OLANZAPINA KRKA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Leaflet: Information for the patient

Olanzapine Krka 10mg orodispersible tablets EFG

Read the entire leaflet carefully before starting to take this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience 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 is Olanzapine Krka and what is it used for
2. What you need to know before taking Olanzapine Krka
3. How to take Olanzapine Krka
4. Possible side effects

5 Conservation of Olanzapine Krka

1. Package contents and additional information

1. What is Olanzapine Krka and what is it used for

Olanzapine Krka contains the active substance olanzapine. Olanzapine Krka belongs to the therapeutic group of antipsychotics and is used to treat the following diseases:

• Schizophrenia, a disease with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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.

Olanzapine Krka 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 taking Olanzapine Krka

Do not take Olanzapine Krka

• if you are allergic to olanzapine or any of the other components of this medication (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

Consult your doctor or pharmacist before starting to take Olanzapine Krka

• Olanzapine Krka is not recommended for use in elderly patients with dementia, as it may have serious side effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Krka, tell your doctor.
• Very rarely, medications 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 olanzapine. You and your doctor should check your weight regularly. Consider consulting a dietitian or helping yourself with a diet plan if necessary.
• High levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking olanzapine. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Olanzapine Krka and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medications of this type have been associated with the formation of blood clots.

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

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

• Diabetes
• Seizures
• If you think you may have loss of salts due to prolonged and intense diarrhea and vomiting (being sick) or due to the use of diuretic medications (water pills)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a 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 of age should not take Olanzapine Krka.

Other medications and Olanzapine Krka

Only take other medications at the same time as Olanzapine Krka if your doctor authorizes it. You may feel a certain sensation of sleepiness if you combine Olanzapine Krka with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

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

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 Olanzapine Krka may need to be changed.

Use of Olanzapine Krka with alcohol

You should not drink alcohol while taking Olanzapine Krka because it can cause sleepiness.

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 medication. You should not take this medication while breastfeeding, as small amounts of Olanzapine Krka may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine Krka in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, agitation, respiratory problems, and difficulty eating. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of sleepiness when you are taking Olanzapine Krka. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine Krka contains aspartame

This medication contains 0.50 mg of aspartame in each 5 mg orodispersible tablet.

This medication contains 0.75 mg of aspartame in each 7.5 mg orodispersible tablet.

This medication contains 1.00 mg of aspartame in each 10 mg orodispersible tablet.

This medication contains 1.50 mg of aspartame in each 15 mg orodispersible tablet.

This medication contains 2.00 mg of aspartame in each 20 mg orodispersible tablet.

Aspartame is a source of phenylalanine.

Phenylalanine may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Olanzapine Krka

Follow your doctor's instructions for taking this medication exactly. If you are in doubt, consult your doctor or pharmacist again. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Your doctor will tell you how many Olanzapine Krka tablets you should take and for how long. The daily dose of olanzapine ranges from 5 mg to 20 mg.

Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine Krka unless your doctor tells you to.

Olanzapine Krka tablets should be taken 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.

How to take Olanzapine Krka

Olanzapine Krka orodispersible tablets break easily, so they should be handled carefully. Do not handle the tablets with wet hands, as they may disintegrate. Remove the tablet from the packaging as follows:

1. Hold the blister pack by the sides and separate an individual packaging from the rest along the perforations.
2. Pull the aluminum edge and remove it completely.
3. Let the tablet fall into your hand.
4. Place the tablet on your tongue immediately.

Within a few seconds, the tablet begins to disintegrate and can be swallowed with or without water. Your mouth should be empty before placing the tablet on your tongue.

You can also put the tablet in a glass of water, orange juice, apple juice, milk, or coffee, stirring it. With a little liquid, the mixture may change color and possibly become cloudy. It should be drunk immediately.

If you take more Olanzapine Krka than you should

Patients who have taken more olanzapine 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Olanzapine Krka

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

If you stop taking Olanzapine Krka

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

If you stop taking Olanzapine Krka suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or 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.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences 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 (a rare 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, see a doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (affecting more than 1 in 10 people) include weight gain, sleepiness, and increased prolactin levels in the blood. In the early stages of treatment, some people feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will pass on its own, but if it doesn't, inform your doctor.

Common side effects (affecting up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and, in the early stages of treatment, temporary increases in liver enzymes; increased blood sugar and urine levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesias); 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.

Rare side effects (affecting up to 1 in 1,000 people) include hypothermia; 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.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially manifests with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

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

Olanzapine Krka may worsen symptoms in patients with Parkinson's disease.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Olanzapine Krka

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from light and moisture. This medication does not require any special storage temperature.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olanzapine Krka

• The active substance is olanzapine. Each Olanzapine Krka tablet contains 10 mg of olanzapine.
• The other components are: mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose LH-21, aspartame, calcium silicate, and magnesium stearate.

See section 2 "Olanzapine Krka contains aspartame".

Appearance of Olanzapine Krka and package contents

Olanzapine Krka 10 mg orodispersible tablets EFG are yellow, round (diameter = 7 mm), slightly biconvex tablets with possible isolated spots.

Olanzapine Krka 10 mg orodispersible tablets EFG are available in packs with 14, 28, 35, 56, or 70 tablets packaged in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warsaw, Poland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Planta baja, Oficina 1, 28108 Alcobendas, Madrid.

Date of last revision of this leaflet:April 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).