Olanzapin Krka

Leaflet accompanying the packaging: patient information

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 packaging 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 the patient 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 include 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 the patient is 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, the doctor should be informed.
• If the patient has eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting treatment with Olanzapin Krka, the patient should consult a doctor or pharmacist.

• Olanzapin Krka is not recommended for use in elderly patients with a diagnosis of dementia, as it may cause serious side effects.
• Medicines of this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olanzapin Krka, the doctor should be informed.
• 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, the doctor should be contacted immediately.
• Patients taking Olanzapin Krka have been observed to have weight gain. The patient's weight should be checked regularly. If necessary, consideration should be given to consulting a dietitian or seeking help in establishing a diet.
• Patients taking Olanzapin Krka have been observed to have high blood sugar and high lipid levels. Before and during treatment with Olanzapin Krka, the doctor should perform blood tests to determine blood sugar and lipid levels.
• The doctor should be informed if the patient or their family members have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

If the patient has any of the following diseases, they should immediately inform their doctor:

• 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 the patient knows they may have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretics.

If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver) should inform the doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

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

Olanzapin Krka and other medicines

Patients taking Olanzapin Krka may only take other medicines with the doctor's consent.
Taking Olanzapin Krka in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
The doctor should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be informed about the use of:

• 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

Alcohol should not be consumed after taking Olanzapin Krka, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a 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, breathing difficulties, and feeding difficulties. If such symptoms are observed in the patient's child, the doctor should be contacted.

Driving and operating machines

Olanzapin Krka may cause drowsiness. If drowsiness occurs, the patient should not drive vehicles or operate any machines and mechanical devices. The doctor should be informed.

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 the patient has phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Olanzapin Krka

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide how many tablets and how long to take Olanzapin Krka. The daily dose of Olanzapin Krka is from 5 mg to 20 mg.
If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Olanzapin Krka unless the doctor decides to do so.
Olanzapin Krka tablets should be taken once a day as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food.

How to take Olanzapin Krka

Olanzapin Krka orally disintegrating tablets can be easily broken, so they should be handled carefully. The tablets should not be taken with wet hands, as they may disintegrate. To remove a tablet from the packaging:

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

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

The tablet disintegrates 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.
The tablet can also be placed in a glass or cup of water, orange juice, apple juice, milk, or coffee and stirred. In the case of some drinks, the mixture may change color and become cloudy. The resulting mixture should be taken 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, choking, high or low blood pressure, abnormal heart rhythm.
The doctor should be contacted immediately if any of the above symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Olanzapin Krka

As soon as remembered, the tablets should be taken. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Olanzapin Krka

In case of improvement, the patient should not stop taking the tablets. It is important to take Olanzapin Krka for as long as the doctor recommends.
In case of sudden discontinuation of Olanzapin Krka, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may occur. The doctor may suggest gradually reducing the dose of Olanzapin Krka before discontinuing it.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Olanzapin Krka can cause side effects, although not everybody gets them.
The doctor should be informed immediately if the following occur:

• 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 breathing difficulties. If any of these symptoms are observed, the doctor should be consulted 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, the doctor should be informed.
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 increase in liver enzyme activity at the beginning 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 before (epilepsy); muscle stiffness or rigidity (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 abnormal 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, enlarged lymph nodes, increased liver enzyme activity, 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, redness of the skin, and walking difficulties. 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 any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the 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.
No special precautions are required for the storage temperature of the medicinal product.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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.
• Other ingredients are: mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropyl cellulose, aspartame, calcium silicate, magnesium stearate. See section 2 "Olanzapin Krka contains aspartame".

What Olanzapin Krka looks like and what the packaging contains

Olanzapin Krka, 5 mg, orally disintegrating tablets: yellow, round (diameter 5.5 mm), slightly convex on both sides, marbled tablets with possible single spots
Olanzapin Krka, 7.5 mg, orally disintegrating tablets: yellow, round (diameter 6.5 mm), slightly convex on both sides, marbled tablets with possible single spots
Olanzapin Krka, 10 mg, orally disintegrating tablets: yellow, round (diameter 7 mm), slightly convex on both sides, marbled tablets with possible single spots
Olanzapin Krka, 15 mg, orally disintegrating tablets: yellow, round (diameter 8 mm), slightly convex on both sides, marbled tablets with possible single spots
Olanzapin Krka, 20 mg, orally disintegrating tablets: yellow, round (diameter 10 mm), slightly convex on both sides, marbled 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