ZYPREXA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ZYPREXA 2.5 mg film-coated tablets

ZYPREXA 5 mg film-coated tablets

ZYPREXA 7.5 mg film-coated tablets

ZYPREXA 10 mg film-coated tablets

ZYPREXA 15 mg film-coated tablets

ZYPREXA 20 mg film-coated 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 is and what it is used for
2. What you need to know before you take ZYPREXA
3. How to take ZYPREXA
4. Possible side effects
5. Storing 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 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such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

ZYPREXA has been shown to prevent the 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

Do not take 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

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 side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking ZYPREXA, tell your doctor.
• In very rare cases, medicines of this type can 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. 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.
• If you or a family member have 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 temporary 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 salt loss due to prolonged and intense diarrhea and vomiting or the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or family member 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

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

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

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 may need to be changed.

Using 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, 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 can pass into breast milk.

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

Driving and using machines

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

ZYPREXA contains lactose

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

3. How to take ZYPREXA

Follow exactly the administration instructions of this medicine given by your doctor. In case of 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 film-coated tablets are for oral administration. You should 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/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 notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take ZYPREXA

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

If you stop taking ZYPREXA

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

If you stop taking ZYPREXA 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, go to the 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 a lying or sitting position. This feeling usually goes away on its own, 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 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.

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, 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 mammary gland in men and women, such as abnormal milk production or abnormal growth.

Very rare side effects (which can affect up to 1 in 1000 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 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 is manifested with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen 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, a rise in body temperature, skin redness, 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 nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed 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 which is stated on the carton.

ZYPREXA should be stored in the original package 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

• The active substance is olanzapine. Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg of active substance. The exact amount is shown on your ZYPREXA package.
• The other ingredients are

• Core of the tablet: lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate,
• Coating of the tablet: hypromellose, titanium dioxide (E171), and carnauba wax.

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

Appearance and packaging

ZYPREXA 2.5 mg film-coated tablets are white and have "LILLY" and a numerical identification code "4112" printed on them.

ZYPREXA 5 mg film-coated tablets are white and have "LILLY" and a numerical identification code "4115" printed on them.

ZYPREXA 7.5 mg film-coated tablets are white and have "LILLY" and a numerical identification code "4116" printed on them.

ZYPREXA 10 mg film-coated tablets are white and have "LILLY" and a numerical identification code "4117" printed on them.

ZYPREXA 15 mg film-coated tablets are blue.

ZYPREXA 20 mg film-coated tablets are pink.

ZYPREXA is available in packs of 28, 35, 56, 70, or 98 tablets. Not all 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.

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/.