Leaflet: information for the user

Olanzapine pensa 5 mg buccal tablets EFG

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

• 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 youonlyand should not be given to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceside effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Olanzapine Pensa is and for what it is used

2. What you need to know beforestarting totake Olanzapine Pensa

3. How to take Olanzapine Pensa

4. Possible side effects

5. Storage of Olanzapine Pensa

6. Contents of the pack and additional information

OLANZAPINA PENSA contains the active ingredient olanzapina. OLANZAPINA PENSA belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic disorder, a disease whose symptoms are excitement or euphoria.

OLANZAPINA PENSA has demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Olanzapina Pensa

- If you are allergic to olanzapina or any of the other components of this medication (listed in section 6). 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 precautionsConsult your doctor or pharmacist before starting to take Olanzapina Pensa.

- Olanzapina Pensa is not recommended for use in elderly patients with dementia as it may have severe adverse effects.

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

- In rare cases, medications of this type may produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.

- Weight gain has been observed in patients taking Olanzapina Pensa. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer you to a nutritionist.

- Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Pensa. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting regular treatment with Olanzapina Pensa.

- If you or a family member has a history of blood clots, consult your doctor, as medications of this type have been associated with blood clot formation.

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

• Stroke or transient ischemic attack (temporary lack of blood flow to the brain)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretics (water pills)

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

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 Pensa.

Use of Olanzapina Pensa with other medications

Only use other medications at the same time as Olanzapina Pensa if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Pensa with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Specifically, tell your doctor if you are taking:

• Medication for Parkinson's disease

Carbamazepine (an antiepileptic and mood stabilizer),

• fluvoxamine (antidepressant), or ciprofloxacin (antibiotic), your doctor may need to adjust your Olanzapina Pensa dose.

Olanzapina Pensa and alcohol

You should not drink alcohol while taking Olanzapina Pensa as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.Olanzapina Pensa should not be taken while breastfeeding as small amounts may pass into breast milk.

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

Driving and operating machinery

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

Olanzapina Pensa contains lactose

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

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

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

You should take your Olanzapina Pensa tablets 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 Pensa tablets are for oral administration.

Olanzapina Pensa tablets break easily, so they must be handled carefully. Do not handle the tablets with wet hands because they may disintegrate.

1 and 2. Hold the blister pack by the ends.

3. Gently push the tablet to avoid breaking.

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

You can also place the tablet in 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. You should drink it immediately.

If you take more Olanzapina Pensa than you should

Patients who have taken more Olanzapina Pensa than they should have experienced the following symptoms: rapid heartbeat, 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 if you notice any of the mentioned symptoms.Show the doctor the packaging with the tablets.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91.562.04.20.

If you forget to take Olanzapina Pensa

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 Pensa

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

If you stop taking Olanzapina Pensa 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 medication, ask your doctor or pharmacist.

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

Immediately contact your doctor if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.

• blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

•?combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Frequent side effects(that can affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects(that can affect up to 1 in 10 people) include changes in levels of some blood cells, circulating lipids, and at the beginning of treatment temporary increases in liver enzymes, increased levels of blood sugar and urine, increased levels of uric acid and creatine phosphokinase in the blood, increased appetite, dizziness, agitation, tremor, strange movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing inflammation of the hands, ankles, or feet, fever, joint pain, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects(that can affect up to 1 in 100 people) include hypersensitivity (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), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech problems, slow pulse, sensitivity to sunlight, nasal bleeding, abdominal distension, memory loss or forgetfulness, urinary incontinence, loss of ability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the breast gland in men and women such as abnormal milk production or abnormal growth, excessive salivation.

Very rare side effects(that can affect up to 1 in 1000 people) include a decrease in normal body temperature, abnormal heart rhythm, sudden death without apparent explanation, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and white areas of the eye, muscle disorder that presents as unexplained pain, and 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 olanzapine, 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.

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

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 Pharmacovigilance 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.

Keepthis medicationout of the sight andreach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Olanzapina Pensa should be stored in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

any unused medications at the SIGREcollection 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.

Composition of Olanzapina Pensa

The active ingredient is olanzapine. Each buccal dispersible tablet of Olanzapina Pensa contains 5 mg of active ingredient.

• The other components are crospovidone (type A), lactose monohydrate, anhydrous colloidal silica, hydroxypropylcellulose, peppermint essence (consists of peppermint essential oil, terpene-free peppermint essential oil, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.

Appearance of Olanzapina Pensa and packaging size

Olanzapina Pensa 5 mg tablets are yellow.

A buccal dispersible tablet is the technical name for a tablet that dissolves directly in the mouth for easier swallowing.

Olanzapina Pensa 5 mg is presented in packaging containing 28 tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder andresponsible manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

Pharmathen S.A., Dervenakion 6, 15351, Pallini, Attiki, Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

ES:Olanzapina Pensa 5 mg buccal dispersible tablets EFG

IT:Olanzapina Pensa Pharma

This leaflet has beenreviewedinApril 2020

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