Leaflet: Information for the User

Olanzapina Aurovitas 7.5 mg 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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 characterized by symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also experience depression, anxiety, or tension.

?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 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 occurs, 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 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. 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:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Seizures
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Transient cerebral ischemia or stroke symptoms
• If you think you may be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications (urine tablets)

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

Taking Olanzapina Aurovitas with other medications

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 Aurovitas 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.Olanzapina should not be taken while breastfeeding as small amounts may pass into breast milk.

Newborns of mothers who have used Olanzapina Aurovitas in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn experiences 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 lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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

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

You should take your olanzapina 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 tablets are for oral administration. Swallow the tablets whole with water.

If you take more Olanzapina Aurovitas than you should

Patients who have taken more olanzapina 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. Show the doctor the packaging with the tablets.

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 forget to take Olanzapina Aurovitas

Take your tablets as soon as you remember. Do not take a double dose to make up 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 olanzapina as long as your doctor tells you to.

If you stop taking olanzapina 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:

• 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, see your 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).

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(may affect more than 1 in 10 people) include: weight gain, drowsiness, and elevated prolactin levels in the blood.

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 sensation usually disappears on its own, but if it does not, inform your doctor.

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

• Changes in levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment.
• Elevated blood sugar and urine levels.
• Elevated levels of uric acid and creatine phosphokinase in the blood.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremor.
• Unusual movements (dyskinesia).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fluid retention causing swelling of the hands, ankles, or feet.
• Fever.
• Pain in the joints and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare(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 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.
• Stuttering.
• Slow pulse.
• Sensitivity to sunlight.
• Nasal bleeding.
• 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 breast gland in men and women such as abnormal milk production or abnormal growth.

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

• Decreased normal body temperature.
• Abnormal heart rhythm.
• Sudden death without apparent explanation.
• Pancreatitis causing severe stomach pain, fever, and discomfort.
• Liver disease with yellowing of the skin and white areas of the eye.
• Muscular disorder presenting 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, elevated 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.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the 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 tablet contains 7.5 mg of olanzapine.

- The other components are: lactose monohydrate, crospovidone (type B), hydroxypropylcellulose (low density), magnesium stearate.

Appearance of the product and content of the container

Yellow, uncoated, round tablets (7.5 mm in diameter), biconvex, with the mark “OA” on one face and “7.5” on the other.

Olanzapina Aurovitas tablets are available in PVC/Poliamide/Al/PVC/Al blister packs containing 7, 14, 28, 30, 35, 50, 56, 70, 96, 98, and 100 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

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: June 2020

The 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/ ).