Olanzapine krka

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Olanzapin Krka is and what it is used for
2. What you need to know 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 Olanzapin Krka is and what it is 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 in which patients hear, see, or sense things that do not exist in reality, have beliefs that are not based on reality, are excessively suspicious, and withdraw from social contact. Patients may also experience depression, anxiety, or tension;
• moderate to severe manic episodes – illness states characterized by excitement or euphoria.

Olanzapin Krka has been shown to prevent 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 very 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, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy. If such symptoms occur, contact a doctor immediately.
• Weight gain has been observed in patients treated with Olanzapin Krka. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing a proper diet.
• Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients taking Olanzapin Krka. Before initiating and during treatment with Olanzapin Krka, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform the doctor if the patient or a family member has a history of blood clots, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the treating doctor as soon as possible:

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

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 and other medicines
Patients taking Olanzapin Krka should use other medicines only under the guidance of a doctor.
Concomitant use of Olanzapin Krka with antidepressants, sedatives, or hypnotics may cause drowsiness.
Inform the doctor about all medicines currently used, recently taken, or planned for use.
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) – a 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 become pregnant, she should consult a doctor before using this medicine. Women who are breastfeeding 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 problems. 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 motor vehicles or operate any machines or mechanical equipment. Inform the doctor.

Olanzapin Krka contains lactose
If the patient has been diagnosed by a doctor with an intolerance to certain sugars, consult the doctor before taking this medicine.

3. How to take Olanzapin Krka

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will decide how many tablets you should take and for how long you should continue
treatment with Olanzapin Krka. The daily dose of Olanzapin Krka ranges from 5 mg to 20 mg.
If symptoms of the illness reappear, you should inform your doctor. However, do not stop taking
Olanzapin Krka unless your doctor specifically advises you to do so.
Olanzapin Krka tablets should be taken once daily, as directed by your doctor. Try to take the
medicine at the same time each day. It does not matter whether you take the tablets with or
without food.
Swallow the tablet whole with water.

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
characterized by fever, rapid breathing, sweating, muscle stiffness, and drowsiness; slowed
breathing, choking, high or low blood pressure, irregular heartbeat.
If any of the above symptoms occur, contact your doctor immediately or go to a hospital.
Show the doctor the medicine packaging.

Missing a dose of Olanzapin Krka
Take the missed dose as soon as you remember. Do not take a double dose to make up for a
missed dose.

Stopping Olanzapin Krka
Even if you feel better, do not stop taking the tablets. It is important to continue taking
Olanzapin Krka for as long as your doctor recommends.
If you suddenly stop taking Olanzapin Krka, symptoms such as sweating, difficulty sleeping,
tremors, anxiety, or nausea and vomiting may occur. Your 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 immediately inform your doctor if any of the following occur:

• abnormal movements, especially of the face or tongue (a commonly 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 blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms are observed, medical advice should be sought immediately;
• occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sedation at the same time (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (may occur in more than 1 in 10 patients) include:
weight gain; drowsiness; and increased blood prolactin levels. In the early stages of treatment, dizziness or fainting (with slowed heart function) may occur, particularly 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 occur in up to 1 in 10 patients) include:
changes in the number of certain blood cells and blood lipid levels, and transient increases in liver enzyme activity at the beginning of treatment; increased blood and urine glucose levels; increased blood uric acid and creatine phosphokinase activity; increased appetite; dizziness; restlessness; tremor; movement disorders (dyskinesias); constipation; dryness of the oral mucosa; rash; weakness; 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 occur in up to 1 in 100 patients) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma; seizures, usually in patients who have previously experienced seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech disorders; stuttering; slowed heart function; 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 the breastfeeding period or unusual breast enlargement.

Rarely reported adverse reactions (may occur in up to 1 in 1,000 patients) 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 are flu-like with facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and elevated levels of a specific type of white blood cells (eosinophilia).

During treatment with olanzapine 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 gait disturbances. There have been several fatal cases reported in these patient groups.

In patients with Parkinson's disease, the medicine Olanzapin Krka may worsen 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
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 the medicine.

5. How to store Olanzapin Krka

Keep this 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 for this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack 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.
• The other ingredients are: lactose monohydrate; cellulose, powdered; pregelatinized corn starch; corn starch; colloidal anhydrous silicon dioxide; magnesium stearate. See section 2, "Olanzapin Krka contains lactose".

What Olanzapin Krka looks like and contents of the pack
Olanzapin Krka, 5 mg, tablets: round (7 mm in diameter), slightly biconvex, light yellow tablets with possible single yellow specks and marked with the number "5"
Olanzapin Krka, 10 mg, tablets: round (9 mm in diameter), slightly biconvex, light yellow tablets with possible single yellow specks and marked with the number "10"
Olanzapin Krka, 15 mg, tablets: round (11 mm in diameter), slightly biconvex, light yellow tablets with possible single yellow specks and marked with the number "15"
Olanzapin Krka, 20 mg, tablets: round (12 mm in diameter), slightly biconvex, light yellow tablets with possible single yellow specks and marked with the number "20"
Packaging: 28 and 56 tablets in blister packs contained 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., Równoległa Street, 02-235 Warsaw, Poland