Zyprexa 10 mg powder for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ZYPREXA 10 mg powder for solution for injection

Olanzapine

Read the entire leaflet carefully before you start using 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.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What ZYPREXA is and what it is used for.

2. What you need to know before using ZYPREXA.

3. How to use ZYPREXA.

4. Possible side effects.

5. How to store ZYPREXA.

6. Contents of the pack and other information.

1. What ZYPREXA is and what it is used for

ZYPREXA contains the active substance olanzapine. ZYPREXA injectable belongs to a group of medicines called antipsychotics and is indicated for the treatment of agitation and anxiety symptoms that may occur in 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 experience depression, anxiety, or tension.

• Manic disorder, a condition characterized by symptoms of excitement or euphoria.

ZYPREXA injectable is used when rapid control of agitation and nervousness is required and treatment with ZYPREXA tablets is not suitable. Your doctor will switch your treatment to ZYPREXA tablets as soon as appropriate.

2. What you need to know before using ZYPREXA

Do not use ZYPREXA:

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may present as 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 nurse before receiving injectable ZYPREXA.

• Tell your doctor or nurse if you feel dizzy or faint after the injection. You may need to lie down until you feel better. In addition, your doctor or nurse may want to check your blood pressure and pulse.

• The use of ZYPREXA is not recommended in elderly patients with dementia (confusion or memory loss), as it may cause serious adverse effects.

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

• Very rarely, medicines of this type cause a group of symptoms such as fever, rapid breathing, sweating, muscle stiffness, and a state of mental confusion or drowsiness. If this happens to you, contact your doctor immediately. You will not be given further injections.

• Weight gain has been observed in patients taking ZYPREXA. 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 blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking ZYPREXA. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking ZYPREXA and regularly during treatment.

• Consult your doctor if you or a family member has a history of blood clots, as medicines of this type have been associated with blood clot formation.

If you have any of the following conditions, tell 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

• 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 body salts due to prolonged 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

Patients under 18 years of age must not take ZYPREXA.

Other medicines and ZYPREXA

You may feel increased drowsiness if ZYPREXA is taken together with any of the following medicines: those used to treat anxiety or help with sleep (tranquilizers, including benzodiazepines), and antidepressants. Only use other medicines together with ZYPREXA if authorized by your doctor.

If you are receiving injectable ZYPREXA, simultaneous injection of benzodiazepines is not recommended, as it may lead to excessive sedation, serious effects on heart rate or breathing, and very rarely, death. If your doctor needs to administer a benzodiazepine injection to treat your condition, at least one hour should pass after the ZYPREXA injection, and you must be closely monitored after receiving the benzodiazepine.

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

Use of ZYPREXA with alcohol

Do not drink alcohol if you have been given ZYPREXA, as combining it 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. This medicine should not be given if you are breastfeeding, 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 during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and using machines

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

3. How to use ZYPREXA

At the end of this leaflet, on a detachable page, information about reconstitution and administration method is provided.

Your doctor will decide how much ZYPREXA you need and for how long. Generally, the dose is 10 mg for the first injection, but it may be lower. Up to 20 mg may be given within 24 hours. The dose for patients over 65 years of age is 2.5 mg or 5 mg.

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

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 disorders, 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 or decreased blood pressure, abnormal heart rhythms. Discuss this with your doctor or healthcare professional.

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

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

4. Possible adverse effects

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

Contact your doctor immediately if you have:

• unusual movements (a common adverse effect affecting up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon adverse effect affecting up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from the available data).

Common adverse effects (may affect up to 1 in 10 people) with injectable ZYPREXA include faster or slower heartbeat, drowsiness, low blood pressure, and discomfort at the injection site.

Some people may feel dizzy or faint (due to a slowed heart rate) after the injection, especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, inform your doctor or nurse as soon as possible.

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

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

Other very common adverse effects (affecting 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 slowed heartbeat), especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Other common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, and 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; agitation; tremor; unusual movements (dyskinesia); constipation; dry mouth; rash; loss of strength; excessive tiredness; 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.

Other uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. mouth and throat swelling, 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 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; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the breast gland in both men and women, such as abnormal milk production or abnormal breast enlargement.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pain; and prolonged and/or painful erection.

Very rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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

ZYPREXA 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 nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ZYPREXA

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

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

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

Use the reconstituted ZYPREXA injectable solution within one hour after reconstitution.

Do not freeze after reconstitution.

Discard any unused solution.

6. Contents of the pack and other information

Composition of ZYPREXA injectable

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

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

Appearance of the product and contents of the pack

ZYPREXA is presented as a yellow powder, packed in a vial. One vial of ZYPREXA contains 10 mg of olanzapine. Your doctor or healthcare professional will prepare a solution from it to administer by injection.

ZYPREXA powder for injectable solution is available in packs of 1 or 10 vials. Only certain pack 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 most recent revision of this leaflet:

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

(Perforation with information intended for healthcare professionals, allowing separation 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 must not be mixed in the syringe with any commercially available medication due to incompatibilities. See examples below.

Olanzapine for injection must 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 must not be mixed in a syringe or used concomitantly with benzodiazepines.

Powder for injectable solution

ZYPREXA 10 mg powder for injectable solution must be reconstituted using standard aseptic techniques for reconstitution of parenteral products.

Whenever the solution and container permit, parenteral medications should be inspected before administration to ensure they do not contain solid particles.