Package Insert: Information for the User

Olanzapine Flas Viatris 10 mg Bucodispersible Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

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

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

Olanzapina Flas Viatris is used to treat moderate to severe manic episodes, a condition with symptoms such as a feeling of euphoria, excessive energy, needing to sleep much less than usual, speaking very quickly, accelerated thoughts and, occasionally, great irritability. It is also a mood stabilizer, which prevents the recurrence of extreme and incapacitating states of euphoria and depression associated with this condition.

Do not take Olanzapina Flas Viatris:

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

Warnings and precautions

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

• If you have or have a family history of blood clots, as this type of medication has been associated with blood clot formation.
• 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 that you have imbalances in blood salts (especially low levels of potassium or magnesium).
• 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 may be caused by some medications, radiation therapy, chemotherapy, or bone marrow disease).
• If you have been told that you have an increased white blood cell count 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 symptoms of a stroke).
• If you are a smoker (as it may be necessary to adjust the dose of olanzapina).

During treatment

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

If you experience involuntary movements of the face or tongue, speak with your doctor, as they may need to reduce the dose of olanzapina or discontinue treatment.

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

High blood sugar and high lipid levels (triglycerides and cholesterol) have been observed in patients taking olanzapina. Your doctor may want to perform blood tests to check blood sugar and certain 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 olanzapina is not recommended in patients under 18 years old.

Other medications and Olanzapina 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 to adjust the dose of olanzapina.
• Medications that can alter heart rhythm, such as antiarrhythmics (like amiodarone, sotalol, quinidine, disopyramide), antibiotics (which belong 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 olanzapina, as it may interfere with the absorption of this medication.

Taking Olanzapina Flas Viatris with alcohol

Do not drink alcohol while taking olanzapina, as the combination may cause drowsiness.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication during breastfeeding, as small amounts of olanzapina may pass into breast milk.

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

Driving and operating machinery

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

Olanzapina Flas Viatris contains aspartame and sodium

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

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder 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, so it can be considered sodium-free.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how to take 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 reappear, 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 every day. It does not matter if you take them with or without food. Olanzapine is administered orally.

Olanzapine tablets break easily, so they must be handled carefully. The tablets must be handled with dry hands, otherwise they may dissolve.

1. In the case of blister packs with perforated lines, you must hold the blister pack by the edges and separate one cell from the rest of the strip by cutting gently along the perforated lines that surround it.
2. Carefully remove the back. In the case of blister packs without perforated lines, be careful not to remove the back of the adjacent tablets.
3. Next, and 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 filled with water, orange juice, apple juice, milk, or coffee, and stir it. With some drinks, it is possible that the mixture will change color and become cloudy. Drink it immediately.

If you take more Olanzapina Flas Viatris than you should

Get in touch with your doctor or the nearest hospital. Show your doctor the packaging of your 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 be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and lethargy or drowsiness, slower breathing,inhalation of liquids into the trachea and lungs (aspiration)hypertension or hypotension, 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 the missed dose. Do not take two doses on the same day.

If you interrupt treatment with Olanzapina Flas Viatris

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

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 ending treatment.

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

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

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

Common(may affect 1 in 10 people)

• An increase in the number of infections that cause sore throat, mouth ulcers, intense chills, or fever. These signs may be indicative of a decrease in the number of white blood cells that help fight infections (leucopenia, neutropenia).

Uncommon(may affect 1 in 100 people)

• Severe allergic reactions, such as skin rashes, itching, swelling of the face, lips, mouth, or throat, which may make it difficult to breathe or swallow.
• Unusual or uncontrollable movement of the mouth, tongue, cheeks, or jaw, which may spread to the arms and legs (tardive dyskinesia).
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may 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 cause loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, muscle pain, or weakness, fatigue, or discomfort) or coma.
• Abnormal heart rhythm that can be seen on an electrocardiogram (ECG).
• Seizures, in most cases related to a history of seizures (epilepsy).
• Difficulty urinating or emptying the bladder.

Rare(may affect 1 in 1,000 people)

• Bleeding or bruising that lasts longer than usual. These signs may be indicative of a low platelet count in the blood.
• A combination of 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 drowsy or tired, fever, nausea, weakness, and abdominal pain (these signs may be indicative of liver problems).
• Pelvic heart rhythm or irregular heart rhythm (fibrillation/ventricular tachycardia).
• Pancreatitis that causes severe stomach pain that extends to the back.
• Decreased body temperature that causes shivering, coldness, or pale skin.
• Muscle rupture that causes muscle pain, weakness, or stiffness accompanied by dark urine (rhabdomyolysis).
• Prolonged and/or painful erection.

Frequency not known(cannot be estimated from available data)

• Symptoms similar to the flu, with a skin rash on the face that spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzymes in blood tests, and increased eosinophils (a type of white blood cell). These signs may be indicative of drug reaction with eosinophilia and systemic symptoms (DRESS).

Other possible side effects

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

• Weight gain.
• Drowsiness.
• Increased prolactin levels, which can be seen in a blood test.
• In the early stages of treatment, some people may feel dizzy or faint (with slower heart rate), especially when getting up from lying down or sitting. This feeling usually goes away on its own, but if it doesn't, consult your doctor.

Common(may affect up to 1 in 10 people)

• Increased white blood cell count and circulating fatty acids, and temporary increases in liver enzymes that can be seen in a blood test.
• Increased glucose levels in the blood and urine that can be seen in a blood or urine test.
• Increased levels of uric acid, alkaline phosphatase, and creatine phosphokinase in the blood that can be seen in a blood test.
• Increased hunger.
• Dizziness.
• Restlessness or difficulty staying seated.
• Tremors, rigid posture, slow movements, and walking without balance and dragging the feet (parkinsonism).
• Unusual movements (dyskinesias).
• Constipation.
• Dry mouth.
• Hives.
• Loss of energy.
• Extreme fatigue.
• Fluid retention that causes swelling in the hands, ankles, or feet.
• Fever, joint pain.
• Sexual problems such as decreased libido 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 that affect the head (including eye movements), neck, and body.
• Restless legs syndrome.
• Speech problems.
• Stuttering.
• Slow heart rate.
• Increased sensitivity to sunlight.
• Nasal bleeding.
• Feeling 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.
• Changes 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.
• Signs of withdrawal, such as sweating, difficulty sleeping, tremors, anxiety, or feeling unwell (nausea) or feeling unwell (vomiting).

Frequency not known(cannot be estimated from available data)

• Withdrawal symptoms in newborns, such as skin discoloration, 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 fatigue, visual hallucinations (seeing things that are not there), increased body temperature, skin redness, and difficulty walking. 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 are not there).

Reporting side effects

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

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

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

Do not use this medication if you observe visible signs of deterioration.

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

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olanzapina Flas Viatris

Olanzapina Flas Viatris 10 mg contains 10 mg of olanzapina 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 contents of the packaging

Yellowish to yellow tablets, smooth and speckled, round, with flat faces and beveled edges, marked with "M" on one face and "OE2" on the other.

The packaging contains unperforated blisters containing 7, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 buccal dispersible tablets, perforated single-dose blisters of 7, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 buccal dispersible tablets and bottles with 7, 10, 14, 28, 30, 56, 98, 100, 250 and 500 buccal dispersible tablets. The bottles also contain a desiccant.Do not ingest the desiccant.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan út.1

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

SpainOlanzapina Flas Viatris 10 mg buccal dispersible tablets EFG

Last review date of this leaflet:April 2020

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es