OLANZAPINA 7.5 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Olanzapine Aurobindo 7.5 mg, tablets
   1. You should read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
   3. What is Olanzapine Aurobindo and what is it used for
3. Important information before taking Olanzapine Aurobindo
   1. When not to take Olanzapine Aurobindo
   2. Children and adolescents
   3. Pregnancy and breastfeeding:
   4. Driving and using machines
4. How to take Olanzapine Aurobindo
   1. Taking a higher dose of Olanzapine Aurobindo than recommended
   2. Missing a dose of Olanzapine Aurobindo
   3. Stopping treatment with Olanzapine Aurobindo
5. Possible side effects
   1. Common side effects: (which may affect up to 1 in 10 patients) include
   2. Uncommon side effects: (which may affect up to 1 in 100 patients) include
   3. Rare side effects (which may affect up to 1 in 1000 patients)
   4. Reporting side effects
6. HOW TO STORE OLANZAPINE AUROBINDO
7. CONTENTS OF THE PACK AND OTHER INFORMATION
   1. What Olanzapine Aurobindo contains
   2. What Olanzapine Aurobindo looks like and contents of the pack
   3. Marketing Authorisation Holder
   4. Manufacturer
   5. Date of last revision of the leaflet 04/2020

Patient Information Leaflet: User Information

Olanzapine Aurobindo 7.5 mg, tablets

Olanzapine

You should read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any further questions.
• 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 any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1.

What is Olanzapine Aurobindo and what is it used for

Olanzapine Aurobindo contains the active substance olanzapine. Olanzapine Aurobindo belongs to a group of medicines called antipsychotics and is used to treat:

• Schizophrenia - a disease characterized by 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 others. The patient may feel depressed, anxious, or tense.
• Moderate to severe manic episodes - disease states whose symptoms are excitement or euphoria.

It has been shown that Olanzapine Aurobindo 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 Aurobindo

When not to take Olanzapine Aurobindo

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be manifested by a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, you should inform your doctor;
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• Warnings and precautionsBefore starting treatment with Olanzapine Aurobindo, you should consult your doctor or pharmacist. It is not recommended to use Olanzapine Aurobindo in elderly patients with a diagnosis of dementia, as it may cause very serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If you experience such a symptom after taking Olanzapine Aurobindo, you should inform your doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, you should contact your doctor immediately.
• In patients taking Olanzapine Aurobindo, weight gain has been observed. You should regularly check your weight. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Olanzapine Aurobindo, high blood sugar levels and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Olanzapine Aurobindo and during its use, your doctor should perform blood tests to determine blood sugar levels and levels of certain lipids.
• You should tell your doctor if you or a family member have had
• blood clots, as similar medicines have been associated with the formation of blood clots.

If you have any of the following diseases, you should immediately inform your doctor:

• diabetes;
• heart disease;
• liver or kidney disease;
• Parkinson's disease;
• seizures;
• prostate diseases;
• intestinal obstruction (paralytic ileus);
• blood diseases;
• stroke or "mini" stroke (transient stroke symptoms).

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell your doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

Olanzapine Aurobindo is not intended for use in patients under 18 years of age.
Other medicines and Olanzapine AurobindoPeople taking Olanzapine Aurobindo may use other medicines only with the consent of their doctor. Taking Olanzapine Aurobindo in combination with antidepressant, sedative, or sleep-inducing medicines may cause drowsiness.
You should 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, you should tell your doctor about taking:

• medicines used to treat Parkinson's disease
• carbamazepine (an antiepileptic and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Olanzapine Aurobindo may be necessary.

Olanzapine Aurobindo with alcoholYou should not drink alcohol after taking Olanzapine Aurobindo, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. Olanzapine Aurobindo should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
The following symptoms may occur in newborns of mothers who used olanzapine in the last trimester (last three months of pregnancy): trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing difficulties, feeding difficulties. If your child experiences any of these symptoms, you should contact your doctor.

Driving and using machines

Olanzapine Aurobindo may cause drowsiness. If drowsiness occurs, you should not drive or operate machinery. You should inform your doctor.
Olanzapine Aurobindo contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Olanzapine Aurobindo

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Your doctor will decide how many Olanzapine Aurobindo tablets you should take and for how long.
The daily dose of Olanzapine Aurobindo is 5 mg to 20 mg. If symptoms of the disease recur, you should inform your doctor.
Olanzapine Aurobindo tablets should be taken once a day, as directed by your doctor.
You should try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food. Olanzapine Aurobindo tablets are taken orally. The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Olanzapine Aurobindo than recommended

In patients who have taken a higher dose of Olanzapine Aurobindo than recommended, the following symptoms have occurred: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and reduced consciousness. Other symptoms include: severe confusion (disorientation), 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 disorders. You should contact your doctor immediately or go to the hospital if you experience any of these symptoms. You should show your doctor the package of tablets.

Missing a dose of Olanzapine Aurobindo

As soon as you remember, you should take a tablet. You should not take a double dose to make up for a missed dose.

Stopping treatment with Olanzapine Aurobindo

Even if you feel better, you should not stop taking the tablets. It is important to take Olanzapine Aurobindo for as long as your doctor recommends.
If you suddenly stop taking Olanzapine Aurobindo, you may experience the following symptoms: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Olanzapine Aurobindo before stopping treatment.
If you have any further questions about taking Olanzapine Aurobindo, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately inform your doctor if you experience:

• abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 patients);
• blood clots in the veins (a not very common side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, you should seek medical attention 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 common side effects:(which may affect up to 1 in 10 patients) include:
weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a decrease in heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, you should inform your doctor.

Common side effects: (which may affect up to 1 in 10 patients) include

• changes in the number of certain blood cells and lipid levels in the blood, and transient increases in liver enzyme activity at the start of treatment;
• increased blood sugar and urine sugar levels, increased uric acid levels, and increased 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: (which may affect up to 1 in 100 patients) 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 in patients who have had seizures (epilepsy) before,
• muscle stiffness or spasms (including eye movements),
• restless legs syndrome
• speech disorders,
• stuttering;
• slow heart rate;
• sensitivity to sunlight;
• nosebleeds,
• abdominal bloating,
• drooling,
• memory loss or lack of memory,
• urinary incontinence, difficulty urinating;
• hair loss;
• absence or decrease of menstrual periods; and changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.

Rare side effects (which may affect up to 1 in 1000 patients)

include:

• decreased body temperature,
• heart rhythm disorders,
• sudden death from an unknown cause,
• pancreatitis causing severe abdominal pain,
• fever and nausea,
• liver disease characterized by a change in skin and white eye color to yellow,
• muscle disease characterized by unexplained muscle pain and weakness, 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 are flu-like with a rash on the face, followed by a widespread rash, high fever, swollen lymph nodes, elevated liver enzyme activity in blood tests, and increased levels of a specific type of white blood cell (eosinophilia).
During treatment with olanzapine in elderly patients with a diagnosis of dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and difficulty walking. In these patient groups, several fatal cases have been reported.
In patients with Parkinson's disease, Olanzapine Aurobindo may worsen side effects.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLANZAPINE AUROBINDO

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the label, carton, and bottle after the EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olanzapine Aurobindo contains

• The active substance of the medicine is olanzapine. One Olanzapine Aurobindo tablet contains 7.5 mg of the active substance. The content is stated on the packaging of Olanzapine Aurobindo tablets
• The medicine also contains: lactose monohydrate, crospovidone (type B), hydroxypropylcellulose (low viscosity grade), magnesium stearate.

What Olanzapine Aurobindo looks like and contents of the pack

Yellow, round (7.5 mm in diameter), biconvex, uncoated tablets with "C" embossed on one side and "47" on the other side.
PVC/Polyamide/Aluminium/PVC/Aluminium blisters:
7, 14, 28, 30, 35, 50, 56, 70, 96, 98, or 100 tablets.
HDPE bottle with PP cap and a desiccant:
30 or 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
BBG 3000 Birzebbugia
Malta
Orion Corporation, Orion Pharma
Orionintie 1,
FI-02200 Espoo,
Finland

Date of last revision of the leaflet 04/2020