Olanzapine Aurovitas 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Aurovitas 15 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Olanzapina Aurovitas is and what it is used for
2. What you need to know before taking Olanzapina Aurovitas
3. How to take Olanzapina Aurovitas
4. Possible side effects
5. How to store 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 conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also experience depression, anxiety, or tension.

• 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 to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may present 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

Talk to 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 cause serious adverse effects.
• Medicines of this type may cause unusual movements, especially of the face or tongue. If this occurs after taking olanzapine, inform your doctor.
• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a dietitian.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking olanzapine and 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 blood clot formation.

If you have any of the following conditions, tell your doctor as soon as possible:

• Stroke or transient ischemic attack (temporary stroke-like symptoms)
• 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 body salts due to prolonged and severe diarrhea or vomiting, or due to taking diuretic medicines (water 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 ischemic attack.

As a routine precaution, if you are over 65 years of age, your doctor should monitor your blood pressure.

Children and adolescents

Patients under 18 years of age must not take olanzapine.

Other medicines and Olanzapina Aurovitas

Only take other medicines together with olanzapine if authorized by your doctor. You may feel drowsy if olanzapine is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

Specifically, 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 olanzapine dose may need to be adjusted.

Taking Olanzapina Aurovitas with alcohol

You must not drink alcohol while taking olanzapine, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 taken olanzapine during the third trimester of pregnancy may experience symptoms such as tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness while taking olanzapine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Aurovitas contains aspartame

This medicine contains 1.5 mg of aspartame in each 15 mg orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Olanzapina Aurovitas contains sodium

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

3. How to take Olanzapine Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking olanzapine unless your doctor tells you to.

You should take your olanzapine tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. They may be taken with or without food. Olanzapine orodispersible tablets are for oral administration.

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

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

If you take more Olanzapine Aurovitas than you should

Patients who have taken more olanzapine than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital. Show the doctor the pack with the tablets.

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

If you forget to take Olanzapine 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 Olanzapine Aurovitas

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

If you stop taking olanzapine suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Contact your doctor immediately if you have:

• Unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, pain and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (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 presents with flu-like symptoms, skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (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 standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, inform your doctor.

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

• Changes in levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the beginning of treatment.
• Increased blood and urine sugar levels.
• Increased 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 tiredness.
• Fluid retention causing 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. mouth and throat swelling, itching, skin rash).
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma.
• Seizures; in most cases, these are 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 reduction of menstrual periods.
• Changes in the breast 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.
• Inflammation of the pancreas causing severe stomach pain, fever, and malaise.
• Liver disease with yellowing of the skin and whites of the eyes (jaundice).
• Muscle disorder presenting as unexplained muscle pains.
• 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 difficulty walking. Some deaths have been reported in this particular group of patients.

Olanzapine may worsen symptoms in patients with Parkinson's disease.

Reporting of adverse effects

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

5. Storage of Olanzapine Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated 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 from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Aurovitas

• The active substance is olanzapine. Each orodispersible tablet contains 15 mg of olanzapine.
• The other components are: mannitol (SD 200), mannitol (Manitol 35), potassium polacrilin, crospovidone (type A), anhydrous colloidal silica, aspartame (E951), microcrystalline cellulose (grade 112), sodium stearyl fumarate, artificial pineapple flavour (FL SD # 883) (contains flavouring ingredients and modified maize starch).

Appearance of the product and contents of the pack

Yellow, round, flat, bevel-edged tablets, marked with "C" on one side and "53" on the other.

Olanzapine Aurovitas orodispersible tablets are available in blister packs.

Blister: a laminate of primer-coated polyamide/aluminum, with co-extruded PE/polyethylene with desiccant coating and co-extruded PE as forming material, and polyethylene-coated aluminum foil as sealing material.

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and 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

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Date of the most recent review of this leaflet: July 2021

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