 Olanzapina Flas Viatris

Do not stop taking the tablets, even if you feel better. It is important that you take olanzapine for as long as your doctor has instructed.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people)

• An increase in infections, accompanied by sore throat, mouth ulcers, severe chills, or fever. These signs could indicate a reduction in the number of white blood cells that help fight infections (leukopenia, neutropenia).

Uncommon (may affect up to 1 in 100 people)

• Severe allergic reactions, such as skin rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty breathing or swallowing.
• Unusual or uncontrollable movements of the mouth, tongue, cheeks, or jaw, which may 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 may travel through blood vessels to the lungs, causing chest pain and difficulty breathing.
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine), leading to loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain, or feelings of weakness, fatigue, or discomfort, or coma.
• Abnormal heart rhythm detectable on an electrocardiogram (ECG).
• Seizures, mostly in patients with a history of seizures (epilepsy).
• Difficulty urinating or emptying the bladder.

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

• Unexplained bruising or prolonged bleeding. These signs could indicate low platelet count 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 whites of the eyes, dark urine, pale stools, itching, drowsiness or fatigue, fever, nausea, weakness, and abdominal pain (these signs could indicate liver problems).
• Dangerous or unusual fast heart rate (ventricular fibrillation/tachycardia).
• Inflammation of the pancreas causing severe stomach pain that spreads to the back.
• Decrease in normal body temperature causing shivering, coldness, or pale skin.
• Muscle breakdown causing muscle pain, weakness, or tenderness, accompanied by dark urine (rhabdomyolysis).
• Prolonged and/or painful erection.

Frequency not known (cannot be estimated from available data)

• Flu-like symptoms, with a rash on the face that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia). These signs could indicate drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Other possible adverse effects

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

• Weight gain.
• Drowsiness.
• Increased prolactin levels, detectable in a blood test.
• In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common (may affect up to 1 in 10 people)

• Increased levels of white blood cells (blood cells), circulating fatty acids, and temporary increases in liver enzymes at the beginning of treatment, detectable in a blood test.
• Increased levels of glucose in blood and urine, detectable in blood or urine tests.
• Increased levels of uric acid, alkaline phosphatase, and creatine phosphokinase in blood, detectable in a blood test.
• Increased feeling of hunger.
• Dizziness.
• Restlessness or difficulty sitting still.
• Tremors, rigid posture, slow movements, and unbalanced walking with shuffling steps (parkinsonism).
• Unusual movements (dyskinesias).
• Constipation.
• Dry mouth.
• Skin rashes.
• Loss of energy.
• Extreme tiredness.
• Fluid retention causing swelling in hands, ankles, or feet.
• Fever, joint pain.
• Sexual problems such as decreased sex drive in men and women, or difficulty achieving or maintaining an erection in men.

Uncommon (may affect up to 1 in 100 people)

• Uncontrollable muscle stiffness or spasms affecting the head (including eye movements), neck, and body.
• Restless legs syndrome.
• Speech problems.
• Stuttering.
• Slow heart rate.
• Increased sensitivity to sunlight.
• Nosebleeds.
• Feeling of bloating (abdominal distension).
• Excessive salivation.
• Memory loss or forgetfulness.
• Inability to control urination, difficulty starting to urinate, or maintaining urine flow.
• Hair loss.
• Absence of menstruation or reduced menstrual periods.
• Changes in breast size in women and men.
• Abnormal production of breast milk 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 feelings of discomfort (nausea) or malaise (vomiting).

Frequency not known (cannot be estimated from available data)

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

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations (seeing things that are not real), increased body temperature, skin redness, and walking difficulties. 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 are not real).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Flas Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the cardboard box, blister pack, or label of the bottle, indicated after CAD or EXP. The expiry date refers to the last day of the month shown.

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

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Flas Viatris

Olanzapine Flas Viatris 10 mg contains 10 mg of olanzapine as the active substance.

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

Nature of the product and pack sizes

Yellowish to yellow, smooth to mottled, round, flat-faced tablets with bevelled edges, marked with "M" on one side and "OE2" on the other.

The packs contain non-perforated blisters containing 7, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets, single-dose perforated blisters of 7, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets, and bottles containing 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 certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan út. 1

Hungary

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain: Olanzapine Flas Viatris 10 mg orodispersible tablets EFG

Date of the most recent review of this leaflet: April 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es