OLANZAPINE KRKA 5 mg TABLETS

Introduction

Package Leaflet:Information for the Patient

Olanzapine Krka 5mg EFG Tablets

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What Olanzapine Krka is and what it is 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 Olanzapine Krka is and what it is 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with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine Krka and regularly during treatment.
• If you or a family member 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 temporary 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 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 (pills to urinate)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke 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 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).

Tell 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, as it may 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 Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Olanzapine Krka

Follow the administration instructions of this medication indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again. If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Your doctor will indicate 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. The tablets should be swallowed whole with water.

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/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 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 interrupt treatment with Olanzapine Krka

Do not interrupt 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, 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 doubts 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 may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (a rare side effect that may 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 of this side effect cannot be estimated from the available data).

Very common side effects (which may affect 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, tell your doctor.

Common side effects (which may affect 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 dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (which may affect up to 1 in 100 people) include hypersensitivity (e.g., swelling in the mouth or throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with 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 breast gland in men and women, such as abnormal milk production or abnormal growth.

Very rare side effects (which may affect up to 1 in 1000 people) include decreased 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; prolonged and/or painful erections.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested 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, increased 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 of Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the national reporting system: Spanish Medicines 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 that appears on the package. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you 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 5 mg of olanzapine.
• The other components are: lactose monohydrate, cellulose powder, pregelatinized starch, cornstarch, anhydrous colloidal silica, and magnesium stearate.
• See section 2 "Olanzapine Krka contains lactose".

Appearance of Olanzapine Krka and Package Contents

Olanzapine Krka 5 mg EFG tablets are round (diameter = 7 mm), slightly biconvex; light yellow in color, with possible isolated yellow spots and engraved with "5".

Olanzapine Krka 5 mg EFG tablets 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 the last revision of this package 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/).