Package Leaflet: Information for the Patient

Olanzapine Sandoz 10 mg Film-Coated Tablets

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Olanzapine Sandoz

3.How to take Olanzapine Sandoz

4.Possible side effects

5.Storage of Olanzapine Sandoz

6.Contents of the pack and additional information

Olanzapina Sandoz contains the active ingredient olanzapina. Olanzapina Sandoz belongs to a group of medicines called antipsychotics that are used to treat the following diseases:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling unreal things,

erroneous 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 characterized by symptoms such as excitement or euphoria.

Olanzapina Sandoz has shown that it can prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Olanzapina Sandoz

• 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 or pharmacist before starting to take Olanzapina Sandoz.

• the use of olanzapina in elderly patients with dementia is not recommended as it may cause serious adverse reactions,
• medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking olanzapina, tell your doctor,
• in very rare cases, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately,
• weight gain has been observed in patients taking olanzapina. You and your doctor must monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist,
• high levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapina. Your doctor must perform blood tests to monitor your blood sugar and fat levels before starting olanzapina and regularly during treatment,
• if you or a family member has a history of blood clots, consult your doctor, 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 transient ischemic attack (temporary lack of blood flow to the brain),
• Parkinson's disease,
• prostate problems,
• intestinal blockage (paralytic ileus),
• liver or kidney disease,
• blood disorders,
• heart disease,
• diabetes,
• seizures
• if you think you may be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills).

If you have dementia, you or your caregiver or family member must inform your doctor if you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, your blood pressure must be monitored by your doctor.

Children and adolescents

Olanzapina is not indicated for patients under 18 years old.

Taking Olanzapina Sandoz with other medications

Only take any other medication while taking olanzapina if your doctor tells you it is safe to do so. You may feel dizzy if you take olanzapina in combination with antidepressants or medications for anxiety or to help you sleep (tranquilizers).

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

Particularly, inform your doctor if you are taking:

• medication for Parkinson's disease,
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), it may be necessary to change the dose of Olanzapina Sandoz.

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

Taking Olanzapina Sandoz with food and drinks and alcohol

You should not drink alcohol while taking Olanzapina Sandoz because the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or planning to become pregnant, ask your doctor for advice before taking this medication.

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

The following symptoms may occur in newborn babies of mothers who used Olanzapina Sandoz in the last three months of pregnancy: tremors, muscle stiffness, and/or weakness, lack of sleep, agitation, breathing problems, difficulty feeding. If your baby develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina Sandoz. If this happens, do not drive vehicles, operate tools, or machines. Consult your doctor.

Olanzapina Sandoz contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many tablets of Olanzapina Sandoz you should take and for how long. The daily dose of Olanzapina Sandoz ranges from 5 mg to 20 mg.

Consult your doctor if you experience symptoms again, but do not stop taking Olanzapina Sandoz unless your doctor tells you to.

You should take your Olanzapina Sandoz tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. There is no problem taking them with food or not. The coated tablets of Olanzapina Sandoz are for oral administration. You should swallow the Olanzapina Sandoz tablets with water.

The coated tablet can be divided into equal doses.

If you take more Olanzapina Sandoz than you should

Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heart rate, agitation/aggressiveness, 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 rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Consult your doctor or hospital immediately if you experience any of the above symptoms. Show the doctor the packaging of the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Olanzapina Sandoz

Take your tablet as soon as you remember. Do not take two doses in one day.

If you interrupt treatment with Olanzapina Sandoz

Do not stop taking your tablets because you feel better. It is essential that you continue taking olanzapine as long as your doctor tells you to.

If you suddenly stop taking Olanzapina Sandoz, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, or nausea and vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other doubts 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.

Consult your doctor immediately if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 patients) mainly in the face or tongue,

patients) especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately,

Frequent side effects (can affect more than 1 in 10 patients):

• weight gain,
• somnolence,
• increased levels of prolactin in the blood,
• in the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This feeling usually disappears on its own, but if it doesn't, consult your doctor.

Frequent side effects (can affect up to 1 in 10 patients):

• changes in levels of some circulating blood cells and lipids,
• temporary increases in liver enzymes at the start of treatment,
• increased levels of sugar in the blood and urine,
• increased levels of uric acid and creatine phosphokinase in the blood,
• increased appetite,
• dizziness,
• agitation,
• tremor,
• strange movements (dyskinesia),
• constipation,
• dry mouth,
• skin rash,
• loss of strength,
• excessive fatigue,
• fluid retention causing 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 patients):

• hypersensitivity (e.g. inflammation of the mouth and throat, itching, skin rash),
• diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in the blood and urine) or coma,
• seizures, in most cases related to a history of seizures (epilepsy),
• muscle stiffness or spasms (including eye movements),
• speech problems,
• stammering,
• slow pulse,
• sensitivity to sunlight,
• nosebleeds,
• abdominal distension,
• excessive salivation,
• memory loss or forgetfulness,
• urinary incontinence, loss of ability 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 patients):

• decreased normal body temperature,
• abnormal heart rhythm,
• sudden death without apparent explanation,
• pancreatitis, which causes severe stomach pain, fever, and discomfort,
• liver disease, with yellowing of the skin and white parts of the eye,
• muscle disorder presenting as unexplained pain,
• prolonged and/or painful erection.

During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular side effects, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Fatalities have been reported in this particular group of patients.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 and on the HDPE bottle label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Storage conditions after the first opening of the bottle:

Do not store at a temperature above 25?°C.

Expiration date after the first opening of the bottle:

6 months.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask

your pharmacist how to dispose of the packaging and the medicines that you do not need. In this

way, you will help protect the environment.

Composition of Olanzapina Sandoz

The active ingredient is olanzapine.

Each film-coated tablet contains 10 mg of olanzapine.

The other components are:

Tablet core:lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate.

Tablet coating:polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171) and talc.

Appearance of the product and contents of the package

White, round, biconvex film-coated tablets, approximately 10 mm in diameter, with the inscription “10” in relief on one face and a groove on the other face.

Film-coated tablets are presented in aluminum/aluminum blisters inserted in a cardboard package or in HDPE bottles with a desiccant in the cap.

Package sizes:

Blister: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 70, 98, 100, 500 film-coated tablets.

HDPE bottles: 50, 100, 250, 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

D-39179 Barleben,

Germany

or

LEK S.A.

Ul. Podlipie 16 C,

PL-95 010 Strykow,

Poland

or

LEK S.A.

Ul. Domaniewska 50 C,

PL-02-672 Warszawa,

Poland

or

Lek Pharmaceuticals d.d

Verovskova 57,

SI-1526 Ljubljana,

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2 D

9220 Lendava

Slovenia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria:Olanzapin Sandoz 10 mg – Filmtabletten

Belgium:Olanzapine Sandoz 10 mg filmomhulde tabletten

Czech Republic:Olanzapin Sandoz 10 mg

Denmark:Olanzapin “Sandoz”

Finland:Olanzapin Sandoz 10 mg

France:Olanzapine Sandoz 10 mg, comprimé pelliculé

United Kingdom:Olanzapine Sandoz 10 mg Film-coated Tablets

Greece:Olanzapin/Sandoz 10 mg δισκ?α επικαλυμμ?να με λεπτ? υμ?νιο

Iceland:Olanzapin Sandoz 10 mg filmuhúðaðar töflur

Italy:Olanzapina Sandoz 10 mg compresse rivestite con film

Norway:Olanzapin Sandoz 10 mg filmdrasjerte tabletter

Netherlands:Olanzapine Sandoz 10 mg, filmomhulde tabletten

Sweden:Olanzapin Sandoz 10 mg filmdragerade tabletter

Last review date of this leaflet: November 2019

For detailed information about this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/