PATIENT INFORMATION LEAFLET

Olanzapina Flas Aristo 10 mg orally disintegrating tablets EFG

Olanzapina

Read this leaflet carefully before you start taking the 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 their symptoms are the same. It may harm them.

−If you think any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

2. Before taking Olanzapina Flas Aristo

3. How to take Olanzapina Flas Aristo

4. Possible side effects

5. Storage of Olanzapina Flas Aristo

6. Additional information

Olanzapina Flas Aristo belongs to the therapeutic group of antipsychotics.

Olanzapina Flas Aristo 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whose symptoms are hearing, seeing, or feeling unreal things, holding false beliefs, unusual suspicion, and becoming withdrawn.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 Aristo is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking 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 Aristo

- If you are allergic (hypersensitive) to olanzapina or any of the other components of Olanzapina Flas Aristo. 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 Aristo

- Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Flas Aristo, tell your doctor.

- In rare cases, medications 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 Aristo 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 cerebral hypoperfusion (transient symptoms of cerebral infarction).

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a cerebral infarction or cerebral hypoperfusion.

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

Patients under 18 years old should not take Olanzapina Flas Aristo.

Use of other medications

Only use other medicines at the same time as Olanzapina Flas Aristo if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Flas Aristo 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 Olanzapina Flas Aristo dose.

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 Aristo with food and drinks

You should not drink alcohol while taking Olanzapina Flas Aristo as the combination of Olanzapina Flas Aristo 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 Aristo may pass into breast milk.

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

Driving and operating machinery

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

Important information about some of the components of Olanzapina Flas Aristo

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

Olanzapina Flas Aristo 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 Aristo tablets are for oral administration.

Olanzapina Flas Aristo 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 Aristo buccal tablet.

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

If you take more Olanzapina Flas Aristo than you should

Patients who have taken more Olanzapina Flas Aristo than they should have experienced the following symptoms: rapid heart rate, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced 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 take Olanzapina Flas Aristo

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 Aristo

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

If you stop taking Olanzapina Flas Aristo 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 Aristo can 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 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 experience dizziness or fainting (with slower heartbeats), especially when getting up from lying or sitting.

This sensation usually disappears spontaneously, but if it does not, 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 1,000 patients

- Slow pulse.

- Sensitivity to sunlight.

- Urinary incontinence.

- Hair loss.

- Absence or irregularity of menstrual periods.

- Changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

- Restless legs syndrome

- Excessive salivation

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

- 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.

- Decreased normal body temperature.

- Convulsions, in most cases related to a history of convulsions (epilepsy).

- Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness.

- Spasms in the eye muscles causing circular movements of the eyes.

- Abnormal heart rhythm.

- Sudden death without apparent explanation.

- Blood clots such as deep vein thrombosis of the legs and blood clots in the lung.

- Inflammation of the pancreas, causing severe stomach pain, fever, and discomfort.

- Liver disease, with yellowing of the skin and white areas of the eye.

- Muscle disorder presenting as unexplained pain.

- Difficulty urinating.

- Prolonged and/or painful erection.

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 walking difficulties. Some deaths have been reported in this particular group of patients.

Olanzapina Flas Aristo 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 menstrual periods, or amenorrhea. If this situation persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina Flas Aristo in the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with flu-like symptoms, skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased eosinophils.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use Olanzapina Flas Aristo 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.

Do not dispose of medications through drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Olanzapine Flas Aristo 10 mg Composition

The active ingredient is olanzapine. Each Olanzapine Flas Aristo buccal dispersible tablet contains 10 mg of active ingredient.

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

Appearance of Olanzapine Flas Aristo 10 mg and packaging contents

Olanzapine Flas Aristo 10 mg buccal dispersible tablets are yellow.

Olanzapine Flas Aristo 10 mg buccal dispersible tablets are available in packaging of 28 and 56 tablets.

Other presentations:

Olanzapine Flas Aristo 5 mg buccal dispersible tablets: packaging of 28 tablets

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible Manufacturer

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