Rivotril: Uses, Side Effects and Dosage

What is RIVOTRIL used for?

RIVOTRIL is used alone or with other anti-seizure medicines to treat certain types of seizures called:

• myoclonic seizures,
• akinetic seizures,
• petit mal seizures in patients who suffer from Lennox-Gastaut syndrome, a type of epilepsy and

Serious Warnings and Precautions

• petit mal seizures in patients who do not respond to anti-seizure medicines called succinimides.

If you are 65 years or older, talk to your healthcare professional before starting RIVOTRIL. RIVOTRIL may not be an effective treatment for you and you may be more sensitive to experiencing side effects.

How does RIVOTRIL work?

RIVOTRIL contains the active ingredient clonazepam. Clonazepam belongs to a group of medicines called benzodiazepines. It can slow down electrical impulses in the brain that cause seizures.

What are the ingredients in RIVOTRIL?

Medical ingredient: clonazepam

Non-medicinal ingredients:

0.5 mg tablets: cornstarch, iron oxide red, iron oxide yellow, lactose, magnesium stearate, potato starch and talc.

2 mg tablets: cornstarch, lactose, magnesium stearate and microcrystalline cellulose.

RIVOTRIL comes in the following dosage forms:

Tablet: 0.5 mg and 2 mg.

Do not use RIVOTRIL if you/your child:

• are allergic to the group of medicines known as benzodiazepines (such as diazepam, chlordiazepoxide, bromazepam, or flurazepam).
• are allergic to clonazepam. or to any other ingredient in RIVOTRIL.
• have severe breathing problems.
• have severe liver problems.
• have narrow angle glaucoma (increased pressure in the eye).
• have myasthenia gravis (muscle weakness).
• suffer from sleep apnea (pauses in breathing during sleep).

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

• have lung or breathing problems.
• have liver or kidney problems.

• regularly or occasionally drink alcohol or use recreational drugs. Do not drink alcohol while taking RIVOTRIL without first talking to your healthcare professional.

• suffer from ataxia (inability to coordinate muscle movements).
• have a history of depression and/or suicide attempts.

• are lactose intolerant or have one of the following rare hereditary diseases:

  • galactose intolerance,
  • total lactase deficiency,
  • glucose-galactose malabsorption.

• have ever had a problem with:

  • substance use, including prescribed or illegal drugs, or
  • alcohol.
• have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness).
• have porphyria (a condition that affects the nervous system and skin).
• are 65 years of age or older.

Other warnings you should know about:

Do not stop your treatment with RIVOTRIL without first checking with your healthcare professional. This could lead to a sudden worsening of your seizures.

Worsening Seizures: During treatment with RIVOTRIL, your seizures may get worse or you may develop a new type of seizure. If you start to have more seizures or your seizures get worse, tell you healthcare professional right away.

Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild to severe or life threatening. Some of your withdrawal symptoms can last for months after your stop RIVOTRIL.

Your risk of going through withdrawal is higher if you are taking RIVOTRIL for a long time or at high doses. However, symptoms can still occur if you are taking RIVOTRIL as directed for a short period of time or slowly reducing the dose.

The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).

Tell your doctor right away if you experience any symptoms of withdrawal after changing or stopping your treatment.

Severe symptoms of withdrawal include:

• Feeling like you cannot move or respond (catatonia)
• Severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
• Feeling depressed
• Feeling disconnected from reality (dissociation)
• Seeing or hearing things that are not there (hallucinations)
• Overactive behaviour and thoughts (mania)
• Believing in things that are not true (psychosis)
• Convulsions (seizures), including some that do not stop
• Thoughts or actions of suicide.

For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).

To reduce your chances of going through withdrawal:

• Always contact your doctor before stopping or reducing your dose of RIVOTRIL or changing medications
• Always follow your doctor’s instructions on how to reduce your dose carefully and safely
• Tell your doctor right away if you experience any unusual symptoms after changing or stopping your treatment.

Driving and Using Machines: RIVOTRIL may affect your ability to be alert. It may make you feel dizzy, drowsy and affect your coordination. These effects may be worse if you drink alcohol, increase your dose or change the timings of when you take your medication.

While you are taking RIVOTRIL, do not drive, use machinery, or do activities that require you to be alert:

• for the first few days, or until you know how RIVOTRIL affects you.
• if you are also taking an opioid medicine.

Falls and Fractures: Benzodiazepines like RIVOTRIL can cause you to feel sleepy, dizzy and affect your balance. This increases the risks of falling, which can cause fractures or other fall-related injuries, especially if you:

• Take other sedatives
• Consume alcohol
• Are elderly or
• Have a condition that causes weakness or frailty.

Mental and Behavioural Changes: A variety of abnormal thinking and behaviour changes may occur when you take RIVOTRIL. Some of these changes include aggressiveness, irritability, agitation, anger, delusions, strange behaviour, anxiety, nightmares, restlessness, hallucinations, and inappropriate behaviour. If you develop any unusual thoughts or behaviour while using RIVOTRIL, tell your healthcare professional right away

Self-harm or Suicide: If you have thoughts of harming or killing yourself at any time, contact your healthcare professional or go to a hospital right away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses. Ask them to read this leaflet. You might ask them to tell you if they:

• think your depression or mental illness is getting worse, or
• are worried about changes in your behaviour

Pregnancy and breastfeeding:

• If you take RIVOTRIL during pregnancy, your baby is at risk for serious birth defects, and cognitive disabilities.
• Tell your healthcare professional right away if you become pregnant or think you are pregnant during treatment with RIVOTRIL. You and your healthcare professional should decide if you will continue to take RIVOTRIL while you are pregnant.
• Pregnancy Registry: If you become pregnant while taking RIVOTRIL, talk to your healthcare professional 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 information about the safety of antiepileptic medicines during pregnancy. Information about the registry can also be found at the website: http://www.aedpregnancyregistry.org/.
• RIVOTRIL passes into breast milk and may harm your baby. Do not breastfeed during treatment with RIVOTRIL. Talk to your healthcare professional about the best way to feed your baby during this time.

Check-ups and testing: RIVOTRIL may cause changes in your blood and liver. During long-term treatment with RIVOTRIL, your healthcare professional may perform tests to monitor your blood count and liver.

Amnesia: RIVOTRIL can cause a type of memory loss known as amnesia. This is more likely to happen with higher doses of RIVOTRIL.

Hypersecretion: RIVOTRIL can cause increased secretion from the lungs (hypersecretion). Children should be watched carefully as this might cause difficulties in breathing and/or severe choking and coughing.

Tell your 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 RIVOTRIL:

• other medicines to control seizures such as phenytoin, phenobarbital, carbamazepine, lamotrigine and valproate
• muscle relaxants
• medicines used to treat depression such as Monoamine Oxidase Inhibitors (MAOIs) and tricyclic antidepressants
• hypnotics and sedatives such as barbiturates, used to treat anxiety or sleep problems
• antihistamines, used to treat allergies
• antipsychotics, used to treat mental health problems
• fluconazole, used to treat fungal infections
• alcohol. Do not consume alcohol when taking RIVOTRIL.
• grapefruit juice. Avoid drinking grapefruit juice or eating grapefruit when taking RIVOTRIL.

How to take RIVOTRIL:

• Take RIVOTRIL exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Swallow the tablets with water. DO NOT chew the tablets.

Usual dose:

Adults and Children:

Your healthcare professional will determine the dose that is right for you/your child. Your/your child’s dose and how often you/your child take it will depend on your/your child’s age, weight, other medical conditions, and severity of your/your child’s seizures.

Your healthcare professional will advise you when to stop taking the medicine. Your healthcare professional will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your healthcare professional’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.

Overdose:

Signs of an overdose with RIVOTRIL include:

• drowsiness,
• involuntary eye movements (side-to-side, up and down, circular motion),
• lack of muscle control or coordination,
• below normal or absence reflexes,
• low blood pressure,
• breathing or lung problems,
• coma.

Missed Dose:

If you/your child missed a dose of this medication, take it as soon as you/your child remember. However, if it is almost time for your/your child’s next dose, skip the missed dose and continue with your/your child’s next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.

What are possible side effects from using RIVOTRIL?

These are not all the possible side effects you may have when taking RIVOTRIL. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects are:

• Feeling drowsy or tired, especially at the start of treatment.
• Some muscle weakness and dizziness.
• Increased salivation.
• Movement control and balance issues.

Less common possible side effects are:

• Increased secretion from the lungs (hypersecretion).
• Falls and fractures.

Other side effects may include:

• Fever, nausea, vomiting, constipation, diarrhea and headache
• Dry mouth
• Increased or decreased appetite
• Pain in the abdomen or lower back
• Sore gums
• Increased or decreased libido
• Weight gain or loss
• Dehydration
• Seeing double
• Trouble falling asleep
• Tremors
• Slurred speech

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Reporting Side Effects

Storage:

Store RIVOTRIL at room temperature (15-30°C) in the original light-resistant package provided by the healthcare professional.

Keep out of reach and sight of children.

If you want more information about RIVOTRIL:

• Talk to your 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 importer's website (https://xediton.com/ ); or by calling 1-888-XEDITON (933-4866).

RIVOTRIL® is a registered trade-mark of CHEPLAPHARM Arzneimittel GmbH used under license.

RIVOTRIL is imported and distributed by Xediton Pharmaceuticals Inc, 2000 Argentia Rd, Mississauga, Ontario L5N 1W1.

Last Revised: April 28, 2022