OLANZAPINE SANDOZ 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olanzapine Sandoz 2.5 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Olanzapine Sandoz contains the active substance olanzapine. Olanzapine Sandoz belongs to a group of medicines called antipsychotics, which are used to treat the following diseases:

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

misconceptions, unusual suspicion, and tendency to withdraw. People suffering from these diseases may also feel depressed, anxious, or tense.

• Manic episodes of moderate to severe, a disorder characterized by symptoms such as excitement or euphoria.

Olanzapine Sandoz has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before you take Olanzapine Sandoz

Do not take Olanzapine Sandoz

• 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 or pharmacist before starting to take Olanzapine Sandoz.

• the use of olanzapine in elderly patients with dementia is not recommended as it may produce serious adverse reactions,
• 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,
• in very rare cases, 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 monitor your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist,
• high levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking olanzapine. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking olanzapine and regularly during treatment,
• if you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

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

• stroke or transient lack of blood flow to the brain (transient symptoms of stroke),
• Parkinson's disease,
• prostate problems,
• intestinal blockage (paralytic ileus),
• liver or kidney disease,
• blood disorders,
• heart disease,
• diabetes,
• seizures
• if you think you may have loss of salts 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 a lack of blood flow to the brain.

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

Children and Adolescents

Olanzapine is not indicated for patients under 18 years of age.

Taking Olanzapine Sandoz with other medicines

Only take any other medicine while taking olanzapine if your doctor tells you to. You may feel dizzy if you take olanzapine in combination with antidepressants or medications for the treatment of anxiety or to help you sleep (tranquilizers).

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medicine.

In particular, 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 Olanzapine Sandoz.

Taking Olanzapine Sandoz with food and drinks and alcohol

You should not drink alcohol if you have been given Olanzapine Sandoz because the combination with alcohol can cause drowsiness.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take this medicine when you are breastfeeding because small amounts of Olanzapine Sandoz may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine Sandoz in the last trimester of pregnancy (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 using machines

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

Olanzapine Sandoz contains lactose.

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

3. How to take Olanzapine Sandoz

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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

Consult your doctor if you suffer from symptoms again but do not stop taking Olanzapine Sandoz unless your doctor tells you to.

You should take your Olanzapine 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 film-coated tablets of Olanzapine Sandoz are for oral administration. You should swallow the Olanzapine Sandoz tablets with water.

If you take more Olanzapine Sandoz than you should

Patient who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and dizziness or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Consult your doctor immediately if you experience any of the above symptoms. Show the doctor the package of the tablets.

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

If you forget to take Olanzapine Sandoz

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

If you stop taking Olanzapine Sandoz

Do not stop taking your tablets because you feel better. It is important that you continue taking olanzapine while your doctor indicates it.

If you suddenly stop taking Olanzapine Sandoz, you may have symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may suggest reducing the dose gradually 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.

Consult your doctor immediately if you have:

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

blood clots in the veins (an uncommon adverse effect that can affect up to 1 in 100 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,

Very common side effects (may affect more than 1 in 10 patients):

• weight gain,
• drowsiness,
• increased prolactin levels 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 does not, consult your doctor.

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

• changes in the levels of some blood cells and lipids,
• at the beginning 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 (dyskinesia),
• 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 patients):

• hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash),
• diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in 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,
• stuttering,
• 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 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 patients):

• decrease in body temperature,
• abnormal heart rhythm,
• sudden unexplained death,
• pancreatitis, which causes severe stomach pain, fever, and discomfort,
• liver disease, with yellowing of the skin and the white areas of the eyes,
• muscle disorder that presents as unexplained pain,
• prolonged and/or painful erection.

During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular adverse effects, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, and walking difficulties. Deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister/label of the HDPE bottle after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Storage conditions after the first opening of the bottle:

Do not store above 25°C.

Shelf life after the first opening of the bottle:

6 months.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Sandoz

The active substance is olanzapine.

Each film-coated tablet contains 2.5 mg of olanzapine.

The other ingredients are:

Core of the tablet:lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate.

Coating of the tablet:polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), and talc.

Appearance of the product and contents of the pack

White and round film-coated tablets, biconvex, and approximately 6.5 mm in diameter with the inscription "2.5" in relief on one side.

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

Pack 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.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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

Warsaw

Poland

or

Lek Pharmaceuticals d.d

Verovskova 57

SI-1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2 D

9220 Lendava

Slovenia

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

Austria: Olanzapin Sandoz 2.5 mg - Filmtabletten

Denmark: Olanzapin "Sandoz"

Greece: Olanzapin/Sandoz 2.5 mg δισκία επικαλυμμένα με λεπτό υμένιο

Iceland: Olanzapin Sandoz

Italy: Olanzapina Sandoz 2.5 mg compresse rivestite con film

Netherlands: Olanzapine Sandoz 2.5 mg, filmomhulde tabletten

Sweden: Olanzapin Sandoz 2.5 mg filmdragerade tabletter

United Kingdom: Olanzapine Sandoz 2.5 mg Film-coated Tablets

Date of the last revision of this leaflet: November 2019

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