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Details for: RIVA-CYCLOBENZAPRINE

Company: LABORATOIRE RIVA INC.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02242079RIVA-CYCLOBENZAPRINECYCLOBENZAPRINE HYDROCHLORIDE10 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

RIVA-CYCLOBENZAPRINE (cyclobenzaprine hydrochloride) is a prescription medication used along with rest and physical therapy for relief of muscle spasm due to acute, painful musculoskeletal conditions.

What it does

RIVA-CYCLOBENZAPRINE relieves skeletal muscle spasm without interfering with muscle function. Your doctor may choose to use this medication for other conditions not listed here. If you're unsure why you are taking this medication, contact your doctor.

When it should not be used

RIVA-CYCLOBENZAPRINE should not be used by anyone who:

  • is hypersensitive or allergic to the drug cyclobenzaprine or any ingredients of the medication (See section titled What the nonmedicinal ingredients are).
  • is taking antidepressants known as monoamine oxidase (MAO) inhibitors, or has taken them in the past 14 days.
  • recently had a heart attack.
  • has heart rhythm problems (arrhythmias)
  • has heart failure.
  • has an overactive thyroid gland (hyperthyroidism).

RIVA-CYCLOBENZAPRINE tablets should not be used for more than two or three weeks.

It is not known if it is safe or effective in children below 15 years of age.

What the medicinal ingredient is

Cyclobenzaprine Hydrochloride

What the non-medicinal ingredients are

Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Lactose, Magnesium Stearate, Pregelatinized Starch, Purified Water and Synthetic Yellow Iron Oxide

What dosage form it comes in

RIVA-CYCLOBENZAPRINE comes as a tablet containing 10 mg of cyclobenzaprine hydrochloride.

Warnings and precautions

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

  • have a history of eye problems including glaucoma
  • have heart problems or have had a heart attack
  • have liver problems
  • have trouble emptying your bladder (urinary retention)
  • are pregnant or plan to become pregnant. It is not known if this drug will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if this drug passes into your breast milk. You and your healthcare provider should decide if you will take this drug or breastfeed.

Do not drive, operate machinery, or do other dangerous activities until you know how RIVA-CYCLOBENZAPRINE affects you.

You should not drink alcohol until you know how RIVA-CYCLOBENZAPRINE affects you. Taking this medication with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times.

RIVA-CYCLOBENZAPRINE may affect the way other medicines work, and other medicines may affect how this drug works. Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. It is especially important to tell your doctor if you are taking a medication listed under Interactions with this Medication.

Interactions with this medication

Drugs that may interact with RIVA-CYCLOBENZAPRINE include:

  • alcohol, barbiturates and other medications that cause sedation
  • MAO inhibitors (e.g., phenelzine, tranylcypromine) tricyclic antidepressants (e.g., amitriptyline, doxepin, imipramine, nortriptyline)
  • medicines to treat depression, mood, anxiety, psychotic or thought disorders
  • a pain medicine called tramadol or meperidine
  • barbiturates or other medicines that depress your central nervous system (CNS depressants)
  • a medicine that prevents nerve impulses (anticholinergic medicines)
  • a medicine to help quit smoking called bupropion
  • a blood pressure medicine called verapamil

If you are taking any of these drugs, speak with your doctor or pharmacist

Proper use of this medication

Usual Dose

The usual dosage of RIVA-CYCLOBENZAPRINE tablets is 10 mg three times a day; with a range of 20 to 40 mg a day in divided doses. Dosage should not exceed 60 mg a day.

Over Dosage

High doses may cause temporary confusion, disturbed concentration, transient visual hallucinations, agitation, hyperactive reflexes, muscle rigidity, vomiting, or hyperpyrexia. Based on the known pharmacological actions of the drug, over dosage may cause drowsiness, hypothermia, tachycardia and other cardiac rhythm abnormalities such as bundle branch block, ECG evidence of impaired conduction, and congestive heart failure. Other manifestations may be dilated pupils, convulsions, severe hypotension, stupor, and coma.

In the event of an overdose, you should IMMEDIATELY contact either your doctor, the nearest hospital emergency department or poison control centre.

Missed Dose

Talk to your doctor if you miss a dose.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking RIVA-CYCLOBENZAPRINE. If you experience any side effects not listed here, contact your healthcare professional.

The most common side effects of RIVA-CYCLOBENZAPRINE include:

  • drowsiness
  • dry mouth
  • dizziness
  • fatigue
  • constipation
  • nausea
  • upset stomach

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention.
Less common
Fast heartbeat (tachycardia), irregular or abnormal heartbeats (arrhythmias)    
Rare or Uncommon
Serotonin Syndrome - severe illness with some or all of: agitation, hallucinations, coma or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle stiffness or tightness    
Allergic reaction – including rash, hives, itching, and edema of the face and tongue, difficulty breathing.    
Rare
Angle-closure Glaucoma [eye pain, changes in vision and swelling or redness in or around the eye    

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

How to store

Store at room temperature between 15ºC and 30ºC in tightly sealed containers. Protect from heat.

Keep out of reach and sight of children.

Reporting side effects

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

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

If you want more information about RIVA-CYCLOBENZAPRINE:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared forhealthcare professionals and includes this ConsumerInformation by visiting the Health Canada website orLaboratoire Riva Inc. website www.labriva.com or bycalling Laboratoire Riva Inc. at 1-800-363-7988.

This leaflet was prepared by

Laboratoire Riva Inc.
Blainville, Quebec
J7C 3V4

Last revised: October 5, 2018

Date modified: