Olanzapine Aurovitas

Leaflet attached to the packaging: information for the user

Olanzapine Aurovitas, 5 mg, tablets

Olanzapine Aurovitas, 10 mg, 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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. 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 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 contains the active substance olanzapine. 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 contact with the environment. The patient may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes - disease states whose symptoms include excitement or euphoria.

It has been shown that Olanzapine Aurovitas 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 shortness of breath. 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 to take 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, and drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• In patients taking Olanzapine Aurovitas, 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 to take 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:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Seizures
• Prostate disease
• Blocked intestine (paralytic ileus)
• Blood diseases
• Stroke or "mini" stroke (transient stroke symptoms)
• 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 medicines).

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 check 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 antidepressant, anti-anxiety, or sleep-inducing medicines (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 change of Olanzapine Aurovitas may be necessary.

Olanzapine Aurovitas with alcohol

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

Pregnancy and breastfeeding

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, excitement, breathing problems, and feeding difficulties. If such symptoms are observed in the child, the doctor should be contacted.

Driving and operating 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 lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Olanzapine Aurovitas

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will inform the patient how many tablets and for how long they should 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 them to do so.
Olanzapine Aurovitas 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 tablets are intended for oral use. The tablet should be swallowed whole, washed down with water.

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, excitement 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 disorders. 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 the missed dose.

Stopping 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 recommends.
In case of sudden stopping of Olanzapine Aurovitas, the following symptoms may occur: sweating, insomnia, trembling, anxiety, or nausea and vomiting. The doctor may recommend gradual reduction of the dose before stopping treatment.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (not very common side effect, which may affect up to 1 in 100 people), especially in the legs (symptoms include 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).

Very common side effects:(may affect more than 1 in 10 people) include weight gain; drowsiness; and 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 some blood cells, blood fat levels, and in the early period of treatment, temporary increase in liver enzyme activity.
• Increased blood sugar and urine sugar levels.
• Increased blood uric acid and creatine phosphokinase activity levels.
• 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
• Abdominal bloating
• Salivation
• Memory loss or lack of memory
• Urinary incontinence, difficulty urinating
• Hair loss
• Lack or decrease of menstrual bleeding and 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 disorders
• Sudden unexplained death
• Pancreatitis causing severe abdominal pain, fever, and nausea
• Liver disease characterized by yellowing of the skin and whites of the eyes;
• Prolonged and (or) painful erection.

Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms include flu-like symptoms with a rash on the face, and then a widespread rash, high fever, swollen lymph nodes, elevated liver enzyme activity, and increased white blood cell count (eosinophilia).
During treatment with olanzapine in elderly patients with dementia, stroke, pneumonia, urinary 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 side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this 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 stated.
There are no special precautions for storing the medicine.
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. Contents of the packaging and other information

What Olanzapine Aurovitas contains

• The active substance of the medicine is olanzapine. Each tablet contains 5 mg or 10 mg of the active substance. The exact amount is stated on the packaging of Olanzapine Aurovitas tablets.
• The other ingredients are: lactose monohydrate, crospovidone (type B), hydroxypropyl cellulose (low viscosity), and magnesium stearate.

What Olanzapine Aurovitas looks like and what the pack contains

Olanzapine Aurovitas, 5 mg, tablets: [Size approximately 6.5 mm]
Yellow, round, biconvex tablets without a coating, with the inscription "OA" on one side and "5" on the other side.
Olanzapine Aurovitas, 10 mg, tablets: [Size approximately 8 mm]
Yellow, round, biconvex tablets without a coating, with the inscription "OA" on one side and "10" on the other side.
Olanzapine Aurovitas tablets are available in cold-formed foil blisters (PVC/Aluminum/Polyamide/Aluminum), in a cardboard box.

Pack sizes:

Blisters: 28, 98, and 112 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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 5mg/10mg tablets
Poland:
Olanzapine Aurovitas

Date of last revision of the leaflet: 04/2024