Olanzapina Viatris

Leaflet attached to the packaging: information for the user

Olanzapina Viatris, 5 mg, orally disintegrating tablets

Olanzapina Viatris, 10 mg, orally disintegrating tablets

Olanzapina Viatris, 15 mg, orally disintegrating tablets

Olanzapina Viatris, 20 mg, orally disintegrating tablets

Olanzapinum

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

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

Olanzapina Viatris contains the active substance olanzapine, which belongs to a group of medicines called antipsychotics.
Olanzapina Viatris is used to treat schizophrenia, a disease characterized by the patient hearing, seeing, or feeling things that do not exist in reality, having beliefs that are inconsistent with reality, being overly suspicious, and withdrawing from contact with others.
The patient may experience depression, anxiety, or tension.
Olanzapina Viatris is used to treat moderate to severe manic episodes, a condition in which patients have extremely good mood, are full of energy, need much less sleep than usual, talk very quickly, and have a racing mind. This condition is sometimes characterized by extreme irritability. This medicine is also a mood stabilizer, preventing the recurrence of extreme mood swings - elevated and lowered mood (depression) - associated with this disease.

2. Important information before taking Olanzapina Viatris

When not to take Olanzapina Viatris:

• if the patient is allergic 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, lips, mouth, or throat, which can cause difficulty swallowing or breathing. If such symptoms occur, the doctor should be informed;
• if the patient has eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting to take Olanzapina Viatris, the patient should discuss it with their doctor or pharmacist:

• if the patient or their family has a history of blood clots, as the use of medicines in this group has been associated with the formation of blood clots
• if the patient is elderly with a diagnosis of dementia, as this may cause severe side effects
• if the patient has diabetes
• if the patient has heart disease
• if the patient has been informed that they have electrolyte imbalance in the blood (especially low potassium or magnesium levels)
• if the patient was born with a prolonged QT interval (visible in the ECG recording of heart activity)
• if the patient has liver or kidney disease
• if the patient has Parkinson's disease
• if the patient has a history of seizures (epilepsy)
• if the patient has an enlarged prostate
• if the patient has intestinal obstruction (paralysis of the intestine)
• if the patient has a blood disease with a low number of white blood cells (which may be caused by certain medicines, radiation therapy, chemotherapy, or bone marrow diseases)
• if the patient has been informed that they have an increased number of white blood cells or a bone marrow disease characterized by excessive production of blood cells, called myeloproliferative disease
• if the patient has had a stroke or a "mini" stroke (transient stroke symptoms)
• if the patient smokes (as a dose change of olanzapine may be necessary).

During treatment

If the patient experiences the following symptoms together: very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness, they should consult their doctor, as the doctor may decide to discontinue Olanzapina Viatris.
If the patient experiences uncontrolled movements of the face or tongue, they should consult their doctor, as the doctor may decide to reduce the dose or discontinue Olanzapina Viatris.
Weight gain has been observed in patients taking olanzapine. The patient's weight should be checked regularly. A visit to a dietitian or help with meal planning should be considered if necessary.
Increased blood sugar and fat levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. The doctor may recommend blood tests to check blood sugar and fat levels before starting treatment. As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

Olanzapina Viatris is not intended for use in patients under 18 years of age.

Olanzapina Viatris and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should tell their doctor about taking any of the following medicines:

• medicines used to treat Parkinson's disease
• antidepressants or medicines taken for anxiety or to help with sleep (sedatives) as the patient may feel drowsy
• carbamazepine (an antiepileptic and mood-stabilizing medicine)
• fluvoxamine (an antidepressant)
• ciprofloxacin (an antibiotic)
• medicines that can change heart rhythm, such as antiarrhythmic medicines (like amiodarone, sotalol, quinidine), antibiotics (which belong to the macrolide group), tricyclic antidepressants
• activated charcoal (a chemical used to bind other medicines), which should be taken at least 2 hours before or after taking Olanzapina Viatris, as it may interfere with the absorption of olanzapine.

Taking Olanzapina Viatris with alcohol

Patients taking Olanzapina Viatris should not drink alcohol in any form, as Olanzapina Viatris 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 or pharmacist before taking this medicine.
This medicine should not be taken by breastfeeding women, as small amounts of olanzapine may pass into breast milk.
In newborn babies of mothers taking olanzapine in the third trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: trembling, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the baby experiences any of these side effects, the doctor should be contacted.

Driving and operating machinery

Olanzapina Viatris may cause drowsiness or dizziness. If these occur, the patient should not drive or operate any machinery or equipment. The doctor should be informed.

Aspartame content

Olanzapina Viatris 5 mg orally disintegrating tablets contain 1.975 mg of aspartame in each tablet.
Olanzapina Viatris 10 mg orally disintegrating tablets contain 3.950 mg of aspartame in each tablet.
Olanzapina Viatris 15 mg orally disintegrating tablets contain 5.950 mg of aspartame in each tablet.
Olanzapina Viatris 20 mg orally disintegrating tablets contain 7.900 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU).
This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Sodium content

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Olanzapina Viatris

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.
The doctor will decide how many tablets and how long to take Olanzapina Viatris. The recommended daily dose of Olanzapina Viatris is 5 to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking this medicine unless the doctor decides to do so.
Olanzapina Viatris 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. Olanzapina Viatris orally disintegrating tablets should be taken orally.
Olanzapina Viatris tablets are easily broken, so they should be handled carefully. The patient should not take the tablets with wet hands, as they may break apart.
Perforated blisters:

• 1. Holding the blister by the edges, separate one square with a tablet from the rest. Tear off carefully along the perforation.
• 2. Carefully peel off the back foil.
• 3. Gently push the tablet out of the blister.
• 4. Place the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easy to swallow.

Non-perforated blisters:

• 1. Carefully peel off the back foil, being careful not to peel off the foil from the adjacent tablets.
• 2. Gently slide the tablet out.
• 3. Place the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easy to swallow.

The tablet can also be placed in a full glass of water, orange juice, apple juice, milk, or coffee and then stirred. Some drinks may change color or become cloudy when the tablet is added and stirred. The resulting liquid should be drunk immediately.

Taking a higher dose of Olanzapina Viatris than recommended

The doctor or hospital should be contacted immediately. The patient should show the doctor the packaging of the tablets. In patients who have taken a higher dose of olanzapine than recommended, the following symptoms have occurred: rapid heartbeat, agitation and/or aggressive behavior, difficulty speaking, involuntary 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, mood changes, muscle stiffness, high blood pressure, and drowsiness or excessive sleepiness, decreased breathing rate, inhalation of fluid into the trachea and lungs (choking), high or low blood pressure, and heart rhythm disorders.

Missing a dose of Olanzapina Viatris

As soon as remembered, the patient should take a tablet. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Olanzapina Viatris

In case of improvement, the patient should not stop taking the tablets. It is important to take Olanzapina Viatris for as long as the doctor recommends.
If treatment with Olanzapina Viatris is stopped suddenly, the following symptoms may occur: sweating, difficulty sleeping, trembling, anxiety, feeling nauseous (nausea) or vomiting. The doctor may recommend gradually reducing the dose of Olanzapina Viatris before stopping treatment.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should contact their doctor immediately:

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

• increased number of infections causing sore throat, mouth ulcers, or fever. These may be symptoms of a decrease in the number of white blood cells, which help fight infections (leukopenia, neutropenia)

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

• allergic reactions, such as rash, itching, swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing or breathing
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, breathing difficulties, slow heart rate, unusual muscle pain or feelings of weakness, fatigue, or discomfort)
• heart rhythm disorders
• seizures, usually associated with a history of seizures (e.g., epilepsy)
• uncontrolled movements of the mouth, tongue, cheeks, and jaws, which can affect the arms and legs (tardive dyskinesia)
• difficulty urinating or emptying the bladder

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

• yellowing of the skin or whites of the eyes, dark urine, pale stools, itching, feeling drowsy or weak, fever, nausea, weakness, and stomach pain (may be symptoms of liver problems)
• simultaneous occurrence of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness or sleepiness (neuroleptic malignant syndrome)
• abnormal or dangerously fast heartbeat (ventricular tachycardia/ventricular fibrillation)
• pancreatitis causing severe stomach pain radiating to the back
• decreased body temperature causing shivering, feeling cold, or pale skin
• muscle fiber damage causing muscle pain, weakness, or tenderness, and dark urine (rhabdomyolysis)
• prolonged and/or painful erection

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

• symptoms similar to flu with a rash on the face, which spreads to other areas of the body, high fever, enlarged lymph nodes, increased liver enzyme activity visible in blood tests, and increased levels of a type of white blood cell (eosinophilia). These may be symptoms of a drug reaction with eosinophilia and systemic symptoms (DRESS)

Other possible side effects include

Very common (may affect more than 1 in 10 patients):

• weight gain
• drowsiness
• increased prolactin levels in the blood, which may be visible in blood tests
• in the early stages of treatment, dizziness or fainting (due to slow heart rate), 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 (may affect up to 1 in 10 patients):

• changes in the number of certain white blood cells, blood lipid levels, and transient increases in liver enzyme activity, which may be visible in blood tests
• increased blood sugar and urine levels, which may be visible in blood or urine tests
• increased levels of uric acid and alkaline phosphatase, creatine phosphokinase in the blood, which may be visible in blood tests
• increased appetite
• dizziness
• restlessness or difficulty sitting still
• trembling, stiff posture, slow movements, and shuffling gait (parkinsonism)
• abnormal movements (dyskinesias)
• constipation
• dry mouth
• rash
• unusual weakness
• excessive fatigue
• fluid retention in the body causing swelling of the hands, feet, or ankles
• fever
• joint pain
• sexual dysfunction, such as decreased libido in men and women or difficulty achieving or maintaining an erection in men

Uncommon (may affect up to 1 in 100 patients):

• uncontrolled stiffness or muscle spasms affecting the head (including eye movements), neck, and rest of the body
• restless legs syndrome
• speech disorders
• stuttering
• slow heart rate
• increased sensitivity of the skin to sunlight
• nosebleeds
• feeling of fullness (bloating)
• drooling
• memory loss or forgetfulness
• urinary incontinence, difficulty starting to urinate, or weak urine stream
• hair loss
• absence or decrease of menstrual periods
• changes in breast size in men and women
• abnormal production of milk from the breasts (not during breastfeeding) in women
• increased bilirubin levels in the blood, which may be visible in blood tests

Rare (may affect up to 1 in 1000 patients):

• withdrawal symptoms, such as sweating, difficulty sleeping, trembling, anxiety, nausea, or vomiting
• bruising or bleeding that lasts longer than usual or without an obvious reason (thrombocytopenia)
• sudden unexplained death

Frequency not known (frequency cannot be estimated from the available data):

• withdrawal symptoms in newborns, such as skin spots, diarrhea, excessive sucking or crying, poor feeding, slow weight gain, hiccups

During treatment with olanzapine in elderly patients with dementia, the following symptoms may occur: stroke, pneumonia, incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, redness of the skin, and walking difficulties. Several fatal cases have been reported in this group of patients.
In patients with Parkinson's disease, taking olanzapine may worsen the symptoms of the disease and cause hallucinations (seeing, hearing, or feeling things that do not exist).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 gather more information on the safety of the medicine.

5. How to store Olanzapina Viatris

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 packaging and blister or bottle, after the EXP label.
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 Olanzapina Viatris contains

Each orally disintegrating tablet contains 5 mg of olanzapine as the active substance.
Each orally disintegrating tablet contains 10 mg of olanzapine as the active substance.
Each orally disintegrating tablet contains 15 mg of olanzapine as the active substance.
Each orally disintegrating tablet contains 20 mg of olanzapine as the active substance.
The other ingredients are: mannitol, microcrystalline cellulose and guar gum (Avicel CE 15), crospovidone, magnesium stearate, anhydrous colloidal silica, aspartame (E 951, see section 2 "Aspartame content"), sodium lauryl sulfate.

What Olanzapina Viatris looks like and contents of the pack

Olanzapina Viatris 5 mg are yellow to light yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE1" on the other side.
Olanzapina Viatris 10 mg are yellow to light yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE2" on the other side.
Olanzapina Viatris 15 mg are yellow to light yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE3" on the other side.
Olanzapina Viatris 20 mg are yellow to light yellow, uniform to mottled, round, flat, with beveled edges, with "M" embossed on one side and "OE4" on the other side.
Olanzapina Viatris orally disintegrating tablets are available in blisters and cardboard boxes of 28 and 30 tablets or in perforated blisters for single doses and cardboard boxes of (28 and 30) x 1 tablets, and in bottles containing 28, 30, 56, 250, or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer / Importer

Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary
To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, the local representative of the marketing authorization holder should be contacted:

Viatris Healthcare Sp. z o. o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:December 2024