OLANZAPIN 5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Olanzapin Krka, 5 mg, tablets
3. Olanzapin Krka, 10 mg, tablets
4. Olanzapin Krka, 15 mg, tablets
5. Olanzapin Krka, 20 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Olanzapin Krka and what is it used for
7. Important information before taking Olanzapin Krka
   1. When not to take Olanzapin Krka:
   2. Warnings and precautions
   3. Children and adolescents
   4. Olanzapin Krka and other medicines
   5. Olanzapin Krka with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
   8. Olanzapin Krka contains lactose
8. How to take Olanzapin Krka
   1. Taking a higher dose of Olanzapin Krka than recommended
   2. Missing a dose of Olanzapin Krka
   3. Stopping Olanzapin Krka
9. Possible side effects
   1. Reporting side effects
10. How to store Olanzapin Krka
11. Package contents and other information
    1. What Olanzapin Krka contains
    2. What Olanzapin Krka looks like and what the package contains
    3. Marketing authorization holder
    4. Manufacturer

Leaflet attached to the packaging: patient information

Olanzapin Krka, 5 mg, tablets

Olanzapin Krka, 10 mg, tablets

Olanzapin Krka, 15 mg, tablets

Olanzapin Krka, 20 mg, tablets

Olanzapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Olanzapin Krka and what is it used for
• 2. Important information before taking Olanzapin Krka
• 3. How to take Olanzapin Krka
• 4. Possible side effects
• 5. How to store Olanzapin Krka
• 6. Package contents and other information

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

Olanzapin Krka contains the active substance olanzapine. Olanzapin Krka belongs to a group of
medicines called antipsychotics and is used to treat:

• Schizophrenia, a disease characterized by hearing, seeing or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious and withdrawing from contact with the environment. The patient may also experience depression, anxiety or tension.
• Moderate to severe manic episodes - disease states whose symptoms are agitation or euphoria.

It has been shown that Olanzapin Krka prevents the recurrence of these symptoms in patients with bipolar affective disorder, who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Olanzapin Krka

When not to take Olanzapin Krka:

• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling or shortness of breath. If such symptoms occur, you should inform your doctor.
• If you have eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting to take Olanzapin Krka, you should consult your doctor or pharmacist.

• Olanzapin Krka is not recommended for use in elderly patients with a diagnosis of dementia, as it may cause very serious side effects.
• Medicines of this group may cause the occurrence of abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olanzapin Krka, you should inform your doctor.
• Very rarely, medicines of this type cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness. If such symptoms occur, you should contact your doctor immediately.
• In patients taking Olanzapin Krka, weight gain has been observed. You should regularly check your weight. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Olanzapin Krka, high blood sugar levels and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Olanzapin Krka and during its use, your doctor should perform blood tests to determine blood sugar levels and levels of certain lipids.
• You should tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

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

• stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• prostate disorders;
• intestinal obstruction (paralytic);
• liver or kidney disease;
• blood diseases;
• heart disease;
• diabetes;
• seizures;

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell your doctor.
As a precaution, in people over 65 years of age, the doctor may check blood pressure.

Children and adolescents

Olanzapin Krka is not intended for use in patients under 18 years of age.

Olanzapin Krka and other medicines

People taking Olanzapin Krka may only take other medicines with the consent of their doctor.
Taking Olanzapin Krka in combination with antidepressant, sedative or sleeping medicines may cause drowsiness.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor if you are taking:

• medicines used to treat Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - a dose adjustment of Olanzapin Krka may be necessary.

Olanzapin Krka with alcohol

You should not drink alcohol after taking Olanzapin Krka, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should consult your doctor before taking this medicine. Olanzapin Krka should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Olanzapin Krka in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties and feeding difficulties. If you notice such symptoms in your child, you should contact your doctor.

Driving and operating machinery

Olanzapin Krka may cause drowsiness. If drowsiness occurs, you should not drive vehicles or operate any machines and mechanical devices. You should inform your doctor.

Olanzapin Krka contains lactose

If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Olanzapin Krka

This medicine should always be taken according to your doctor's instructions. If you are unsure, you should consult your doctor or pharmacist.
Your doctor will decide how many tablets and how long you should take Olanzapin Krka. The daily dose of Olanzapin Krka is from 5 mg to 20 mg.
If the symptoms of the disease recur, you should inform your doctor. However, you should not stop taking Olanzapin Krka unless your doctor decides to do so.
Olanzapin Krka tablets should be taken once a day as directed by your doctor. You should try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food.
You should swallow the tablet whole, with a glass of water.

Taking a higher dose of Olanzapin Krka than recommended

In patients who took a higher dose of Olanzapin Krka than recommended, the following symptoms occurred: rapid heartbeat, agitation/aggression, speech disorders, abnormal movements (especially of the face and tongue), decreased level of consciousness.
Other symptoms include confusion (disorientation), seizures, coma, syndrome of symptoms with fever, rapid breathing, sweating, muscle stiffness and drowsiness; slow breathing rate, choking, high or low blood pressure, abnormal heart rhythm.
You should contact your doctor or go to the hospital immediately if you experience any of these symptoms. You should show your doctor the package of tablets.

Missing a dose of Olanzapin Krka

As soon as you remember, you should take the tablets. You should not take a double dose to make up for the missed dose.

Stopping Olanzapin Krka

If you feel better, you should not stop taking the tablets. It is important to take Olanzapin Krka for as long as your doctor recommends.
If you suddenly stop taking Olanzapin Krka, you may experience symptoms such as sweating, insomnia, tremors, anxiety or nausea and vomiting. Your doctor may suggest gradually reducing the dose of Olanzapin Krka before stopping it.
If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapin Krka can cause side effects, although not everybody gets them.
You should tell your doctor immediately if you experience:

• abnormal movements, especially in the face or tongue (a common side effect that may occur in up to 1 in 10 patients);
• blood clots in the veins (a not very common side effect that may occur in up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, you should seek medical attention immediately;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be determined from the available data).

Very common side effects (may occur in more than 1 in 10 patients) include:
weight gain; drowsiness and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a decrease in heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, you should inform your doctor.
Common side effects (may occur in up to 1 in 10 patients) include: changes in the number of certain blood cells and lipid levels in the blood, and transient increases in liver enzyme activity at the start of treatment; increased blood sugar and urine levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremors; movement disorders (dyskinesias); constipation; dry mouth; weakness; extreme fatigue; water retention in the body causing swelling of the hands, feet or ankles; fever; joint pain; sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects (may occur in up to 1 in 100 patients) include: hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma; seizures, usually in patients who have had seizures (epilepsy) before; muscle stiffness or spasms (including eye movements); restless legs syndrome; speech disorders; stuttering; slow heart rate; hypersensitivity to sunlight; nosebleeds; abdominal bloating; memory loss or lack of memory; urinary incontinence, difficulty urinating; hair loss; absence or decrease of menstrual periods; changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rare reported side effects (may occur in up to 1 in 1000 patients) include: decreased body temperature; heart rhythm disorders; sudden death from an unknown cause; pancreatitis causing severe abdominal pain, fever and nausea; liver disease characterized by a change in skin and white eye color to yellow; muscle disease characterized by unexplained muscle pain and weakness; prolonged and (or) painful erection.
Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high fever, swollen lymph nodes, elevated liver enzyme activity in blood tests and increased levels of a specific type of white blood cell (eosinophilia).
During treatment with olanzapine in elderly patients with a diagnosis of dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness and walking disorders. In these patient groups, several fatal cases have been reported.
In patients with Parkinson's disease, Olanzapin Krka may exacerbate side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Olanzapin Krka

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
There are no special precautions for storage temperature of the medicinal product.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Olanzapin Krka contains

• The active substance is olanzapine. Each tablet contains 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
• Other ingredients are: lactose monohydrate; cellulose powder; corn starch; cornstarch; colloidal silica anhydrous; magnesium stearate. See section 2 "Olanzapin Krka contains lactose".

What Olanzapin Krka looks like and what the package contains

Olanzapin Krka, 5 mg, tablets: round (diameter 7 mm), slightly convex on both sides, light yellow tablets with possible single yellow spots and the inscription "5"
Olanzapin Krka, 10 mg, tablets: round (diameter 9 mm), slightly convex on both sides, light yellow tablets with possible single yellow spots and the inscription "10"
Olanzapin Krka, 15 mg, tablets: round (diameter 11 mm), slightly convex on both sides, light yellow tablets with possible single yellow spots and the inscription "15"
Olanzapin Krka, 20 mg, tablets: round (diameter 12 mm), slightly convex on both sides, light yellow tablets with possible single yellow spots and the inscription "20"
Packaging: 28 and 56 tablets in blisters in a cardboard box

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., Równoległa Street, 02-235 Warsaw
Date of last revision of the leaflet:17.07.2019