OLANZAPINE KRKA

Package leaflet: Information for the patient

Olanzapin Krka, 5 mg, orodispersible tablets
Olanzapin Krka, 7.5 mg, orodispersible tablets
Olanzapin Krka, 10 mg, orodispersible tablets
Olanzapin Krka, 15 mg, orodispersible tablets
Olanzapin Krka, 20 mg, orodispersible tablets
Olanzapinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 disorder characterized by hearing, seeing or sensing things that do not exist in reality, having beliefs that are contrary to reality, being excessively suspicious and withdrawing from social contact. The patient may also experience depression, anxiety or tension.
• moderate to severe manic episodes – disease states characterized by excitement or euphoria.

It has been shown that Olanzapin Krka prevents recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment during 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 rash, itching, facial swelling, lip swelling or difficulty breathing. If such symptoms occur, inform the doctor immediately.
• if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzapin Krka, consult a doctor or pharmacist.

• Use of Olanzapin Krka is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Olanzapin Krka, inform the doctor.
• Very rarely, this type of medicine may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation. If these symptoms occur, contact a doctor immediately.
• Weight gain has been observed in patients taking Olanzapin Krka. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients taking Olanzapin Krka. Before starting and during treatment with Olanzapin Krka, the doctor should perform blood tests to monitor blood sugar and certain lipid levels.
• Inform the doctor if the patient has had blood clots in the past, either personally or in family members, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the treating doctor immediately:

• stroke or "mini" stroke (transient ischaemic attack);
• Parkinson's disease;
• prostate gland disorders;
• intestinal obstruction (paralytic ileus);
• liver or kidney disease;
• blood disorders;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they may have low salt levels due to prolonged, severe diarrhoea, vomiting, or use of diuretics (water tablets).

If the patient has dementia and has ever had a stroke or "mini" stroke, this should be reported (by the patient or caregiver) to the doctor.
As a routine precaution, doctors may monitor blood pressure in patients over 65 years of age.

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

Olanzapin Krka with other medicines
Patients taking Olanzapin Krka should use other medicines only with the approval of a doctor.
Concomitant use of Olanzapin Krka with antidepressants, sedatives or sleeping medicines may cause drowsiness.
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

• medicines used to treat Parkinson's disease;
• carbamazepine (an anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – dose adjustment of Olanzapin Krka may be necessary.

Olanzapin Krka and alcohol
Do not drink alcohol while taking Olanzapin Krka, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine. Breastfeeding women should not take Olanzapin Krka, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Olanzapin Krka during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the newborn, contact a doctor immediately.

Driving and operating machinery
Olanzapin Krka may cause drowsiness. If drowsiness occurs, do not drive or operate any vehicles, machines or mechanical equipment. Inform the doctor.

Olanzapin Krka contains aspartame
The medicine contains 0.50 mg of aspartame in each 5 mg orodispersible tablet.
The medicine contains 0.75 mg of aspartame in each 7.5 mg orodispersible tablet.
The medicine contains 1.00 mg of aspartame in each 10 mg orodispersible tablet.
The medicine contains 1.50 mg of aspartame in each 15 mg orodispersible tablet.
The medicine contains 2.00 mg of aspartame in each 20 mg orodispersible 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 impaired excretion.

3. How to take Olanzapin Krka

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the
doctor or pharmacist.
The doctor will decide how many tablets to take and for how long to take Olanzapin Krka. The daily
dose of Olanzapin Krka ranges from 5 mg to 20 mg.
If symptoms of the illness reappear, inform the doctor. However, do not stop taking Olanzapin Krka
unless instructed by the doctor.
Olanzapin Krka tablets should be taken once daily as directed by the doctor. Try to take the medicine
at the same time each day. It does not matter whether the tablets are taken with or without food.
How to take Olanzapin Krka tablets
Olanzapin Krka orally disintegrating tablets crumble easily, so handle them with care. Do not handle
the tablets with wet hands, as they may disintegrate. To remove a tablet from the packaging:

1. Holding the blister by the edges, separate the square containing the tablet from the rest of the blister. Gently tear along the perforation.
2. Pull the edge of the foil and completely remove it.
3. Push the tablet out onto your hand.
4. Immediately after removing 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.
Alternatively, the tablet may be placed in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. The resulting mixture should be consumed immediately.
Taking more Olanzapin Krka than prescribed
In patients who have taken more than the prescribed dose of Olanzapin Krka, the following symptoms have occurred: rapid heartbeat, agitation/aggression, speech disorders, abnormal movements (especially of the facial muscles and tongue), reduced level of consciousness.
Other symptoms include confusion (disorientation), seizures, epilepsy, coma, a syndrome with fever, rapid breathing, sweating, muscle stiffness, and drowsiness; slowed breathing, choking, high or low blood pressure, irregular heartbeat.
Contact a doctor immediately or go to hospital if any of these symptoms occur. Show the doctor the tablet packaging.
If you miss a dose of Olanzapin Krka
Take the tablet as soon as you remember. Do not take a double dose to make up for a missed dose.
Stopping Olanzapin Krka treatment
Do not stop taking the tablets just because you feel better. It is important to continue taking Olanzapin Krka for as long as your doctor recommends.
If Olanzapin Krka is stopped suddenly, symptoms such as sweating, difficulty sleeping, tremors, anxiety, or nausea and vomiting may occur. The doctor may recommend gradually reducing the dose before stopping the medicine completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following occur:

• abnormal movements, especially of the face or tongue (a frequently reported adverse reaction which may occur in up to 1 in 10 patients);
• blood clots in the veins (an uncommonly reported adverse reaction which may occur in up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, redness of the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If any of these symptoms are observed, medical advice should be sought immediately;
• concomitant occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (may affect more than 1 in 10 people) include:
weight gain; drowsiness; and increased blood prolactin levels. Dizziness or fainting (with slowed heart rate) may occur early in treatment, especially when rising from a lying or sitting position. These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.
Common adverse reactions (may affect up to 1 in 10 people) include:
changes in the number of certain blood cells and blood lipid levels, and transient increase in liver enzyme activity at the beginning of treatment; increased blood and urine sugar levels; increased blood uric acid and creatine phosphokinase activity; increased appetite; dizziness; restlessness; tremor; movement disorders (dyskinesias); constipation; dryness of the oral mucosa; rash; loss of strength; extreme fatigue; fluid retention 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 adverse reactions (may affect up to 1 in 100 people) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma; seizures, usually in patients with a previous history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech disorders; stuttering; slowed heart rate; photosensitivity; nosebleeds; abdominal distension; memory loss or amnesia; urinary incontinence, difficulty urinating; hair loss; absence or reduction of menstruation; breast changes in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rarely reported adverse reactions (may affect up to 1 in 1000 people) include:
reduced body temperature; heart rhythm disturbances; sudden unexplained death; pancreatitis causing severe abdominal pain, fever, and nausea; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease manifesting as unexplained muscle aches and pain; prolonged and/or painful erection.
Very rare adverse reactions include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms resemble influenza with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and increased levels of a specific type of white blood cell (eosinophilia).
During olanzapine treatment in elderly patients diagnosed with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. There have been several fatal cases reported in these patient groups.
In patients with Parkinson's disease, Olanzapin Krka may exacerbate adverse reaction symptoms.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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 regarding 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Olanzapin Krka contains

• The active substance is olanzapine. Each orodispersible 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 hydroxypropyl cellulose, aspartame, calcium silicate, magnesium stearate. See section 2 "Olanzapin Krka contains aspartam".

What Olanzapin Krka looks like and contents of the pack
Olanzapin Krka 5 mg, orodispersible tablets: yellow, round (diameter 5.5 mm), biconvex, marbled tablets, possibly with single spots.
Olanzapin Krka 7.5 mg, orodispersible tablets: yellow, round (diameter 6.5 mm), biconvex, marbled tablets, possibly with single spots.
Olanzapin Krka 10 mg, orodispersible tablets: yellow, round (diameter 7 mm), biconvex, marbled tablets, possibly with single spots.
Olanzapin Krka 15 mg, orodispersible tablets: yellow, round (diameter 8 mm), biconvex, marbled tablets, possibly with single spots.
Olanzapin Krka 20 mg, orodispersible tablets: yellow, round (diameter 10 mm), biconvex, marbled tablets, possibly with single spots.
Pack sizes: 28 and 56 orodispersible tablets in blisters packed in a cardboard box.

Marketing Authorisation 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 Warszawa