DRUGS AND SUPPLEMENTS

Fluoxetine

March 21, 2017

Fluoxetine Hydrochloride Oral capsule [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 helps to treat mood problems such as depression, obsessive compulsive disorder, and panic attacks. It can also treat certain eating disorders.

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

  • glaucoma

  • 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. You can take this medicine with or without food. Take your medicine at regular intervals. Do not take it 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.

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

What may interact with this medicine?

Do not take fluoxetine with any of the following medications:

  • other medicines containing fluoxetine, like Sarafem or Symbyax

  • cisapride

  • 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

  • aspirin and aspirin-like medicines

  • carbamazepine

  • certain medicines for depression, anxiety, or psychotic disturbances

  • certainmedicines 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

  • phenytoin

  • procarbazine

  • propafenone

  • rasagiline

  • ritonavir

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

  • tramadol

  • tryptophan

  • 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?

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.

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

  • eye pain, changes in vision

  • fast or irregular heart rate, palpitations

  • flu-like fever, chills, cough, muscle or joint aches and pains

  • seizures

  • suicidal thoughts or other mood changes

  • swelling or redness in or around the eye

  • tremors

  • 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):

  • 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.

Fluoxetine Hydrochloride Oral capsule [Premenstrual Syndrome]

What is this medicine?

FLUOXETINE (floo OX e teen) belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). It is used for premenstrual dysphoric disorder (PMDD). PMDD causes intense mood and physical symptoms a week or two before your period every month. This drug helps improve mood swings, tiredness, tension, and breast tenderness.

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

  • glaucoma

  • 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. You can take it with or without food. Take your medicine at regular intervals. Do not take it 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. 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, skip the missed dose and go back to your regular dosing schedule. Do not take double or extra doses.

What may interact with this medicine?

Do not take fluoxetine with any of the following medications:

  • other medicines containing fluoxetine, like Prozac or Symbyax

  • cisapride

  • linezolid

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

  • methylene blue (injected into a vein)

  • pimozide

  • thioridazine

Fluoxetine may also interact with the following medications:

  • alcohol

  • aspirin and aspirin-like medicines

  • carbamazepine

  • certain medicines for depression, anxiety, or psychotic disturbances

  • certainmedicines 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

  • phenytoin

  • procarbazine

  • propafenone

  • rasagiline

  • ritonavir

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

  • tramadol

  • tryptophan

  • 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?

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.

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.

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

  • eye pain, changes in vision

  • fast or irregular heart rate, palpitations

  • flu-like fever, chills, cough, muscle or joint aches and pains

  • seizures

  • suicidal thoughts or other mood changes

  • swelling or redness in or around the eye

  • 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):

  • 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.

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

  • glaucoma

  • 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 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. 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

  • cisapride

  • linezolid

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

  • methylene blue (injected into a vein)

  • pimozide

  • thioridazine

Fluoxetine may also interact with the following medications:

  • alcohol

  • aspirin and aspirin-like medicines

  • carbamazepine

  • certain medicines for depression, anxiety, or psychotic disturbances

  • certainmedicines 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

  • phenytoin

  • procarbazine

  • propafenone

  • rasagiline

  • ritonavir

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

  • tramadol

  • tryptophan

  • 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?

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.

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

  • eye pain, changes in vision

  • fast or irregular heart rate, palpitations

  • flu-like fever, chills, cough, muscle or joint aches and pains

  • seizures

  • suicidal thoughts or other mood changes

  • swelling or redness in or around the eye

  • 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):

  • 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.

Fluoxetine Hydrochloride 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.

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

  • glaucoma

  • 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. 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.

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

What may interact with this medicine?

Do not take fluoxetine with any of the following medications:

  • other medicines containing fluoxetine, like Sarafem or Symbyax

  • cisapride

  • 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

  • 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

  • phenytoin

  • procarbazine

  • propafenone

  • rasagiline

  • ritonavir

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

  • tramadol

  • tryptophan

  • 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?

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.

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

  • eye pain, changes in vision

  • fast or irregular heart rate, palpitations

  • flu-like fever, chills, cough, muscle or joint aches and pains

  • seizures

  • suicidal thoughts or other mood changes

  • swelling or redness in or around the eye

  • tremors

  • 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):

  • 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.

Fluoxetine Hydrochloride Oral tablet [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 helps to treat mood problems such as depression, obsessive compulsive disorder, and panic attacks. It can also treat certain eating disorders.

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

  • glaucoma

  • 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. You can take this medicine with or without food. Take your medicine at regular intervals. Do not take it 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.

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

What may interact with this medicine?

Do not take fluoxetine with any of the following medications:

  • other medicines containing fluoxetine, like Sarafem or Symbyax

  • cisapride

  • 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

  • aspirin and aspirin-like medicines

  • carbamazepine

  • certain medicines for depression, anxiety, or psychotic disturbances

  • certainmedicines 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

  • phenytoin

  • procarbazine

  • propafenone

  • rasagiline

  • ritonavir

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

  • tramadol

  • tryptophan

  • 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?

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.

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

  • eye pain, changes in vision

  • fast or irregular heart rate, palpitations

  • flu-like fever, chills, cough, muscle or joint aches and pains

  • seizures

  • suicidal thoughts or other mood changes

  • swelling or redness in or around the eye

  • tremors

  • 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):

  • 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.

Fluoxetine Hydrochloride Oral tablet [Premenstrual Syndrome]

What is this medicine?

FLUOXETINE (floo OX e teen) belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). It is used for premenstrual dysphoric disorder (PMDD). PMDD causes intense mood and physical symptoms a week or two before your period every month. This drug helps improve mood swings, tiredness, tension, and breast tenderness.

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

  • glaucoma

  • 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. You can take it with or without food. Take your medicine at regular intervals. Do not take it 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. 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, skip the missed dose and go back to your regular dosing schedule. Do not take double or extra doses.

What may interact with this medicine?

Do not take fluoxetine with any of the following medications:

  • other medicines containing fluoxetine, like Prozac or Symbyax

  • cisapride

  • linezolid

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

  • methylene blue (injected into a vein)

  • pimozide

  • thioridazine

Fluoxetine may also interact with the following medications:

  • alcohol

  • aspirin and aspirin-like medicines

  • carbamazepine

  • certain medicines for depression, anxiety, or psychotic disturbances

  • certainmedicines 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

  • phenytoin

  • procarbazine

  • propafenone

  • rasagiline

  • ritonavir

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

  • tramadol

  • tryptophan

  • 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?

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.

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.

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

  • eye pain, changes in vision

  • fast or irregular heart rate, palpitations

  • flu-like fever, chills, cough, muscle or joint aches and pains

  • seizures

  • suicidal thoughts or other mood changes

  • swelling or redness in or around the eye

  • 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):

  • 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.

Updated:  

March 21, 2017

Sources:  

U.S. FDA-approved Package Insert