What Fycompa is used for and how to use it
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Fycompa - Consumer Medicine Information

Manufacture: Eisai Inc.
Country: Canada
Condition: Epilepsy, Seizures (Convulsions)
Class: AMPA receptor antagonists, Anticonvulsants
Form: Tablets
Ingredients: perampanel, lactose monohydrate, giproloza low substituted, povidone, magnesium stearate, MCC

Perampanel Tablets

Keep all medicines in a safe place away from children. Accidental use by a child is a medical emergency and may result in death. Never take medicine in front of small children as they will want to copy you. If a child accidentally takes FYCOMPA, get emergency help right away.

What is the Most Important Information i Should Know About Fycompa

Do Not Stop FYCOMPA Without First Talking to a Healthcare Provider. Stopping FYCOMPA Suddenly Can Cause Serious Problems, Including Having More Seizures More Often

  1. FYCOMPA can cause mental (psychiatric) problems, including:
    • new or worse aggressive behaviour, hostility, anger, or irritability
    • being suspicious or distrustful (believing things that are not true)
    • other unusual or extreme changes in behaviour or mood

    Tell your healthcare provider right away if you have any new or worsening mental problems while using FYCOMPA.

  2. Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

    Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

    • thoughts about suicide or dying
    • attempt to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking
    • other unusual changes in behaviour or mood

    Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

  3. FYCOMPA can make you feel dizzy, sleepy, tired or weak, and or cause double or blurred vision.
    • These can happen when you first begin treatment and when your dose is increased.
    • Don’t drive or operate heavy machinery until you know how FYCOMPA affects you.
  4. Increased risk of falls. Taking FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly.

About This Medication

What the Medication is Used For

FYCOMPA is a prescription medicine used to treat seizures when taken together with other seizure medicines in adults 18 years or older.

What It Does

The exact way in which FYCOMPA controls seizures is not known.

When It Should not be Used

Do not take FYCOMPA:

  • if you are allergic (hypersensitive) to perampanel or any of the other ingredients of FYCOMPA

What the Medicinal Ingredient Is

Perampanel

What the Nonmedicinal Ingredients Are

FYCOMPA tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below.


2 mg tablets: yellow ferric oxide, red ferric oxide

4 mg tablets: red ferric oxide

6 mg tablets: red ferric oxide

8 mg tablets: black ferric oxide, red ferric oxide

10 mg tablets: FD&C Blue #2 indigo carmine aluminum lake, yellow ferric oxide

12 mg tablets: FD&C Blue #2 indigo carmine aluminum lake

What Dosage Form It Comes In

Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg

Warnings and Precautions

Before You use Fycompa Talk to Your Doctor or Pharmacist if You:

  • Have or have had depression, mood problems, or suicidal thoughts or behaviour
  • Have liver or severe kidney problems
  • Have abused prescription medicines, street drugs, or alcohol in the past
  • Have other medical problems
  • Are taking birth control pills, as FYCOMPA makes certain types less effective (see INTERACTIONS WITH THIS MEDICATION)
  • Are pregnant or plan to become pregnant. It is not known if FYCOMPA can harm your unborn baby. Tell your doctor right away if you become pregnant while taking FYCOMPA. You and your healthcare provider will decide if you should take FYCOMPA while you are pregnant.
  • Are breastfeeding or plan to breastfeed. It is not known whether FYCOMPA can pass into breast milk. Talk to your doctor about breastfeeding while you are taking FYCOMPA. You and your healthcare provider should decide if you will take FYCOMPA or breastfeed. You should not do both.

Pregnancy Registration

If you use FYCOMPA while you are pregnant, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect valuable information about the safety of antiepileptic medicine during pregnancy.Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/

Serious Psychiatric and Behavioural Reactions

You and your family and caregivers should be informed that FYCOMPA may increase your risks of psychiatric events, such as emergence of anger, aggression, hostility, unusual changes in mood, personality, or behaviour, and other behavioural symptoms. You are advised to report any such symptoms immediately to your health care providers.

Suicidal Thinking and Behaviour

FYCOMPA may increase the risk of suicidal thinking and behaviour. It is advised your caregiver and families need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behaviour, or the emergence of suicidal thoughts, behaviour or thoughts about self-harm. Instruct your families and care giver to report behaviours of concern immediately to your health care provider.

How do you watch for early symptoms of psychiatric and behaviour reactions, and suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviour, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call you healthcare provider between visits as needed, especially if you are worried about symptoms.

Neurologic Effects: Dizziness, Gait Disturbance,Somnolence, and Fatigue

FYCOMPA may cause dizziness, gait disturbance (problems walking normally), somnolence, and fatigue. While you are taking FYCOMPA, you are advised not to drive, operate heavy machinery, or engage in other hazardous activities until you know how FYCOMPA affects you.

Increased risk of falls

Taking of FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly.

Fycompa with Alcohol

As with some other anti-epileptic drugs, be careful about consuming alcohol with FYCOMPA.

  • Drinking alcohol while taking FYCOMPA can make you less alert and affect your ability to drive or use tools or machines.
  • Drinking alcohol while taking FYCOMPA may make any feelings of anger, confusion or sadness worse.

Lactose Intolerance

FYCOMPA contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

FYCOMPA may cause double or blurred vision. If you experience problems with your vision while taking FYCOMPA, notify your doctor.

Interactions With This Medication

Tell your doctor about all the medicines you take including prescription or non-prescription medicines, vitamins or herbal supplements. FYCOMPA and other medicines can affect each other, causing side effects. Especially tell your doctor if you take:

  • Carbamazepine (TEGRETOL), Oxcarbazepine (TRILEPTAL), Phenytoin (DILANTIN),
  • Other medications, such as ketoconazole, midazolam, levodopa, rifampin or St. John’s Wort, as these can also interact with FYCOMPA
  • Oral contraceptives (birth control pills). FYCOMPA may interfere with your oral contraceptive’s ability to prevent pregnancy if your oral contraceptive contains levonorgestrel. Talk to your doctor about using other forms of safe and effective contraception when taking FYCOMPA and for one month after stopping treatment.

Do not drink alcohol or take other medications that make you sleepy or dizzy while taking FYCOMPA until you talk to your doctor. Taking FYCOMPA with alcohol or medications that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Proper Use of This Medication

Usual Dose

The usual starting dose is 2 mg or 4 mg once a day depending on what other anti-epileptics drugs you are taking. Your doctor may increase your dose in 2 mg steps to a dose of 4 mg up to 12 mg once a day, depending on your response. The maximum recommended daily dose is 12 mg.

FYCOMPA should be taken once a day, at bed time, with or without food.

If you have liver or severe kidney problems, your doctor may give you a reduced dose of FYCOMPA.

Don’t take any more FYCOMPA than your doctor has recommended. It may take a few weeks to find the right dose of FYCOMPA for you.

Take FYCOMPA for as long as your doctor recommends. Don’t stop unless your doctor advises you to. Your doctor may reduce your dose slowly to avoid your seizures coming back or getting worse.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Make sure you have your medicine bottle with you so that you have the correct information.

Missed Dose

If you forget to take a tablet, resume dosing the following day at the prescribed daily dose. Contact your doctor if more than one day of dosing is missed.

Side Effects and What to Do About Them

Like all medicines, FYCOMPA can cause side effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not listed below, please tell you doctor or pharmacist.

The most common side effects of FYCOMPA include:

  • dizziness
  • sleepiness
  • tiredness
  • irritability
  • fall
  • problems with muscle coordination
  • problems with walking normally (gait disturbance)
  • vertigo (sense of spinning)
  • weight gain
  • nausea

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / effect Talk with your
doctor or
pharmacist
Seek
Emergency
Medical
Attention
Only if
severe
In all
cases
Common Irritability
Fall
Uncommon Thoughts of suicide or hurting yourself
Extreme sleepiness or tiredness and/or difficulty coordination muscles normally
Unusual mood change, aggression, hostility, personality change, behaviour change
Allergic reactions (symptoms include swelling in the eyes, lips, mouth, tongue, face and throat, itching, rash, hives)

This is not a complete list of side effects. For any unexpected effects while taking FYCOMPA, contact your doctor or pharmacist.

How to Store It

Store FYCOMPA tablets at room temperature, 15°C to 30°C. Keep out of the reach and sight of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Eisai Limited, at: 1-877-873-4724.