Olanzapine Bluefish

Leaflet attached to the packaging: information for the user

Olanzapine Bluefish, 5 mg, orally disintegrating tablets

Olanzapine Bluefish, 10 mg, orally disintegrating tablets

Olanzapine Bluefish, 15 mg, orally disintegrating tablets

Olanzapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Olanzapine Bluefish and what is it used for
• 2. Important information before taking Olanzapine Bluefish
• 3. How to take Olanzapine Bluefish
• 4. Possible side effects
• 5. How to store Olanzapine Bluefish
• 6. Contents of the packaging and other information

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

Olanzapine Bluefish contains the active substance olanzapine. Olanzapine Bluefish belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disease characterized by the patient hearing, seeing, or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious, and withdrawing from contact with others. People with this disease may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes - conditions characterized by symptoms of excitement or euphoria.

It has been shown that Olanzapine Bluefish prevents the recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Olanzapine Bluefish

When not to take Olanzapine Bluefish

• If the patient is allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or difficulty breathing. If such symptoms occur, the doctor should be informed.
• If the patient has previously been diagnosed with eye disorders related to a certain form of glaucoma (increased pressure in the eyeball).

Warnings and precautions

Before starting treatment with Olanzapine Bluefish, the patient should discuss it with their doctor or pharmacist. It is not recommended to take Olanzapine Bluefish in elderly patients with dementia, as it may cause severe side effects.

• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olanzapine Bluefish, the doctor should be informed.
• Very rarely, medicines of this type cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• In patients taking Olanzapine Bluefish, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consideration should be given to consulting a dietitian or seeking help in establishing a diet.
• In patients taking Olanzapine Bluefish, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Olanzapine Bluefish and during its use, the doctor should regularly perform blood tests to determine blood sugar levels and certain lipid levels.
• The doctor should be informed if the patient or their family has a history of blood clots, as similar medicines have been associated with the formation of blood clots.
• If the patient experiences any of the following conditions, they should immediately inform their doctor:
• stroke or "mini" stroke (transient symptoms of a stroke),
• Parkinson's disease,
• prostate disorders,
• intestinal obstruction (paralytic ileus),
• liver or kidney disease,
• blood diseases,
• heart disease,
• diabetes,
• seizures,
• if the patient knows that they may have experienced salt loss due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (diuretic drugs).

If the patient has dementia and has ever had a stroke or "mini" stroke, they or their caregiver should tell their doctor.
A routine precaution in people over 65 years of age is to measure blood pressure.

Children and adolescents

Olanzapine Bluefish is not intended for use in patients under 18 years of age.

Olanzapine Bluefish and other medicines

A patient taking Olanzapine Bluefish may only take other medicines with the doctor's consent.
Taking Olanzapine Bluefish with antidepressant, sedative, or sleeping medicines may cause drowsiness (tranquilizing medicines).
The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about the use of:

• medicines for 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 Olanzapine Bluefish.

Olanzapine Bluefish with alcohol

If the patient is taking Olanzapine Bluefish, they should not drink alcohol in any form, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. The patient should not take this medicine if they are breastfeeding, as small amounts of Olanzapine Bluefish may pass into breast milk.
In newborns whose mothers took Olanzapine Bluefish in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing difficulties, and feeding difficulties. If such symptoms are observed in their own child, the doctor should be contacted.

Driving and operating machines

If the patient is taking Olanzapine Bluefish, there is a risk of drowsiness. If drowsiness occurs, the patient should not drive vehicles or operate any machines and mechanical devices.
The doctor should be informed about this.

Olanzapine Bluefish contains lactose and aspartame.

Olanzapine Bluefish contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
Olanzapine Bluefish contains 1.25 mg, 2.5 mg, and 3.75 mg of aspartame in 5 mg, 10 mg, and 15 mg orally disintegrating tablets, respectively. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disease in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Olanzapine Bluefish

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide how many tablets and how long to take Olanzapine Bluefish. The daily dose of Olanzapine Bluefish is from 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Olanzapine Bluefish unless the doctor decides to do so.
Olanzapine Bluefish tablets should be taken once a day, as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food. Olanzapine Bluefish orally disintegrating tablets should be taken orally.
Olanzapine Bluefish tablets are easily broken, so they should be handled carefully. The patient should not take the tablets with wet hands, as they may disintegrate.

• 1. Holding the blister strip by the edges, the patient should separate the marked square from the rest of the strip. It should be torn off gently along the perforation.
• 2. The patient should carefully peel off the back foil.
• 3. The patient should gently push the tablet out of the blister.
• 4. The patient should place the tablet in their mouth. The tablet will dissolve directly in the mouth, making it easier to swallow.

The tablet can also be dropped into a glass of water, orange juice, apple juice, milk, or coffee, and then stirred. Some drinks may change color or become cloudy after the tablet is dropped in and stirred. The resulting liquid should be taken immediately.

Taking a higher dose of Olanzapine Bluefish than recommended

In patients who have taken a higher dose of Olanzapine Bluefish than recommended, the following symptoms have occurred: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, abnormal movements (especially of the face and tongue), and decreased consciousness.
Other symptoms include: severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, and heart rhythm disorders. The doctor should be contacted immediately if any of these symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Olanzapine Bluefish

The patient should take the tablets as soon as they remember. The patient should not take a double dose in one day to make up for a missed dose.

Stopping treatment with Olanzapine Bluefish

The patient should not stop taking the tablets, even if they feel better. It is important to take Olanzapine Bluefish for as long as the doctor has prescribed.
If the patient suddenly stops taking Olanzapine Bluefish, they may experience symptoms such as sweating, insomnia, trembling, anxiety, or nausea and vomiting. The doctor may recommend a more gradual reduction in dose before stopping treatment.
If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapine Bluefish can cause side effects, although not everybody gets them.
The doctor should be told immediately if the patient experiences:

• abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 people);
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, redness of the leg). Blood clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, the doctor should be consulted immediately;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include:

• weight gain,
• drowsiness,
• increased prolactin levels in the blood,
• in the early stages of treatment, dizziness or fainting (with a slow heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, the doctor should be informed.

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

• changes in the number of certain blood cells, blood lipid levels, and transient increases in liver enzyme activity at the beginning of treatment,
• increased blood sugar levels and urea,
• increased uric acid and creatine phosphokinase levels in the blood,
• increased appetite,
• dizziness,
• restlessness,
• trembling,
• movement disorders (dyskinesias),
• constipation,
• dry mouth,
• rash,
• loss of strength,
• extreme fatigue,
• water retention in the body, causing swelling of the hands, ankles, or feet,
• fever, joint pain, sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (may affect up to 1 in 100 people) include:

• hypersensitivity (e.g., swelling in the mouth and throat, itching, rash),
• diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma,
• seizures, usually in patients who have previously had seizures (epilepsy),
• muscle stiffness or spasms (including eye movements),
• restless legs syndrome,
• difficulty speaking,
• stuttering,
• slow heart rate,
• hypersensitivity to sunlight,
• nasal bleeding,
• abdominal bloating,
• salivation,
• memory loss or forgetfulness,
• urinary incontinence,
• inability to urinate,
• hair loss,
• absence or shortening of the menstrual cycle,
• breast disorders in men and women, such as abnormal milk production or abnormal breast enlargement.

Rare side effects (may affect up to 1 in 1000 people) include:

• decreased body temperature,
• abnormal heart rhythm,
• sudden, unexplained death,
• pancreatitis causing severe abdominal pain, fever, and nausea,
• liver disease characterized by a change in skin and white eye color to yellow,
• muscle disease characterized by unexpected muscle pain,
• prolonged and (or) painful erection.

Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high fever, enlarged lymph nodes, elevated liver enzyme activity, and increased eosinophil counts.
In the treatment of olanzapine in elderly patients with dementia, the following have been reported: stroke, pneumonia, urinary incontinence, falls, significant fatigue, visual hallucinations, elevated body temperature, redness of the skin, and walking disturbances. Several fatal cases have also been reported in this particular patient group.
In patients with Parkinson's disease, Olanzapine Bluefish may worsen the symptoms of the disease.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olanzapine Bluefish

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month.
The medicine should be stored in its original packaging to protect it from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Olanzapine Bluefish contains

• The active substance is olanzapine.
• Each orally disintegrating tablet contains 5 mg, 10 mg, or 15 mg of olanzapine.
• Other ingredients of the medicine are: calcium carbonate DC CS90 (consisting of cornstarch, maize starch, calcium carbonate), lactose monohydrate, crospovidone, aspartame (E 951), and magnesium stearate.

What Olanzapine Bluefish looks like and contents of the pack

5 mg: yellow to light yellow, round, biconvex tablets with a diameter of 6.4 mm, with the number "5" embossed on one side.
10 mg: yellow to light yellow, round, biconvex tablets with a diameter of 9.1 mm, with the number "10" embossed on one side.
15 mg: yellow to light yellow, round, biconvex tablets with a diameter of 10.4 mm, with the number "15" embossed on one side.
Olanzapine Bluefish is available in aluminum/aluminum/paper blisters in a cardboard box.
Pack sizes:
5 mg: 14 or 28 orally disintegrating tablets
10 mg: 14, 28, or 56 orally disintegrating tablets
15 mg: 14 or 28 orally disintegrating tablets

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., 18th km Marathonos Avenue, 15351 Pallini Attikis, Greece

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

Date of last revision of the leaflet:21.08.2020