Leaflet: information for the user

Olazax Disperzi 5 mg buccal dispersible tablets EFG

Olazax Disperzi 10 mg buccal dispersible tablets EFG

Olazax Disperzi 15 mg buccal dispersible tablets EFG

Olazax Disperzi 20 mg buccal dispersible tablets EFG

Olanzapine

Read this leaflet carefully before you start taking this medicine, because 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

Olazax Disperzi contains the active ingredient olanzapina. Olazax Disperzi belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

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

Do not take Olazax Disperzi

Consult your doctor or pharmacist before starting to take Olazax Disperzi

• If you are allergic to olanzapine or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, 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

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

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a cerebral infarction or transient cerebral ischemia.

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 old should not take Olazax Disperzi.

Use of Olazax Disperzi with other medications

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

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

Specifically, tell your doctor if you are taking:

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 breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take this medication while 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, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Driving and operating machinery

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

Olazax Disperzi contains aspartame

The Olazax Disperzi buccal dispersible tablets contain aspartame, which is a source of phenylalanine. Therefore, this medication may be harmful to individuals with phenylketonuria.

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Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olazax Disperzi buccal tablets to 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.

Take your Olazax Disperzi buccal 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 buccal 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 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/aggressiveness, 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 rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the doctor the packaging 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 the missed dose.

If you interrupt treatment with Olazax Disperzi

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

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

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

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

Immediately contact your doctor if you have:

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

Common side effects can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and at the beginning of treatment temporary increases in liver enzymes; increased blood sugar and urine levels; increased blood uric acid and creatine phosphokinase levels; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention causing inflammation 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.

Rare 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; nasal bleeding; 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 breast 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 decrease in normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

Rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS for its acronym in English). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with extensive 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, a rise in body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAnnex V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister. The expiration date refers to the last day of the month indicated.

Store below 30 °C

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Olazax Disperzi

• The active ingredient 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.

Appearance of Olazax Disperzi and contents of the packaging

Olazax Disperzi 5 mg :

Round, flat-edged, bisected buccal dispersible tablets with a yellow color and a "B" inscribed on one face.

Olazax Disperzi 10 mg:

Round, flat-edged, bisected buccal dispersible tablets with a yellow color, "OL" inscribed on one face, and a "D" inscribed on the other face.

Olazax Disperzi 15 mg:

Round, flat-edged, bisected buccal dispersible tablets with a yellow color, "OL" inscribed on one face, and an "E" inscribed on the other face.

Olazax Disperzi 20 mg:

Round, flat-edged, bisected buccal dispersible tablets with a yellow color, "OL" inscribed on one face, and an "F" inscribed on the other face.

Olazax Disperzi 5 mg, 10 mg, 15 mg, and 20 mg are presented in a blister pack of aluminum foil containing 28, 56, or 70 buccal dispersible tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.

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

Republic of Czech

Responsible manufacturer

Glenmark Pharmaceuticals s.r.o.

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

Republic of Czech

Last reviewed date of this leaflet: May 2020

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