Olanzapine aurovitas

Package leaflet: Information for the user

Olanzapine Aurovitas, 5 mg, tablets
Olanzapine Aurovitas, 10 mg, tablets
Olanzapinum
Please read this leaflet carefully before taking the 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 the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

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 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 disorder in which the patient hears, sees or feels things that do not exist in reality, has beliefs that are contrary to reality, is excessively suspicious and withdraws from contact with others. The patient may also experience depression, anxiety or tension.
• Moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

It has been shown that Olanzapine Aurovitas 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, swollen lips 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.

• Use of Olanzapine Aurovitas in elderly patients with dementia is not recommended, as it may cause serious adverse effects.
• Medicines of this type may cause abnormal movements, particularly 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 sedation. If any of these symptoms occur, contact the doctor immediately.
• Weight gain has been observed in patients taking Olanzapine Aurovitas. 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 and regularly during therapy, the doctor should perform blood tests to monitor blood glucose and certain lipid 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 thrombosis.

If the patient has any of the following conditions, inform the doctor immediately:

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

If the patient has dementia and has ever had a stroke or "mini" stroke, the patient, 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 with 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-inducing medicines (sedatives) may cause drowsiness.
Inform the doctor about all medicines currently or recently taken by the patient, 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 drink any alcohol while taking Olanzapine Aurovitas, as alcohol combined with this medicine may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 have taken Olanzapine Aurovitas during the third trimester (last three months of pregnancy) may experience symptoms such as tremors, 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 lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Olanzapine Aurovitas

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.
The doctor will inform the patient how many tablets and for how long Olanzapine Aurovitas should be taken.
The daily dose of Olanzapine Aurovitas ranges from 5 mg to 20 mg. If symptoms of the illness recur, the doctor should be informed. However, do not stop taking Olanzapine Aurovitas unless instructed by the doctor.
Olanzapine Aurovitas tablets should be taken once daily as directed by the 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. Olanzapine Aurovitas tablets are intended for oral use. Swallow the tablet whole with water.

Taking more Olanzapine Aurovitas than recommended
In patients who have taken more than the recommended 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, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness and lethargy or drowsiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disturbances. Seek immediate medical attention or go to a hospital if any of these symptoms occur. Show the doctor the tablet packaging.

Missing a dose of Olanzapine Aurovitas
Take the missed tablet as soon as remembered. Do not take a double dose to make up for a missed dose.

Stopping Olanzapine Aurovitas
Do not stop taking the tablets just because the patient feels better. It is important to continue taking Olanzapine Aurovitas for as long as directed by the doctor.
If Olanzapine Aurovitas is stopped suddenly, symptoms such as sweating, difficulty sleeping, tremor, restlessness, nausea and vomiting may occur. The doctor may recommend gradually reducing the dose before stopping treatment.

If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact your doctor immediately if any of the following occur:

• Unusual movements (a common side effect which may affect up to 1 in 10 people), mainly of the face or tongue;
• Blood clots in veins (an uncommon side effect 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 blood vessels to the lungs causing chest pain and difficulty breathing. If any of these symptoms occur, contact your doctor immediately.
• Concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy (the frequency of this side effect cannot be determined from available data).

Very common side effects: (may affect more than 1 in 10 people) include
increased body weight; drowsiness; and 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 lying or sitting positions. These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.

Common side effects: (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 phosphokinase activity.
• Increased appetite
• Dizziness
• Restlessness
• Tremor
• Movement disorders (dyskinesias)
• Constipation
• Dry mouth
• Rash
• Weakness
• Extreme tiredness
• 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 side effects: (may affect 1 in 100 people) include

• Hypersensitivity (e.g. swelling of the mouth and throat, itching, rash)
• Diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma
• Seizures, usually associated 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, and breast changes in men and women, such as abnormal milk production or unusual breast enlargement.

Rare side effects: (may affect 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 manifested by yellowing of the skin and whites of the eyes (jaundice)
• 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 syndrome, initial symptoms resemble influenza with facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity in blood tests, and increased white blood cell count (eosinophilia).

When olanzapine is used 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 side effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 directly to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

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 carton and blister pack after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must 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 pack and other information

What Olanzapine Aurovitas contains

• The active substance 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: monohydrate lactose, crospovidone (type B), hydroxypropylcellulose (low viscosity), and magnesium stearate.

What Olanzapine Aurovitas looks like and contents of the pack
Olanzapine Aurovitas 5 mg tablets: [Approx. 6.5 mm in diameter]
Yellow, round, biconvex, uncoated tablets, embossed with "OA" on one side and "5" on the other side.
Olanzapine Aurovitas 10 mg tablets: [Approx. 8 mm in diameter]
Yellow, round, biconvex, uncoated tablets, embossed with "OA" on one side and "10" on the other side.
Olanzapine Aurovitas tablets are available in cold-forming foil blisters (PVC/Aluminium/Polyamide/Aluminium), packed in cardboard cartons.
Pack sizes:
Blister packs: 28, 98 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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 countries under the following names:
Malta: Olanzapine Aurobindo Pharma 5mg/10mg tablets
Poland: Olanzapine Aurovitas