Consumer Information for: MYLAN-CYCLOBENZAPRINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

MYLAN-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

MYLAN-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

MYLAN-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).

MYLAN-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

Lactose, magnesium stearate, pregelatinized starch, hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, synthetic yellow iron oxide, titanium dioxide and triacetin.

What dosage form it comes in

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

Warnings and precautions

BEFORE you use MYLAN-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 MYLAN-CYCLOBENZAPRINE affects you.

You should not drink alcohol until you know how MYLAN-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.

MYLAN-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 MYLAN-CYCLOBENZAPRINE include:

  • alcohol, barbiturates and other medications that cause sedation
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • tricylic 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 MYLAN-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.

Overdose

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 MYLAN-CYCLOBENZAPRINE. If you experience any side effects not listed here, contact your healthcare professional.

The most common side effects of MYLAN-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 get immediate medical help
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 15°C and 30°C.

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:

  • Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6

Revised on: July 24, 2017

Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca

Date modified: