OLANZAPINE STADA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine Flas Stada5 mg orodispersible tablets EFG

Read the package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Olanzapine Flas Stada is and what it is used for
2. What you need to know before you take Olanzapine Flas Stada
3. How to take Olanzapine Flas Stada
4. Possible side effects
5. Storing Olanzapine Flas Stada
6. Contents of the pack and other information

1. What Olanzapine Flas Stada is and what it is used for

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

• Schizophrenia, a disease with symptoms such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and a tendency to withdraw. People with these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic episodes, a disorder with symptoms of excitement or euphoria.

It has been shown that olanzapine prevents the recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to treatment with olanzapine.

2. What you need to know before you take Olanzapine Flas Stada

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• if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• if you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take olanzapine.

• The use of olanzapine in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine, tell your doctor.
• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking olanzapine. You and your doctor should review your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High blood sugar and high fat levels (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor should perform blood tests to check your blood sugar and certain fat levels before starting to take olanzapine and regularly during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, as medicines of this type have been associated with the formation of blood clots.

If you have any of the following diseases, tell your doctor as soon as possible:

• Stroke or "mini" stroke (temporary stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Hematological disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have salt loss due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take olanzapine.

Other medicines and Olanzapine Flas Stada

Only use other medicines at the same time as olanzapine if your doctor authorizes it. You may feel a certain sensation of sleepiness if you combine olanzapine with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

Tell your doctor if you are taking, have recently taken, or may need to take any other medication.

In particular, tell your doctor if you are taking:

• medications for Parkinson's disease.
• carbamazepine (antiepileptic and mood stabilizer), fluvoxamine (antidepressant), or ciprofloxacin (antibiotic), as it may be necessary to change your dose of olanzapine.

Taking Olanzapine Flas Stada with alcohol

You should not drink alcohol if you have been given olanzapine because the combination of olanzapine and alcohol can cause sleepiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You should not take this medicine when you are breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used olanzapine in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty feeding. If your baby presents any of these symptoms, it is possible that you need to contact your doctor.

Driving and using machines

There is a risk of feeling sleepy when taking olanzapine. If this happens, do not drive or operate tools or machines. Tell your doctor.

Olanzapine Flas Stada contains aspartame (E951)

This medicine contains 2.8 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of having phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to take Olanzapine Flas Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many olanzapine tablets you should take and for how long. The daily dose of olanzapine ranges from 5 mg to 20 mg. Consult your doctor if you suffer from symptoms again, but do not stop taking olanzapine unless your doctor tells you to.

You should take your olanzapine tablets once a day, following your doctor's instructions.

Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine orodispersible tablets are administered orally.

The olanzapine tablets break easily, so you should handle the tablets with care. Do not handle the tablets with wet hands, as they may break.

Applicable to blister packs with peelable foil:

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently at the perforations that surround it.
2. Gently remove the back of the cell.
3. Carefully remove the tablet.
4. Put the tablet in your mouth. It will dissolve directly in your mouth, so you can swallow it easily.

You can also place the tablet in a glass or cup of water, orange juice, apple juice, milk, or coffee and stir. With some beverages, the mixture may change color and take on a cloudy appearance. Take it immediately.

If you take moreOlanzapine Flas Stadathan you should

Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, sleepiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

If you experience any of the above symptoms, in case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to takeOlanzapine Flas Stada

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapine Flas Stada

Do not stop treatment just because you feel better. It is very important that you continue taking olanzapine while your doctor tells you to.

If you stop taking olanzapine suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you have:

• unusual movement (frequent adverse effect that may affect up to 1 in 10 people), mainly of the face or tongue;
• blood clots in the veins (uncommon adverse effect that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, go to the doctor immediately;

• a combination of fever, rapid breathing, sweating, muscle stiffness, sleepiness or lethargy (the frequency of this adverse effect cannot be estimated from the available data).

• severe allergic reactions, e.g., inflammation of the mouth and throat, itching, rash (uncommon adverse effect that may affect up to 1 in 100 people)
• prolonged and/or painful erection (rare adverse effect that may affect up to 1 in 1,000 people)
• inflammation of the pancreas, which causes severe stomach pain, fever, and malaise (rare adverse effect that may affect up to 1 in 1,000 people)
• muscle disorder, e.g., rhabdomyolysis, which presents as unexplained muscle pain (rare adverse effect that may affect up to 1 in 1,000 people)
• liver disease with nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (rare adverse effect that may affect up to 1 in 1,000 people).

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

Very common side effects (may affect more than 1 in 10 people), including

• weight gain
• sleepiness
• increased prolactin levels in the blood

In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from a lying or sitting position.

This sensation usually disappears spontaneously, but if it does not, tell your doctor.

Common side effects (may affect up to 1 in 10 people), including

• changes in the levels of some blood cells and circulating lipids and, at the start of treatment, temporary increases in liver enzymes.
• increased blood sugar and urine levels.
• increased uric acid and creatine phosphokinase levels in the blood.
• increased appetite.
• dizziness.
• agitation.
• tremors.
• unusual movements (dyskinesias).
• constipation.
• dry mouth.
• skin rash.
• loss of strength.
• excessive fatigue.
• fluid retention that causes swelling of the hands, ankles, or feet.
• fever, joint pain.
• sexual dysfunctions, such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (may affect up to 1 in 100 people), including

• diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones 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 problems.
• stuttering
• slow pulse.
• sensitivity to sunlight.
• nosebleeds.
• abdominal distension.
• excessive salivation.
• memory loss or forgetfulness
• urinary incontinence.
• inability to urinate.
• hair loss.
• absence or decrease of menstrual periods.
• changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (may affect up to 1 in 1,000 people), including

• decrease in body temperature.
• abnormal heart rhythm.
• sudden unexplained death.

During treatment with olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine Flas STADA may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Olanzapine Flas Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the package. The expiration date is the last day of the month indicated.

Store in the original package to protect it from light and moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Flas Stada

• The active substance is olanzapine.

Each orodispersible tablet contains 5 mg of olanzapine. The exact amount is shown on your olanzapine package.

• The other ingredients are: magnesium stearate, L-methionine, colloidal anhydrous silica, low-substitution hydroxypropylcellulose, crospovidone (Type B), aspartame (E-951), microcrystalline cellulose, guar gum, heavy magnesium carbonate, and orange flavor.

Appearance of the product and package size

Olanzapine Flas Stada 5 mg orodispersible tablets are round, biconvex, yellow tablets, 6 mm in diameter, and marked with "O" on one face.

Package sizes:

Blister pack with press-through foil:10 (sample), 14, 28, 30, 56, 60, 98, 126, and 154 orodispersible tablets

Blister pack with peelable foil:10 (sample), 14, 28, 30, 56, 60, 98, 126, and 154 orodispersible tablets

It is possible that not all package sizes are marketed.

Marketing authorization holder and manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Coripharma ehf.

Reykjavíkurvegur 78

IS-220 Hafnarfjörður

Iceland

or

Actavis Ltd.

B16, Bulebel Industrial Estate

Zejtun ZTN 08

Malta

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

LAMP S. Prospero S.P.A.

Via della Pace 25/A, 41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, A-1190 Wien

Austria

or

N.V. Eurogenerics S.A. Heizel Esplanade Heysel b22, 1020 Brussels

Belgium

or

Sanico N.V.

Industriezone, Veedijk 59, BE - 2300 Turnhout

Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium Olanzapine Instant EG 5 mg orodispergeerbare tabletten

Spain Olanzapina Flas Stada 5 mg buccal dispersible tablets EFG

Italy OLANZAPINA EUROGENERICI 5 mg, orodispersible tablets

Luxembourg Olanzapin Instant EG 5 mg orodispersible tablets

Portugal Olanzapina Ciclum

Sweden Olanzapine STADA 5 mg orally disintegrating tablets

Date of the last revision of this leaflet: June 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/