Olanzapine Aurovitas

Package Leaflet: 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 package leaflet carefully before taking the medicine, as it contains important information for you.

Keep this package leaflet. You may need to read it again.
In case of any doubts, consult 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 package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package 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 package 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 hearing, seeing, or feeling things that do not exist in reality, having beliefs that are not true, 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 you are 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 shortness of breath. If such symptoms occur, inform your doctor.
• If you have been diagnosed with eye disorders, such as certain types of

glaucoma (increased eye pressure).

Warnings and precautions

Before taking Olanzapine Aurovitas, discuss it with your 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 you experience such a symptom after taking Olanzapine Aurovitas, inform your doctor.
• Very rarely, medicines of this type cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapine. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help with diet planning.
• In patients taking Olanzapine Aurovitas, high blood sugar and high fat levels (triglycerides and cholesterol) have been observed. Before starting and regularly during treatment with Olanzapine Aurovitas, your doctor should perform blood tests to determine blood sugar and certain fat levels.
• Tell your doctor if you or a family member have had blood clots in the past, as taking such medicines may cause blood clots.

If you have any of the following diseases, inform your 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 you know you have a salt deficiency due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (diuretic medicines).

If you have dementia and have had a stroke or "mini" stroke, you, your caregiver, or a family member should inform your 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, take other medicines only with your doctor's consent.
Taking Olanzapine Aurovitas in combination with antidepressant, anti-anxiety, or sleep-inducing medicines (sedatives) may cause drowsiness.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are 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

Do not drink any alcohol while taking Olanzapine Aurovitas, as it may cause drowsiness when combined with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Do not take this medicine 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, contact your doctor.

Driving and using machines

There is a risk of drowsiness after taking Olanzapine Aurovitas. In such a case, do not drive vehicles or operate any tools or machines. Inform your doctor.

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

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take and for how long to take Olanzapine Aurovitas.
The daily dose of Olanzapine Aurovitas is between 5 mg and 20 mg. If symptoms of the disease recur, inform your doctor. However, do not stop taking Olanzapine Aurovitas unless your doctor tells you to.
Take the tablets once a day as directed by your doctor.
Try to take the tablets at the same time every day. It does not matter whether the tablets are taken with or without food. Olanzapine Aurovitas orodispersible tablets are intended for oral use.
The tablets are fragile, so handle them carefully.
Do not handle the tablets with wet hands, as they may disintegrate.
You can also put the tablet in a glass or cup of water, orange juice, apple juice, milk, or coffee and stir. With some drinks, the mixture may change color and become cloudy. Drink the mixture immediately.

Taking more Olanzapine Aurovitas than prescribed

In patients who have taken more Olanzapine Aurovitas than prescribed, the following symptoms have occurred: rapid heartbeat, agitation or aggression, speech problems, abnormal movements (especially of the face or tongue), and 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, and heart rhythm disturbances. Contact your doctor immediately or go to the hospital if you experience any of these symptoms. Show your doctor the package of tablets.

Missing a dose of Olanzapine Aurovitas

Take the tablets as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping treatment with Olanzapine Aurovitas

Do not stop taking the tablets just because you feel better. It is important to continue taking Olanzapine Aurovitas for as long as your doctor recommends.
If you suddenly stop taking Olanzapine Aurovitas, you may experience symptoms such as sweating, insomnia, trembling, anxiety, or nausea and vomiting. Your doctor may recommend gradually reducing the dose of Olanzapine Aurovitas before stopping treatment.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapine Aurovitas can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience:

• Abnormal movements (very common 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 bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately;

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

• Very rare side effects include: severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like 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 standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include:

• Changes in the number of certain blood cells, fat levels, and early in treatment, temporary increases 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 (dyskinesia)
• 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 unexplained death
• 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.

When taking olanzapine in elderly patients with dementia, stroke, pneumonia, incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties have been reported. 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 you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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, you can help provide more information on the safety of this medicine.

5. How to store Olanzapine Aurovitas

Keep the medicine out of the 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 month.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Olanzapine Aurovitas contains

• The active substance 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 flavorings and modified food starch].

What Olanzapine Aurovitas looks like and contents of the package

Orodispersible tablets.
Olanzapine Aurovitas, 5 mg, orodispersible tablets
Yellow, round, flat tablets with beveled edges, engraved with "C" on one side and "51" on the other.
Olanzapine Aurovitas, 10 mg, orodispersible tablets
Yellow, round, flat tablets with beveled edges, engraved with "C" on one side and "52" on the other.
Olanzapine Aurovitas, 15 mg, orodispersible tablets
Yellow, round, flat tablets with beveled edges, engraved with "C" on one side and "53" on the other.
Olanzapine Aurovitas, 20 mg, orodispersible tablets
Yellow, round, flat tablets with beveled edges, 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.
Package sizes: 7, 14, 21, 28, 35, 42, 56, 62, 70, 98, and 140 orodispersible tablets.
Not all package 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 package leaflet: 05/2024