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What is fluoxetine?

• 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.

• You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk.
• o 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), 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).
• Before taking fluoxetine, tell your doctor 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 during treatment.
• FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
• 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.

• 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. 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.
• Try to take the medicine at the same time each day.
• It may take 4 weeks or more for you to 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. You may also begin taking the medication 14 days before the anticipated start of your period. Follow your doctor's directions carefully.
• Store fluoxetine at room temperature away from moisture and heat.

• 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 the drug 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.

• 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.

• Do not take fluoxetine together with thioridazine (Mellaril), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
• Avoid drinking alcohol, which can increase some of the side effects of fluoxetine.
• Avoid using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxants). They can add to sleepiness caused by fluoxetine.
• Fluoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

• 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.
• Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of 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;
  • unusual thoughts or behavior;
  • seizure (convulsions);
  • problems with balance or coordination; or
  • agitation, confusion, sweating, fast heartbeat.
• Other less serious side effects are more likely to occur, such as:
  • feeling anxious, nervous, restless, or unable to sit still;
  • drowsiness, dizziness, weakness;
  • sleep problems (insomnia);
  • 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.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Fluoxetine has the potential to interact with a variety of medications, check with your healthcare professional. The following list contains some of these interactions.

Do not take fluoxetine with any of the following medications:

• astemizole (Hismanal®)
• cisapride (Propulsid®)
• pimozide (Orap®)
• terfenadine (Seldane®)
• thioridazine (Mellaril®)
• medicines called MAO inhibitors-phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), selegiline (Eldepryl®)

Fluoxetine may also interact with the following medications:

• alcohol
• amphetamine
• aspirin
• benzodiazepines, commonly used for anxiety or sleeping problems, such as diazepam or alprazolam
• buspirone
• carbamazepine
• certain diet drugs (dexfenfluramine, fenfluramine, phentermine, sibutramine)
• certain medicines for migraine headache (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan, dihydroergotamine, ergotamine, methysergide)
• cimetidine
• cyproheptadine
• dextroamphetamine
• dextromethorphan
• dofetilide
• ergonovine
• furazolidone
• linezolid
• lithium
• metoprolol
• medicines for diabetes
• medicines for mental depression
• medicines for mental problems or psychotic disturbances
• methylergonovine
• nonsteroidal antiinflammatory drugs (NSAIDs, like ibuprofen)
• phenytoin
• propafenone
• propranolol
• St. John's wort
• warfarin

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.

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