Product Information for the User

ZYPREXA 10 mg Powder for Injectable Solution

Olanzapine

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this product information. See section 4.

6. Contents of the pack and additional information.

ZYPREXA contains the active ingredient olanzapina. ZYPREXA injectable belongs to a group of medicines called antipsychotics and is indicated to treat symptoms of agitation and restlessness that may occur in the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious or tense.

• Manic disorder, a disease whose symptoms are excitement or euphoria.

ZYPREXA injectable is used when rapid control of agitation and nervousness is needed and treatment with ZYPREXA tablets is not suitable. Your doctor will change your treatment to ZYPREXA tablets as soon as they consider it appropriate.

Do not use ZYPREXA:

• If you are allergic to olanzapine 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 nurse before receiving ZYPREXA injectable.

• Inform your doctor or nurse if you feel dizzy or faint after the injection. You may need to lie down until you feel better. Your doctor or nurse may also want to measure your blood pressure and pulse.

• ZYPREXA is not recommended for elderly patients with dementia (confusion or memory loss) as it may have serious side effects.

• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after receiving ZYPREXA, tell your doctor.

• In rare cases, medications of this type may produce a set of symptoms such as fever, rapid breathing, sweating, muscle stiffness, and a state of drowsiness or somnolence. If this happens, contact your doctor immediately. No further injections will be administered.

• Patients taking ZYPREXA have been observed to gain weight. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or refer you to a nutritionist.

• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking ZYPREXA. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting ZYPREXA and regularly during treatment.

• Consult 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 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

• If you have recently had a heart attack or have a heart condition, including unstable angina or low blood pressure.

• Diabetes

• Seizures

• If you believe you may be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications.

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

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

Children and adolescents

Patients under 18 years old should not take ZYPREXA.

Other medications and ZYPREXA

You may feel drowsy if you combine ZYPREXA with any of the following medications: those that combat anxiety or help you sleep (tranquilizers, including benzodiazepines), and antidepressants. Only use other medications at the same time as ZYPREXA if your doctor authorizes it.

If you receive ZYPREXA injectable, do not receive benzodiazepine injections at the same time, as it may result in excessive sedation, serious effects on your heart rate or breathing, and in rare cases, death. If your doctor needs to administer a benzodiazepine injection to treat your condition, they should wait at least one hour after the ZYPREXA injection and closely monitor you after the benzodiazepine injection.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. Especially tell your doctor if you are using medications for Parkinson's disease.

Use of ZYPREXA with alcohol

You should not drink alcohol if you have been administered ZYPREXA, as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. Do not administer this medication if you are breastfeeding your child, as small amounts of ZYPREXA may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with ZYPREXA in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Driving and operating machinery

You may experience drowsiness when administered ZYPREXA. If this happens, do not drive vehicles or operate machinery and contact your doctor.

At the end of this leaflet, on a page that can be detached from it, information on reconstitution and administration method is provided.

Your doctor will decide the amount of ZYPREXA you need and for how long. Generally, the dose is 10 mg for the first injection, but it may be lower. You may receive up to 20 mg in 24 hours. The dose for patients over 65 years is 2.5 mg or 5 mg.

ZYPREXA is presented in powder form. Your doctor or healthcare staff will prepare a solution with it and inject the appropriate amount of solution into a muscle. ZYPREXA injection is for intramuscular use.

If you receive more ZYPREXA than you should

Patients who have received more ZYPREXA than they should have, 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, slowing of respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Discuss it with your doctor or healthcare staff.

Only a few injections of ZYPREXA are needed. Your doctor will decide when you need to receive ZYPREXA injectable.

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

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

Get in touch with your doctor immediately if you have:

• Unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see your doctor immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data)

Frequent side effects (can affect up to 1 in 10 people) with ZYPREXA injectable include a faster or slower pulse, drowsiness, low blood pressure, and discomfort at the injection site.

Some people feel dizzy or faint (due to a drop in heart rate) after the injection, especially when getting up from lying or sitting. This feeling usually goes away on its own, but if it doesn't, report it to your doctor or nurse as soon as possible.

Rare side effects (can affect up to 1 in 100 people) include slower breathing and an abnormal heart rhythm, which can be serious.

Additionally, when taking ZYPREXA tablets, the following side effects may occur.

Other very frequent side effects (can affect more than 1 in 10 people) include weight gain; and 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 or sitting. This feeling usually goes away on its own, but if it doesn't, consult your doctor.

Other frequent side effects (can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and 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; strange movements (dyskinesia); constipation; dry mouth; rash; loss of strength; excessive fatigue; fluid retention causing inflammation of the hands, ankles, or feet; fever; joint pain; and 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) include hypersensitivity (e.g. inflammation of the mouth and throat, itching, rash on the skin); 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); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nasal bleeding; abdominal distension; excessive salivation; loss of memory or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; and 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 1000 people) include a drop in 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 that presents as unexplained pain; and prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS for its English acronym). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with a widespread rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia).

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

ZYPREXA may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.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.

Do not store above 25°C. Store in the original packaging to protect it from light.

Use the ZYPREXA injectable solution before an hour has passed since its reconstitution.

Do not freeze after reconstitution.

Discard the unused solution.

Composition of ZYPREXA injectable

• The active ingredient is olanzapine. Each vial contains 10 mg of active ingredient.

• The other components are lactose monohydrate, tartaric acid, hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the package

ZYPREXA is presented in the form of yellow powder, packaged in a vial. A vial of ZYPREXA contains 10 mg of olanzapine. Your doctor or healthcare professional will prepare a solution with it to be injected.

ZYPREXA powder for injectable solution is presented in packaging of 1 or 10 vials. Some package sizes may only be marketed.

Marketing Authorization Holder

CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach, Germany.

Responsible for manufacturing

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH, Borsigstrasse 2, 63755 Alzenau, Germany.

CHEPLAPHARM Registration GmbH, Weiler Straße 5e, 79540 Lörrach,Germany

Last review date of this leaflet:

The detailed information of this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu

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(Perforation with information directed at healthcare professionals, which allows it to be separated from the body of this leaflet)

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

Reconstitution and administration of ZYPREXA

Reconstitute ZYPREXA powder for injectable solution only with water for injection.

ZYPREXA powder for injectable solution should not be mixed in the syringe with any available market medication due to incompatibilities. See examples below.

Olanzapine for injection should not be mixed in a syringe with haloperidol for injection since the resulting low pH has shown that it degrades olanzapine over time.

Olanzapine for injection cannot be mixed in a syringe or used in conjunction with benzodiazepines.

Powder for injectable solution

ZYPREXA 10 mg powder for injectable solution should be reconstituted using standard aseptic methods for reconstituting parenteral products.

Whenever the solution and packaging allow, parenteral medications should be examined before administration to check that they do not contain solid particles.