OLANZAPINE PENSA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapina Pensa 5 mg orodispersible tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Olanzapina Pensa is and what it is used for
2. What you need to know before you take Olanzapina Pensa
3. How to take Olanzapina Pensa
4. Possible side effects
5. Storing Olanzapina Pensa
6. Contents of the pack and other information

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

Olanzapina Pensa contains the active substance olanzapine. Olanzapina Pensa belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not real, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also be depressed, anxious or tense.
• Moderate to severe manic episodes, a disease with symptoms such as 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 you take Olanzapina Pensa

Do not take Olanzapina Pensa

• If you are allergic to olanzapine or any of the other ingredients of this medicine (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 pressure in the eye).

Warnings and precautions Consult your doctor or pharmacist before taking Olanzapina Pensa.

• Olanzapina Pensa is not recommended for use in elderly patients with dementia as it may have serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapina Pensa, tell your doctor.
• Very rarely, medicines 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) in the blood have been observed in patients taking Olanzapina Pensa. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapina Pensa regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

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

• Stroke or transient lack of blood flow to the brain (symptoms of stroke)
• 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 loss of salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or relative should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

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 of age should not take Olanzapina Pensa.

Using Olanzapina Pensa with other medicines

Only use other medicines 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 that help you sleep (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

Do 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 medicine. You should not take this medicine when you are breastfeeding, as small amounts of Olanzapina Pensa can 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, breathing 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 medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to TAKE OLANZAPINA PENSA

Follow your doctor's instructions for taking this medicine exactly. If you are in 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 is between 5 and 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 drinks, 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 stop taking 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 (an uncommon 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 (the frequency cannot be estimated from the available data)

Very common side effects(which can affect 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 lying down or sitting. This feeling usually goes away on its own, but if it doesn't, consult your doctor.

Common side effects(which can affect up to 1 in 10 people) include changes in the levels of some 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 that causes swelling of the hands, ankles, or feet, fever, joint pain, and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects(which 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 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, 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 mammary gland in men and women, such as abnormal milk production or growth.

Rare side effects(which can affect 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 the white parts of the eyes, muscle disorder that presents 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 is initially manifested 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, redness of the skin, 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing OLANZAPINA PENSA

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapina Pensa

The active substance is olanzapine. Each Olanzapina Pensa orodispersible tablet contains 5 mg of active substance.

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

Appearance of Olanzapina Pensa and pack size

Olanzapina Pensa 5 mg orodispersible tablets are yellow.

Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth to make it easier to swallow.

Olanzapina Pensa 5 mg is available in packs containing 28 tablets.

Not all pack 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 medicine is authorized in the Member States of the European Economic Area under the following names:

ES: Olanzapina Pensa 5 mg orodispersible tablets EFG

IT: Olanzapina Pensa Pharma

This leaflet was last revised in April 2020

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