OLAZAX DISPERZI 15 mg ORALLY DISPERSIBLE TABLETS

Contents of the package leaflet:

1. What is Olazax Disperzi and what is it used for
2. What you need to know before you take Olazax Disperzi
3. How to take Olazax Disperzi
4. Possible side effects
5. Storage of Olazax Disperzi
6. Package contents and further information

1. What is Olazax Disperzi and what is it used for

Olazax Disperzi contains the active substance olanzapine. Olazax Disperzi belongs to a group of medicines called antipsychotics and is used to treat the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic disorder characterized by symptoms such as excitement or euphoria.

Olazax Disperzi has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before you take Olazax Disperzi

Do not take Olazax Disperzi

Consult your doctor or pharmacist before taking Olazax Disperzi

• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

• Olanzapine is not recommended for use in elderly patients with dementia as it may have serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olazax Disperzi, tell your doctor.
• In very rare cases, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olazax Disperzi. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olazax Disperzi. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olazax Disperzi and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, tell your doctor as soon as possible:

• Stroke or transient lack of blood flow to the brain (transient symptoms of stroke).
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you suffer from dementia, you or your caregiver or relative should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take Olazax Disperzi.

Using Olazax Disperzi with other medicines

Only use other medicines at the same time as Olazax Disperzi if your doctor authorizes it. You may feel drowsy if you combine Olazax Disperzi with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

In particular, tell your doctor if you are taking:

• medication for Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olazax Disperzi may need to be changed.

Using Olazax Disperzi with alcohol

You should not drink alcohol if you have been given Olazax Disperzi because it can cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take this medicine when you are breastfeeding, as small amounts of Olazax Disperzi may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olazax Disperzi in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olazax Disperzi. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olazax Disperzi contains aspartame

Olazax Disperzi orodispersible tablets contain aspartame, which is a source of phenylalanine. Therefore, this medicine may be harmful to people with phenylketonuria.

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3. How to take Olazax Disperzi

Follow the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olazax Disperzi orodispersible tablets you should take and for how long. The daily dose of Olazax Disperzi ranges from 5 mg to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olazax Disperzi unless your doctor tells you to.

You should take your Olazax Disperzi orodispersible tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olazax Disperzi orodispersible tablets are for oral administration. Place the tablet in your mouth. It will dissolve directly and you can swallow it easily. You can also dissolve the tablet in a glass of water or orange juice, apple juice, milk, or coffee, stirring. Drink immediately.

If you take more Olazax Disperzi than you should

Patients who have taken more Olazax Disperzi than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take Olazax Disperzi

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olazax Disperzi

Do not stop treatment just because you feel better. It is very important that you continue taking Olazax Disperzi while your doctor tells you to.

If you stop taking Olazax Disperzi suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data)

Very common side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes swelling of the hands, ankles, or feet; fever, joint pain, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1,000 people) include a drop in normal body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to those of the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin, and walking problems. Some deaths have been reported in this particular group of patients.

Olazax Disperzi may worsen symptoms in patients with Parkinson's disease

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olazax Disperzi

Keep out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the package and blister. The expiration date refers to the last day of the month indicated.

Store below 30°C

Medicines should 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. Package contents and further information

Composition of Olazax Disperzi

• The active substance is olanzapine.
• Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg of olanzapine.
• The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, and magnesium stearate.

Appearance of Olazax Disperzi and package contents

Olazax Disperzi 5 mg:

orodispersible tablets, round, flat, with beveled edges, yellow, with a "B" engraved on one side.

Olazax Disperzi 10 mg:

orodispersible tablets, round, flat, with beveled edges, yellow, with "OL" engraved on one side and "D" engraved on the other side.

Olazax Disperzi 15 mg:

orodispersible tablets, round, flat, with beveled edges, yellow, with "OL" engraved on one side and "E" engraved on the other side.

Olazax Disperzi 20 mg:

orodispersible tablets, round, flat, with beveled edges, yellow, with "OL" engraved on one side and "F" engraved on the other side.

Olazax Disperzi 5 mg, 10 mg, 15 mg, and 20 mg are available in aluminum foil blisters of 28, 56, or 70 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvezdova 1716/2b, 140 78 Prague 4

Czech Republic

Manufacturer

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvezdova 1716/2b, 140 78 Prague 4

Czech Republic

Date of last revision of this package leaflet: May 2020

Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu