OLANZAPINE BLUEFISH 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapina Bluefish 5 mg orodispersible tablets EFG

olanzapine

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Olanzapina Bluefish and what is it used for
2. What you need to know before taking Olanzapina Bluefish
3. How to take Olanzapina Bluefish
4. Possible side effects
5. Storage of Olanzapina Bluefish

Contents of the pack and further information

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

Olanzapina Bluefish contains the active substance olanzapine. Olanzapina Bluefish belongs to the therapeutic group of antipsychotics and is used to treat the following conditions:

• 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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, tense, or anxious.
• Moderate to severe manic episodes, a disease with symptoms of excitement or euphoria.

It has been shown that Olanzapina Bluefish prevents the recurrence of symptoms in patients with bipolar disorder whose manic episode has responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina Bluefish

Do not take Olanzapina Bluefish

• If you are allergic (hypersensitive) to olanzapine or any of the other components 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 pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Bluefish. The use of Olanzapina Bluefish 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 Olanzapina Bluefish, tell your doctor.
• In very rare cases, 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 Olanzapina Bluefish. You and your doctor should check your weight regularly.
• High levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking Olanzapina Bluefish. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Olanzapina Bluefish and regularly during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, 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:

• Stroke or lack of blood flow to the brain (transient symptoms of stroke)
• 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 salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets).

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

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 Olanzapina Bluefish.

Use of Olanzapina Bluefish with other medicines

Only use other medicines at the same time as Olanzapina Bluefish if your doctor authorizes it.

You may feel drowsy if you combine Olanzapina Bluefish with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using or have recently used or may need to use other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are using:

• medication to treat Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic)

It may be necessary to change the dose of Olanzapina Bluefish.

Taking Olanzapina Bluefish with alcohol

Do not drink alcohol while taking Olanzapina Bluefish, as the combination of the two may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapina Bluefish may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapina Bluefish in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding.

If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapina Bluefish. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapina Bluefish contains lactose and aspartame

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.

Olanzapina Bluefish 5 mg contains 1.25 mg of aspartame.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Olanzapina Bluefish

Follow your doctor's or pharmacist's instructions for taking Olanzapina Bluefish exactly. If in doubt, consult your doctor or pharmacist again.

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

Olanzapina Bluefish tablets should be taken 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 Bluefish orodispersible tablets are for oral administration.

Olanzapina Bluefish tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may crumble.

1. Take the blister pack by one end and separate a dose with the help of the perforations.
2. Carefully separate the blister pack from the back.
3. Gently push the tablet out.
4. Place the tablet in your mouth. It dissolves directly in the mouth, so you can swallow it easily.

You can also put the tablet in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, stirring. With some beverages, the mixture may change color and appear cloudy. It should be drunk immediately.

If you take more Olanzapina Bluefish than you should

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.

Patients who have taken more Olanzapina Bluefish than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, 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, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you have any of these symptoms. Show the doctor the package with the tablets.

If you forget to take Olanzapina Bluefish

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapina Bluefish

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapina Bluefish while your doctor tells you to.

If you stop taking Olanzapina Bluefish 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, Olanzapina Bluefish can cause side effects, although not everyone gets them.

Contact your doctor immediately if you have:

• Unusual movements (a common side effect that can affect 1 in 10 people), mainly of the face or tongue.
• Blood clots in the veins (an uncommon 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 vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, go to the doctor immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy (the frequency of this side effect cannot be estimated from the available data).

Very common side effects: that can affect more than 1 in 10 patients 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 a slow heart rate), especially when getting up from a lying or sitting position. This usually goes away on its own, but if it doesn't, tell your doctor.

Common side effects: that can affect up to 1 in 10 patients include:

• Changes in the levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes.
• Increased levels of sugar in the blood and urine.
• 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 dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: that can affect up to 1 in 100 patients include:

• Hypersensitivity (e.g., swelling in the mouth and throat, itching, skin rash).
• Diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones 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 side effects: (can affect up to 1 in 1000 people) include:

• Decrease in body temperature.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Pancreatitis, which 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 pain.
• Prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapina Bluefish may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapina Bluefish

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

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Olanzapina Bluefish

• The active substance is olanzapine.

Each Olanzapina Bluefish orodispersible tablet contains 5 mg of active substance.

• The other components are:

Calcium carbonate, pregelatinized corn starch, corn starch, lactose monohydrate, crospovidone, aspartame (E951), and magnesium stearate.

Appearance of Olanzapina Bluefish and pack size

Yellow to yellowish round biconvex tablets with a diameter of 6.4 mm and a "5" embossed on one side.

Olanzapina Bluefish is available in Alu/Alu blisters.

Pack size:

14 or 28 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

Genepharm S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

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

Date of last revision of this package leaflet:September 2020

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/