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 only. Do not pass it on to others. It may harm them, 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.

Leaflet contents:

1. What Olanzapina Viatris is and what it is used for
2. What you need to know before you take 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 patients may hear, see, or feel things that are not there, may have beliefs not based on reality, may be excessively suspicious and withdraw from contact with others.
Patients may also feel depressed, anxious, or tense.
Olanzapina Viatris is used to treat moderate to severe manic episodes, a condition in which patients feel extremely good, have excessive energy, need much less sleep than usual, speak very quickly, and experience racing thoughts. This state may sometimes be associated with severe irritability. This medicine is also a mood stabilizer, helping to 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 the 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 with the doctor or pharmacist if:

• the patient has or has a family history of thromboembolic disorders, as use of medicines in this class has been associated with blood clots;
• the patient is elderly with a diagnosis of dementia, as this may lead to serious adverse effects;
• the patient has diabetes;
• the patient has heart disease;
• the patient has been informed of electrolyte imbalance in the blood (especially low levels of potassium or magnesium);
• the patient was born with prolonged QT interval (visible on ECG heart recording);
• the patient has liver or kidney disease;
• the patient has Parkinson's disease;
• the patient has had seizures (epilepsy) in the past;
• the patient has an enlarged prostate;
• the patient has intestinal obstruction (paralytic ileus);
• the patient has a blood disorder with low white blood cell count (which may be caused by certain medications, radiotherapy, chemotherapy or bone marrow disorders);
• 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;
• the patient has had a stroke or "mini" stroke (transient ischemic attack);
• the patient smokes (as this may require adjustment of the olanzapine dose).

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
the 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 the
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 help with dietary planning if necessary.
Increased levels of glucose and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. The doctor may recommend blood tests to check glucose and certain fat levels before starting treatment.
As a precautionary measure, in patients over 65 years of age, the doctor may routinely 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
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 aid 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 (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, 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 the doctor immediately.

Driving and operating machinery
Olanzapina Viatris may cause drowsiness or dizziness. If these occur, do not drive or operate any machinery or mechanical equipment. Inform the doctor.

Aspartame content
Olanzapina Viatris 5 mg orodispersible tablets contain 1.975 mg aspartame per tablet.
Olanzapina Viatris 10 mg orodispersible tablets contain 3.950 mg aspartame per tablet.
Olanzapina Viatris 15 mg orodispersible tablets contain 5.950 mg aspartame per tablet.
Olanzapina Viatris 20 mg orodispersible tablets contain 7.900 mg aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria (PKU).
This is 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 you should continue taking Olanzapina Viatris. The recommended daily dose of Olanzapina Viatris is 5 to 20 mg. If symptoms of the illness recur, 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 the tablets are taken with or without food. Olanzapina Viatris orally disintegrating tablets should be administered orally.
Olanzapina Viatris tablets are fragile and should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Perforated blisters:

1. Hold the blister 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. Carefully 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. Gently peel back the backing foil, taking care not to lift the foil under adjacent tablets.
2. Carefully 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 prepared liquid should be drunk immediately.

Taking more Olanzapina Viatris than recommended
Seek immediate medical attention or go to the hospital. Show the doctor the medicine packaging. In patients who have taken an overdose of olanzapine, the following symptoms have been observed: 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, reduced breathing rate, inhalation of fluid into the trachea and lungs (aspiration), high or low blood pressure, and heart rhythm disturbances.
Missing a dose of Olanzapina Viatris
Take the tablet as soon as you remember. Do not take a double dose to make up for a missed dose.
Stopping Olanzapina Viatris
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 has instructed.
If Olanzapina Viatris is stopped abruptly, the following symptoms may occur: sweating, difficulty sleeping, tremor, anxiety, nausea, or vomiting. Your doctor may advise gradually reducing the dose before stopping the medicine 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 everyone will experience 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 number of white blood cells, 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 the 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 existing diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, breathing difficulties, slow heartbeat, 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)
• uncontrolled movements of the mouth, tongue, cheeks and jaw, which may involve arms and legs (tardive dyskinesia)
• difficulty urinating or incomplete bladder emptying

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

• yellowing of the skin or whites of the eyes, dark urine, pale stools, itching, feeling drowsy or tired, 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 paleness of the skin
• damage to muscle fibres causing muscle pain, weakness or tenderness combined with dark 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 enzyme activity seen 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 seen in blood tests
• dizziness or fainting (with slow heart rate), particularly when standing up from a lying or sitting position, may occur early in treatment. 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 seen in blood tests
• increased blood and urine glucose levels, which may be seen in blood or urine tests
• increased uric acid levels and increased activity of alkaline phosphatase and creatine phosphokinase in blood, which may be seen in blood tests
• increased appetite
• dizziness
• restlessness or difficulty remaining still
• tremor, stiff posture, slow movements and shuffling gait, unsteady walk (parkinsonism)
• abnormal movements (dyskinesias)
• constipation
• dryness of the oral mucous membrane
• 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 skin sensitivity to sunlight
• nosebleeds
• feeling of fullness (bloating)
• salivation
• memory loss or forgetfulness
• urinary incontinence, difficulty starting 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 by women's breasts
• increased bilirubin levels in blood, which may be seen in blood tests

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

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

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 treatment with olanzapine 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 real), increased body temperature, skin redness and walking problems. Several fatal cases have been reported in this patient group.

In patients with Parkinson's disease, the use of olanzapine may worsen symptoms of the disease and may cause hallucinations (seeing, hearing or feeling things that are not real).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform 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 to provide more information on the safety of the medicine.

5. How to store Olanzapina Viatris

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle, following the label "EXP".
Store 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. This will help protect the environment.

6. Contents of the pack and other information

What Olanzapina Viatris contains
Each orodispersible tablet contains 5 mg of olanzapine as the active substance.
Each orodispersible tablet contains 10 mg of olanzapine as the active substance.
Each orodispersible tablet contains 15 mg of olanzapine as the active substance.
Each orodispersible 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
"Content of aspartame"), sodium lauryl sulphate.

What Olanzapina Viatris looks like and contents of the pack
Olanzapina Viatris 5 mg are light yellow to yellow, uniform to mottled, round, flat tablets with bevelled edges, embossed with the mark "M" on one side and "OE1" on the other side.
Olanzapina Viatris 10 mg are light yellow to yellow, uniform to mottled, round, flat tablets with bevelled edges, embossed with the mark "M" on one side and "OE2" on the other side.
Olanzapina Viatris 15 mg are light yellow to yellow, uniform to mottled, round, flat tablets with bevelled edges, embossed with the mark "M" on one side and "OE3" on the other side.
Olanzapina Viatris 20 mg are light yellow to yellow, uniform to mottled, round, flat tablets with bevelled edges, embossed with the mark "M" on one side and "OE4" on the other side.
Olanzapina Viatris orodispersible tablets are available in blister packs and cardboard boxes containing 28 or 30 tablets, or in perforated unit-dose blister strips 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 this medicinal product and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00