Olanzapine Bluefish 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Olanzapina Bluefish 10 mg orodispersible tablets EFG

olanzapine

Read the entire leaflet carefully before you start taking this medicine, because 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, pharmacist or nurse.
• 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 may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side 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 side effects
5. How to store Olanzapina Bluefish
6. Contents of the pack 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 disorder may also experience depression, tension, or anxiety.
• Moderate to severe manic episodes, a condition 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 manifest as 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 of the face or tongue. If this happens after taking Olanzapina Bluefish, tell your doctor.
• Very rarely, medicines of this type can 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 blood sugar and fats (triglycerides and cholesterol) 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 treatment 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)
• 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 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 increased drowsiness if Olanzapina Bluefish is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).

Inform 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, tell your doctor if you are taking:

• Medicines to treat 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

You must 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 are planning to become pregnant, consult your doctor before using this medicine. You must 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 whose mothers 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, you should contact your doctor.

Driving and using machines

There is a risk of drowsiness while taking Olanzapina Bluefish. If this occurs, 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 your doctor before taking this medicine.

Olanzapina Bluefish 10 mg contains 2.5 mg of aspartame.

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 properly eliminate it.

3. How to take Olanzapina Bluefish

Follow exactly the administration instructions for Olanzapina Bluefish given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapina Bluefish tablets you should 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 do so.

Olanzapina Bluefish tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time each day. They may be taken with or without food. Olanzapina Bluefish orodispersible tablets are for oral use.

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

1. Hold the blister pack at one end and separate one dose using the perforations
2. Carefully peel back the backing from the blister
3. Gently push the tablet through the foil
4. Place the tablet in your mouth. It dissolves directly in the mouth, allowing it to be easily swallowed

Alternatively, the tablet may be placed into a cup or glass containing water, orange juice, apple juice, milk, or coffee and stirred. With some beverages, the mixture may change color and appear cloudy. The mixture should be drunk 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 telephone number: 91 562 04 20, indicating the medicine 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 or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of these symptoms. Show the doctor the packaging and 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 to continue taking Olanzapina Bluefish for as long as your doctor instructs.

If you stop taking Olanzapina Bluefish 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, Olanzapina Bluefish may produce adverse effects, although not everyone experiences them.

Contact your doctor immediately if you have:

• Unusual movements (a common side effect which may affect 1 in 10 people), mainly of the face or tongue.
• Blood clots in the veins (an uncommon side 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 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, 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 heartbeat), especially when getting up 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, include:

• Changes in levels of certain blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes.
• Increased levels of sugar in blood and urine.
• Increased levels of uric acid and creatine phosphokinase in blood.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremor.
• Strange 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, 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 rigidity or spasms (including abnormal 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 mammary 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 (jaundice).
• 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, facial skin rash spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of 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.

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

Reporting of adverse effects:

If you experience any adverse effect, consult 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: 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 the 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 it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Olanzapina Bluefish

• The active substance is olanzapine.

Each orodispersible tablet of Olanzapina 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 Olanzapina Bluefish and pack sizes

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

Olanzapina 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

Local Representative:

Bluefish Pharma S.L.U.,
P.O. Box 36007
2832094 Madrid, Branch 36

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: 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/