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Fycompa

Fycompa

(perampanel)

Fycompa (Perampanel) belongs to the class of medications called anti-epileptic agents. It is used in combination with other medications to treat partial-onset seizures for people aged 7 years and older.

Available form

Dosage

Tablet

2MG, 4MG, 6MG, 10MG

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Fycompa information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The most appropriate dose of Fycompa (Perampanel) is one that provides good control of seizures without causing side effects that are too severe.

The recommended starting dose for adults and children is 2 mg or 4 mg once daily at bedtime, depending on whether you are taking certain anti-epileptic medications, including Phenytoin, Carbamazepine, or oxcarbamazepine. The dose of Fycompa (Perampanel) can be gradually increased to a maximum dose of 12 mg per day until satisfactory seizure control is seen or side effects become intolerable.

Fycompa (Perampanel) tablets may be taken with food or on an empty stomach. Fycompa (Perampanel) suspension should be taken without food for the first 2 weeks when you start taking the suspension or if you have switched from tablets to the suspension.

If you are using Fycompa (Perampanel) suspension, shake the medication bottle for at least 5 seconds before measuring the dose of medication. An oral syringe should be used to measure each dose of the liquid, as it provides a more accurate measurement than household teaspoons.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Fycompa (Perampanel) be taken exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. Contact your doctor if you miss more than one day of medication.

Store Fycompa (Perampanel) at room temperature, protect it from light and moisture, and keep it out of the reach of children. The suspension should be used within 90 days after opening the bottle.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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 Fycompa (Perampanel). If you are concerned about side effects, discuss the risks and benefits of Fycompa (Perampanel) with your doctor.

The following side effects have been reported by at least 1% of people taking Fycompa (Perampanel). Many of these side effects can be managed, and some may go away on their own over time.

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.

dizziness
falls
irritability
nausea
sense of spinning
sleepiness
tiredness
weight gain
vision changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

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

extreme sleepiness or tiredness
mood or mental changes (e.g., anxiety, restlessness, panic attacks, trouble sleeping, irritability, being suspicious or mistrustful, impulsive behavior, increased sociability, or increased talking)
problems with muscle coordination
problems with walking normally
signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

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

signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, severe Hives, or swelling of the face and throat)
signs of severe skin reactions (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with Fever or discomfort)
thoughts of suicide or self-harm

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 Fycompa (Perampanel).

2 mg
Each orange, round, biconvex, film-coated tablet debossed with "2" on one side and "Є 275" on the other contains 2 mg of Fycompa (Perampanel). Nonmedicinal ingredients: hypromellose 2910, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, povidone, talc and titanium dioxide, yellow ferric oxide, and red ferric oxide.

4 mg
Each red, round, biconvex tablet debossed with "4" on one side and "Є 277" on the other contains 4 mg of Fycompa (Perampanel). Nonmedicinal ingredients: hypromellose 2910, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, povidone, talc and titanium dioxide, and red ferric oxide.

6 mg
Each pink, round, biconvex tablet debossed with "6" on one side and "Є 294" on the other contains 6 mg of Fycompa (Perampanel). Nonmedicinal ingredients: hypromellose 2910, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, povidone, talc and titanium dioxide, and red ferric oxide.

8 mg
Each purple, round, biconvex tablet debossed with "8" on one side and "Є 295" on the other contains 8 mg of Fycompa (Perampanel). Nonmedicinal ingredients: hypromellose 2910, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, povidone, talc and titanium dioxide, black ferric oxide, and red ferric oxide.

10 mg
Each green, round, biconvex tablet debossed with "10" on one side and "Є 296" on the other contains 10 mg of Fycompa (Perampanel). Nonmedicinal ingredients: hypromellose 2910, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, povidone, talc and titanium dioxide, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and yellow ferric oxide.

12 mg
Each blue, round, biconvex tablet debossed with "12" on one side and "Є 297" on the other contains 12 mg of Fycompa (Perampanel). Nonmedicinal ingredients: hypromellose 2910, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, povidone, talc and titanium dioxide, and FD&C Blue No. 2 Indigo Carmine Aluminum Lake.

Oral Suspension
Each mL of white-to-off-white opaque liquid contains 0.5 mg of Fycompa (Perampanel). Nonmedicinal ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer 188, simethicone emulsion (purified water, polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, benzoic acid, sorbic acid, sulfuric acid), anhydrous citric acid, sodium benzoate, and purified water.

There may be an interaction between Fycompa (Perampanel) and any of the following:

alcohol
antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
azelastine
barbiturates (e.g., butalbital, Phenobarbital)
benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
birth control pills
Bosentan
brimonidine
Buprenorphine
Buspirone
cannabis
chloral hydrate
Clonidine
Dabrafenib
Deferasirox
diphenoxylate
Entacapone
Enzalutamide
general anesthetics (medications used to put people to sleep before surgery)
Guanfacine
HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
lumacaftor and Ivacaftor
magnesium sulfate
Mefloquine
Mirtazapine
Mitotane
Modafinil
muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
Nabilone
narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
Orlistat
Pramipexole
progestins (e.g., Levonorgestrel, medroxyprogesterone, Norethindrone)
rifabutin
rifampin
Ropinirole
Rotigotine
St. John's wort
Sarilumab
scopolamine
other seizure medications (e.g., carbamazepine, Gabapentin, Levetiracetam, phenytoin, Topiramate)
selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
siltuximab
sodium oxybate
suvorexant
Tapentadol
thalidomide
tolcapone
Tocilizumab
Tramadol
tricyclic antidepressants (e.g., Amitriptyline, Imipramine)
Zolpidem
Zopiclone

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 Fycompa (Perampanel). 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.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fycompa (Perampanel).

Aggressive behaviour: People taking Fycompa (Perampanel) may experience feelings of anger, irritability, agitation (restless, anxious, aggressive, hostile, emotional, and feeling not like themselves), or they may experience new or worse aggressive behavior. If you experience these side effects or notice them in a family member who is taking Fycompa (Perampanel), contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Fycompa (Perampanel). Drinking alcohol while taking Fycompa (Perampanel) may increase the risk for behaviour changes.

Alcohol and other medications that cause drowsiness: Do not combine Fycompa (Perampanel) with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additional drowsiness can occur and be dangerous. Alcohol can also worsen behavior-related side effects from Fycompa (Perampanel).

Birth control: Fycompa (Perampanel) may cause a decrease in the effectiveness of certain hormonal birth control medications. An additional, non-hormonal method of birth control, such as using condoms, is recommended for women taking Fycompa (Perampanel).

Drowsiness/reduced alertness: Fycompa (Perampanel) may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Fycompa (Perampanel) affects you.

Galactose intolerance: Fycompa (Perampanel) tablets are prepared with lactose. If you have lactose or galactose intolerance you should not take the tablet form of Fycompa (Perampanel).

Hypersensitivity syndrome: A severe hypersensitivity syndrome has occurred for some people with the use of Fycompa (Perampanel). This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a Anaphylaxis (severe allergic reaction), including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Kidney function: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Fycompa (Perampanel) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fycompa (Perampanel), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Fycompa (Perampanel) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Fycompa (Perampanel) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fycompa (Perampanel), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Fycompa (Perampanel).

Stopping the medication: Fycompa (Perampanel) is effective for seizure control only as long as it is being taken regularly. Stopping Fycompa (Perampanel) may result in seizures occurring more often. If Fycompa (Perampanel) needs to be stopped, it should be done gradually, under the supervision of your doctor. If you believe you need to stop taking Fycompa (Perampanel), discuss your concerns with your doctor.

Suicidal thoughts and behaviour: Some people taking anti-seizure medications may have suicidal thoughts or behaviour. If this happens to you or you notice this in a family member who is taking Fycompa (Perampanel), contact your doctor immediately. You should be closely monitored by your doctor for emotional and behavioural changes while taking Fycompa (Perampanel).

Pregnancy: Fycompa (Perampanel) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fycompa (Perampanel), contact your doctor immediately.

Breast-feeding: It is not known if Fycompa (Perampanel) passes into breast milk. If you are a breast-feeding mother and are taking Fycompa (Perampanel), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fycompa (Perampanel) for children under 7 years of age have not been established for children.

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