perampanel 4 mg tablet

Generic name:
Perampanel - oral

Pronunciation
(per-AM-pa-nel)

Brand name(s)
Fycompa

Perampanel may cause or worsen mental/mood disorders. Tell your doctor right away if you or your family/caregiver notice any unusual behavior changes (including aggression, attempts to hurt others, impulsive actions) or other mental/mood changes (including anxiety, irritability, hostile/angry feelings, paranoia, hallucinations, delusions, thoughts of harming others). Be especially watchful for these symptoms when you first start this medication or when the dose is changed. These symptoms may also occur even after stopping perampanel. Do not drink alcoholic beverages while taking perampanel because alcohol may make these symptoms worse.

Perampanel is used to treat certain types of seizures (including focal and generalized tonic-clonic seizures). Perampanel belongs to a class of drugs known as anticonvulsants.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking perampanel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily at bedtime.

If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning Section.

Dizziness, a feeling of spinning, unsteadiness, trouble walking, loss of balance, drowsiness, weakness, nausea, vomiting, headache, or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• blurred/double vision
• frequent falls

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking perampanel, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• kidney problems
• mental/mood disorders
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• galactose intolerance (such as Lapp lactase deficiency or glucose-galactose malabsorption)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially falls, drowsiness, and weakness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• orlistat

Other medications can affect the removal of perampanel from your body, which may affect how perampanel works. Examples include rifamycins (such as rifabutin), St. John's wort, among others.

This medication may decrease the effectiveness of levonorgestrel-containing birth control. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable non-hormonal backup birth control methods (such as condoms, diaphragm with spermicide) while using perampanel and for a month after you stop using perampanel. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: mental/mood/behavior changes such as agitation, aggressive behavior.

Do not share this medication with others. Sharing it is against the law.

Medical tests (such as weight measurement, mental/mood screenings) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. If you miss more than 1 dose, contact your doctor for more information.

Store the tablets at room temperature away from light and moisture. Do not store in the bathroom. Store the liquid form at room temperature or in the refrigerator. Do not freeze. Once the bottle for the liquid form is opened, the medication expires after 90 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.