Leaflet: information for the user

Olanzapina Aurovitas 15 mg buccodispersible tablets EFG

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Olanzapina Aurovitas

3.How to take Olanzapina Aurovitas

4.Possible side effects

5.Storage of Olanzapina Aurovitas

6.Contents of the pack and additional information

Olanzapina Aurovitas belongs to a group of medications called antipsychotics and is indicated for the treatment of the following diseases:

?Schizophrenia, a disease whose symptoms include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

Olanzapina 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 Aurovitas

• 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 precautions

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

• Olanzapina 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, 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, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapina. 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.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapina. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting olanzapina and regularly during treatment.
• 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, tell your doctor as soon as possible:

• Stroke or transient cerebral ischemia (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 be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications (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 cerebral ischemia.

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.

Other medications and Olanzapina Aurovitas

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

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

Specifically, tell your doctor if you are taking:

• Medications for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). You may need to adjust your olanzapina dose.

Taking Olanzapina Aurovitas with alcohol

You should not drink alcohol if you have been administered olanzapina as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

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

Olanzapina Aurovitas contains aspartame

This medication contains 1.5 mg of aspartame in each 15 mg buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to properly eliminate it.

Olanzapina Aurovitas contains sodium

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

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

Your doctor will tell you how many olanzapine tablets to 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. Olanzapine buccal 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 because they may disintegrate.

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. It should be consumed immediately.

If you take more Olanzapina Aurovitas than you should

Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeats, 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 packaging with the tablets to the doctor.

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

If you forgot to take Olanzapina Aurovitas

Take your tablets as soon as you remember. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Olanzapina Aurovitas

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

If you stop taking olanzapine suddenly, you may experience symptoms such as sweating, inability to sleep, 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.

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

Immediately contact your doctor if you have:

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 then 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).

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

During the initial 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 disappears on its own, but if it doesn't, inform your doctor.

Common(can affect up to 1 in 10 people) include:

Rare(can affect up to 1 in 100 people) include:

Very rare(can affect up to 1 in 1,000 people) include:

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 may worsen symptoms in patients with Parkinson's disease.

Reporting of 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 the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Olanzapina Aurovitas

-The active ingredient is olanzapine. Each buccal dispersible tablet contains 15 mg of olanzapine.

-The other components are: mannitol (SD 200), mannitol (Mannitol 35), potassium polacrilex, crospovidone (type A), anhydrous colloidal silica, aspartame (E951), microcrystalline cellulose (grade 112), sodium fumarate estearate, artificial pineapple flavor (FL SD # 883) (contains flavoring ingredients and modified cornstarch).

Appearance of the product and contents of the packaging

Yellow-colored, round, flat, beveled tablets with the mark “C” on one face and “53” on the other.

OlanzapinaAurovitas buccal dispersible tabletsare available in blister packaging.

Blister:Polyamide/Aluminum coated with Primer, PE coextruded/polietheylene with desiccant coating and PE coextruded as forming material, and Aluminum coated with PE as sealing material.

Packaging sizes:1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 buccal dispersible tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible 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 with the following names:

Last review date of this leaflet: July 2021

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