Olanzapine bluefish

Package leaflet: Information for the user

Olanzapine Bluefish, 5 mg, orodispersible tablets
Olanzapine Bluefish, 10 mg, orodispersible tablets
Olanzapine Bluefish, 15 mg, orodispersible tablets
Olanzapinum
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Olanzapine Bluefish is and what it is 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 pack and other information

1. What Olanzapine Bluefish is and what it is 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 disorder characterized by hearing, seeing, or sensing things that do not exist in reality, having beliefs that contradict reality, excessive suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

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

2. Important information before using Olanzapine Bluefish

When not to use 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 rash, itching, facial swelling, swollen lips or difficulty breathing. If such symptoms occur, inform the doctor immediately.
• If the patient has previously been diagnosed with eye disorders related to a certain form of glaucoma (increased intraocular pressure).

Warnings and precautions
Before starting treatment with Olanzapine Bluefish, discuss it with your doctor or
pharmacist. Use of Olanzapine Bluefish is not recommended in elderly patients with dementia, as it may cause severe adverse reactions.

• Medicines of this class may cause abnormal movements, particularly of the face or tongue. If such symptoms occur after taking Olanzapine Bluefish, inform your doctor immediately.
• Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation. If any of these symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients treated with Olanzapine Bluefish. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients treated with Olanzapine Bluefish. Before starting and during treatment with Olanzapine Bluefish, your doctor should perform regular blood tests to monitor blood glucose and certain lipid levels.
• Inform your doctor if the patient has previously had blood clots, or if there is a family history of blood clots, as similar medicines have been associated with blood clot formation.
• If the patient has any of the following conditions, inform the doctor immediately:
• stroke or "mini" stroke (transient ischaemic attack),
• Parkinson's disease,
• prostate gland disorders,
• intestinal obstruction (paralytic ileus),
• liver or kidney disease,
• blood disorders,
• heart disease,
• diabetes,
• seizures,
• if the patient knows they may have lost body salts due to prolonged, severe diarrhoea and vomiting (nausea with vomiting) or use of diuretics (water tablets).

If the patient has dementia and has ever had a stroke or "mini" stroke, the patient or their caregiver should inform the doctor.
As a routine precaution in patients over 65 years of age, blood pressure should be monitored.

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

Olanzapine Bluefish and other medicines
The patient taking Olanzapine Bluefish should only use other medicines with the approval of a doctor.
Taking Olanzapine Bluefish together with antidepressants, sedatives or hypnotics may cause drowsiness (sedative effect).
Inform the doctor about all medicines currently or 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 anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Olanzapine Bluefish may be necessary.

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

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. This medicine should not be taken if the patient is breastfeeding, as small amounts of Olanzapine Bluefish may pass into breast milk.

Newborns whose mothers took Olanzapine Bluefish during the last trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms are observed in the newborn, contact the doctor immediately.

Driving and operating machinery
If the patient is taking Olanzapine Bluefish, there is a risk of drowsiness. If drowsiness occurs, the patient should not drive or operate any machinery or mechanical equipment. Inform the doctor about this.

Olanzapine Bluefish contains lactose and aspartame.
Olanzapine Bluefish contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Olanzapine Bluefish contains 1.25 mg, 2.5 mg, and 3.75 mg of aspartame in the 5 mg, 10 mg, and 15 mg orodispersible tablets, respectively. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

3. How to use Olanzapine Bluefish

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Your doctor will decide how many tablets to take and for how long. The daily dose of Olanzapine Bluefish ranges
from 5 mg to 20 mg. If symptoms reappear, you should inform your doctor. However, do not stop taking
Olanzapine Bluefish unless your doctor advises you to do so.
Olanzapine Bluefish tablets should be taken once daily, as directed by your doctor. Try to take the medicine
at the same time each day. It does not matter whether the tablets are taken with or without food.
Olanzapine Bluefish orally disintegrating tablets should be administered by mouth.
Olanzapine Bluefish tablets are fragile and should therefore be handled with care. Do not handle the tablets
with wet hands, as they may break apart.

1. Holding the blister strip by the edges, carefully separate the marked square containing the tablet from the rest of the strip. Gently tear along the perforation.
2. Carefully peel back the backing foil.
3. Gently push the tablet out of the blister pack.
4. Place the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easier to swallow.

The tablet may also be placed in a glass filled with water, orange juice, apple juice, milk, or coffee, and then stirred.
Some liquids may change colour or become cloudy after the tablet is added and stirred. The resulting mixture
should be drunk immediately.
Taking more Olanzapine Bluefish than prescribed
In patients who have taken an overdose of Olanzapine Bluefish, the following symptoms have been reported:
rapid heartbeat, agitation or aggressive behaviour, difficulty speaking, unusual movements (especially of the
facial muscles and tongue), and reduced level of consciousness. Other symptoms include acute confusion
(disorientation), seizures (epilepsy), coma, concurrent occurrence of fever, faster breathing, sweating, muscle
rigidity, drowsiness or excessive sleepiness, reduced breathing rate, choking, high or low blood pressure,
and irregular heart rhythm. If any of these symptoms occur, seek immediate medical attention or go to
a hospital. Show the doctor the medicine packaging.
If you forget to take Olanzapine Bluefish
Take the missed dose as soon as you remember. Do not take a double dose on the same day to make up
for a missed dose.
Stopping Olanzapine Bluefish
Do not stop taking the tablets, even if you feel better. It is important to continue taking Olanzapine Bluefish
for as long as your doctor has instructed.
If you suddenly stop taking Olanzapine Bluefish, symptoms such as sweating, insomnia, tremor, anxiety,
nausea, or vomiting may occur. Your doctor may recommend gradually reducing the dose before stopping
treatment completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
You should inform your doctor immediately if any of the following occur:

• unusual movements, especially of the face or tongue (a commonly reported adverse reaction, which may affect up to 1 in 10 people);
• blood clots in the veins (an uncommonly reported adverse reaction, which may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain, redness of the leg). Blood clots may travel through blood vessels to the lungs, causing chest pain and difficulty in breathing. If any of these symptoms occur, medical advice should be sought immediately;
• occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy at the same time (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (may affect more than 1 in 10 people) include:

• weight gain,
• drowsiness,
• increased blood prolactin levels,
• dizziness or fainting (with slowing of the heartbeat), especially when rising from a lying or sitting position, particularly at the beginning of treatment. These symptoms usually resolve spontaneously, but if they persist, inform your doctor.

Common adverse reactions (may affect up to 1 in 10 people) include:

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

Uncommon adverse reactions (may affect up to 1 in 100 people) include:

• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash),
• diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in 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,
• photosensitivity,
• nosebleeds,
• abdominal distension,
• salivation,
• memory loss or forgetfulness,
• urinary incontinence,
• inability to pass urine,
• 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 adverse reactions (may affect up to 1 in 1000 people) include:

• decreased body temperature,
• irregular heart rhythm,
• sudden, unexplained death,
• pancreatitis causing severe abdominal pain, fever and nausea,
• liver disease manifesting as yellowing of the skin and whites of the eyes,
• muscle disease manifesting as unexpected muscle pain,
• prolonged and/or painful erection.

Very rare adverse reactions include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms resemble influenza with facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and increased levels of a specific type of white blood cells (eosinophilia).

During treatment with olanzapine in elderly patients with dementia, the following may occur: stroke, pneumonia, urinary incontin

5. How to store 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 cardboard packaging after
"Expiry date". The expiry date refers to the last day of that month.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the packaging and other information

What Olanzapine Bluefish contains

• The active substance is olanzapine.
• Each orodispersible tablet contains 5 mg, 10 mg or 15 mg of olanzapine.
• Other ingredients are: calcium carbonate DC CS90 (containing: pregelatinized corn starch, corn starch, calcium carbonate), monohydrate lactose, 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, imprinted with the number "5" on one side.
10 mg: yellow to light yellow, round, biconvex tablets with a diameter of 9.1 mm, imprinted with the number "10" on one side.
15 mg: yellow to light yellow, round, biconvex tablets with a diameter of 10.4 mm, imprinted with the number "15" on one side.
Olanzapine Bluefish is available in aluminum/aluminum/paper foil blisters packed in cardboard cartons.
Pack sizes:
5 mg: 14 or 28 orodispersible tablets
10 mg: 14, 28 or 56 orodispersible tablets
15 mg: 14 or 28 orodispersible tablets

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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 authorised in the European Economic Area member states under the following names: