Olanzapine viatris

Package leaflet: Information for the user

Olanzapina Viatris, 5 mg, orodispersible tablets
Olanzapina Viatris, 10 mg, orodispersible tablets
Olanzapina Viatris, 15 mg, orodispersible tablets
Olanzapina Viatris, 20 mg, orodispersible tablets
Olanzapinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Olanzapina Viatris is and what it is used for
2. What you need to know before taking Olanzapina Viatris
3. How to take Olanzapina Viatris
4. Possible side effects
5. How to store Olanzapina Viatris
6. Contents of the pack and other information

1. What Olanzapina Viatris is and what it is 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 condition in which the patient hears, sees, or feels things that are not real, has beliefs that are not based in reality, is excessively suspicious, and withdraws from contact with others.
The patient may also feel depressed, anxious, or tense.
Olanzapina Viatris is also used to treat moderate to severe manic episodes, a condition in which patients feel extremely well, are full of energy, need much less sleep than usual, speak very quickly, and have racing thoughts. This state may sometimes be characterized by severe irritability. This medicine is also a mood stabilizer that helps prevent the recurrence of extreme mood states—elevated and depressed mood (depression)—associated with this illness.

2. Important information before using Olanzapina Viatris

When not to use 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 rash, itching, facial swelling, swelling of lips, tongue or throat, difficulty breathing or shortness of breath. If such symptoms occur, inform the doctor immediately;
• if the patient has eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzapina Viatris, discuss the following with a doctor or pharmacist:

• if the patient or a family member has a history of thromboembolic disorders, as use of medicines in this class has been associated with blood clots;
• if the patient is elderly and has been diagnosed with dementia, as this may lead to serious adverse effects;
• if the patient has diabetes;
• if the patient has heart disease;
• if the patient has been informed of having electrolyte imbalance in the blood (especially low potassium or magnesium levels);
• if the patient has congenital prolongation of the QT interval (visible on ECG heart recording);
• if the patient has liver or kidney disease;
• if the patient has Parkinson's disease;
• if the patient has previously experienced seizures (epilepsy);
• if the patient has an enlarged prostate;
• if the patient has intestinal obstruction (bowel paralysis);
• if the patient has a blood disorder with low white blood cell count (which may result from certain medications, radiotherapy, chemotherapy, or bone marrow disorders);
• if the patient has been diagnosed with high white blood cell count or a bone marrow disorder involving excessive production of blood cells, called myeloproliferative disease;
• if the patient has had a stroke or "mini" stroke (transient ischemic attack);
• if the patient smokes cigarettes (as this may necessitate a dose adjustment of olanzapine).

During treatment
If the patient develops the following symptoms together: very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure, and drowsiness, consult a doctor immediately, as the doctor may decide to discontinue treatment with Olanzapina Viatris.
If the patient develops uncontrolled movements of the face or tongue, consult a doctor, as the doctor may decide to reduce the dose or discontinue treatment with Olanzapina Viatris.
Weight gain has been observed in patients taking olanzapine. The patient's weight should be monitored regularly. Consider consulting a dietitian or seeking dietary advice if necessary.
Increased levels of glucose and lipids (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. The doctor may recommend blood tests to check glucose and certain lipid levels before starting treatment with Olanzapina Viatris.
As a routine precaution, doctors may monitor blood pressure in patients over 65 years of age.

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

Olanzapina Viatris and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. In particular, inform the doctor if the patient is taking any of the following medicines:

• medicines used to treat Parkinson's disease;
• antidepressants or medicines taken for anxiety or to help sleep (sedatives), as the patient may feel drowsy;
• carbamazepine (an anticonvulsant and mood-stabilizing medicine);
• fluvoxamine (an antidepressant);
• ciprofloxacin (an antibiotic);
• medicines that may affect heart rhythm, such as antiarrhythmics (e.g. amiodarone, sotalol, quinidine, disopyramide), antibiotics belonging to the macrolide group, tricyclic antidepressants;
• activated charcoal (a chemical substance 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.

Use of Olanzapina Viatris with alcohol
Patients taking Olanzapina Viatris must not consume alcohol in any form, as Olanzapina Viatris combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Breastfeeding women should not take this medicine, as small amounts of olanzapine may pass into breast milk.
Newborns of mothers who took olanzapine during the third trimester of pregnancy (last three months) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these adverse effects occur in the newborn, contact a doctor immediately.

Driving and operating machinery
Olanzapina Viatris may cause drowsiness or dizziness. If these occur, the patient should not drive or operate any vehicles, machines, or mechanical equipment. Inform the doctor if such symptoms occur.

Aspartame content
Olanzapina Viatris 5 mg orodispersible tablets contain 1.975 mg of aspartame per tablet.
Olanzapina Viatris 10 mg orodispersible tablets contain 3.950 mg of aspartame per tablet.
Olanzapina Viatris 15 mg orodispersible tablets contain 5.950 mg of aspartame per tablet.
Olanzapina Viatris 20 mg orodispersible tablets contain 7.900 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

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

3. How to take Olanzapina Viatris

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Your doctor will decide how many tablets you should take and for how long to continue treatment with Olanzapina Viatris. The recommended daily dose of Olanzapina Viatris is 5 to 20 mg. If symptoms of the illness return, you should inform your doctor. However, do not stop taking this medicine unless your doctor advises you to do so.
Olanzapina Viatris 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 you take the tablets with or without food. Olanzapina Viatris orally disintegrating tablets should be administered orally.
Olanzapina Viatris tablets are fragile and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Perforated blisters:

1. Hold the blister pack by the edges and separate one square containing the tablet from the rest. Carefully tear along the perforation.
2. Gently peel back the backing foil.
3. Gently push the tablet out of the blister.
4. Place the tablet in the mouth. The tablet will dissolve rapidly in the oral cavity, making it easy to swallow.

Non-perforated blisters:

1. Carefully peel back the backing foil, taking care not to peel the foil under adjacent tablets.
2. Gently push the tablet out.
3. Place the tablet in the mouth. The tablet will dissolve rapidly in the oral cavity, making it easy to swallow.

The tablet may also be placed in a full glass of water, orange juice, apple juice, milk, or coffee and stirred. Some beverages may change color and possibly become cloudy after the tablet is added and stirred. The resulting solution should be drunk immediately.

Taking more Olanzapina Viatris than recommended
Seek immediate medical advice from your doctor or go to the nearest hospital. Show the tablet packaging to the doctor. In patients who have taken an overdose of olanzapine, the following symptoms have been reported: rapid heartbeat, agitation and (or) aggressive behavior, difficulty speaking, involuntary movements (especially of the facial and tongue muscles), and reduced level of consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, concurrent occurrence of fever, rapid breathing, sweating, muscle rigidity, drowsiness or excessive sleepiness, decreased respiratory rate, aspiration of fluid into the trachea and lungs (choking), high or low blood pressure, and irregular heart rhythm.
If you forget to take Olanzapina Viatris
Take the missed dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.
Stopping Olanzapina Viatris treatment
Do not stop taking the tablets just because you feel better. It is important to continue taking Olanzapina Viatris for as long as your doctor recommends.
If treatment with Olanzapina Viatris is stopped abruptly, the following symptoms may occur: sweating, difficulty sleeping, tremor, anxiety, nausea or vomiting. Your doctor may recommend gradually reducing the dose before stopping the medicine completely.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur in the patient,
contact a doctor immediately:

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

• increased number of infections causing sore throat, mouth ulcers or fever. These may be symptoms of reduced white blood cell count, which help fight infections (leukopenia, neutropenia)

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

• allergic reactions such as rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing
• blood clots in veins, particularly in the legs (symptoms include swelling, pain, redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties
• diabetes or worsening of pre-existing diabetes, occasionally associated with ketoacidosis (presence of ketones in blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain or feeling of weakness, fatigue or discomfort) or coma
• heart rhythm disorders
• seizures, usually associated with a history of seizures (e.g. epilepsy)
• involuntary movements of the mouth, tongue, cheeks and jaw, which may involve arms and legs (tardive dyskinesia)
• difficulty passing urine or incomplete bladder emptying

Rare (may affect up to 1 in 1,000 people):

• yellowing of the skin or whites of the eyes, dark-coloured urine, pale stools, itching, drowsiness or fatigue, fever, nausea, weakness and abdominal pain (these may be symptoms of liver problems)
• combination of very high fever, rapid breathing, excessive sweating, mood changes, muscle stiffness, high blood pressure and feeling drowsy or sleepy (neuroleptic malignant syndrome)
• unusual or dangerously fast heartbeat (ventricular tachycardia/fibrillation)
• pancreatitis causing severe stomach pain radiating to the back
• lowering of normal body temperature causing chills, coldness or pale skin
• damage to muscle fibres causing muscle pain, weakness or tenderness combined with dark-coloured urine (rhabdomyolysis)
• prolonged and (or) painful erection

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

• influenza-like symptoms with rash on the face spreading to other parts of the body, high fever, swollen lymph nodes, increased liver enzymes visible in blood tests and increased number of one type of white blood cells (eosinophilia). These may be symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS)

Other possible adverse reactions include
Very common (may affect more than 1 in 10 patients):

• weight gain
• drowsiness
• increased prolactin levels in blood, which may be observed in blood tests
• at the beginning of treatment, dizziness or fainting (with slow heart rate), especially when rising from a lying or sitting position. These symptoms usually resolve spontaneously, but if they persist, inform your doctor.

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

• changes in the number of certain white blood cells, blood lipid levels, and transient increase in liver enzyme activity at the beginning of treatment, which may be observed in blood tests
• increased blood and urine glucose levels, which may be observed in blood or urine tests
• increased uric acid levels and increased alkaline phosphatase and creatine kinase activity in blood, which may be observed in blood tests
• increased appetite
• dizziness
• restlessness or difficulty remaining still
• tremor, rigid posture, slow movements and shuffling gait, unsteady walking (parkinsonism)
• abnormal movements (dyskinesias)
• constipation
• dryness of the oral mucosa
• rash
• unusual weakness
• excessive fatigue
• fluid retention causing swelling of hands, feet or ankles
• fever
• joint pain
• sexual disorders such as decreased libido in men and women, or difficulty achieving or maintaining erection in men

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

• uncontrolled muscle stiffness or spasms involving 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)
• salivation
• memory loss or forgetfulness
• urinary incontinence, difficulty initiating urination or weak urine stream
• hair loss
• absence or reduction of menstruation
• changes in breast size in men and women
• abnormal production (outside of breastfeeding period) of milk from the breasts of women
• elevated bilirubin levels in blood, which may be observed in blood tests

Rare (may affect up to 1 in 1,000 patients):

• withdrawal symptoms such as sweating, sleep disturbances, tremor, anxiety, nausea or vomiting
• bruising or bleeding lasting longer than normal or without clear cause (thrombocytopenia)
• sudden death of unknown cause

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

• withdrawal symptoms in newborns such as mottled skin, diarrhoea, excessive sucking or crying, poor feeding, slow weight gain, sneezing

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Olanzapina Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle, following the label EXP.
Keep the medicine in its original packaging to protect it from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents 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, colloidal anhydrous 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 light yellow to yellow tablets, uniform to mottled, round, flat, with bevelled edges, embossed with "M" on one side and "OE1" on the other.
Olanzapina Viatris 10 mg are light yellow to yellow tablets, uniform to mottled, round, flat, with bevelled edges, embossed with "M" on one side and "OE2" on the other.
Olanzapina Viatris 15 mg are light yellow to yellow tablets, uniform to mottled, round, flat, with bevelled edges, embossed with "M" on one side and "OE3" on the other.
Olanzapina Viatris 20 mg are light yellow to yellow tablets, uniform to mottled, round, flat, with bevelled edges, embossed with "M" on one side and "OE4" on the other.
Olanzapina Viatris orally disintegrating tablets are available in blister packs and cardboard boxes containing 28 or 30 tablets, or in perforated blisters divided into single doses and cardboard boxes containing (28 and 30) x 1 tablets, as well as in bottles containing 28, 30, 56, 250 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer / Importer
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary

For further information about the medicinal product and its names in the Member States of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00