PATIENT INFORMATION LEAFLET

Olanzapina Flas Kern Pharma 20 mg buccal tablets EFG

Olanzapina

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See Section 4.

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

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

3.How to take Olanzapina Flas Kern Pharma

4.Possible side effects

5.Storage of Olanzapina Flas Kern Pharma

6.Contents of the pack and additional information

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

Olanzapina Flas is indicated for treating a disease whose symptoms are hearing, seeing, or feeling unreal things, holding false beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.

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

Do not take Olanzapina Flas Kern Pharma

• if you are allergic to olanzapina or any of the other components of Olanzapina Flas Kern Pharma. An 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 may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Flas Kern Pharma, tell your doctor.
• In rare cases, 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 Olanzapina Flas in elderly patients with dementia is not recommended as it may have severe adverse effects.

If you have any of the following conditions, 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
• Cerebral infarction or lack of blood flow to the brain (transient symptoms of cerebral infarction).

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

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

Children and adolescents

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

Olanzapina Flas Kern Pharma interactions with other medications

Only use other medicines at the same time as Olanzapina Flas Kern Pharma if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Flas Kern Pharma with antidepressants or medications for anxiety or to help sleep (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 Olanzapina Flas Kern Pharma.

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

Olanzapina Flas Kern Pharma interactions with food and drinks

You should not drink alcohol while taking Olanzapina Flas as the combination of Olanzapina Flas and alcohol may cause drowsiness.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

Olanzapina Flas may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Olanzapina Flas Kern Pharma contains lactose

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

Olanzapina Flas Kern Pharma contains aspartame

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

Follow exactly the administration instructions of Olanzapina Flas Kern Pharma provided by your doctor.

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

Olanzapina 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. Olanzapina Flas bucodispersable tablets are for oral administration.

Olanzapina Flas Kern Pharma tablets break easily, so they should be handled carefully. Do not handle the tablets with wet hands because they may disintegrate.

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

You can also pour the tablet into a cup or a glass filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. It should be consumed immediately.

If you take more Olanzapina Flas Kern Pharma than you should

Patients who have taken more Olanzapina Flas than they should have experienced the following symptoms:rapid heartbeats, agitation/aggressiveness, 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 rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the packaging with the tablets to the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Olanzapina Flas Kern Pharma

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

If you interrupt treatment with Olanzapina Flas Kern Pharma

Do not stop treatment simply because you feel better. It is very important that you continue taking Olanzapina Flas as long as your doctor tells you to.

If you stop taking Olanzapina Flas suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, 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.

Like all medicines, Olanzapina Flas Kern Pharma can have side effects, although not everyone will experience them.

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

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

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

• Changes in the levels of some blood cells and circulating lipids.
• Increased levels of sugar in the blood and urine.
• Increased appetite.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or spasms (including eye movements).
• Language alterations.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fluid retention causing swelling of the hands, ankles, or feet.
• In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when getting up from lying or sitting.
• This sensation usually disappears on its own, but if it doesn't, inform your doctor.
• Sexual dysfunction 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 irregular periods.
• Changes in the breast 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 the blood and urine) or coma.
• Seizures, in most cases related to a history of seizures (epilepsy).
• Eye muscle spasms causing circular movements of the eyes.
• Excessive salivation.

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

• Decreased normal body temperature.
• Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness.
• Abnormal heart rhythm.
• Sudden death without apparent explanation.
• 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 white areas of the eye.
• Muscular disorder presenting as unexplained pain.
• Difficulty urinating.
• Prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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

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

In rare cases, women taking this type of medication for a long period may experience milk secretion from the breast gland, irregular or absent periods, or irregular periods. If this persists, consult your doctor. In very rare cases, babies born to mothers who took Olanzapina Flas in the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: http//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Olanzapina Flas Kern Pharma after the expiration date that appears on the packaging 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 drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Olanzapina Flas Kern Pharma 20 mg tablets

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

Appearance of the product and content of the packaging

Olanzapina Flas Kern Pharma are round, flat, bisected, and yellow tablets. The tablets are packaged in aluminum/aluminum blisters that open by separating a sheet, in boxes of 28 tablets.

Olanzapina Flas Kern Pharma is also available in 5 mg buccal dispersible tablets in boxes of 28 tablets, 10 mg tablets in boxes of 28 and 56 tablets, and 15 mg tablets in boxes of 28 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Last review of this leaflet was in April 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es