Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sarafem (fluoxetine)?

Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor.

What should I discuss with my healthcare provider before taking Sarafem (fluoxetine)?

Do not use fluoxetine if you are using any of the following drugs:

• pimozide (Orap);
• thioridazine (Mellaril); or
• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril) or an MAOI.Before taking fluoxetine, tell your doctor if you are allergic to any drugs, or if you have:

• cirrhosis of the liver;
• kidney disease;
• diabetes;
• seizures or epilepsy;
• bipolar disorder (manic depression); or
• a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use fluoxetine, or you may need a dosage adjustment or special tests.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor. Fluoxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give fluoxetine to anyone younger than 18 years old without a doctor’s advice. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression.

How should I take Sarafem (fluoxetine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from the medication.

Do not break, chew, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.Measure the liquid form of fluoxetine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It may take 4 weeks or longer before you start feeling better. Do not stop using fluoxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor’s instructions.

Store fluoxetine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed.Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a fluoxetine overdose may include nausea, vomiting, fever, sleepiness, rapid or uneven heartbeat, confusion, fainting, seizures, or coma.

Sarafem (fluoxetine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);
• tremors, shivering, muscle stiffness or twitching;
• a red, blistering, peeling skin rash;
• problems with balance or coordination; or
• agitation, confusion, sweating, fast heartbeat.

Less serious side effects may include:

• drowsiness, dizziness, weakness;
• runny nose, sore throat, headache, flu symptoms;
• nausea, diarrhea, changes in appetite;
• weight changes;
• decreased sex drive, impotence, or difficulty having an orgasm; or
• dry mouth, increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Sarafem (fluoxetine)?

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine may cause you to bruise or bleed easily.

Before taking fluoxetine, tell your doctor if you are using any of the following medicines:

• alprazolam (Xanax);
• clozapine (Clozaril, Fazaclo);
• digitoxin (Crystodigin);
• flecainide (Tambocor);
• haloperidol (Haldol);
• seizure medication such as phenytoin (Dilantin) or carbamazepine (Tegretol);
• tryptophan (also called L-tryptophan);
• vinblastine (Velban);
• a blood thinner such as warfarin (Coumadin);
• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
• any other antidepressants such as amitriptyline (Elavil), escitalopram (Lexapro), imipramine (Tofranil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with fluoxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Zyban is used for Helping certain patients to stop smoking cigarettes. It may also be used for other conditions as determined by your doctor.

Zyban Sustained-Release Tablets is an antidepressant that has been found to aid in the stopping of smoking.

Do NOT use Zyban Sustained-Release Tablets if:

• you are allergic to any ingredient in Zyban Sustained-Release Tablets
• you are taking any other medicine that contains bupropion
• you have a history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)
• you are suddenly stopping the use of alcohol or sedatives (eg, benzodiazepines) after long-term use
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zyban Sustained-Release Tablets:

Some medical conditions may interact with Zyban Sustained-Release 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 or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse
• if you have diabetes, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), or a recent heart attack
• if you have a history of seizure, head injury, tumor in the brain or spinal cord, or liver problems (eg, cirrhosis)

Some MEDICINES MAY INTERACT with Zyban Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antipsychotics (eg, haloperidol, risperidone), corticosteroids (eg, prednisone), insulin, levodopa, MAOIs (eg, phenelzine), nicotine patches, oral hypoglycemics (eg, glipizide), other antidepressants (eg, fluoxetine, amitriptyline), sympathomimetics (eg, pseudoephedrine), theophylline, or tiagabine because they may increase the risk of Zyban Sustained-Release Tablets’s side effects
• Carbamazepine, phenobarbital, or phenytoin because they may decrease Zyban Sustained-Release Tablets’s effectiveness
• Antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine), or tricyclic antidepressants (eg, nortriptyline) because the risk of their side effects may be increased by Zyban Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zyban Sustained-Release 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 Zyban Sustained-Release Tablets:

Use Zyban Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zyban Sustained-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zyban Sustained-Release Tablets refilled.
• Take Zyban Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Zyban Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Several weeks may pass before your symptoms improve. Do not stop taking Zyban Sustained-Release Tablets without checking with your doctor.
• Take your doses at the same times each day at least 8 hours apart unless directed otherwise by your doctor. This may help to decrease the risk of seizures with Zyban Sustained-Release Tablets.
• It takes about 1 week for Zyban Sustained-Release Tablets to work. You should begin taking Zyban Sustained-Release Tablets while you are still smoking. However, you and your doctor should decide on a date that you will stop smoking during the 2nd week of taking Zyban Sustained-Release Tablets.
• If you have not made progress towards stopping smoking by the 12th week, contact your doctor.
• If you are not able to stop smoking while using Zyban Sustained-Release Tablets, talk to your doctor to determine why you were not successful. After the reasons have been reduced or eliminated, you should try to stop smoking again.
• Continue to take Zyban Sustained-Release Tablets even if you feel well. Do not miss any doses.
• If you miss a dose of Zyban Sustained-Release Tablets, skip the missed dose. Go back to your regular dosing schedule. Do not take more than 1 dose within 8 hours. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zyban Sustained-Release Tablets.

Important safety information:

• Zyban may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zyban Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Zyban Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Zyban Sustained-Release Tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you drink large amounts of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Zyban Sustained-Release Tablets.
• If you already drink alcohol or use sedatives, do not suddenly stop them without first checking with your doctor. Suddenly stopping them may increase your seizure risk.
• Do not take decongestants (eg, pseudoephedrine), stimulants, or diet pills while you are taking Zyban Sustained-Release Tablets without first checking with your doctor. They may increase your risk of seizures.
• The risk of seizures may be greater if you take Zyban Sustained-Release Tablets in high doses or for a long time. Do NOT take more than the recommended dose, change your dose, or use Zyban Sustained-Release Tablets for longer than prescribed without checking with your doctor.
• Children, teenagers, and young adults who take Zyban Sustained-Release Tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take Zyban Sustained-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• If you have trouble sleeping, you may be taking your dose too close to bedtime. Talk with your doctor about changing your dosing schedule.
• It is important to follow the program that your doctor has prescribed, including behavioral changes, counseling, or support services, in order to stop smoking.
• Zyban Sustained-Release Tablets can be used together with the nicotine skin patches only under the supervision of your doctor. Using these medicines together may raise your blood pressure. If you are already using a nicotine skin patch, your blood pressure should be checked regularly.
• Do not smoke if you are using Zyban Sustained-Release Tablets along with the nicotine skin patch or any nicotine product.
• Stopping smoking may change the amount of certain medicines (eg, theophylline, warfarin) in your blood. Be sure your doctor knows all the medicines that you are taking.
• Zyban Sustained-Release Tablets contains the same ingredients as Wellbutrin, an antidepressant. Do not take Zyban Sustained-Release Tablets if you are also taking Wellbutrin or other brands of bupropion. Discuss any questions or concerns with your doctor.
• Use Zyban Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Zyban Sustained-Release 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 Zyban Sustained-Release Tablets while you are pregnant. Zyban Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Zyban Sustained-Release Tablets.

Possible side effects of Zyban:

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:

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; loss of appetite; nausea; nervousness; stomach pain; stuffy nose; trouble sleeping.

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); blurred vision or other vision changes; chest pain; concentration problems, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated sense of well-being, inability to sit still, or other unusual or severe mental or mood changes; confusion; changes in sexual desire or ability; delusions; fainting; fast or irregular heartbeat; fever or chills; hallucinations; hearing problems or ringing in the ears; joint or muscle pain; menstrual changes; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent anxiety, agitation, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor.

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