PATIENT INFORMATION LEAFLET

Olanzapine Flas Kern Pharma 10 mg buccal tablets EFG

Olanzapine

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See Section 4.

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

Olanzapina Flas Kern Pharma 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whose symptoms are hearing, seeing, or feeling unreal things, holding false beliefs, unusual suspicion, and becoming withdrawn.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 Kern Pharma is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less 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 (hypersensitive) 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).

Be especially careful with Olanzapina Flas Kern Pharma

• 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 produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, contact your doctor immediately.
• The use of Olanzapina Flas Kern Pharma in elderly patients with dementia is not recommended as it may have severe adverse 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
• 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.

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

Use of other medications

Only use other medicines at the same time as Olanzapina Flas Kern Pharma, if your doctor authorizes it. You may feel a certain sense of drowsiness if you combine Olanzapina Flas Kern Pharma with antidepressants or medications for anxiety or that help you 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 to treat Parkinson's disease.

Taking Olanzapina Flas Kern Pharma with food and drinks

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

Pregnancy and breastfeeding

Tell your doctor as soon as possible if you are pregnant or if you 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 Kern Pharma may pass into breast milk.

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

Driving and using machines

There is a risk of drowsiness when taking Olanzapina Flas Kern Pharma. If this happens, do not drive vehicles or use machinery. Consult your doctor.

Important information about some of the components of Olanzapina Flas Kern Pharma

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

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Follow exactly the administration instructions forOlanzapina Flas Kern Pharmaas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Olanzapina Flas Kern Pharma 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 Kern Pharma tablets are for oral administration.

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

Separate the upper aluminum foil from a blister and carefully remove the Olanzapina Flas Kern Pharma buccal tablet.

Deposit the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

If you take moreOlanzapina Flas Kern Pharmathan you should

Patients who have taken more Olanzapina Flas Kern Pharma 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 or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging with the tablets.

If you forget to takeOlanzapina Flas Kern Pharma

Take your tablet as soon as you remember. Do not take a double dose to make up 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 Kern Pharma as long as your doctor tells you to.

If you stop taking Olanzapina Flas Kern Pharma 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 Pharmamay cause side effects, although not everyone will experience them.

Very common side effects: affecting 1 in 10 patients

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

Common side effects: affecting between 1 and 10 in every 100 patients

• Changes in levels of some blood cells and circulating lipids.
• Increased levels of sugar in the blood and urine.
• Increased appetite.
• Dizziness.
• Agitation.
• 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 inflammation 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 down. 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: affecting between 1 and 10 in every 1,000 patients

• Slow pulse.
• Sensitivity to sunlight.
• 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).
• Eyeball 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), have been reported. 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 Kern Pharmamay 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. Rarely, babies born to mothers who tookOlanzapina Flas Kern Pharmain the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

Reporting 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 about the safety of this medication.

Keep out of the sight and reach of children.

Do not useOlanzapina Flas Kern Pharmaafter 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 pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Olanzapina Flas Kern Pharma 10 mg

The active ingredient is olanzapine. Each buccal dispersible tablet ofOlanzapina Flas Kern Pharmacontains 10 mg of active ingredient.

The other components are lactose monohydrate, calcium silicate, low-substitution hydroxypropyl cellulose, crospovidone, aspartame, orange aroma, banana aroma, anhydrous colloidal silica, and magnesium stearate.

Appearance of Olanzapina Flas Kern Pharma 10 mg and content of the packaging

Olanzapina Flas Kern Pharma 10mg buccal dispersible tablets are yellow.

Olanzapina Flas Kern Pharma 10mg buccal dispersible tablets are available in packaging of 28 and 56 tablets.

Other presentations:

Olanzapina Flas Kern Pharma 5 mg buccal dispersible tablets: packaging of 28 tablets.

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 - Spain

This leaflet was revised in April 2020

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/