Olanzapine Aurovitas 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Aurovitas 5 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 sensing things that are not real, false beliefs, unusual suspicion, and social withdrawal. People with this disorder may also feel 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 to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor immediately.

• 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.

• 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 while taking olanzapine, inform your doctor.
• Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If you experience these symptoms, 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 lipid 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.

Tell your doctor as soon as possible if you have any of the following conditions:

• 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 lost body salts due to prolonged 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

Olanzapine must not be given to patients under 18 years of age.

Other medicines and Olanzapina Aurovitas

Only take other medicines together with olanzapine if authorized by your doctor. You may feel drowsiness if olanzapine is combined with antidepressants or medicines used for anxiety or to help sleep (tranquilizers).

Inform 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 should not drink alcohol while taking olanzapine, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant, 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 the following symptoms: 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

Olanzapine may cause drowsiness. If this occurs, do not drive or operate machinery. Discuss this with 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, 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; therefore, 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 from 5 mg to 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 each day. You may take them with or without food. Olanzapine orodispersible tablets are for oral use.

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 can 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 become 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 medicine packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 to continue taking olanzapine for as long as your doctor instructs.

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

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 that may affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (an uncommon adverse effect that 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 help immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from the available data).

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, skin rash on the face that then spreads 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 lying or sitting positions. 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., swelling of the mouth and throat, itching, skin rash).
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma.
• Seizures, which in most cases 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 discomfort.
• 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 via 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 the 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 refers to 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 medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 5 mg of olanzapine.
• The other components are: mannitol (SD 200), mannitol (Manitol 35), polacriline potassium, crospovidone (type A), colloidal anhydrous 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, bevelled tablets, marked with “C” on one side and “51” on the other.

Olanzapine Aurovitas orodispersible tablets are available in blister packs.

Blister: Polyamide/Aluminum film coated with primer, coextruded PE/polyethylene with desiccant coating and coextruded PE as forming material, and aluminum foil with PE coating as sealing material.

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

Only certain pack sizes may be marketed.

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 latest review of this leaflet: July 2021

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