Olzapin

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Package leaflet: Information for the user

Olzapin, 15 mg, coated tablets
Olzapin, 20 mg, coated tablets
Olanzapinum

Read the entire leaflet carefully before taking this medicine, because it contains important information for the patient.

• 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 other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents

1. What Olzapin is and what it is used for
2. Important information before taking Olzapin
3. How to take Olzapin
4. Possible side effects
5. How to store Olzapin
6. Contents of the pack and other information

1. What Olzapin is and what it is used for

Olzapin contains the active substance olanzapine. Olzapin belongs to a group of medicines called antipsychotics and is used to treat:

• schizophrenia – a disorder characterized by patients hearing, seeing, or sensing things that do not exist in reality, having beliefs that contradict reality, being excessively suspicious and withdrawing from social interactions. 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 Olzapin prevents the 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 using Olzapin

When not to take Olzapin

• if the patient is allergic to olanzapine, or to any of the other ingredients of this medicine (listed in section 6), peanuts or soy. An allergic reaction may manifest as a rash, itching, facial swelling, swollen lips 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 Olzapin, discuss this with your doctor or pharmacist.

• Use of Olzapin 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 Olzapin, inform your doctor.
• Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation. If such symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking Olzapin. 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 glucose levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking Olzapin. Before starting and during treatment with Olzapin, 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 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 lost body salts due to prolonged, severe diarrhea and vomiting (nausea with 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
Olzapin is not intended for use in patients under 18 years of age.

Olzapin and other medicines
Patients taking Olzapin should use other medicines only with the approval of a doctor. Concomitant use of Olzapin with antidepressants, sedatives or hypnotics may cause drowsiness.
Inform the doctor about all medicines currently 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) – a dose adjustment of Olzapin may be necessary.

Use of Olzapin with alcohol
Do not drink alcohol after taking Olzapin, 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 her doctor before using this medicine. Women who are breastfeeding should not take Olzapin, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Olzapin 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 your newborn, contact your doctor immediately.

Driving and operating machinery
Olzapin may cause drowsiness. If drowsiness occurs, do not drive motor vehicles or operate any machines or mechanical equipment. Inform your doctor.

Olzapin contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Olzapin contains lecithin
This medicine contains lecithin of soy origin. Do not use if hypersensitivity to peanuts or soy has been diagnosed.

3. How to take Olzapin

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Adults
Your doctor will decide how many tablets to take and for how long to take Olzapin. The daily dose of
Olzapin ranges from 5 mg to 20 mg. If symptoms of the illness recur, inform your doctor. However, do
not stop taking Olzapin unless your doctor advises you to do so.
Olzapin 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 the tablets are taken with or without food. Olzapin
coated tablets are taken orally. The tablet should be swallowed whole with water.
Taking more Olzapin than prescribed
In patients who have taken more than the prescribed dose of Olzapin, the following symptoms have
occurred: rapid heartbeat, agitation or aggressive behaviour, difficulty speaking, involuntary movements
(particularly of the facial and tongue muscles), and reduced consciousness. Other symptoms include:
acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid
breathing, sweating, muscle rigidity, and drowsiness or somnolence, reduced respiratory rate, choking,
high or low blood pressure, and cardiac arrhythmias. Seek immediate medical attention or go to the
hospital if any of these symptoms occur. Show the doctor the medicine packaging.
Missed dose of Olzapin
Take the missed tablet as soon as you remember. Do not take a double dose to make up for a missed
dose.
Stopping Olzapin treatment
Do not stop taking the tablets even if you feel better. It is important to continue taking Olzapin for as
long as your doctor recommends.
If Olzapin is stopped abruptly, the following symptoms may occur: sweating,
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insomnia, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the
dose before stopping treatment 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 affect up to 1 in 10 patients);
• blood clots in the veins (a less frequently reported adverse reaction, which may affect 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 occur, seek medical advice immediately.
• concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy (the frequency of this adverse reaction cannot be determined based on available data).

Very common adverse reactions (which may affect 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 (which may affect up to 1 in 10 patients) include:
changes in the count of certain blood cells, 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 kinase activity, increased appetite, dizziness, anxiety, tremor, movement disorders (dyskinesias), constipation, dryness of the oral mucosa,
rash, weakness, extreme fatigue, fluid retention causing swelling of the hands, feet, or around the ankles, fever, joint pain, and sexual disorders such as decreased libido in
men and women or erectile dysfunction in men.
Less common adverse reactions (which may affect up to 1 in 100 patients) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash), diabetes or worsening of diabetes, occasionally with ketoacidosis (presence of ketone compounds in blood and urine) or coma, seizures, usually in patients who previously had seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome,
speech disorders, stuttering, slowed heart function, photosensitivity, nosebleeds, abdominal bloating, salivation, memory loss or amnesia, urinary incontinence, difficulty urinating, hair loss, absence or reduction of menstruation, breast changes in men and women, such as milk discharge outside of breastfeeding or unusual breast enlargement.
Rarely reported adverse reactions (which may affect up to 1 in 1000 patients):
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 serious allergic reactions, such as: drug reaction with eosinophilia and systemic symptoms (DRESS), which initially presents as flu-like symptoms with facial rash, followed by widespread rash, high fever, swollen lymph nodes, elevated liver enzyme activity evident in blood tests, and increased count of one type of white blood cells (eosinophilia).
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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. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, Olzapin may worsen adverse reaction symptoms.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or nurse. 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.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Olzapin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Olzapin should be stored in the original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Olzapin contains

• The active substance is olanzapine. Each coated tablet contains 15 mg or 20 mg of the active substance. The specific strength is indicated on the Olzapin packaging.
• The other ingredients (excipients) are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, crospovidone, hydroxypropylcellulose, talc, magnesium stearate.

Tablet coating: Opadry AMB White OY-B-28920 [lecithin (E322), polyvinyl alcohol, talc, xanthan gum (E415), titanium dioxide (E171)].

• Additionally:
• Olzapin 15 mg tablets contain the coating Opadry AMB Grey 80W26503 [polyvinyl alcohol, lecithin (E322), talc, xanthan gum (E415), titanium dioxide (E171), indigo carmine, lac dye (E132), yellow iron oxide (E172), black iron oxide (E172)].
• Olzapin 20 mg tablets contain the coating Opadry AMB Pink 80W24003 [polyvinyl alcohol, lecithin (E322), talc, xanthan gum (E415), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)].

What Olzapin looks like and contents of the pack

Olzapin 15 mg: light blue, elongated, biconvex coated tablets.
Olzapin 20 mg: pink, elongated, biconvex coated tablets.

Olzapin is available in packages containing 28 or 56 tablets, packed in blisters made of PA/Aluminium/PVC/Aluminium.
The blisters are placed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
tel.: (+48)(22) 785 27 60
fax: (+48)(22) 785 27 60 ext. 106
Poland

Manufacturer
Pharmathen S.A.
6, Dervenakion Str.
153 51 Pallini, Attiki
Greece