Consumer Drug Information

Zyprexa Zydis Orally Disintegrating Tablets

Generic Name: Olanzapine Orally Disintegrating Tablets (oh-LAN-za-peen)
Brand Name: Zyprexa Zydis

Zyprexa Zydis Orally Disintegrating Tablets is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Zyprexa Zydis Orally Disintegrating Tablets is not approved to treat mental problems caused by dementia.

Zyprexa Zydis Orally Disintegrating Tablets is used for:

Treating schizophrenia or bipolar disorder. It may also be used for other conditions as determined by your doctor.

Zyprexa Zydis Orally Disintegrating Tablets is an atypical antipsychotic. Exactly how it works is not known. It is thought to affect certain substances in the brain.

Do NOT use Zyprexa Zydis Orally Disintegrating Tablets if:

you are allergic to any ingredient in Zyprexa Zydis Orally Disintegrating Tablets

Contact your doctor or health care provider right away if this applies to you.

Before using Zyprexa Zydis Orally Disintegrating Tablets:

Some medical conditions may interact with Zyprexa Zydis Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of seizures, heart problems (eg, heart failure; fast, slow or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke, blood vessel problems, high blood cholesterol levels, or high or low blood pressure
if you have a history of liver problems, stomach or bowel problems (eg, decreased muscle movement), enlarged prostate, narrow-angle glaucoma, neuroleptic malignant syndrome (NMS), aspiration pneumonia, or suicidal thoughts or attempts
if you have Alzheimer disease, dementia, phenylketonuria, or trouble swallowing
if you have diabetes or are very overweight, or if a family member has had diabetes
if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk for breast cancer
if you are dehydrated, drink alcohol, or smoke, or you will be exposed to high temperatures

Some MEDICINES MAY INTERACT with Zyprexa Zydis Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Alpha blockers (eg, doxazosin), diazepam, or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased
Anticholinergics (eg, scopolamine), fluvoxamine, or lorazepam because they may increase the risk of Zyprexa Zydis Orally Disintegrating Tablets's side effects
Carbamazepine, HIV protease inhibitors (eg, ritonavir), omeprazole, or rifampin because they may decrease Zyprexa Zydis Orally Disintegrating Tablets's effectiveness
Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Zyprexa Zydis Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zyprexa Zydis Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zyprexa Zydis Orally Disintegrating Tablets:

Use Zyprexa Zydis Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Zyprexa Zydis Orally Disintegrating Tablets by mouth with or without food.
Do not remove the blister from the outer pouch until you are ready to take Zyprexa Zydis Orally Disintegrating Tablets. Make sure that your hands are dry when you open the blister pack.
Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. It dissolves quickly and can be swallowed with saliva. Zyprexa Zydis Orally Disintegrating Tablets may be taken with or without water.
Take Zyprexa Zydis Orally Disintegrating Tablets immediately after opening the blister pack. Do not store the removed tablet for future use.
Drinking extra fluids while you are taking Zyprexa Zydis Orally Disintegrating Tablets is recommended. Check with your doctor for instructions.
Continue to take Zyprexa Zydis Orally Disintegrating Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Zyprexa Zydis Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zyprexa Zydis Orally Disintegrating Tablets.

Important safety information:

Zyprexa Zydis Orally Disintegrating Tablets may cause dizziness, drowsiness, or decreased vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zyprexa Zydis Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol while you are using Zyprexa Zydis Orally Disintegrating Tablets.
Talk with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zyprexa Zydis Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Zyprexa Zydis Orally Disintegrating Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Do not become overheated in hot weather or while you are being active; heatstroke may occur.
This product contains phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
Zyprexa Zydis Orally Disintegrating Tablets may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Zyprexa Zydis Orally Disintegrating Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
Some patients who take Zyprexa Zydis Orally Disintegrating Tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Zyprexa Zydis Orally Disintegrating Tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Zyprexa Zydis Orally Disintegrating Tablets.
Lab tests, including fasting blood sugar levels and liver function, may be performed while you use Zyprexa Zydis Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Zyprexa Zydis Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
Zyprexa Zydis Orally Disintegrating Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zyprexa Zydis Orally Disintegrating Tablets while you are pregnant. Zyprexa Zydis Orally Disintegrating Tablets is found in breast milk. Do not breast-feed while taking Zyprexa Zydis Orally Disintegrating Tablets.

Possible side effects of Zyprexa Zydis Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; constipation; cough; dizziness; drowsiness; dry mouth; increased appetite; indigestion; lightheadedness; numbness or tingling of the skin; restlessness; sore throat; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; chest pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; fever; increased saliva production or drooling; increased sweating; memory loss; menstrual changes; muscle pain, weakness, or stiffness; new or worsening mental or mood changes (eg, depression, hallucinations); seizures; severe or prolonged dizziness or headache; shortness of breath; swelling of the hands, legs, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include aggression; agitation; chest pain; coma; difficult or slurred speech; fast or irregular heartbeat; seizure; severe drowsiness; slow or shallow breathing; uncontrolled muscle movements.

Proper storage of Zyprexa Zydis Orally Disintegrating Tablets:

Store Zyprexa Zydis Orally Disintegrating Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Zyprexa Zydis Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Zyprexa Zydis Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
Zyprexa Zydis Orally Disintegrating Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Zyprexa Zydis Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 5, 2008

Database Edition 08.4.1.002