Riva-Clonazepam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RIVA-CLONAZEPAM is used for the treatment of certain types of seizures.

If you are 65 years or older, talk to your doctor before starting RIVA-CLONAZEPAM. RIVA-CLONAZEPAM may not be an effective treatment for you and you may be more sensitive to experiencing side effects.

What it does:

RIVA-CLONAZEPAM contains the active ingredient clonazepam, which belongs to a group of medicines known as benzodiazepines. RIVA-CLONAZEPAM has anticonvulsant properties which help to manage seizures.

When it should not be used:

• If you are allergic to the group of medicines known as

  benzodiazepines (e.g., diazepam, chlordiazepoxide, bromazepam, or flurazepam)

• If you are allergic to the medicinal ingredient

  (clonazepam)

• If you are allergic to any of the other non-medicinal

  ingredients it contains (see ‘What the non-medicinal ingredients are’)

• If you suffer from lung disease.
• If you have a liver condition.
• If you have glaucoma.
• If you have myasthenia gravis.
• If you suffer from sleep apnea.

What the medicinal ingredient is:

Clonazepam.

What the non-medicinal ingredients are:

Corn Starch, FD&C Yellow # 6 Lake (0.5 mg), Lactose, Magnesium Stearate, and Microcrystalline Cellulose.

What dosage forms it comes in: Tablets: 0.5 mg and 2 mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Addiction, Abuse and Misuse: Even if you take RIVA-CLONAZEPAM exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in overdose or death, especially if you take RIVA-CLONAZEPAM with:

• Opioids

• Alcohol or

• Ilicit drugs

Your doctor should:

• Talk to you about the risks of treatment with RIVA-CLONAZEPAM as well as other treatment (including non-drug) options
• Assess your risk for these behaviours before prescribing RIVA-CLONAZEPAM

• Monitor you while you are taking RIVA-

  CLONAZEPAM for the signs and symptoms of misuse and abuse. If you feel like you are craving RIVA-CLONAZEPAM, or not using it as directed, talk to your doctor right away.

Store RIVA-CLONAZEPAM in a secure place to avoid theft or misuse.

Withdrawal: If you suddenly stop taking RIVA-CLONAZEPAM, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms (see the Withdrawal section below)

• Always contact your doctor before stopping, or lowering your dose of RIVA-CLONAZEPAM or changing your medicine

RIVA-CLONAZEPAM with Opioids: Taking RIVA-CLONAZEPAM with opioid medicines can cause:

• Severe drowsiness
• Decreased awareness
• Breathing problems
• Coma
• Death

Withdrawal:

• If you suddenly stop your treatment, lower your dose too fast, or witch 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 RIVA-CLONAZEPAM.

• Your risk of going through higher if you are taking

  RIVA-CLONAZEPAM for a long time or at high doses. However, symptoms can still occur if you are taking RIVA-CLONAZEPAM 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 or suicide

• For other symptoms of withdrawal, see the SERIOUS

  SIDE EFFECTS, HOW OFTEN THEY HAPPEN 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 RIVA-CLONAZEPAM 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

RIVA-CLONAZEPAM with Opioids: Taking RIVA-CLONAZEPAM with opioid medicines can cause severe drowsiness and breathing problems.

• Tell your doctor if you:

  • Are taking opioid medicines

  • Are prescribed an opioid medicine after you

    start taking RIVA-CLONAZEPAM

• RIVA-CLONAZEPAM may affect your ability to be

  alert. Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and RIVA-CLONAZEPAM affects you. This effect of RIVA-CLONAZEPAM may be made worse if you take alcoholic drinks. If you increase your dose or change the timings of when you take your medication this may also modify your reactions.

  Falls and Fractures: Benzodiazepines like RIVA-CLONAZEPAM 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
  • Benzodiazepines such as RIVA-CLONAZEPAM are not recommended for the primary treatment of psychotic illness.
  • Memory loss may occur when RIVA-CLONAZEPAM is used at therapeutic doses.

  • Do not take this medicine if you are pregnant, or might become pregnant, unless advised by your doctor. Contact your doctor if you think you may be pregnant, or are intending to become pregnant. If you are pregnant or thinking about becoming pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling (1-888)233-2334 (toll free). Women who are pregnant and planning to take an antiepileptic drug should call the pregnancy registry to enable collection of valuable data about its use in pregnancy. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/

  • RIVA-CLONAZEPAM passes into breast milk.

    Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you.

  • A small number of people being treated with

    anti-epileptics such as RIVA-CLONAZEPAM have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

BEFORE you use RIVA-CLONAZEPAM talk to your doctor or pharmacist if you:

• Have a lung, liver or kidney condition.
• Have glaucoma.

• Are taking or plan on taking ANY other drugs

  (including herbal preparations, drugs you purchase without prescriptions, and those not prescribed by your doctor).

• Regularly drink alcohol or use recreational drugs.
• Suffer from a form of incoordination of the muscles called spinal or cerebellar ataxia.
• Have a history of depression and/or suicide attempts.
• Have rare hereditary problems of galactose intolerance.

• 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)

INTERACTIONS WITH THIS MEDICATION

Serious Drug Interactions

Taking RIVA-CLONAZEPAM and opioids may cause:

• Severe drowsiness
• Trouble breathing
• Coma
• Death

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food store without a prescription.

Some medicines may interfere with RIVA-CLONAZEPAM. These medicines include:

• medicines to control seizures

• narcotics and narcotic pain relievers (opioids, e.g.,

  morphine, codeine; see Serious Warnings and Precautions box)

• muscle relaxants
• sleeping medication

• medicines to treat your mood, such as monoamine

  oxidase inhibitors, tricyclic antidepressants, phenothiazines

• phenytoin, phenobarbital, carbamazepine, and valproate.

These medicines may be affected by RIVA-CLONAZEPAM or may affect how well RIVA-CLONAZEPAM works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of the above, tell him/her before you start taking RIVA-CLONAZEPAM.

You must not consume alcohol while taking RIVA-CLONAZEPAM as its effects may worsen side effects that some patients experience with RIVA-CLONAZEPAM.

Grapefruit juice may increase blood levels of RIVA-CLONAZEPAM, therefore you should avoid drinking grapefruit juice while you are taking RIVA-CLONAZEPAM.

PROPER USE OF THIS MEDICATION

Usual dose:

Always take the tablets exactly as your doctor tells you to. Your doctor will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and body weight. The table below shows the different doses that your doctor may prescribe according to your age. Your doctor will start you on an initial low dose and gradually increase it until the desired effect is achieved.

Initial Dose Maintenance

Dose

Adults 1.5 mg/day or less in

divided doses

8-10 mg/day in divided doses Children

(up to 10

years or

30kg)

0.01-0.03 mg/kg/day in divided doses

0.1-0.2 mg/kg/day in divided doses

The total daily dose should be taken as advised by your doctor.

Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.

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

Overdose:

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

Missed Dose:

Take the missed dose of RIVA-CLONAZEPAM as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take 2 doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications RIVA-CLONAZEPAM can cause some side effects. For most patients these side effects are likely to be minor and temporary as your body adjusts to the medicine. However, some may be serious. Consult your doctor or pharmacist as soon as you can if you do not feel well while taking RIVA-CLONAZEPAM.

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 may occur. Children should therefore be watched carefully as this might cause difficulties in breathing and/or severe choking and coughing.
• In rare cases, changes in your blood and liver may occur and your doctor will monitor for these.
• Falls and fractures

Withdrawal-related side effects:

• With long-term RIVA-CLONAZEPAM treatment, development of physical and psychological dependence may occur. If treatment is stopped suddenly, symptoms of withdrawal may occur, including: shaking, sweating, agitation/restlessness, sleep disturbances, anxiety (possibly extreme), headaches, muscle pain, tension, restlessness, confusion and irritability. In severe cases of withdrawal, symptoms may include numbness and tingling of the extremities, hallucinations (see or hear things that are not there), increased sensitivity to light, noise and physical contact.

This is not a complete list of side effects. For any unexpected

effects while taking RIVA-CLONAZEPAM, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep RIVA-CLONAZEPAM in a cool dry place stored at room temperature (15-30°C).

• Keep this medicine out of sight and reach of

  children

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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Reminder: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.

If you want more information about RIVA-CLONAZEPAM:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer 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.labriva.com, or by calling 1-800-363-7988.

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Quebec

J7C 3V4

www.labriva.com

Last revised: March 7, 2022