Product Information for the User

ZYPREXA 2.5 mg Coated Tablets

ZYPREXA 5 mg Coated Tablets

ZYPREXA 7.5 mg Coated Tablets

ZYPREXA 10 mg Coated Tablets

ZYPREXA 15 mg Coated Tablets

ZYPREXA 20 mg Coated Tablets

olanzapine

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

ZYPREXA contains the active ingredient olanzapina. ZYPREXA belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

ZYPREXA has demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take ZYPREXA

• If you are allergic to olanzapine or any of the other ingredients in 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 pharmacist before starting to take ZYPREXA.

• ZYPREXA is not recommended for use in elderly patients with dementia as it may have serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking ZYPREXA, tell your doctor.
• In rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking ZYPREXA. You and your doctor should check your weight regularly. If necessary, your doctor may 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.
• If you or a family member has a history of blood clots, consult your doctor, 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
• Heart disease
• Diabetes
• Seizures
• If you think you may be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretics (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

Patients under 18 years old should not take ZYPREXA.

Other medications and ZYPREXA

Only use other medications at the same time as ZYPREXA if your doctor authorizes it. You may feel drowsy if you combine ZYPREXA with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Specifically, tell your doctor if you are taking:

• Medication for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). You may need to adjust your ZYPREXA dose.

Use of ZYPREXA with alcohol

You should not drink alcohol if you have been given ZYPREXA as it may cause drowsiness.

Pregnancy and breastfeeding

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

The following symptoms may occur in newborns of mothers who used ZYPREXA in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby experiences any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking ZYPREXA. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

ZYPREXA contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many ZYPREXA tablets to take and for how long. The daily dose of ZYPREXA ranges from 5 mg to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking ZYPREXA unless your doctor tells you to.

You should take your ZYPREXA tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. ZYPREXA coated tablets are for oral administration. Swallow the ZYPREXA tablets whole with water.

If you take more ZYPREXA than you should

Patients who have taken more ZYPREXA than they should have experienced the following symptoms: rapid heartbeat, 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, slowed respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to the doctor.

If you forgot to take ZYPREXA

Take your tablets as soon as you remember. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with ZYPREXA

Do not stop treatment simply because you feel better. It is very important that you continue taking ZYPREXA as long as your doctor tells you to.

If you stop taking ZYPREXA suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

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

Immediately contact your doctor 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 (frequency cannot be estimated from available data)

Frequent side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; 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 down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (which 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; skin 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 (which can 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 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; memory loss 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 (which can affect up to 1 in 1000 people) include a decrease 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 extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of 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, increased 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 is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification 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 reach and sight of children.

Do not use this medication after the expiration date shown on the packaging.

ZYPREXA should be stored in its original packaging to protect it from light and moisture.

Unused medications should not be disposed of through the drains or in the trash. Ask your pharmacist how to properly dispose of the packaging and unused medications. This will help protect the environment.

Composition of ZYPREXA

• The active ingredient is olanzapina. Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of active ingredient. The exact amount is shown on your ZYPREXA packaging.
• The other components are

• Tablet core: lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate,
• Tablet coating: hypromellose, titanium dioxide (E171) and carnauba wax.

• In addition, the different concentrations of ZYPREXA also contain the following components:

Appearance of the product and contents of the packaging

ZYPREXA 2.5 mg coated tablets are white and have printed “LILLY” and a numeric identification code “4112”.

ZYPREXA 5 mg coated tablets are white and have printed “LILLY” and a numeric identification code “4115”.

ZYPREXA 7.5 mg coated tablets are white and have printed “LILLY” and a numeric identification code “4116”.

ZYPREXA 10 mg coated tablets are white and have printed “LILLY” and a numeric identification code “4117”.

ZYPREXA 15 mg coated tablets are blue.

ZYPREXA 20 mg coated tablets are pink.

ZYPREXA is available in packaging of 28, 35, 56, 70 or 98 tablets. Some packaging 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.

Last review date of this leaflet:

The detailed information on this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu/.