Olanzapin Krka

Package Leaflet: Information for the Patient

Olanzapin Krka, 5 mg, orally disintegrating tablets

Olanzapin Krka, 7.5 mg, orally disintegrating tablets

Olanzapin Krka, 10 mg, orally disintegrating tablets

Olanzapin Krka, 15 mg, orally disintegrating tablets

Olanzapin Krka, 20 mg, orally disintegrating tablets

Olanzapine

Read the package 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, please inform 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. Contents of the pack 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 not based on reality, being overly suspicious, and withdrawing from social contacts. The patient may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes - conditions characterized by excitement 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 difficulty breathing. If such symptoms occur, inform your doctor.
• If you have eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before taking Olanzapin Krka, consult your doctor or pharmacist.

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

If you have any of the following conditions, inform your doctor immediately:

• Stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• Prostate disorders;
• Intestinal obstruction (paralytic);
• Liver or kidney disease;
• Blood disorders;
• Heart disease;
• Diabetes;
• Seizures;
• If you know you have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretics.

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should inform your doctor.
Routinely, as a precaution, your doctor may check your blood pressure if you are over 65 years old.

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 should only take other medicines with their doctor's consent.
Taking Olanzapin Krka in combination with antidepressant, sedative, or sleep-inducing medicines may cause drowsiness.
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, inform 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

Do 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 plan to have a child, 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, excitement, difficulty breathing, and feeding difficulties. If you observe such symptoms in your child, contact your doctor.

Driving and using machines

Olanzapin Krka may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any machines or mechanical devices. Inform your doctor.

Olanzapin Krka contains aspartame

The medicine contains 0.50 mg of aspartame in each 5 mg orally disintegrating tablet.
The medicine contains 0.75 mg of aspartame in each 7.5 mg orally disintegrating tablet.
The medicine contains 1.00 mg of aspartame in each 10 mg orally disintegrating tablet.
The medicine contains 1.50 mg of aspartame in each 15 mg orally disintegrating tablet.
The medicine contains 2.00 mg of aspartame in each 20 mg orally disintegrating tablet.
Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Olanzapin Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 your symptoms recur, inform your doctor. However, do not stop taking Olanzapin Krka unless your doctor tells you to.
Take Olanzapin Krka once a day, as directed by your doctor. Try to take your medicine at the same time each day. It does not matter if you take the tablets with or without food.

How to take Olanzapin Krka

Olanzapin Krka orally disintegrating tablets dissolve easily in the mouth, so handle them carefully. Do not touch the tablets with wet hands, as they may break. To remove a tablet from the packaging:

• 1. Holding the blister by the edges, separate the blister square with the tablet from the rest of the blister. Tear it off gently along the perforation.
• 2. Pull the edge of the foil and remove it completely.

• 3. Push the tablet out onto your hand.
• 4. Immediately after removal from the packaging, place the tablet on your tongue.

The tablet dissolves in the mouth within a few seconds and can then be swallowed with or without water. The mouth should be empty before placing the tablet on the tongue.
You can also put the tablet in a glass or cup of water, orange juice, apple juice, milk, or coffee and stir. With some drinks, the mixture may change color and become cloudy. Drink the mixture immediately.

Taking a higher dose of Olanzapin Krka than recommended

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

Missing a dose of Olanzapin Krka

Take the tablets as soon as you remember. Do not take a double dose to make up for a missed dose.

Stopping treatment with Olanzapin Krka

Do not stop taking the tablets even if you feel better. 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapin Krka can cause side effects, although not everybody gets them.
Inform 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 (an uncommon 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 bloodstream to the lungs, causing chest pain and difficulty breathing. If you observe any of these symptoms, seek medical attention immediately;
• A combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated 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 slow 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, 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 blood lipid levels; 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:
allergic reactions (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 before (epilepsy); muscle stiffness or rigidity (including eye movements); restless legs syndrome; speech disorders; stuttering; slow heart rate; sensitivity 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 side effects (may occur in up to 1 in 1,000 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 erections.
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, and increased levels of a specific type of white blood cell (eosinophilia).
During treatment with olanzapine in elderly patients with dementia, the following have been reported: stroke, pneumonia, incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, redness of the skin, and walking disturbances. Several fatal cases have been reported in these patient groups.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
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

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture.
No special precautions for storage temperature are required.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olanzapin Krka contains

• The active substance is olanzapine. Each orally disintegrating tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
• The other ingredients are: mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate. See section 2 "Olanzapin Krka contains aspartame".

What Olanzapin Krka looks like and contents of the pack

Olanzapin Krka, 5 mg, orally disintegrating tablets: yellow, round (diameter 5.5 mm), slightly convex on both sides, mottled tablets with possible single spots
Olanzapin Krka, 7.5 mg, orally disintegrating tablets: yellow, round (diameter 6.5 mm), slightly convex on both sides, mottled tablets with possible single spots
Olanzapin Krka, 10 mg, orally disintegrating tablets: yellow, round (diameter 7 mm), slightly convex on both sides, mottled tablets with possible single spots
Olanzapin Krka, 15 mg, orally disintegrating tablets: yellow, round (diameter 8 mm), slightly convex on both sides, mottled tablets with possible single spots
Olanzapin Krka, 20 mg, orally disintegrating tablets: yellow, round (diameter 10 mm), slightly convex on both sides, mottled tablets with possible single spots
Packaging: 28 and 56 orally disintegrating 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., ul. Równoległa 5, 02-235 Warsaw
Date of last revision of the leaflet:17.07.2019