ZYPREXA 10 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

ZYPREXA 10 mg powder for solution for injection

olanzapine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What ZYPREXA is and what it is used for.
2. What you need to know before you use ZYPREXA.
3. How to use ZYPREXA.
4. Possible side effects.
5. Storing ZYPREXA.
6. Package contents and further information.

1. What ZYPREXA is and what it is used for

ZYPREXA contains the active substance olanzapine. ZYPREXA injection belongs to a group of medicines called antipsychotics and is used 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.
• Manic disorder, a disease whose symptoms are excitement or euphoria.

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

2. What you need to know before you use ZYPREXA

Do not use ZYPREXA:

• 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, 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 receiving ZYPREXA injection.

• Tell your doctor or pharmacist if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. Also, your doctor or pharmacist may want to measure your blood pressure and pulse.
• ZYPREXA is not recommended for use in elderly patients with dementia (confusion or memory loss) as it may have serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after receiving ZYPREXA, tell your doctor.
• Very rarely, medicines of this type produce a set of symptoms such as fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately. You will not be given any more injections.
• A weight gain has been observed in patients taking ZYPREXA. You and your doctor should check 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) in the blood have been observed in patients taking ZYPREXA. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking ZYPREXA and regularly during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, as medicines of this type have been associated with the formation of blood clots.

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

• Stroke or transient lack of blood flow to the brain (temporary stroke symptoms)
• 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 heart disease, including sick sinus syndrome, unstable angina, or low blood pressure.
• Diabetes
• Seizures
• If you think you may have lost salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medicines (water pills)

If you suffer from dementia, you or your caregiver or relative 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, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take ZYPREXA.

Other medicines and ZYPREXA

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

If you receive ZYPREXA injection, it is not recommended to inject benzodiazepines at the same time, as it may result in excessive drowsiness, may have serious effects on your heart rate or breathing, and in very rare cases may cause death. If your doctor needs to administer a benzodiazepine injection to treat your disease, it should be at least one hour after the ZYPREXA injection and you should be closely monitored after the benzodiazepine is injected.

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

Using ZYPREXA with alcohol

Do not drink alcohol if you have been given ZYPREXA because the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not be given this medicine 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, you should contact your doctor.

Driving and using machines

Drowsiness may occur when you are given ZYPREXA. If this happens, do not drive vehicles or use machinery and contact your doctor.

ZYPREXA contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

ZYPREXA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

3. How to use ZYPREXA

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

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 less. You may be given up to 20 mg in 24 hours. The dose for patients over 65 years old is 2.5 mg or 5 mg.

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

If you receive more ZYPREXA than you should

Patients who have received more ZYPREXA 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 stiffness, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Tell your doctor or healthcare professional.

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

If you have any further questions on 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.

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon side effect that may 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 a doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Common side effects (may affect up to 1 in 10 people) with ZYPREXA injection include rapid or slow pulse, drowsiness, low blood pressure, injection site reactions.

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

Uncommon side effects (may affect up to 1 in 100 people) include slow breathing and abnormal heart rhythm, which can be serious.

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

Very common side effects (may affect more than 1 in 10 people) include weight gain; and 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 a lying or sitting position. This feeling usually goes away on its own, but if it doesn't, talk to your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in blood cell counts, circulating lipids, and 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; rash; loss of strength; excessive fatigue; fluid retention causing swelling 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.

Uncommon side effects (may affect up to 1 in 100 people) include 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, mostly 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; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of urination ability; 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 (may affect up to 1 in 1,000 people) include decreased 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 parts of the eyes; muscle disorder that presents as unexplained pain; and prolonged and/or painful erections.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with a widespread rash, fever, enlarged 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, elevated body temperature, redness of the skin, and walking problems. 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 side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing ZYPREXA

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

Do not use this medicine after the expiry date stated on the package.

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

Use the ZYPREXA injection solution before one hour has passed since its reconstitution.

Do not freeze after reconstitution.

Discard the solution that has not been used.

6. Container Content and Additional Information.

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 Container Content

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 personnel will prepare a solution with it for injection.

ZYPREXA powder for injectable solution is presented in packages of 1 or 10 vials. Only some package sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

Date of the Last Revision of this Prospectus:

Detailed information on this medication is available on the European Medicines Agency website http://www.ema.europa.eu

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(Perforation with information addressed to healthcare personnel, allowing it to be separated from the body of this prospectus)

INSTRUCTIONS FOR HEALTHCARE PERSONNEL

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 a syringe with any marketed medication due to incompatibilities. See examples below.

Olanzapine for injection should not be mixed in a syringe with haloperidol for injection, as the resulting low pH has been shown to degrade 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.

1. Introduce 2.1 ml of water for injection into a sterile syringe. Inject it into the vial of ZYPREXA powder for injectable solution.

1. Rotate the vial until the contents are completely dissolved, producing a yellow-colored solution. The vial contains 11.0 mg of olanzapine, resulting in a 5 mg/ml solution. When 2.0 ml of solution is used, 1 mg of olanzapine remains in the vial and syringe; therefore, 10 mg of olanzapine is recovered.

1. The following table indicates the injection volumes for the different doses of olanzapine:

1. The solution should be administered intramuscularly. Do not administer intravenously or subcutaneously.

1. Dispose of the syringe and any remaining solution in a responsible manner.

1. Use the reconstituted solution within the next hour after reconstitution. Do not store at a temperature above 25°C. Do not freeze.

Whenever the solution and container permit, parenteral medications should be examined before administration to check for solid particles.