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
Olanzapinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:

1. What Olanzapine Aurovitas is and what it is 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 pack and other information

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

Olanzapine Aurovitas 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 senses things that do not exist in reality, has beliefs that are contrary to reality, is excessively suspicious and withdraws from social contact. The patient may also experience depression, anxiety or tension.
• Moderate to severe manic episodes – disease states characterized by excitement or euphoria. Olanzapine prevents recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment during a manic episode.

2. Important information before using Olanzapine Aurovitas

When not to use 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 rash, itching, facial swelling, lip swelling or shortness of breath. If such symptoms occur, inform the doctor immediately.
• If the patient has previously been diagnosed with eye disorders such as certain types of

glaucoma (increased pressure in the eye).
Warnings and precautions
Before starting treatment with Olanzapine Aurovitas, discuss this with the doctor or pharmacist.

• Olanzapine Aurovitas is not recommended for elderly patients with dementia, as it may cause severe adverse reactions.
• Medicines of this type may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Olanzapine Aurovitas, inform the doctor.
• Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sleepiness. If such symptoms occur, contact the doctor immediately.
• Weight gain has been observed in patients taking olanzapine. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing a proper diet.
• Elevated blood sugar levels and increased levels of fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine Aurovitas. Before starting treatment with Olanzapine Aurovitas and regularly during treatment, the doctor should perform blood tests to monitor blood glucose and certain fat levels.
• Inform the doctor if the patient or a family member has a history of blood clots, as use of such medicines may increase the risk of blood clot formation.

If the patient has any of the following conditions, inform the doctor as soon as possible:

• Stroke or "mini" stroke (transient ischemic attack)
• Parkinson's disease
• Prostate gland disorders
• Bowel obstruction (paralytic ileus)
• Liver or kidney disorders
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If the patient knows they may have salt deficiency due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or use of diuretics (water pills).

If the patient has dementia and has ever had a stroke or "mini" stroke, the patient, their caregiver, or relative should inform the doctor.
As a routine precaution, doctors may monitor blood pressure in patients over 65 years of age.
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 on the advice of a doctor. Taking Olanzapine Aurovitas together with antidepressants, anxiolytics, or sleep aids (sedatives) may cause drowsiness.
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the 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) – a dose adjustment of Olanzapine Aurovitas may be necessary.

Olanzapine Aurovitas and alcohol
Do not consume any alcohol while taking Olanzapine Aurovitas, as alcohol combined with this medicine may increase drowsiness.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult the doctor before using this medicine.
This medicine should not be used during breastfeeding, as small amounts of Olanzapine Aurovitas may pass into human milk.
Newborns whose mothers used Olanzapine Aurovitas during the third trimester (last three months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor.
Driving and operating machinery
There is a risk of drowsiness after taking Olanzapine Aurovitas. In such a case, the patient should not drive or operate any tools or machinery. Inform the doctor 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 for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Olanzapine Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Olanzapine Aurovitas

This medicine should always be taken as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will inform you how many tablets to take and for how long you should continue taking Olanzapine Aurovitas.
The daily dose of Olanzapine Aurovitas ranges from 5 mg to 20 mg. If symptoms of the illness recur, inform your doctor.
However, do not stop taking Olanzapine Aurovitas unless instructed by your doctor.
Olanzapine Aurovitas tablets should be taken once daily as directed by your doctor.
Try to take the tablets at the same time each day. It does not matter whether the tablets are taken with or without food.
Orally disintegrating tablets of Olanzapine Aurovitas are intended for oral use.
Olanzapine Aurovitas tablets disintegrate easily and should therefore be handled with care.
Do not handle the tablets with wet hands, as they may disintegrate.
Alternatively, the tablet may be placed in a glass or cup of water, orange juice, apple juice, milk, or coffee and stirred.
With some beverages, the mixture may change colour and become cloudy. The resulting mixture should be consumed immediately.
Taking more Olanzapine Aurovitas than prescribed
In patients who have taken more than the prescribed dose of Olanzapine Aurovitas, the following symptoms have occurred:
rapid heartbeat, agitation or aggression, difficulty speaking, unusual movements (especially of the face and tongue), reduced level of consciousness.
Other symptoms may include: acute confusion, seizures (epilepsy), coma, development of fever together with rapid breathing, sweating, muscle stiffness, and drowsiness or sedation, reduced breathing rate, choking, high or low blood pressure, irregular heart rhythm.
Seek immediate medical attention or go to a hospital if any of these symptoms occur. Show the tablet packaging to the doctor.
If you forget to take Olanzapine Aurovitas
Take the tablet as soon as you remember. Do not take a double dose to make up for a missed dose.
Stopping 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 Olanzapine Aurovitas is stopped abruptly, symptoms such as sweating, difficulty sleeping, tremor, restlessness, nausea, or vomiting may occur.
Your doctor may advise gradually reducing the dose before stopping treatment 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 your doctor immediately if any of the following occur:

• Unusual movements (a common adverse reaction, which may affect up to 1 in 10 people), mainly of the face or tongue;
• Blood clots in the veins (an uncommon adverse reaction, which may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, you should

contact your doctor immediately;

• Concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sedation (the frequency of this adverse reaction cannot be determined from available data).

Very rare adverse reactions include: severe allergic reactions, such as drug reaction with
eosinophilia and systemic symptoms (DRESS). In DRESS syndrome, initial symptoms resemble influenza with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity in blood tests, and increased white blood cell count (eosinophilia).
Very common adverse reactions (may affect more than 1 in 10 people) include:

• Weight gain
• Drowsiness
• Increased blood prolactin levels.

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 resolve on their own, but if they persist, you should inform your doctor.
Common adverse reactions (may affect 1 in 10 people) include:

• Changes in the count of certain blood cells, circulating lipid levels, and transient increase in liver enzyme activity in the early phase of treatment.
• Increased blood and urine glucose levels.
• Increased blood uric acid and creatine kinase activity.
• Increased appetite
• Dizziness
• Motor restlessness
• Tremor
• Movement disorders (dyskinesias)
• Constipation
• Dry mouth
• Rash
• Loss of strength
• Extreme fatigue
• Fluid retention 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 adverse reactions (may affect 1 in 100 people) include:

• Hypersensitivity (e.g. swelling of the mouth and throat, itching, rash)
• Diabetes or worsening of existing diabetes, occasionally 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 eye movements)
• Restless legs syndrome
• Speech disorders
• Stuttering
• Slowed heart rate
• Photosensitivity
• Nosebleeds
• Abdominal distension
• Salivation
• Memory loss or amnesia
• Urinary incontinence
• Difficulty urinating
• Hair loss
• Absence or reduction of menstrual bleeding
• Breast changes in men and women, such as abnormal milk production or unusual breast enlargement.

Rare adverse reactions (may affect 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 manifested by yellowing of the skin and whites of the eyes
• Muscle disease manifested by unexplained muscle aches and pains
• Prolonged and/or painful erection.

During olanzapine treatment in elderly patients with dementia, stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness and walking difficulties may occur. In this specific patient group, several fatal cases have been reported.
In patients with Parkinson's disease, Olanzapine Aurovitas may worsen disease symptoms.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Olanzapine Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack
after: EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging 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. Such measures help protect the environment.

6. Contents of the pack 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), anhydrous colloidal silicon dioxide, aspartame (E 951), microcrystalline cellulose (type 112), sodium stearyl fumarate and pineapple flavour (FL SD # 883) [containing flavouring substances and modified food starch].

What Olanzapine Aurovitas looks like and contents of the pack
Orodispersible tablets.
Olanzapine Aurovitas, 5 mg, orodispersible tablets
Yellow, round, flat tablets with bevelled edges, embossed with the mark “C” on one side and “51” on the other side.
Olanzapine Aurovitas, 10 mg, orodispersible tablets
Yellow, round, flat tablets with bevelled edges, embossed with the mark “C” on one side and “52” on the other side.
Olanzapine Aurovitas, 15 mg, orodispersible tablets
Yellow, round, flat tablets with bevelled edges, embossed with the mark “C” on one side and “53” on the other side.
Olanzapine Aurovitas, 20 mg, orodispersible tablets
Yellow, round, flat tablets with bevelled edges, embossed with the mark “C” on one side and “54” on the other side.
Olanzapine Aurovitas, 5 mg, 10 mg, 15 mg, 20 mg, orodispersible tablets are available in blister packs contained in cardboard boxes.
Pack sizes: 7, 14, 21, 28, 35, 42, 56, 62, 70, 98 and 140 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warszawa
e-mail: [email protected]

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 medicinal product is authorised in the European Economic Area member states 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 Schmelztabletten
Poland: Olanzapine Aurovitas