Anzorin

Leaflet attached to the packaging: information for the user

Anzorin, 5 mg, orally disintegrating tablets

Anzorin, 10 mg, orally disintegrating tablets

Anzorin, 15 mg, orally disintegrating tablets

Anzorin, 20 mg, orally disintegrating tablets

Olanzapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Anzorin and what is it used for
• 2. Important information before taking Anzorin
• 3. How to take Anzorin
• 4. Possible side effects
• 5. How to store Anzorin
• 6. Package contents and other information

1. What is Anzorin and what is it 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 disease characterized by the patient hearing, seeing, or feeling things that do not exist in reality, having beliefs that contradict reality, being overly suspicious, and withdrawing from contact with the environment. The patient may also experience depression, anxiety, or tension;
• Moderate and severe manic episodes - a disease state characterized by excitement and euphoria.

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

2. Important information before taking Anzorin

When not to take 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 a rash, itching, swelling of the face, lip swelling, or difficulty breathing. If such symptoms occur, the doctor should be informed;
• If the patient has eye diseases, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting Anzorin, the patient should discuss it with their doctor or pharmacist.

• Anzorin is not recommended for patients of advanced age with a diagnosis of dementia, as it may cause very serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Anzorin, the doctor should be informed.
• Very rarely, these types of medicines cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• A weight gain has been observed in patients taking Anzorin. The patient, in cooperation with their doctor, should systematically check their weight. If necessary, consider consulting a dietitian or help in establishing a diet plan.
• High sugar and fat (cholesterol and triglycerides) levels have been observed in the blood of patients taking Anzorin. The doctor should order blood tests to check sugar and certain fat levels in the blood before the patient takes Anzorin and systematically during treatment.
• The doctor should be told if the patient or anyone in their family has had a history of blood clots, as the use of such medicines has been associated with the formation of blood clots.

If the patient has any of the mentioned diseases, they should immediately inform their doctor:

• stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• prostate problems;
• intestinal obstruction (paralytic);
• liver or kidney disease;
• blood diseases;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they have a salt deficiency due to prolonged severe diarrhea and vomiting or due to the use of diuretics (urinary medicines).

If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver) should tell their doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

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

Anzorin and other medicines

People taking Anzorin may only take other medicines with their doctor's consent. Taking Anzorin with antidepressant, sedative, or sleeping medicines may cause drowsiness.
The doctor should be told about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be informed if the patient is taking:

• medicines for Parkinson's disease;
• carbamazepine (an antiepileptic and mood-enhancing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - as the dose of Anzorin may need to be changed.

Anzorin with alcohol

People taking Anzorin should not drink alcohol in any form, as Anzorin in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, she should consult her doctor before taking this medicine. Women who are breastfeeding should not take Anzorin, as small amounts of it may pass into breast milk.
In newborns whose mothers took Anzorin in the last trimester of pregnancy (the last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If such symptoms are observed in the baby, the doctor should be contacted.

Driving and operating machinery

After taking Anzorin, the patient may experience drowsiness. If drowsiness occurs, the patient should not drive or operate machinery. The doctor should be informed.

Anzorin contains aspartame

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

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium in one tablet, which means the medicine is considered "sodium-free".

3. How to take Anzorin

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide what dose of Anzorin to take and for how long. The recommended daily dose of Anzorin is 5 to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Anzorin unless the doctor decides to do so.
Anzorin tablets should be taken once a day as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food. Anzorin orally disintegrating tablets are taken orally.
Anzorin tablets are easily broken, so they should be handled carefully. The patient should not touch the tablet with wet hands, as it may disintegrate.

• 1. Holding the blister by the edges, separate the designated square of the blister with the tablet from the rest. It should be torn off gently along the perforation.
• 2. Carefully peel off the back foil.
• 3. Gently push the tablet out of the blister.
• 4. Place the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easier to swallow.

The tablet can also be placed in a full glass of water, orange juice, apple juice, milk, or coffee and then mixed. Some drinks may change color or become cloudy after the tablet is added and mixed. The resulting liquid should be taken immediately.

Taking a higher dose of Anzorin than recommended

In patients who took a higher dose of Anzorin than recommended, the following symptoms occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and decreased consciousness. Other symptoms include:
severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disturbances. The doctor should be contacted immediately or the patient should go to the hospital if they notice any of these symptoms. The doctor should be shown the packaging of the tablets.

Missing a dose of Anzorin

As soon as the patient remembers, they should take the tablet. A double dose should not be taken to make up for the missed tablet.

Stopping Anzorin treatment

The patient should not stop taking Anzorin even if they feel better. It is important to take the medicine for as long as the doctor recommends.
If Anzorin is suddenly stopped, symptoms such as sweating, insomnia, trembling, anxiety, or nausea and vomiting may occur. The doctor may recommend gradually reducing the dose of Anzorin before stopping it.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Anzorin can cause side effects, although not everybody gets them.
The doctor should be told immediately if the patient experiences:

• abnormal movements (frequent side effect, which may occur in 1 in 10 patients), especially in the face or tongue;
• blood clots in the veins (uncommon side effect, which may occur in 1 in 100 patients), which particularly affect the legs (including symptoms such as swelling, pain, and redness of the legs), and can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If the patient notices any of these symptoms, they should immediately see a doctor;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of these symptoms cannot be determined from the available data).

Other side effects

Very common (may occur in more than 1 in 10 patients):

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

In the early stages of treatment, dizziness or fainting (with a decrease in heart activity) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, the doctor should be informed.

Common (may occur in less than 1 in 10 patients):

• changes in the number of certain blood cells, blood lipid levels, and initially transient increased activity of liver enzymes;
• increased blood sugar and urine levels;
• increased levels of uric acid and creatine phosphokinase in the blood;
• increased appetite;
• dizziness;
• restlessness;
• trembling;
• abnormal movements (dyskinesias);
• constipation;
• dry mouth;
• rash;
• loss of strength; extreme fatigue;
• water retention in the body, causing swelling of the hands, feet, or ankles;
• fever, joint pain;
• sexual function disorders, such as decreased libido in men and women, and erectile dysfunction in men.

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

• hypersensitivity (e.g., oral and throat swelling, itching, rash);
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the 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;
• decreased heart activity;
• sensitivity to sunlight;
• nosebleeds;
• abdominal bloating;
• drooling;
• memory loss or forgetfulness;
• urinary incontinence;
• urinary retention;
• hair loss;
• absence or cessation of menstruation;
• breast changes in men and women, such as abnormal milk production or abnormal breast enlargement.

Rare (may occur in 1 in 1,000 patients):

• decreased body temperature;
• heart rhythm disturbances;
• sudden death from an unknown cause;
• pancreatitis, causing severe abdominal pain, fever, and nausea;
• liver disease, characterized by yellowing of the skin and whites of the eyes;
• muscle disease, characterized by unexplained muscle pain and weakness;
• prolonged and (or) painful erection.

Very rare (may occur in 1 in 10,000 patients):

• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is characterized by initial symptoms of a flu-like illness with a rash on the face, followed by a widespread rash, high fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increased number of a certain type of white blood cell (eosinophilia) (the frequency of this side effect cannot be determined from the 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, and redness of the skin, as well as gait disturbances.
A few cases of death have been reported in this patient group.
In patients with Parkinson's disease, taking Anzorin may worsen the symptoms of the disease.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be told, or the nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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:
ndl@urpl.gov.pl. website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Anzorin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the words "Expiry Date:" and on the blister after the words "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Anzorin contains

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

What Anzorin looks like and what the package contains

Anzorin orally disintegrating tablets are yellow, round, convex on one side, and flat on the other.
Anzorin orally disintegrating tablets are available in OPA/Aluminum/PVC/Aluminum blisters with perforation for single doses,
in cardboard boxes containing 28, 30, 56, 98 tablets in the package.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
To obtain more detailed information about this medicine, the local representative of the marketing authorization holder should be contacted:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland:
Anzorin
Lithuania:
Olanzapine Orion 5 mg, 10 mg, 15 mg, 20 mg orally disintegrating tablets
Date of last revision of the leaflet:10.08.2022