Olanzapine Aurovitas

Leaflet attached to the packaging: information for the user

Olanzapine Aurovitas, 5 mg, orodispersible tablets

Olanzapine Aurovitas, 10 mg, orodispersible tablets

Olanzapine Aurovitas, 15 mg, orodispersible tablets

Olanzapine Aurovitas, 20 mg, orodispersible 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 further questions, ask your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Olanzapine Aurovitas and what is it used for

Olanzapine Aurovitas 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 are contrary to reality, being overly suspicious, and withdrawing from social contacts. The patient may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes - disease states whose symptoms are agitation or euphoria. Olanzapine prevents the recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Olanzapine Aurovitas

When not to take Olanzapine Aurovitas

• 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 been previously diagnosed with eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting treatment with Olanzapine Aurovitas, the patient should discuss it with their doctor or pharmacist.

• Olanzapine Aurovitas is not recommended for use in elderly patients with dementia, as it may cause severe side effects.
• Medicines of this type may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olanzapine Aurovitas, the doctor should be informed.
• Very rarely, medicines of this type cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, drowsiness, or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• In patients taking olanzapine, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consideration should be given to consulting a dietitian or helping to establish a diet.
• In patients taking Olanzapine Aurovitas, high blood sugar and high fat levels (triglycerides and cholesterol) have been observed. Before starting treatment with Olanzapine Aurovitas and regularly during its use, the doctor should perform blood tests to determine blood sugar and certain fat levels.
• The doctor should be informed if the patient or someone in their family has had a history of blood clots, as taking such medicines may cause blood clots.

If the patient has any of the following diseases, they should inform their doctor as soon as possible:

• Stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• Prostate diseases
• Intestinal obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Seizures
• If the patient knows they may have a salt deficiency due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (urinary medications).

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

Children and adolescents

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

Olanzapine Aurovitas and other medicines

While taking Olanzapine Aurovitas, other medicines should only be taken with the doctor's consent. Taking Olanzapine Aurovitas in combination with antidepressants, anxiolytics, or sleep aids (sedatives) may cause drowsiness. The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, the doctor should be told if the patient is taking:

• Medicines for Parkinson's disease
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Olanzapine Aurovitas may be necessary.

Olanzapine Aurovitas with alcohol

No alcohol should be consumed while taking Olanzapine Aurovitas, as it may cause drowsiness in combination with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. This medicine should not be given during breastfeeding, as small amounts of Olanzapine Aurovitas may pass into human milk. In newborns whose mothers took Olanzapine Aurovitas in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If such symptoms are observed in the child, the doctor should be contacted.

Driving and using machines

There is a risk of drowsiness after taking Olanzapine Aurovitas. In such a case, the patient should not drive vehicles or operate any tools or machines. The doctor should be informed about this.

Olanzapine Aurovitas contains aspartame

This medicine contains 0.5 mg of aspartame in each 5 mg orodispersible tablet. This medicine contains 1 mg of aspartame in each 10 mg orodispersible tablet. This medicine contains 1.5 mg of aspartame in each 15 mg orodispersible tablet. This medicine contains 2 mg of aspartame in each 20 mg orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion).

Olanzapine Aurovitas contains sodium

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

3. How to take Olanzapine Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted. The doctor will inform the patient how many tablets and how long to take Olanzapine Aurovitas. The daily dose of Olanzapine Aurovitas is from 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Olanzapine Aurovitas unless the doctor advises it. The tablets should be taken once a day as directed by the doctor. The patient should try to take the tablets at the same time every day. It does not matter whether the tablets are taken with food or without. Olanzapine Aurovitas orodispersible tablets are intended for oral use. The tablets are fragile, so they should be handled carefully. The tablets should not be taken with wet hands, as they may disintegrate. The tablet can also be placed in a glass or cup of water, orange juice, apple juice, milk, or coffee and stirred. In the case of some drinks, the mixture may change color and become cloudy. The resulting mixture should be taken immediately.

Taking a higher dose of Olanzapine Aurovitas than recommended

In patients who have taken a higher dose of Olanzapine Aurovitas than recommended, the following symptoms have occurred: rapid heartbeat, agitation or aggression, speech problems, abnormal movements (especially of the face or tongue), decreased level of consciousness. Other symptoms may include: acute confusion, 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 if any of these symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Olanzapine Aurovitas

The tablets should be taken as soon as the patient remembers. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Olanzapine Aurovitas

The patient should not stop taking the tablets just because they feel better. It is important to continue taking Olanzapine Aurovitas for as long as the doctor advises. If treatment with Olanzapine Aurovitas is stopped suddenly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, or nausea and vomiting. The doctor may advise gradual reduction of the dose before stopping treatment. If there are any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Olanzapine Aurovitas can cause side effects, although not everybody gets them. The doctor should be told immediately if the following occur:

• Abnormal movements (frequent side effect, which may affect up to 1 in 10 people), mainly of the face or tongue;
• Blood clots in the veins (uncommon side effect, which may affect up to 1 in 100 people), especially in the legs (symptoms are: swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the doctor should be contacted immediately;

• Simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be determined from the available data).

Rare side effects include: severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS syndrome, initial symptoms are flu-like symptoms with a rash on the face, and then a widespread rash, high body temperature, enlarged lymph nodes, visible liver enzyme activity in blood tests, and an increased white blood cell count (eosinophilia). Very common side effects (may affect more than 1 in 10 people) include:

• Weight gain
• Drowsiness
• Increased prolactin levels in the blood.

In the early stages of treatment, some people may experience dizziness or fainting (with slow heart rate), especially when getting 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 side effects (may affect up to 1 in 10 people) include:

• Changes in the number of certain blood cells, fat levels, and in the early treatment period, temporary increase in liver enzyme activity.
• Increased blood sugar and urine sugar levels.
• Increased uric acid and creatine phosphokinase activity in the blood.
• Increased appetite
• Dizziness
• Restlessness
• Trembling
• Movement disorders (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 and sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (may affect up to 1 in 100 people) include:

• Hypersensitivity (e.g., swelling in the mouth and throat, itching, rash)
• Diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma
• Seizures, usually related to a history of seizures (epilepsy)
• Muscle stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech disorders
• Stuttering
• Slow heart rate
• Sensitivity to sunlight
• Nosebleeds
• Bloating
• Salivation
• Memory loss or lack of memory
• Urinary incontinence
• Difficulty urinating
• Hair loss
• Absence or decrease of menstrual bleeding
• Changes in the breasts in men and women, such as abnormal milk production or unusual breast enlargement.

Rare side effects (may affect up to 1 in 1,000 people) include:

• 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.

In elderly patients with dementia, the following symptoms may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. In this particular group of patients, several fatal cases have been reported. In patients with Parkinson's disease, Olanzapine Aurovitas may worsen the symptoms of the disease.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Olanzapine Aurovitas

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. The medicine should be stored in its original packaging to protect it from moisture. 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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Olanzapine Aurovitas contains

• The active substance of the medicine is olanzapine. Each orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
• The other ingredients are: mannitol (SD 200), mannitol, potassium polyacrylate, crospovidone (type A), colloidal anhydrous silica, aspartame (E 951), microcrystalline cellulose (type 112), sodium stearyl fumarate, and ananas flavor (FL SD # 883) [contains flavoring substances and modified food starch].

What Olanzapine Aurovitas looks like and contents of the pack

Orodispersible tablets. Olanzapine Aurovitas, 5 mg, orodispersible tabletsYellow, round, flat tablets with beveled edges and engraved with "C" on one side and "51" on the other. Olanzapine Aurovitas, 10 mg, orodispersible tabletsYellow, round, flat tablets with beveled edges and engraved with "C" on one side and "52" on the other. Olanzapine Aurovitas, 15 mg, orodispersible tabletsYellow, round, flat tablets with beveled edges and engraved with "C" on one side and "53" on the other. Olanzapine Aurovitas, 20 mg, orodispersible tabletsYellow, round, flat tablets with beveled edges and engraved with "C" on one side and "54" on the other. Olanzapine Aurovitas, 5 mg, 10 mg, 15 mg, 20 mg, orodispersible tablets are available in blisters, in a cardboard box. Pack sizes: 7, 14, 21, 28, 35, 42, 56, 62, 70, 98, and 140 orodispersible tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal

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

Malta: Olanzapine Aurobindo Pharma 5 mg/10 mg/15 mg/20 mg orodispersible tablets Germany: Olanzapin PUREN 5 mg/10 mg/15 mg/20 mg orodispersible tablets Poland: Olanzapine Aurovitas

Date of last revision of the leaflet: 05/2024