Consumer Information for: AG-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
AG-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
AG-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
AG-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).
What the medicinal ingredient is
Cyclobenzaprine Hydrochloride
What the non-medicinal ingredients are
Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Lactose monohydrate, Magnesium Stearate, Partially pregelatinized maize Starch, titanium dioxide, polyethylene glycol, iron oxide yellow, carnauba wax iron oxide red, hypromellose and FD nad C Yellow #6 Aluminum Lake.
What dosage form it comes in
AG-Cyclobenzaprine comes as a tablet containing 10 mg of cyclobenzaprine hydrochloride.
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use AG-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 AG-Cyclobenzaprine affects you.
You should not drink alcohol until you know how AGCyclobenzaprine affects you. Taking this medication with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times.
AG-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 nonprescription 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.
Drugs that may interact with AG-Cyclobenzaprine include:
- alcohol, barbiturates and other medications that cause sedation
- MAO inhibitors (e.g., phenelzine, tranylcypromine) tricyclic antidepressants (e.g., amitriptyline, doxepin, imipramine, nortriptyline) AG-Cyclobenzaprine Product Monograph Page 20 of 21
- 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
Interactions with this medication
Drugs that may interact with AG-Cyclobenzaprine include:
- alcohol, barbiturates and other medications that cause sedation
- MAO inhibitors (e.g., phenelzine, tranylcypromine) tricyclic antidepressants (e.g., amitriptyline, doxepin, imipramine, nortriptyline) AG-Cyclobenzaprine Product Monograph Page 20 of 21
- 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 AG-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
If you think you have taken too much AGCyclobenzaprine, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms
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 AG-Cyclobenzaprine. If you experience any side effects not listed here, contact your healthcare professional. The most common side effects of AG-Cyclobenzaprine include:
- drowsiness
- dry mouth
- dizziness
- fatigue
- constipation
- nausea
- upset stomach
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional 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 | ✔ | ||
How to store
Store at room temperature between 15°- 30°C in tightly sealed containers. Protect from heat. Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Angita Pharma Inc., at 450- 449-9272 This leaflet was prepared by Angita Pharma Inc. Boucherville, Québec J4B 5H3 Last revised: January 31, 2019
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| JAMP DUTASTERIDE | 02484870 | JAMP PHARMA CORPORATION | DUTASTERIDE 0.5 MG |