Olanzapine Sandoz 7.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Olanzapine Sandoz 7.5 mg film-coated tablets EFG

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

• Keep this leaflet; 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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 adverse effects
5. How to store Olanzapine Sandoz
6. Contents of the pack and other information

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

Olanzapina Sandoz contains the active substance olanzapine. Olanzapina 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.

Olanzapina 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 taking 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 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

Talk to your doctor or pharmacist before taking 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 happens to you after taking olanzapine, tell 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 occurs, 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 dietitian,
• 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 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 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 tablets).

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 other medicines 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 for anxiety or to help you sleep (tranquilizers).

Tell 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 if you are 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 newborn babies 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. Discuss this with 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 for use of this medicine provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Contact 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 every day. It does not matter whether you take them with food or not. Olanzapina Sandoz coated tablets are for oral use. 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 problems, unusual movements (especially of the face and tongue), and 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 breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or hospital immediately if you experience any of the above symptoms. Show the doctor the tablet 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 in one day.

If you stop taking Olanzapina Sandoz

Do not stop taking your tablets just because you feel better. It is important that you 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, inability to sleep, 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 will experience them.

Contact your doctor immediately if you have:

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

• blood clots in the veins (an uncommon adverse effect that 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 that 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,
• at the beginning of treatment, some people may experience dizziness or fainting (with slower heartbeats), 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 start of treatment,
• increased levels of blood and urine sugar,
• increased levels of uric acid and creatine phosphokinase in the blood,
• increased appetite,
• dizziness,
• agitation,
• 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., mouth and throat swelling, itching, skin rash),
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma,
• seizures, which in most cases are 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 reduction of menstrual periods,
• changes in the breast gland in men and women such as abnormal production of breast milk 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.

Olanzapina 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 may also report them directly through 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 packaging and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. 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 7.5 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.

Nature of the product and pack contents

Film-coated, white, round, biconvex tablets approximately 9 mm in diameter, with the inscription "7.5" in relief on one side.

The film-coated tablets are supplied in aluminium/aluminium blisters inserted in cardboard packaging 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 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 authorised in the Member States of the European Economic Area under the following names:

Belgium: Olanzapine Sandoz 7.5 mg filmomhulde tabletten

Denmark: Olanzapin “Sandoz”

Finland: Olanzapin Sandoz 7.5 mg tabletti, kalvopäällysteinen

France: Olanzapine Sandoz 7.5 mg, comprimé pelliculé

United Kingdom: Olanzapine Sandoz 7.5 mg Film-coated tablets

Greece: Olanzapin/Sandoz 7.5 mg δισκ?α επικαλυμμ?να με λεπτ? υμ?νιο

Iceland: Olanzapin Sandoz 7.5 mg

Norway: Olanzapin Sandoz 7.5 mg filmdrasgerte tabletter

Date of the most recent revision 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/