OLANZAPINE AUROVITAS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapina Aurovitas 10 mg tablets EFG

Read the entire package leaflet carefully before you start taking 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 signs of illness 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 Olanzapina Aurovitas is and what it is used for
2. What you need to know before you take Olanzapina Aurovitas
3. How to take Olanzapina Aurovitas
4. Possible side effects
5. Storage of Olanzapina Aurovitas
6. Contents of the pack and other information

1. What Olanzapina Aurovitas is and what it is 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a disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion and becoming withdrawn.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 you take 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

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

• The use of olanzapine is not recommended 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 fat (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:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Seizures
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or transient cerebral ischemia (transient stroke symptoms)
• If you think you may have salt loss due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medicines (diuretic pills)

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 of age should not take olanzapine.

Taking Olanzapina Aurovitas with other medicines

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 sleep aids (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 Olanzapina Aurovitas 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 when you are breastfeeding, as small amounts of olanzapine may pass into breast milk.

Newborns of mothers who have used Olanzapina Aurovitas 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 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 Aurovitas

Follow the instructions for administration of this medicine 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 tablets are for oral administration. You should swallow the tablets whole with water.

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/aggressiveness, 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, phone 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 (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 (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 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 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 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 disappears on its own, but if it does not, 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 blood sugar and urine levels.
• 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 dysfunctions 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 milk production 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 muscle 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, increased 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 effect, 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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapina Aurovitas

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 and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of containers and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapina Aurovitas

• The active substance is olanzapine. Each tablet contains 10 mg of olanzapine.
• The other ingredients are: lactose monohydrate, crospovidone (type B), hydroxypropylcellulose (low density), magnesium stearate.

Appearance of the product and contents of the pack

Yellow, round (8.0 mm diameter), biconvex, uncoated tablets with "OA" on one face and "10" on the other.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Date of last revision of this package leaflet: June 2020

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/).