OlaZax Disperzi 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olazax Disperzi 5 mg orodispersible tablets EFG

Olazax Disperzi 10 mg orodispersible tablets EFG

Olazax Disperzi 15 mg orodispersible tablets EFG

Olazax Disperzi 20 mg orodispersible tablets EFG

Olanzapine

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet:

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

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

Olazax Disperzi contains the active substance olanzapine. Olazax Disperzi belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also feel 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 starting to take Olazax Disperzi

Do not take Olazax Disperzi

Consult your doctor or pharmacist before starting to take Olazax Disperzi

• If you are allergic to olanzapine or to any of the other components of this medicine (listed in section 6). The allergic reaction may manifest as 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

• The use of Olazax Disperzi is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olazax Disperzi, inform your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olazax Disperzi. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olazax Disperzi. Your doctor should perform blood tests to monitor 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 blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (temporary stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Children and adolescents

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

Use of Olazax Disperzi with other medicines

Only use other medicines at the same time as Olazax Disperzi if your doctor has instructed you to do so. You may feel drowsy if you combine Olazax Disperzi with antidepressants or medicines for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Specifically, 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 adjusted.

Use of Olazax Disperzi with alcohol

You should not drink alcohol if you have been administered Olazax Disperzi, as it may cause drowsiness.

Pregnancy and lactation

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

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

Driving and operating machinery

There is a risk of experiencing drowsiness when taking Olazax Disperzi. If this occurs, do not drive vehicles or operate machinery. Consult your doctor.

Olazax Disperzi contains aspartame

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

3. How to take Olazax Disperzi

Follow exactly the instructions for use of this medicine provided by your doctor. If in 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 your symptoms return, but do not stop taking Olazax Disperzi unless your doctor tells you to do so.

You should take your Olazax Disperzi orodispersible tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. The Olazax Disperzi orodispersible tablets are for oral administration. Place the tablet in your mouth. It will dissolve quickly and can be swallowed easily. Alternatively, you may dissolve the tablet in a glass of water, orange juice, apple juice, milk, or coffee, stirring it. 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 reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor immediately or go to the hospital if you notice any of the symptoms listed above. Show the doctor the pack 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 interrupt treatment with Olazax Disperzi

Do not stop treatment just because you feel better. It is very important that you continue taking Olazax Disperzi for as long as your doctor advises.

If you stop taking Olazax Disperzi suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend gradually reducing the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you have:

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

Very common adverse effects (which may affect more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin 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 sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, and temporary increases at the beginning of treatment in liver enzymes; increased levels of blood and urine sugar; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; weakness; excessive tiredness; fluid retention causing 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 adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are 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; inability to urinate; hair loss; absence or reduced menstrual periods; and changes in the breast in both men and women such as abnormal production of breast milk or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever and malaise; liver disease, with yellowing of the skin and whites of the eyes; muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection.

Rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular patient group.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the national reporting system detailed in Annex V. By reporting adverse reactions, 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 expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicine and packaging. This helps protect the environment.

6. Package contents and other 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 components are mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone and magnesium stearate.

What Olazax Disperzi looks like and contents of the pack

Olazax Disperzi 5 mg:

Yellow, round orodispersible tablets with a bevelled edge, marked with a "B" on one side.

Olazax Disperzi 10 mg:

Yellow, round orodispersible tablets with a bevelled edge, marked with "OL" on one side and a "D" on the other side.

Olazax Disperzi 15 mg:

Yellow, round orodispersible tablets with a bevelled edge, marked with "OL" on one side and an "E" on the other side.

Olazax Disperzi 20 mg:

Yellow, round orodispersible tablets with a bevelled edge, marked with "OL" on one side and an "F" on the other side.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: May 2020

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