Taro-Perampanel: Uses, Side Effects and Dosage

What is Taro-Perampanel used for?

Taro-Perampanel is used with other medicines to manage:

• a type of seizure called partial-onset seizures in children 7 years of age and older and adults.

• a type of seizure called tonic-clonic (grand mal) seizures in children 12 years of age and older and adults who have epilepsy.

Taro-Perampanel should only be used in patients whose seizures are not controlled with standard treatment.

Serious Warnings and Precautions

Taro-Perampanel can cause serious or life-threatening mental health and behavioural problems including:

• aggression
• hostility
• irritability
• anger
• thoughts of harming or threatening others
• unusual changes in mood, personality, or behaviour

This can happen even in if you/your child have no history of mental health or behavioural problems.

You/your child, your/their caregiver and family must tell your/your child’s healthcare provider right away if you/your child have any new or unusual changes in mood, personality or behaviour while taking Taro-Perampanel or after you/your child stop taking it. Your/your child’s healthcare professional may lower your/their dose or have you/them stop taking Taro-Perampanel.

You/your child should not drink alcohol while taking Taro-Perampanel. Drinking alcohol while on Taro-Perampanel can cause your/their mood to worsen or increase your/their anger. Talk to your/your child’s healthcare professional about your/your child’s alcohol consumption and if you/your child have a history or alcohol dependence.

How does Taro-Perampanel work?

Taro-Perampanel belongs to a group of medicines called antiepileptic medicines. The exact mechanism of action is not entirely understood.

What are the ingredients in Taro-Perampanel?

Medicinal ingredient: Perampanel

Non-medicinal ingredients: hypromellose 2910 (HPMC), lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, macrogol/PEG 8000, povidone, talc and titanium dioxide.

The tablets also contain the following non-medicinal ingredients:

2 mg tablets: iron oxide yellow, iron oxide red

4 mg tablets: iron oxide red

6 mg tablets: iron oxide red

8 mg tablets: iron oxide red, FD&C Blue #2, FD&C Red #40,

10 mg tablets: iron oxide yellow, FD&C Blue #2

12 mg tablets: FD&C Blue #2

Taro-Perampanel comes in the following dosage forms:

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

Do not use Taro-Perampanel if:

• you/your child are allergic to perampanel or any of the other ingredients in Taro-Perampanel.

To help avoid side effects and ensure proper use, talk to you/your child’s healthcare professional before you/your child take Taro-Perampanel. Talk about any health conditions or problems you/your child may have, including if you/your child:

• Have or have had depression, mood problems, or suicidal thoughts or behaviour.
• Have mild or moderate liver problems.
• Have moderate or severe kidney problems or are undergoing hemodialysis.

• Have or ever had a problem with:

  • substance use, including prescribed or illegal drugs, or
  • alcohol
• Are taking birth control, especially birth control containing levonorgestrel. Taro-Perampanel may decrease the efficacy of birth control that contains levonorgestrel.
• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed.
• Are taking other antiepileptic medicines such as carbamazepine, oxcarbazepine, and phenytoin

• Are lactose intolerant or have one of the following rare hereditary disease:

  • galactose intolerance
  • Lapp lactase deficiency
  • glucose-galactose malabsorption
• Regularly or occasionally drink alcohol.
• Are 65 years of age or older.

Other warnings you should know about:

Do not stop your/your child’s treatment with Taro-Perampanel without first checking with your/your child’s healthcare professional. This could lead to a sudden worsening of your/your child’s seizures or make them happen more often.

Severe skin reactions: Serious allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), can be caused by anti-seizure medicines, often involving a skin reaction. These may occur shortly after starting treatment, or several months later. Get help right away if you/your child develop a skin rash, regardless of its severity, either alone or with a combination of the following symptoms:

• any other serious skin reaction such as blistering or peeling of the mouth, nose, eyes or genitals,
• fever,
• swollen glands,
• flu-like feeling,
• swelling of the face and/or legs,
• problems related to the liver, kidneys, heart, lungs or other organs

Driving and Using Machines: Taro-Perampanel may make you/your child feel dizzy, drowsy and affect your/their coordination. These effects may be worse if you/your child drink alcohol. Do not drive, use machinery, or do activities that require you/your child to be alert until you/they know how Taro-Perampanel affects you/them.

Falls and Injuries: Taro-Perampanel may cause you/your child to feel sleepy, dizzy and affect your/your child’s balance and coordination. This increases the risks of falling, which can cause fractures or other fall- related injuries, especially when there is a change in your/your child’s dose, or you are elderly.

Suicidal thoughts and behaviour: Taro-Perampanel may cause you/your child to have suicidal thoughts and behaviours or to become more depressed. If you/your child have thoughts of harming or killing yourself/themselves or others at any time, tell your/their healthcare professional or go to a hospital right away. You/your child may find it helpful to tell a relative or close friend you/your child are taking Taro-Perampanel. Ask them to read this leaflet. You might ask them to tell you if they:

• think your/your child’s depression is getting worse, or
• are worried about changes in your/your child’s behaviour.

Pregnancy and breastfeeding:

• It is not known if Taro-Perampanel can harm your/your child’s unborn baby. Tell your/your child’s

  healthcare professional right away if you/your child become pregnant or think you/your child might be pregnant while taking Taro-Perampanel. You and your/your child’s healthcare professional will decide if you/your child should take Taro-Perampanel while you/your child are pregnant.

• Pregnancy registry: If you/your child become pregnant while taking Taro-Perampanel, talk to

  your/your child’s healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You/your child can enroll in this registry by calling 1-888- 233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. Information about the registry can also be found at the website: http://www.aedpregnancyregistry.org/.

• It is not known whether Taro-Perampanel can pass into breast milk. You must discuss with your/your

  child’s healthcare professional whether to breastfeed or take Taro-Perampanel.

Vision Problems: Taro-Perampanel may cause you/your child to see two of the same image (diplopia) or blurred vision. If you/your child experience problems with your/their vision while taking Taro-Perampanel, talk to your/your child’s healthcare professional.

Tell your/your child’s healthcare professional about all the medicines you/your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Taro-Perampanel:

• other antiepileptic drugs such as carbamazepine, phenytoin, oxcarbazepine, phenobarbital, lamotrigine, topiramate, clobazam, and valproic acid
• alcohol
• birth control containing levonorgestrel
• medicines used to treat HIV
• medicines used to treat bacterial infections such as rifampin and clarithromycin
• St. John’s Wort, a herbal remedy
• medicines used to treat fungal infections such as ketoconazole
• midazolam, used before surgery and other medical procedures to cause drowsiness and decrease anxiety
• central nervous system depressants including benzodiazepines, narcotics, barbiturates and sedating antihistamines
• levodopa, used to treat symptoms of Parkinson’s disease

How to take Taro-Perampanel:

• Take/give Taro-Perampanel exactly as your/your child’s healthcare professionals tell you to. They will decide on the dose that is right for you/your child. Never increase or decrease your/your child’s dose without talking to your/their healthcare professional.

• Do not stop taking/giving Taro-Perampanel without talking to your/your child’s healthcare

  professional. Stopping Taro-Perampanel suddenly can cause your/your child’s seizures to be worse or make them happen more often. Your/your child’s healthcare professional will tell you if and when you/your child can stop taking this medicine.

• Take/give your/your child’s dose once a day at bedtime.

Usual dose:

Usual starting dose: Your/your child’s healthcare professional will determine the starting dose that is right for you/your child. This may be 2 mg or 4 mg once a day. Your/their dose will depend on:

• if you/they have liver or kidney problems
• other antiepileptic medicines you/your child may be taking

Depending on your/your child’s response and tolerability to Taro-Perampanel, your/your child’s healthcare professional may increase your/your child’s dose.

Maximum daily dose: 12 mg a day

Overdose:

Signs of an overdose may include:

• changes to mental status
• agitation
• aggressive behaviour
• dizziness

Missed Dose:

If you/your child miss a dose of this medication, do not make up the missed dose. Skip the missed dose and continue with your/their next scheduled dose. Do not take or give two doses at the same time to make up for the missed dose.

Talk to your/your child’s healthcare professional if you/your child miss more than one dose.

What are possible side effects from using Taro-Perampanel?

These are not all the possible side effects you/your child may have when taking Taro-Perampanel. If you/your child experience any side effects not listed here, tell your/their healthcare professional.

Side effects may include:

• dizziness
• sleepiness
• tiredness
• problems with muscle coordination
• problems with walking normally (gait disturbance)
• vertigo (sense of spinning)
• weight gain
• nausea
• diarrhea
• vomiting
• joint pain
• muscle aches and pain
• feeling weak or lacking of energy
• cough, runny nose, fever, sore throat
• constipation

• headache

  • If you think you, or a person you are caring for, have taken too much Taro-Perampanel, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Serious side effects and what to do about them

If you/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/your child’s daily activities, tell your/their healthcare professional.

Storage:

Store at room temperature (15ºC to 30 ºC).

Keep out of the reach and sight of children.

If you want more information about Taro-Perampanel:

• Talk to your/your child’s healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html); the manufacturer’s website www.taro.com, or by calling 1-800-268-1975.

Last revised: MAR 19, 2024

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your/your child’s health professional if you/they need information about how to manage your/their side effects. The Canada Vigilance Program does not provide medical advice.