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. You may need to read it again.
• If you have any further questions, 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 disease characterized by hearing, seeing or sensing things that do not exist in reality, having beliefs that are not based on reality, being excessively suspicious and withdrawing from social interactions. The patient may also experience depression, anxiety or tension.
• moderate to severe manic episodes – illness 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.

• 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 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 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 a proper 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 glucose and certain lipid levels.
• Inform the doctor if the patient has previously had blood clots, or if there is a family 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 immediately:

• stroke or "mini" stroke (transient ischemic 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 diarrhea, vomiting, or use of diuretics (water pills).

If the patient has dementia and has ever had a stroke or "mini" stroke, the patient (or caregiver) should inform 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.
Taking Olanzapin Krka together with antidepressants, sedatives, or sleeping medicines may cause drowsiness.
Inform the doctor about all medicines currently taken or recently used, 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 antiepileptic 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 have a baby, she should consult a doctor before taking 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 three 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 or operate any machinery or mechanical equipment. Inform the 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 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 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 taking Olanzapin Krka. The daily dose of Olanzapin Krka ranges from 5 mg to 20 mg.
If symptoms of the illness return, you should inform your doctor. However, do not stop taking Olanzapin Krka unless your doctor 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.

How to take Olanzapin Krka
Olanzapin Krka orodispersible tablets disintegrate easily in the mouth, so they 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 carefully separate the square containing the tablet from the rest of the blister, tearing gently along the perforation.
2. Pull the edge of the foil and completely peel it back.
3. Push the tablet out onto your hand.
4. Immediately after removal from the packaging, place the tablet on your 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 can be placed in a glass or cup containing water, orange juice, apple juice, milk, or coffee and stirred. With some drinks, the mixture may change colour and become cloudy. The resulting mixture should be consumed immediately.

If you take more Olanzapin Krka than you should
In patients who have taken an overdose of Olanzapin Krka, the following symptoms have been reported: rapid heartbeat, agitation/aggression, speech disorders, abnormal movements (especially of the facial muscles and tongue), and reduced level of consciousness.
Other symptoms include confusion (disorientation), seizures, epilepsy, coma, a syndrome characterised by fever, rapid breathing, sweating, muscle rigidity, and drowsiness; slowed breathing rate, choking, high or low blood pressure, and irregular heartbeat.
If any of these symptoms occur, seek immediate medical attention by contacting your doctor or going to hospital. Show the doctor the medicine 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 forgotten dose.

Stopping Olanzapin Krka
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 has prescribed.
If Olanzapin Krka is stopped abruptly, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

You should immediately inform your doctor if any of the following occur:

• involuntary 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 (a not very common 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 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 lethargy 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 increase 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.

Rare adverse reactions (may occur in up to 1 in 1000 patients) include:
lowering of normal 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 elevated 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 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 Reactions of Medicinal Products 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
Faks: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Olanzapin Krka

Keep this medicine out of 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 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., ul. Równoległa 5, 02-235 Warsaw