Package Insert: Information for the User

ZYPREXA VELOTAB 5 mg buccal tablets

ZYPREXA VELOTAB 10 mg buccal tablets

ZYPREXA VELOTAB 15 mg buccal tablets

ZYPREXA VELOTAB 20 mg buccal tablets

olanzapine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should 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 they are not listed in this package insert. See section 4.

ZYPREXA VELOTAB contains the active ingredient olanzapina. ZYPREXA VELOTAB belongs to the therapeutic group of antipsychotics and is indicated for the treatment of 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a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn.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.
• Moderate to severe manic disorder, a disease whose symptoms are excitement or euphoria.

ZYPREXA VELOTAB has shown that it can prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take ZYPREXA VELOTAB

• 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 pharmacist before starting to take ZYPREXA VELOTAB

• ZYPREXA VELOTAB is not recommended for 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 VELOTAB, 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 VELOTAB. You and your doctor should check your weight regularly. If necessary, your doctor may 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 VELOTAB. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting ZYPREXA VELOTAB 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 have a loss of 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 check your blood pressure.

Children and adolescents

Patients under 18 years old should not take ZYPREXA VELOTAB.

Other medications and ZYPREXA VELOTAB

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

Inform your doctor if you are taking, have taken recently, or may need to take 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 VELOTAB dose.

Use of ZYPREXA VELOTAB with alcohol

You should not drink alcohol while taking ZYPREXA VELOTAB, 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 take this medication while breastfeeding, as small amounts of ZYPREXA VELOTAB may pass into breast milk.

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

Driving and operating machinery

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

ZYPREXA VELOTAB contains aspartame, sodium methylparahydroxybenzoate, and sodium propylparahydroxybenzoate

This medication contains up to 1.6 mg of aspartame per tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains sodium methylparahydroxybenzoate and sodium propylparahydroxybenzoate, which may cause allergic reactions (possibly delayed). Allergic reactions are recognized by skin rash, itching, or difficulty breathing. They may occur immediately after taking ZYPREXA VELOTAB or some time later.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

ZYPREXA VELOTAB tablets should be taken 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 VELOTAB buccal tablets are for oral administration.

ZYPREXA VELOTAB tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently through the perforations that surround it.
2. Remove the back of the cell gently.
3. Carefully extract the tablet.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

You can also place the tablet in a cup or a glass filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. You should drink it immediately.

If you take more ZYPREXA VELOTAB than you should

Patients who have taken more ZYPREXA VELOTAB than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory rate, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the above symptoms. Show the packaging with the tablets to the doctor.

If you forget to take ZYPREXA VELOTAB

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

If you interrupt treatment with ZYPREXA VELOTAB

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

If you stop taking ZYPREXA VELOTAB 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 blood prolactin levels. 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 blood sugar and urine levels; increased blood uric acid and creatine phosphokinase levels; 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 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; nosebleeds; 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 by 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 VELOTAB 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 theAnexo 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.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of ZYPREXA VELOTAB

• The active ingredient is olanzapine. Each ZYPREXA VELOTAB buccal dispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg of active ingredient. The exact amount is shown on your ZYPREXA VELOTAB packaging.
• The other components are

gelatine, mannitol (E421), aspartame (E951), sodium methylparahydroxybenzoate (E219) and sodium propylparahydroxybenzoate (E217).

Appearance of the product and contents of the packaging

ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg buccal dispersible tablets are yellow.

A buccal dispersible tablet is the technical name for a tablet that dissolves directly in the mouth for easier swallowing.

ZYPREXA VELOTAB packaging contains 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.

Fidelio Healthcare Limburg GmbH, Mundipharmastraße 2, 65549 Limburg an der Lahn, Germany.

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

Last review date of this leaflet:

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