ZYPREXA VELOTAB 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

ZYPREXA VELOTAB 5 mg orodispersible tablets

ZYPREXA VELOTAB 10 mg orodispersible tablets

ZYPREXA VELOTAB 15 mg orodispersible tablets

ZYPREXA VELOTAB 20 mg orodispersible tablets

olanzapine

Read all of this leaflet carefully before you start taking 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What ZYPREXA VELOTAB is and what it is used for
2. What you need to know before you take ZYPREXA VELOTAB
3. How to take ZYPREXA VELOTAB
4. Possible side effects
5. Storing ZYPREXA VELOTAB
6. Contents of the pack and other information

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

ZYPREXA VELOTAB contains the active substance olanzapine. ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a disease with symptoms such as excitement or euphoria.

ZYPREXA VELOTAB has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before you take ZYPREXA VELOTAB

Do not take ZYPREXA VELOTAB

• 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 been previously diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take ZYPREXA VELOTAB

• ZYPREXA VELOTAB is not recommended for use in elderly patients with dementia 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 taking ZYPREXA VELOTAB, tell your doctor.
• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking ZYPREXA VELOTAB. 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 VELOTAB. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking ZYPREXA VELOTAB and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

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

• Stroke or transient lack of blood flow to the brain (transient symptoms of stroke)
• 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 loss of salts as a result of having prolonged and intense diarrhea and vomiting or using diuretic medications (urination tablets)

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 VELOTAB.

Other medicines and ZYPREXA VELOTAB

Only use other medicines 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 to help you sleep (tranquilizers).

Tell your doctor if you are taking, have recently taken or may need to take any other medicine.

In particular, 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). Your dose of ZYPREXA VELOTAB may need to be changed.

Using ZYPREXA VELOTAB with alcohol

Do not drink alcohol while taking ZYPREXA VELOTAB as the combination with alcohol can 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 take this medicine when you are breastfeeding as small amounts of ZYPREXA VELOTAB can pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with ZYPREXA VELOTAB 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 using machines

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

ZYPREXA VELOTAB contains aspartame, sodium methyl parahydroxybenzoate, and sodium propyl parahydroxybenzoate

This medicine contains up to 1.6 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Allergic reactions are recognized by skin rash, itching, or difficulty breathing. They can occur immediately after taking ZYPREXA VELOTAB or sometime later.

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

3. How to take ZYPREXA VELOTAB

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

Your doctor will tell you how many ZYPREXA VELOTAB tablets you should 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 orodispersible tablets are for oral administration.

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

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

You can also put the tablet in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, stirring. With some beverages, the mixture may change color and appear cloudy. It should be drunk 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/aggression, 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 stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the above symptoms. Show the doctor the package with the tablets.

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 forgotten doses.

If you stop taking ZYPREXA VELOTAB

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

If you stop taking ZYPREXA VELOTAB suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or 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 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 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 a 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)

Very common side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; 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 lying down or sitting. This feeling usually goes away on its own, but if it doesn't, 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 temporary increases in liver enzymes at the start of treatment; 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; skin rash; loss of strength; excessive fatigue; fluid retention that causes swelling of the hands, ankles, or feet; fever, joint pain, and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon 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, most often 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 (which can affect up to 1 in 1,000 people) include a drop in normal 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 areas of the eyes; a muscle disorder that presents as unexplained pains 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 an extensive rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (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 problems. 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 side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing ZYPREXA VELOTAB

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of ZYPREXA VELOTAB

• The active substance is olanzapine. Each ZYPREXA VELOTAB orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of active substance. The exact amount is shown on your ZYPREXA VELOTAB packaging.
• The other ingredients are

gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), and sodium propyl parahydroxybenzoate (E217).

Appearance and packaging of the product

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

Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth to make it easier to swallow.

ZYPREXA VELOTAB packages contain 28, 35, 56, 70, or 98 tablets. Some pack sizes may not 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.

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

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

Date of last revision of this leaflet:

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