Olanzapine Bluefish 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olanzapina Bluefish 5 mg orodispersible tablets EFG

olanzapine

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

Pack contents and other information

1. What Olanzapina Bluefish is and what it is 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 disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, tense, or anxious.
• Moderate to severe manic episodes, a disorder characterized by symptoms of excitement or euphoria.

Olanzapina Bluefish has been shown to prevent 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 to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear 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 Bluefish. The use of Olanzapina Bluefish is not recommended in elderly patients with dementia, as it may cause serious adverse effects.

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Bluefish, tell 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 Olanzapina Bluefish. You and your doctor should monitor your weight regularly.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Bluefish. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Olanzapina Bluefish and regularly during treatment.
• Talk to your doctor if you or someone in your family has a history of blood clots, as medicines of this type have been associated with blood clot formation.

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

• Stroke or reduced blood flow to the brain (transient ischemic attack 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 salts due to prolonged severe diarrhea or vomiting, or due to the use of 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 reduced blood flow to the brain.

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

Children and adolescents

Patients under 18 years of age must not take Olanzapina Bluefish.

Taking 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 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, including those obtained without a prescription.

Specifically, inform your doctor if you are taking:

• Medication for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic).

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

Taking Olanzapina Bluefish with alcohol

Do not drink alcohol while taking Olanzapina Bluefish, as combining this medicine with alcohol 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 during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.

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

Driving and using machines

There is a risk of drowsiness when taking Olanzapina Bluefish. If this happens, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Bluefish contains lactose and aspartame

This medicine contains lactose. If your doctor has informed 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 people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Olanzapina Bluefish

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

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

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

1. Hold the blister pack at one end and separate one dose using the perforations
2. Carefully peel the backing from the blister
3. Gently push the tablet out
4. Place the tablet in your mouth. It dissolves directly in the mouth, making it easy to swallow

Alternatively, the tablet can 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 consumed immediately.

If you take more Olanzapina Bluefish than you should

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

Patients who have taken more Olanzapina Bluefish than recommended have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of these symptoms. Show the doctor the packaging and remaining 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 missed 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 for as long as your doctor advises.

If you stop taking Olanzapina Bluefish suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, and vomiting may occur. Your doctor may recommend that you 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, Olanzapine Bluefish may cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• Unusual movements (a common side effect that may affect up to 1 in 10 people), mainly of the face or tongue.
• Blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness, or lethargy (the frequency of this side effect cannot be estimated from available data).

Very common adverse effects: may affect more than 1 in 10 patients and 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 rising from a lying or sitting position. This usually resolves on its own, but if it does not, inform your doctor.

Common adverse effects: may affect up to 1 in 10 patients and include:

• Changes in levels of certain blood cells, circulating lipids, and, at the beginning of treatment, temporary increases in liver enzymes.
• 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 adverse effects: may affect up to 1 in 100 patients and include:

• Hypersensitivity (e.g., swelling of 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 reduction of menstrual periods.
• Changes in the breast gland in men and women, such as abnormal production of breast milk or abnormal growth.

Rare adverse effects: (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.
• Muscle disorder presenting as unexplained muscle pains.
• Prolonged and/or painful erection.

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, a facial skin rash that spreads to other areas, fever, swollen 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, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

Olanzapine Bluefish 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Bluefish

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Bluefish

• The active substance is olanzapine.

Each orodispersible tablet of Olanzapine Bluefish 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 Olanzapine Bluefish and pack sizes

Yellow to pale yellow, biconvex, round tablets with a diameter of 6.4 mm, embossed with a "5" on one side.

Olanzapine Bluefish is available in Alu/Alu blisters.

Pack sizes:

14 or 28 orodispersible tablets.

Only certain 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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,
P.O. Box 36007
28320 Madrid, Branch Office 36
Spain

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: September 2020

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