PATIENT INFORMATION LEAFLET

Olanzapine Flas Stada5 mg buccal tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Olanzapina Flas Stada contains the active ingredient olanzapina. Olanzapinabelongs to a group of medicines called antipsychotics andis used to treat the following disorders:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not real, false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from 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 thatolanzapina preventsthe recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to treatment with olanzapina.

Do not take Olanzapina Flas Stada

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

Warnings and precautions

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

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

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or "mini" stroke (temporary symptoms of stroke)
• 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 a loss of salts due to prolonged diarrhea and vomiting or the use of diuretic medications (urine tablets)

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

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

Children and adolescents

Patients under 18 years old should not take olanzapina.

Other medications and Olanzapina Flas Stada

Only use other medicines at the same time as olanzapina if your doctor authorizes it. You may feel drowsy if you combine olanzapina with antidepressants or medications for anxiety or sleep (tranquilizers).

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

Particularly, inform your doctor if you are taking:

Taking Olanzapina Flas Stada with alcohol

You should not drink alcohol if you have been given olanzapina, as the combination of olanzapina and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

You should not take this medication while breastfeeding, as small amounts of olanzapina may pass into breast milk.

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

Driving and operating machinery

There is a risk of drowsiness when taking olanzapina. If this happens, do not drive or operate tools or machinery. Inform your doctor.

Olanzapina Flas Stada contains aspartame (E951)

This medication contains 2.8 mg of aspartame in each buccodispersible tablet.

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

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

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

You should take your olanzapine tabletsonce 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 tablets are administered orally.

Olanzapine tabletsare easily broken, so you must handle the tablets carefully. Do not manipulate the tablets with wet hands, as they may break.

Applicable to blister packs with a peelable foil:

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently through the perforations that surround it.

2. Remove the back of the cell gently.

3. Carefully extract the tablet.

4. Place the tablet in your mouth. It will dissolve directly in your mouth, allowing you to 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 drinks, the mixture may change color and become cloudy. Take it immediately.

If you take moreOlanzapine Flas Stadathan you should

Patients who have taken moreolanzapinethan they should have experienced the following symptoms: rapid heart rate, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms.

If you experience any of the above symptoms, in case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20,indicating the medicationand theamount used.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to takeOlanzapine Flas Stada

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

If you interrupt treatment with Olanzapina Flas Stada

Do not stop treatment simply because you feel better. It is very important that you continue taking olanzapineas long as your doctor tells you to.

If you stop taking olanzapinesuddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you have:

• severe allergic reactions, e.g. inflammation of the mouth and throat, itching, hives (a rare side effect that can affect up to 1 in 100 people)
• prolonged and/or painful erection (a rare side effect that can affect up to 1 in 1,000 people)
• pancreatitis, which causes severe stomach pain, fever, and discomfort (a rare side effect that can affect up to 1 in 1,000 people)
• muscle disorder, e.g. rhabdomyolysis, which presents as unexplained pain(a rare side effect that can affect up to 1 in 1,000 people)
• liver disease with nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes (jaundice), and dark-colored urine (a rare side effect that can 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 initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

Frequent side effects(can affect more than 1 in 10 people), including

• weight gain
• drowsiness
• increased plasma levels of prolactin

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

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

Frequent side effects (can affect up to 1 in 10 people), including

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

Rare side effects (can affect up to 1 in 100 people), including

• diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones in the 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.
• nasal bleeding.
• abdominal distension.
• excessive salivation.
• memory loss or forgetfulness
• urinary incontinence.
• inability to urinate.
• hair loss.
• absence or decrease of menstrual periods.
• changes in the breast gland in men and women, such as abnormal milk production or abnormal growth.

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

• normal body temperature decrease.
• abnormal heart rhythm.
• sudden death without apparent explanation.

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and difficulty walking. 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 experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly throughthe Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olanzapina Flas Stada

• The active ingredient is olanzapina.

Each buccal dispersible tablet contains 5 mg of olanzapina. The exact amount is shown on the olanzapina packaging.

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

Appearance of the product and packaging size

The Olanzapina Flas Stada 5 mg buccal dispersible tablets are round, biconvex, yellow, 6 mm in diameter, and marked with “O” on one side.

Packaging sizes:

Blister packaging with a push-through foil:10 (sample), 14, 28, 30, 56, 60, 98, 126, and 154 buccal dispersible tablets

Blister packaging with a peelable foil:10 (sample), 14, 28, 30, 56, 60, 98, 126, and 154 buccal dispersible tablets

Only some packaging sizes may be commercially available.

Marketing authorization holder andresponsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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 Brussel
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 with the following names:

BelgiumOlanzapine Instant EG 5 mg orodispergeerbare tabletten

SpainOlanzapina Flas Stada 5 mg comprimidos bucodispersables EFG

ItalyOLANZAPINA EUROGENERICI 5 mg, compresse orodispersibili

LuxembourgOlanzapin Instant EG 5 mg comprimés orodispersibles

PortugalOlanzapina Ciclum

SwedenOlanzapine STADA 5 mg munsönderfallande tabletter

Last review date of this leaflet:June 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/