OLANZAPINE FLAS KERN PHARMA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine Flas Kern Pharma 20 mg orodispersible tablets EFG

Olanzapine

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 and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See Section 4.

Contents of the package leaflet:

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

1. What Olanzapine Flas Kern Pharma is and what it is used for

Olanzapine Flas Kern Pharma belongs to the therapeutic group of antipsychotics.

Olanzapine Flas is indicated for the treatment of a disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, tense, or anxious.

Olanzapine Flas is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme mood swings.

2. What you need to know before taking Olanzapine Flas Kern Pharma

Do not take Olanzapine Flas Kern Pharma

• if you are allergic to olanzapine or any of the other components of Olanzapine Flas Kern Pharma. The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, tell your doctor.
• if you have previously been diagnosed with eye problems such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Flas Kern Pharma, tell your doctor.
• Very rarely, medicines of this type can cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, stop taking the medication and contact your doctor immediately.
• The use of Olanzapine Flas in elderly patients with dementia is not recommended, as it may have serious side effects.

If you have any of the following diseases, inform your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or lack of blood flow to the brain (transient stroke symptoms).

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapine Flas Kern Pharma.

Interaction of Olanzapine Flas Kern Pharma with other medicines

Only use other medicines at the same time as Olanzapine Flas Kern Pharma if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Flas Kern Pharma with antidepressants or medicines for anxiety or sleep aids (tranquilizers).

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapine Flas Kern Pharma.

Please inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription. Especially inform your doctor if you are using medicines for Parkinson's disease.

Interaction of Olanzapine Flas Kern Pharma with food and drinks

You should not drink alcohol while taking Olanzapine Flas, as the combination of Olanzapine Flas and alcohol can cause drowsiness.

Pregnancy and breastfeeding

Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medication during pregnancy unless your doctor recommends it. You should not take this medication while breastfeeding, as small amounts of Olanzapine Flas may pass into breast milk.

Newborns of mothers who have used (olanzapine) in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn experiences any of these symptoms, contact your doctor.

Driving and using machines

Olanzapine Flas can cause symptoms such as drowsiness, dizziness, or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Olanzapine Flas Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Olanzapine Flas Kern Pharma contains aspartame

Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria.

3. How to take Olanzapine Flas Kern Pharma

Follow your doctor's instructions for taking Olanzapine Flas Kern Pharma exactly.

Your doctor will tell you how many Olanzapine Flas tablets to take and for how long. The daily dose of Olanzapine Flas ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine Flas unless your doctor tells you to.

Olanzapine Flas tablets should be taken once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine Flas orodispersible tablets are for oral administration.

Olanzapine Flas Kern Pharma tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may break.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently along the perforations that surround it.
2. Gently remove the back of the cell.
3. Carefully remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

You can also put the tablet in a cup or glass of water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change color and appear cloudy. You should drink it immediately.

If you take more Olanzapine Flas Kern Pharma than you should

Patients who have taken more Olanzapine Flas than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowed breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or the Toxicology Information Service (tel: 91 562 04 20) immediately, indicating the medication and the amount ingested.

If you forget to take Olanzapine Flas Kern Pharma

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapine Flas Kern Pharma

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Flas while your doctor tells you to.

If you stop taking Olanzapine Flas suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible side effects

Like all medicines, Olanzapine Flas Kern Pharma can have side effects, although not everyone experiences them.

Very common side effects: May affect more than 1 in 10 people

• Weight gain.
• Drowsiness.
• Increased prolactin levels in the blood.

Common side effects: May affect up to 1 in 10 people

• Changes in the levels of certain blood cells and circulating lipids.
• Increased blood sugar and urine levels.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremors.
• Muscle stiffness or spasms (including eye movements).
• Language disorders.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fluid retention that causes swelling of the hands, ankles, or feet.
• In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from a lying or sitting position.
• This sensation usually disappears on its own, but if it does not, inform your doctor.
• Sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: May affect up to 1 in 100 people

• Slow pulse.
• Sensitivity to sunlight.
• Urinary incontinence.
• Hair loss.
• Absence or decrease of menstrual periods.
• Changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.
• Restless legs syndrome.
• Allergic reaction (e.g., inflammation of the mouth and throat, itching, skin rash).
• Diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma.
• Seizures, in most cases related to a history of seizures (epilepsy).
• Muscle spasms in the eye muscles, causing circular movements of the eyes.
• Excessive salivation.

Other possible side effects: frequency cannot be estimated from available data

• Decrease in normal body temperature.
• Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Blood clots such as deep vein thrombosis of the legs and blood clots in the lungs.
• Pancreatitis, which causes severe stomach pain, fever, and discomfort.
• Liver disease, with yellowing of the skin and the white areas of the eyes.
• Muscle disorder that presents as unexplained pain.
• Difficulty urinating.
• Prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially manifests with symptoms similar to those of the flu, with a skin rash on the face that then 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).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine Flas may worsen symptoms in patients with Parkinson's disease.

In rare cases, women who have been taking this type of medication for a long time may experience milk secretion from the mammary gland, stop having menstrual periods, or have irregular periods. If this situation persists, consult your doctor. In very rare cases, babies of mothers who have taken Olanzapine Flas in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olanzapine Flas Kern Pharma

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

Do not use Olanzapine Flas Kern Pharma after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olanzapine Flas Kern Pharma 20 mg tablets

• The active ingredient is olanzapine. Each Olanzapine Flas Kern Pharma orodispersible tablet contains 20 mg of olanzapine.
• The other ingredients are lactose monohydrate, calcium silicate (E552), low-substitution hydroxypropyl cellulose, crospovidone, aspartame (E951), orange flavor, banana flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and package contents

Olanzapine Flas Kern Pharma are round, flat, beveled, and yellow tablets. The tablets are packaged in aluminum/aluminum blisters that can be opened by separating a sheet, in packs of 28 tablets.

Olanzapine Flas Kern Pharma is also available in 5 mg orodispersible tablets in packs of 28 tablets, 10 mg in packs of 28 and 56 tablets, and 15 mg in packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

This package leaflet was last revised in April 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es