Fluoxetine Hydrochloride, Olanzapine Oral capsule

What is this medicine?

FLUOXETINE; OLANZAPINE (floo OX e teen; oh LAN za peen) is used to treat episodes of depression that have not been relieved by the use of other medicines and depression caused by bipolar disorder.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Alzheimer's disease or dementia
• diabetes mellitus, high blood sugar or a family history of diabetes
• heart disease, irregular heartbeat, or previous heart attack
• high blood pressure treated with medication
• kidney or liver disease
• low blood pressure
• Parkinson's disease
• receiving electroconvulsive therapy
• strokes, or mini-strokes called transient ischemic attacks (TIAs)
• suicidal thoughts
• an unusual or allergic reaction to fluoxetine, olanzapine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. You should not suddenly stop taking this medicine. You must gradually reduce the dose or your symptoms may get worse. Ask your doctor or health care professional for advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain antibiotics like grepafloxacin and sparfloxacin
• clozapine
• diethylpropion
• droperidol
• halofantrine
• levomethadyl
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• other medicines for mental depression
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• phentermine
• pimozide
• procarbazine
• St. John's Wort
• tryptophan

This medicine may also interact with the following medications:

• aspirin or aspirin-like drugs
• carbamazepine
• certain medicines for migraine headaches like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• dextromethorphan
• digoxin
• flecainide
• haloperidol
• levodopa and other medications for Parkinson's disease
• lithium
• medicines for anxiety or sleeping problems, such as diazepam or alprazolam
• medicines for high blood pressure
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• phenytoin
• vinblastine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Continue to take your medicine even if you do not immediately feel better. It can take several weeks before you feel the full effect of this medicine.

Patients and their families should watch out for depression or thoughts of suicide that get worse. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your doctor.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine can reduce the response of your body to heat or cold. Try not to get overheated or dehydrated from exercise. Avoid temperature extremes, such as saunas, hot tubs, or very hot or cold baths or showers. Dress warmly in cold weather.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• confusion
• difficulty in speaking or swallowing
• excessive thirst and/or hunger
• fast heartbeat
• fast talking and excited feelings or actions that are out of control
• fever or chills, sore throat
• flu-like symptoms
• frequently needing to urinate
• muscle spasms or weakness
• painful or prolonged erections
• seizures
• suicidal thoughts or other mood changes
• swelling of face or legs
• tremors
• unusual bleeding or bruising
• unusually tired or weak
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blurred vision
• change in sex drive or performance
• constipation or diarrhea
• drowsy
• flushing
• lowered blood pressure
• nausea
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.