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Drug Factsheets

Apo-Fluoxetine

(fluoxetine)

DIN (Drug Identification Number)

02216353 APO-FLUOXETINE 10MG CAPSULE
02216361 APO-FLUOXETINE 20MG CAPSULE
02231328 APO-FLUOXETINE ORAL SOLUTION

What side effects are possible with Apo-Fluoxetine?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • anxiety or nervousness
  • decreased appetite
  • decreased sexual drive
  • diarrhea
  • dizziness or lightheadedness
  • drowsiness
  • dry mouth
  • headache
  • heartburn
  • increased sweating
  • nausea
  • tiredness or weakness
  • trembling or shaking
  • trouble sleeping

Check with your doctor as soon as possible if any of the following side effects occur:

  • inability to sit still, or restlessness
  • skin rash, hives, or itching
  • chills or fever
  • joint or muscle pain
  • breast enlargement or pain
  • fast or irregular heartbeat
  • purple or red spots on skin
  • talking, feeling, and acting with excitement and activity you cannot control
  • unusual secretion of milk (women)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • convulsions (seizures)
  • symptoms of hypoglycemia (low blood sugar), including:
    • anxiety or nervousness
    • chills
    • cold sweats
    • confusion
    • cool pale skin
    • difficulty concentrating
    • drowsiness
    • excessive hunger
    • fast heartbeat
    • headache
    • shakiness or unsteady walk
    • unusual tiredness or weakness
  • symptoms of hyponatremia (low blood sodium), including:
    • confusion
    • convulsions (seizures)
    • drowsiness
    • dryness of mouth
    • increased thirst
    • lack of energy
  • symptoms of serotonin syndrome, including:
    • diarrhea
    • fever
    • increased sweating
    • mood or behaviour changes
    • overactive reflexes
    • racing heartbeat
    • restlessness
    • shivering or shaking
  • trouble breathing
  • unusual or incomplete body or facial movements

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Apo-Fluoxetine?

Be sure to inform your doctor of all your medical conditions before you begin taking a medication. Some conditions can affect how you should take this medication.

HEALTH CANADA ADVISORY

March 10, 2006

Health Canada has issued new restrictions concerning the use of fluoxetine. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergy: Approximately 4% of people who take fluoxetine develop a rash or hives. Almost one-third of these people need to stop treatment because of the rash.

Diabetes: For people with diabetes, fluoxetine may alter blood glucose control. Low blood glucose has occurred during therapy with fluoxetine and high blood glucose has developed after treatment stops. As is true for many other types of medication when taken by people with diabetes, dosages of insulin or anti-diabetic tablets may need adjustment when therapy with fluoxetine starts or stops.

Drowsiness/reduced alertness: People taking fluoxetine are cautioned against driving a car or performing hazardous tasks until they determine that this medication does not affect them adversely.

Epilepsy: Fluoxetine should be used with caution by people with epilepsy.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, call your doctor as soon as possible.

Breast-feeding: Fluoxetine passes into breast milk. Women should stop breast-feeding while they are taking this medication.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with Apo-Fluoxetine?

The following medications may affect the way fluoxetine works or increase the risk of side effects:

 
  • alcohol
  • buspirone
  • carbamazepine
  • clarithromycin
  • dextromethorphan
  • levodopa
  • lithium
  • meperidine
  • MAO inhibitors
  • nefazodone
  • other SSRIs (e.g., paroxetine, fluvoxamine)
  • sumatriptan
  • St. John's wort
  • tricyclic antidepressants
  • tryptophan
  • valproic acid
  • divalproex

The following medications may be affected by fluoxetine or increase the risk of side effects:

  • astemizole
  • antipsychotics (e.g., haloperidol, risperidone, clozapine)
  • benzodiazepines
  • carbamazepine
  • digoxin
  • metoprolol
  • nifedipine
  • phenobarbital
  • propranolol
  • phenytoin
  • tricyclic antidepressants (e.g., desipramine, imipramine)
  • terfenadine
  • verapamil
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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