Olanzapine Sandoz 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olanzapine Sandoz 2.5 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Olanzapine Sandoz is and what it is 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 conditions:

• Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real,
  false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, anxious, or tense.

• Moderate to severe manic episodes, 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 starting to take Olanzapine Sandoz

Do not take Olanzapine Sandoz

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

Warnings and precautions

Talk to 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 cause serious adverse reactions,
• medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking olanzapine, inform your doctor,
• very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this happens, contact your doctor immediately,
• weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist,
• elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment 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 blood clot formation.

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

• stroke or transient ischemic attack (temporary stroke-like symptoms),
• 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 body salts due to prolonged and severe diarrhea or vomiting, or due to the use of diuretic medicines (water pills).

If you have dementia, you or your caregiver or family member should 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 doctor should monitor your blood pressure.

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 has told you it is safe to do so. You may feel dizzy if you take olanzapine together with antidepressants or medicines used to treat anxiety or to help you sleep (tranquilizers).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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), as it may be necessary to adjust the dose of Olanzapine Sandoz.

Taking Olanzapine Sandoz with food and drink and alcohol

You should not drink alcohol while taking Olanzapine Sandoz, as combining it with alcohol may cause drowsiness.

Pregnancy and breastfeeding

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

You should not take this medicine while breastfeeding, as small amounts of Olanzapine Sandoz may pass into breast milk.

The following symptoms may occur in newborns of mothers who have taken Olanzapine Sandoz during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleep disturbances, agitation, breathing difficulties, feeding problems. 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 taking Olanzapine Sandoz. If this occurs, do not drive or operate tools or machinery. Consult your doctor.

Olanzapine Sandoz contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Olanzapina Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

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

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

You should take your Olanzapina Sandoz tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. It does not matter whether you take them with food or not. Olanzapina Sandoz coated tablets are for oral administration. Swallow the Olanzapina Sandoz tablets with water.

If you take more Olanzapina Sandoz than you should

Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowed breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or hospital immediately if you experience any of these symptoms. Show the doctor the medicine packaging.

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

If you forget to take Olanzapina Sandoz

Take your tablet as soon as you remember. Do not take two doses on the same day.

If you stop taking Olanzapina Sandoz

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

If you suddenly stop taking Olanzapina Sandoz, you may experience symptoms such as sweating, trouble sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• unusual movements (a common adverse effect which may affect up to 1 in 10 patients), mainly in the face or tongue,

• blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, and redness of the legs), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately,

• a combination of fever, increased breathing rate, sweating, muscle stiffness, and dizziness or drowsiness (a rare adverse effect which may affect up to 1 in 1,000 patients).

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

• weight gain,
• drowsiness,
• increased levels of prolactin in the blood,
• during the initial stages of treatment, some people may experience dizziness or fainting (with slower heartbeat), especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

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

• changes in levels of certain blood cells and circulating lipids,
• temporary increases in liver enzymes at the beginning of treatment,
• increased blood and urine sugar levels,
• increased levels of uric acid and creatine phosphokinase in the blood,
• increased appetite,
• dizziness,
• restlessness,
• tremor,
• unusual movements (dyskinesia),
• constipation,
• dry mouth,
• skin rash,
• loss of strength,
• excessive tiredness,
• fluid retention causing swelling of the hands, ankles, or feet,
• fever,
• joint pain,
• sexual dysfunction such as decreased libido in men and women, or erectile dysfunction in men.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash),
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (acetone in blood and urine) or coma,
• seizures, which in most cases are related to a history of seizures (epilepsy),
• muscle rigidity 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 reduction of menstrual periods,
• changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• decrease in normal body temperature,
• abnormal heart rhythm,
• sudden unexplained death,
• inflammation of the pancreas, causing severe stomach pain, fever, and discomfort,
• liver disease, with yellowing of the skin and whites of the eyes,
• muscle disorder presenting as unexplained muscle pains,
• 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, increased body temperature, skin redness, and difficulty walking. Fatal outcomes have been reported in this particular group of patients.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and on the blister/label of the HDPE bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Storage conditions after first opening of the bottle:

Do not store above 25°C.

Expiry after first opening of the bottle:

6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Olanzapine Sandoz

The active substance is olanzapine.

Each film-coated tablet contains 2.5 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 pack

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

Film-coated tablets are supplied in aluminum/aluminum blisters packed in cardboard cartons 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.

Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Olanzapin Sandoz 2.5 mg - Filmtabletten

Denmark: Olanzapin “Sandoz”

Greece: Olanzapin/Sandoz 2,5 mg δισκ?α επικαλυμμ?να με λεπτ? υμ?νιο

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 most recent review of this leaflet: November 2019

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