OLANZAPINE PENSA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapina Pensa 10 mg orodispersible tablets EFG

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

Contents of the package leaflet:

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

1. What OLANZAPINA PENSA is and what it is used for

Olanzapina Pensa contains the active substance olanzapine. 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering 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 been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina Pensa

Do not take Olanzapina Pensa

• If you are allergic to olanzapine or any of the other components of this medication (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased eye pressure).

Warnings and precautions Consult your doctor or pharmacist before starting to take Olanzapina Pensa.

• The use of Olanzapina Pensa is not recommended in elderly patients with dementia, as it may have serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapina Pensa, tell your doctor.
• In very 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 to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olanzapina Pensa. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking Olanzapina Pensa. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Olanzapina Pensa regularly during treatment.
• If you or a family member have a history of blood clots, consult your doctor, as medications of this type have been associated with the formation of blood clots.

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

• Stroke or transient cerebral ischemia (transient stroke symptoms)
• 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 salt loss due to prolonged and intense diarrhea and vomiting or the use of diuretic medications (urination tablets)

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

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 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 aids (tranquilizers).

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

In particular, tell your doctor if you are taking:

• Medication for Parkinson's disease
• Carbamazepine (an antiepileptic and mood stabilizer)
• Fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), may need to adjust your dose of Olanzapina Pensa.

Olanzapina Pensa with alcohol

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

Pregnancy and breastfeeding

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

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

Driving and using machines

There is a risk of drowsiness when taking Olanzapina Pensa. If this happens to you, do not drive vehicles or use 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.

3. How to TAKE OLANZAPINA PENSA

Follow your doctor's instructions for taking this medication exactly. 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 orodispersible tablets are for oral administration.

Olanzapina Pensa tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

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

1. Gently push the tablet to avoid breaking it.
2. 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, stirring it. With some beverages, the mixture may change color and appear 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 a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

In case of overdose or accidental ingestion, consult the Toxicology 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 make up for forgotten doses.

If you interrupt treatment with Olanzapina Pensa

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Contact your doctor immediately 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, go to the doctor immediately.

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

Very common side effects(affecting more than 1 in 10 people) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects(affecting up to 1 in 10 people) include changes in the levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, agitation, tremors, unusual movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing swelling 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.

Uncommon side effects(affecting 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 blood and urine) or coma, seizures, mostly related to a history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech problems, slow pulse, sensitivity to sunlight, nosebleeds, 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 growth.

Rare side effects(affecting up to 1 in 1,000 people) include a drop in normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and white areas of the eyes, muscle disorder presenting as unexplained pain and weakness, and prolonged and/or painful erections.

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, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of OLANZAPINA PENSA

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olanzapina Pensa

The active substance is olanzapine. Each Olanzapina Pensa orodispersible tablet contains 10 mg of active substance.

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

Appearance of Olanzapina Pensa and package size

Olanzapina Pensa 10 mg orodispersible tablets are yellow.

Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth for easier swallowing.

Olanzapina Pensa 10 mg is available in packages containing 28 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

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

This medication is authorized in the Member States of the European Economic Area under the following names:

ES: Olanzapina Pensa 10 mg orodispersible tablets EFG

IT: Olanzapina Pensa Pharma

This package leaflet was revised inApril 2020.

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