OLANZAPINE AUROVITAS 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapina Aurovitas 5 mg orodispersible tablets EFG

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Olanzapina Aurovitas and what is it used for

Olanzapina Aurovitas belongs to a group of medicines called 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a disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

Olanzapine 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 Aurovitas

Do not take Olanzapina Aurovitas

• 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 eye pressure).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olanzapina Aurovitas.

• Olanzapine is not recommended for use in elderly patients with dementia as it may have serious side effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine, 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 olanzapine. 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 olanzapine. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking olanzapine and regularly during treatment.
• If you or a family member have 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 temporary lack of blood flow to the brain (transient 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 medicines (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 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 olanzapine.

Other medicines and Olanzapina Aurovitas

Only use other medicines at the same time as olanzapine if your doctor authorizes it. You may feel drowsy if you combine olanzapine with antidepressants or anxiety medicines or those that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicine.

In particular, tell your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic). Your dose of olanzapine may need to be changed.

Taking Olanzapina Aurovitas with alcohol

You should not drink alcohol if you have been given olanzapine because it 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 or pharmacist before using this medicine.

You should not take this medicine while breastfeeding as small amounts of olanzapine may pass into breast milk.

Newborns of mothers who have used olanzapine in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when you are taking olanzapine. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapina Aurovitas contains aspartame

This medicine contains 0.5 mg of aspartame in each 5 mg orodispersible tablet.

Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

Olanzapina Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet; this is essentially "sodium-free".

3. How to take Olanzapina Aurovitas

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

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

You should take your olanzapine 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 Aurovitas orodispersible tablets are for oral administration.

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

The tablet can also be placed in a cup or glass of water, orange juice, apple juice, milk or coffee, stirring. With some drinks, the mixture may change color and appear cloudy. It should be taken immediately.

If you take more Olanzapina Aurovitas than you should

Patient who have taken more olanzapine 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, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Olanzapina Aurovitas

Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapina Aurovitas

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

If you stop taking olanzapine 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).

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 lymph nodes, elevated liver enzymes in blood tests and an increase in a type of white blood cell (eosinophilia).

Very common(may affect more than 1 in 10 people) include:

• weight gain.
• drowsiness.
• 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 feeling usually goes away on its own, but if it doesn't, tell your doctor.

Common(may 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 levels of sugar in the blood and urine.
• increased levels of uric acid and creatine phosphokinase 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 dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon(may 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.
• stuttering.
• slow pulse.
• sensitivity to sunlight.
• nosebleeds.
• abdominal distension.
• excessive salivation.
• memory loss or forgetfulness.
• urinary incontinence, loss of ability to urinate.
• hair loss.
• absence or decrease of menstrual periods.
• changes in the mammary gland in men and women such as abnormal production of breast milk or abnormal growth.

Rare(may affect up to 1 in 1,000 people) include:

• decrease in normal body temperature.
• abnormal heart rhythm.
• sudden unexplained death.
• pancreatitis that 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.
• prolonged and/or painful erection.

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.

Olanzapine 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. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Olanzapina Aurovitas

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

Do not use this medicine after the expiry date that appears on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Store 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 medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Olanzapina Aurovitas

• The active ingredient is olanzapine. Each orodispersible tablet contains 5 mg of olanzapine.
• The other ingredients are: mannitol (SD 200), mannitol (Mannitol 35), potassium polacrylate, crospovidone (type A), anhydrous colloidal silica, aspartame (E951), microcrystalline cellulose (grade 112), sodium stearyl fumarate, artificial pineapple flavor (FL SD # 883) (contains flavoring ingredients and modified cornstarch).

Appearance of the product and pack contents

Yellow, round, flat, beveled tablets with the mark "C" on one face and "51" on the other.

Olanzapina Aurovitas orodispersible tablets are available in blister packs.

Blister:polyamide/aluminum laminate coated with primer, PE coextruded/polyethylene with desiccant coating and PE coextruded as forming material, and aluminum with PE coating as sealing material.

Pack sizes:1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Date of last revision of this package leaflet: July 2021

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