Fluoxetine oral solution [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). It can treat mood problems such as depression, obsessive compulsive disorder, and panic attacks. It can also treat certain eating disorders.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take this medicine with or without food. Take it at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

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. While this drug may be prescribed for children as young as 7 years for selected conditions, precautions do apply.

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

• anxious

• black, tarry stools

• breathing problems

• changes in vision

• confusion

• elevated mood, decreased need for sleep, racing thoughts, impulsive behavior

• eye pain

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• feeling agitated, angry, or irritable

• hallucination, loss of contact with reality

• loss of balance or coordination

• loss of memory

• painful or prolonged erections

• restlessness, pacing, inability to keep still

• seizures

• stiff muscles

• suicidal thoughts or other mood changes

• trouble sleeping

• unusual bleeding or bruising

• unusually weak or tired

• vomiting

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

• change in appetite or weight

• change in sex drive or performance

• diarrhea

• dry mouth

• headache

• increased sweating

• indigestion, nausea

• tremors

What may interact with this medicine?

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

• other medicines containing fluoxetine, like Sarafem or Symbyax

• cisapride

• dronedarone

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue (injected into a vein)

• pimozide

• thioridazine

This medicine may also interact with the following medications:

• alcohol

• amphetamines

• aspirin and aspirin-like medicines

• carbamazepine

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for migraine headaches like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• digoxin

• diuretics

• fentanyl

• flecainide

• furazolidone

• isoniazid

• lithium

• medicines for sleep

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• other medicines that prolong the QT interval (an abnormal heart rhythm)

• phenytoin

• procarbazine

• propafenone

• rasagiline

• ritonavir

• supplements like St. John's wort, kava kava, valerian

• tramadol

• tryptophan

• vinblastine

What if I miss a dose?

If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not take double or extra doses.

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.

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 a family history of bipolar disorder

• bleeding disorders

• glaucoma

• heart disease

• liver disease

• low levels of sodium in the blood

• seizures

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• take MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• take medicines that treat or prevent blood clots

• thyroid disease

• an unusual or allergic reaction to fluoxetine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor if your symptoms do not get better or if they get worse. Visit your doctor or health care professional for regular checks on your progress. Because it may take several weeks to see the full effects of this medicine, it is important to continue your treatment as prescribed by your doctor.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden 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 health care professional.

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 may interfere with the effect of this medicine. 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.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.