Anzorin

Package leaflet: Information for the user

Anzorin, 5 mg, orodispersible tablets
Anzorin, 10 mg, orodispersible tablets
Anzorin, 15 mg, orodispersible tablets
Anzorin, 20 mg, orodispersible tablets
Olanzapine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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.

Table of contents of the leaflet

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

1. What Anzorin is and what it is used for

Anzorin contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disorder in which the patient hears, sees or feels things that do not exist in reality, has beliefs that are not in accordance with reality, is excessively suspicious and withdraws from contact with others. The patient may also experience depression, anxiety or tension;
• Moderate to severe manic episodes – a medical condition characterized by excitement and euphoria.

Anzorin prevents the recurrence of these symptoms in patients with bipolar disorder who have previously responded positively to olanzapine treatment during manic episodes.

2. Information before using Anzorin

When not to use Anzorin:

• 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, swelling of the 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 Anzorin, discuss this with your doctor or pharmacist.

• Use of Anzorin is not recommended in elderly patients diagnosed with dementia, as it may lead to very serious adverse effects.
• Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Anzorin, 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 these symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking Anzorin. The patient, in cooperation with the doctor, should regularly monitor body weight. If necessary, consider consulting a dietitian or seeking help in establishing a dietary plan.
• Elevated levels of blood sugar and fats (cholesterol and triglycerides) have been observed in patients taking Anzorin. Your doctor should order blood tests to check blood sugar and certain fat levels before starting Anzorin and periodically during treatment.
• Inform your doctor if the patient or any family member has a history of blood clots, as use of medicines like this has 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 problems;
• intestinal obstruction (paralytic ileus);
• liver or kidney disease;
• blood disorders;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they have low salt levels due to prolonged severe diarrhea and vomiting, or due to use of diuretics (water pills).

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

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

Anzorin with other medicines
Patients taking Anzorin should use other medicines only with the approval of a doctor. Concomitant use of Anzorin with antidepressants, sedatives, or sleeping medications may cause drowsiness.
Inform your doctor about all medicines currently used, recently taken, or planned for use.
In particular, inform your doctor if the patient is taking:

• medicines for Parkinson's disease;
• carbamazepine (an anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as dose adjustment of Anzorin may be necessary.

Anzorin and alcohol
Patients taking Anzorin must not consume alcohol in any form, as Anzorin combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
During pregnancy, when breastfeeding, when pregnancy is suspected, or when planning pregnancy, consult a doctor before using this medicine. Women who are breastfeeding should not take Anzorin, as small amounts may pass into breast milk.
Newborns whose mothers took Anzorin during the third trimester of pregnancy (last 3 months) 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 child, contact your doctor.

Driving and operating machinery
Drowsiness may occur after taking Anzorin. If drowsiness occurs, do not drive or operate machinery. Inform your doctor.

Anzorin contains aspartame
This medicine contains 1.5 mg of aspartame in the 5 mg tablet, 3 mg of aspartame in the 10 mg tablet, 4.5 mg of aspartame in the 15 mg tablet, and 6 mg of aspartame in the 20 mg tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Anzorin

This medicine should always be used exactly as your doctor has instructed. If you are unsure,
you should consult your doctor or pharmacist.
Your doctor will decide how many Anzorin tablets you should take and for how long. The recommended
daily dose of Anzorin is 5 to 20 mg. If symptoms of the disease recur, you should inform your doctor.
However, do not stop taking Anzorin unless your doctor advises you to do so.
Anzorin 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.
Anzorin orally disintegrating tablets are taken by mouth.
Anzorin tablets are fragile and should therefore be handled with care. Do not touch the tablet with
wet hands, as it may break apart.

1. Holding the blister pack at the edges, separate the individual blister square containing the tablet from the rest. Gently tear along the perforation.
2. Carefully peel back the backing foil.
3. Gently push the tablet out of the blister.
4. Place the tablet in the mouth. The tablet will dissolve directly in the oral cavity, making it easier to swallow.

The tablet may also be placed in a full glass of water, orange juice, apple juice, milk, or coffee and then stirred. Some beverages may change color or become cloudy after the tablet is added and stirred. The prepared liquid should be consumed immediately.
Taking more Anzorin than recommended
In patients who have taken more than the recommended dose of Anzorin, the following symptoms
have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary
movements (especially of the facial muscles and tongue), and reduced consciousness. Other symptoms
include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever,
rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy, decreased breathing rate,
choking, high or low blood pressure, and heart rhythm disturbances. You should contact your doctor
immediately or go to a hospital if you experience any of these symptoms. Show the doctor the
medicine packaging.
If you forget to take Anzorin
Take the missed tablet as soon as you remember. Do not take a double dose to make up for a missed
tablet.
Stopping Anzorin
Do not stop taking Anzorin just because you feel better. It is important to continue taking the
medicine for as long as your doctor has instructed.
If you stop taking Anzorin suddenly, symptoms such as sweating, difficulty falling asleep, 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 inform the doctor immediately if the patient experiences:

• abnormal movements (a common adverse reaction, which may occur in 1 out of 10 patients), especially affecting the face or tongue;
• blood clots in the veins (an uncommon adverse reaction, which may occur in 1 out of 100 patients), particularly in the legs (including symptoms such as swelling, pain and redness of the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If the patient notices any of these symptoms, they should seek medical advice immediately;
• occurrence of fever together with rapid breathing, sweating, muscle stiffness and drowsiness or lethargy (the frequency of these symptoms cannot be determined from available data).

Other adverse reactions
Very common (may affect more than 1 in 10 patients):

• weight gain;
• drowsiness;
• increased prolactin levels in blood.

Dizziness or fainting (with slowing of 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, the doctor should be informed.
Common (may affect less than 1 in 10 patients):

• 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 levels of uric acid and creatine phosphokinase in blood;
• increased feeling of hunger;
• dizziness;
• restlessness;
• tremor;
• abnormal movements (dyskinesias);
• constipation;
• dryness of the oral mucosa;
• rash;
• loss of strength; extreme fatigue;
• fluid retention leading to swelling of the hands, feet or ankles;
• fever, joint pain;
• sexual dysfunction, such as decreased libido in men and women, and erectile dysfunction in men.

Uncommon (may affect less than 1 in 100 patients):

• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash);
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma;
• seizures, usually in patients with a history of seizures (epilepsy);
• muscle stiffness or spasms (including muscles responsible for eye movements);
• restless legs syndrome;
• speech disorders;
• stuttering;
• slowing of heart rate;
• photosensitivity;
• nosebleeds;
• abdominal distension;
• hypersalivation;
• memory loss or forgetfulness;
• urinary incontinence;
• urinary retention;
• hair loss;
• absence or cessation of menstruation;
• breast changes in men and women such as unusual milk production or unusual breast enlargement.

Rare (may affect up to 1 in 1,000 patients):

• decreased 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 tenderness and pain;
• prolonged and/or painful erection.

Very rare (may affect up to 1 in 10,000 patients):

• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents with influenza-like symptoms and a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a certain type of white blood cells (eosinophilia) (the frequency of this adverse reaction cannot be determined from available data).

In elderly patients with dementia treated with olanzapine, the following may occur:
stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations,
increased body temperature, skin redness, and disturbances in normal gait.
There have been several reports of death in this patient group.
In patients with Parkinson's disease, treatment with Anzorin may worsen symptoms of the disease.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, e-mail:
[email protected]. Website: https://smz.ezdrowie.gov.pl
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 Anzorin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after the words "Expiry date (EXP):" and on the blister pack after the word "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Anzorin contains

• The active substance is olanzapine. One orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
• Other ingredients are microcrystalline cellulose (E 460a), mannitol (E 421), pregelatinized starch (corn), crospovidone, sodium lauryl sulfate, aspartame (E 951), guar gum (E 412), colloidal anhydrous silica (E 551), magnesium stearate (E 572).

What Anzorin looks like and contents of the pack
Anzorin orodispersible tablets are yellow, round, convex on one side and flat on the other.
Anzorin orodispersible tablets are available in blisters made of OPA/Aluminium/PVC/Aluminium with perforation for single doses, packed in cardboard boxes containing 28, 30, 56, or 98 tablets per package.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Poland: Anzorin
Lithuania: Olanzapine Orion 5 mg, 10 mg, 15 mg, 20 mg burnosios disperguojamosios tabletės