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 all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

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 contact with others. The patient may also experience depression, anxiety, or tension.
• moderate to severe manic episodes – medical conditions 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 your 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.

• Olanzapin Krka is not recommended for 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 your 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 your 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 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, your doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform your doctor if the patient has ever had blood clots in the past, or if there is a family history of thrombosis, 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 and 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 hypnotics may cause drowsiness.
Inform your doctor about all medicines currently used, recently used, or planned for use.
In particular, inform your 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 become pregnant, she should consult her 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 problems. If any of these 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 your doctor.

Olanzapin Krka contains aspartame
The medicine contains 0.50 mg of aspartame in each orally disintegrating tablet of 5 mg strength.
The medicine contains 0.75 mg of aspartame in each orally disintegrating tablet of 7.5 mg strength.
The medicine contains 1.00 mg of aspartame in each orally disintegrating tablet of 10 mg strength.
The medicine contains 1.50 mg of aspartame in each orally disintegrating tablet of 15 mg strength.
The medicine contains 2.00 mg of aspartame in each orally disintegrating tablet of 20 mg strength.
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 as directed by the doctor. If in doubt, consult a
doctor or pharmacist.
The doctor will decide how many tablets and for how long Olanzapin Krka should be taken. The daily
dose of Olanzapin Krka ranges from 5 mg to 20 mg.
If symptoms of the illness recur, 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 orodispersible tablets disintegrate easily in the mouth and therefore must be
handled with care. Do not handle the tablets with wet hands, as they may disintegrate. To remove a tablet from the packaging:

1. Hold the blister by the edges and separate the square containing the tablet from the rest of the blister. Tear gently 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 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.
Alternatively, the tablet may be placed in a glass or cup of water, orange juice, apple juice,
milk, or coffee and stirred. With some beverages, the mixture may change colour and become cloudy.
The resulting mixture should be drunk 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 facial muscles and tongue), decreased level of consciousness.
Other symptoms include confusion (disorientation), seizures, epilepsy, coma, a syndrome with
fever, rapid breathing, sweating, muscle stiffness and drowsiness; slowed breathing rate, choking,
high or low blood pressure, irregular heartbeat.
Seek immediate medical attention or go to hospital if any of the above symptoms occur. Show the
doctor the tablet packaging.
If you forget to take 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 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, nausea, or 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 effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
You should contact your doctor immediately if any of the following occur:

• abnormal movements, especially of the face or tongue (a frequently reported adverse effect which may occur in up to 1 in 10 patients);
• blood clots in the veins (an uncommonly reported adverse effect which may occur in up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain and 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;
• concomitant occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy (the frequency of this adverse effect cannot be determined from the available data).

Very common adverse effects (may affect more than 1 in 10 patients) include:
weight gain; drowsiness and increased blood prolactin levels. Dizziness or fainting (with slowed heart rate) may occur early in treatment, particularly when standing up from a lying or sitting position. These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.

Common adverse effects (may affect 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 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; 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 effects (may affect up to 1 in 100 patients) 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 who have previously experienced 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 the breastfeeding period or unusual breast enlargement.

Rarely reported adverse effects (may affect up to 1 in 1,000 patients) include:
decreased body temperature; heart rhythm disturbances; sudden death of unknown cause; 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 tenderness and pain; prolonged and/or painful erection.

Very rare adverse effects 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 in blood tests, and elevated levels of a specific type of white blood cell (eosinophilia).

In elderly patients with dementia treated with olanzapine, 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 worsen adverse effects.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of 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 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects 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.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer 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 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 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 5, 02-235 Warsaw, Poland