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Fenfluramine (By mouth)

Fenfluramine Hydrochloride (fen-FLUR-a-meen hye-droe-KLOR-ide)

Treats seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome.

Brand Name(s):

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to fenfluramine.

How to Use This Medicine:

Liquid

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • Measure the oral liquid medicine with the marked oral syringe. Do not use a teaspoon or tablespoon to take a dose.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
  • Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away any unused medicine 3 months after first opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Do not use this medicine if you have used an MAO inhibitor within the past 14 days.
  • Some medicines can affect how fenfluramine works. Tell your doctor if you are using any of the following:
    • Clobazam, cyproheptadine, dextromethorphan, lithium, rifampin, stiripentol, St John's wort, tramadol, tryptophan, valproate
    • Medicine to treat depression and other mental problems (including bupropion, fluvoxamine, paroxetine, trazodone, SSRIs, SNRIs, TCAs)
  • Do not drink alcohol while you are using this medicine.
  • Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, lung or breathing problems, depression, high blood pressure, or eye or vision problems.
  • This medicine may cause the following problems:
    • Heart problems (including valvular heart disease)
    • Pulmonary arterial hypertension (high blood pressure in the lungs)
    • Loss of appetite and weight
    • Changes in mood or behavior, including thoughts of suicide
    • Serotonin syndrome (when used with certain other medicines)
    • High blood pressure
    • Eye or vision problems (including glaucoma)
  • This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
  • This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
  • Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
  • Changes in vision, eye pain, seeing halos around lights
  • Decreased appetite, weight loss
  • Dizziness, headache, slow, fast or uneven heartbeat
  • Fever, chills, cough, stuffy or runny nose, sore throat, body aches
  • Thoughts of hurting yourself or others, worsening depression, unusual behavior
  • Trouble breathing, chest pain or tightness, swelling of the feet or lower legs
  • Twitching or muscle movements you cannot control, problems with balance or walking
  • Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

  • Constipation
  • Drooling
  • Drowsiness, trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 4/23/2024

 

 
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