Fluoxetine Hydrochloride Oral capsule, gastro-resistant pellets, weekly [Depression/Mood Disorders]

What is this medicine?

FLUOXETINE (floo OX e teen) belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). The weekly capsules can treat mood problems such as depression.

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:

• bipolar disorder or mania
• diabetes
• liver disease
• psychosis
• seizures
• suicidal thoughts or history of attempted suicide
• an unusual or allergic reaction to fluoxetine, 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. Do not cut, crush, or chew this medicine. You can take this medicine with or without food. Take it on the same day of the week each week. Do not take your medicine more often than directed. Do not stop taking except on your doctor's 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?

Try not to miss your scheduled weekly dose. You may want to mark a calendar to remind you. If you miss a dose, and it is still the day you normally take your medicine each week, then take it as soon as you can. If it is another day, then take the dose as soon as you remember and then adjust your weekly doses to the new day of the week. Do not take double or extra doses. There should be one week between each dose.

What may interact with this medicine?

Do not take fluoxetine with any of the following medications:

• other medicines containing fluoxetine, like Sarafem or Symbyax
• certain diet drugs like dexfenfluramine, fenfluramine, phentermine
• cisapride
• medicines called MAO Inhibitors like Azilect, Carbex, Eldepryl, Emsam, Marplan, Nardil, and Parnate
• pimozide
• procarbazine
• St. John's wort
• thioridazine
• tryptophan

Fluoxetine may also interact with the following medications:

• alcohol
• any other medicines for depression, anxiety, or psychotic disturbances-aspirin and aspirin-like medicines
• carbamazepine
• cyproheptadine
• dextromethorphan
• flecainide
• lithium
• medicines for diabetes
• medicines for migraine headache, like sumatriptan
• medicines for sleep
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• metoprolol
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• phenytoin
• propafenone
• propranolol
• 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 notice the full effect of this medicine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for any 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.

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.

If you have diabetes, this medicine may affect blood sugar levels. Check your blood sugar. Talk to your doctor or health care professional if you notice changes.

If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get side effects or have a worsening of your condition. Ask your doctor or health care professional for advice.

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.

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
• fast or irregular heart rate, palpitations
• flu-like fever, chills, cough, muscle or joint aches and pains
• seizures
• suicidal thoughts or other mood changes
• tremor
• trouble sleeping
• 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
• diarrhea
• dry mouth
• flushing
• headache
• increased or decreased appetite
• nausea
• sweating

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). 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.