Patient Medication Information: uses, side effects, how to take - Pro-Cyclobenzaprine
What is PRO-CYCLOBENZAPRINE used for?
PRO-CYCLOBENZAPRINE is used in adults and children (age 15 and older) to treat muscle spasm due to acute, painful musculoskeletal conditions. PRO-CYCLOBENZAPRINE is for use in combination with rest and physical therapy.
How does PRO-CYCLOBENZAPRINE work?
PRO-CYCLOBENZAPRINE relieves skeletal muscle spasm without interfering with muscle function. The way that PRO-CYCLOBENZAPRINE works is not known.
What are the ingredients in PRO-CYCLOBENZAPRINE?
Medicinal ingredients: cyclobenzaprine hydrochloride.
Non-medicinal ingredients: Carnauba wax, colloidal silicon dioxide, ferric oxide yellow, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch and titanium dioxide.
PRO-CYCLOBENZAPRINE comes in the following dosage forms:
Tablets; 10 mg
Do not use PRO-CYCLOBENZAPRINE if:
you are allergic to cyclobenzaprine hydrochloride or to any other ingredient in PRO-
CYCLOBENZAPRINE.
- you have an overactive thyroid (hyperthyroidism).
- you recently had a heart attack.
- you have heart problems or heart failure.
- you have any problems with your heart rhythm.
- you are using a type of medication called a monoamine oxidase (MAO) inhibitor, or have taken them in the past 14 days. Ask your healthcare professional if you are unsure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PRO-CYCLOBENZAPRINE. Talk about any health conditions or problems you may have, including if you:
- have a history of eye problems including glaucoma
- have liver problems
- have trouble emptying your bladder (urinary retention)
are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed.
Other warnings you should know about:
Driving and using machines: Do not drive, operate machinery, or do other dangerous activities until you know how PRO-CYCLOBENZAPRINE affects you.
Serotonin Toxicity: if you take PRO-CYCLOBENZAPRINE with other drugs that act on a chemical in the brain called serotonin, there is a risk that you may develop a rare but potentially life-threatening condition called Serotonin Toxicity. If you experience any of the following symptoms while taking PRO-CYCLOBENZAPRINE and another drug, get immediate medical help:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness and coma.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with PRO-CYCLOBENZAPRINE:
Serious Drug Interactions Do not take PRO-CYCLOBENZAPRINE if you are taking or have recently taken (in the last 14 days) any of the following drugs as you may have serious side effects:
- MAO Inhibitors such as phenelzine, tranylcypromine, linezolid, methylene blue
alcohol, barbiturates and other medications that cause sedation or depress your central nervous system
- tricylic antidepressants such as amitriptyline, doxepin, imipramine, nortriptyline
- medicines to treat depression, mood, anxiety, psychotic or thought disorders
- a pain medicine called tramadol or meperidine
- medicines that prevent nerve impulses (anticholinergic medicines)
- a medicine to help quit smoking called bupropion
- a blood pressure medicine called verapamil
How to take PRO-CYCLOBENZAPRINE:
- PRO-CYCLOBENZAPRINE is for short term use (no longer than 2 or 3 weeks)
- Take exactly as directed by your healthcare professional
Usual dose:
The usual dose is 1 tablet (10 mg) three times a day; but dosing can range from 2 to 4 tablets a day in divided doses. The maximum dose is 6 tablets (60 mg) a day.
Overdose:
Signs of an overdose may include:
- temporary confusion, disturbed concentration, hallucinations, agitation;
- overactive reflexes, stiff muscles;
- fast heartbeat, severe low blood pressure;
- high fever or hypothermia;
- vomiting;
- drowsiness, dilated pupils, convulsions, stupor, and coma.
If you think you, or a person you are caring for, have taken too much PRO-CYCLOBENZAPRINE, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
Talk to your healthcare professional if you miss a dose.
What are possible side effects from using PRO-CYCLOBENZAPRINE?
These are not all the possible side effects you may have when taking PRO-CYCLOBENZAPRINE. If you experience any side effects not listed here, tell your healthcare professional.
- drowsiness
- dry mouth
- dizziness
- fatigue
- constipation
- nausea
- upset stomach
| Serious side effects and what to do about them | |||
| Talk to your healthcare | |||
| Stop taking drug | |||
| professional | |||
| and get immediate | |||
| Symptom / effect | |||
| Only if severe | In all cases | medical help | |
| COMMON | |||
| Tachycardia (abnormally fast heartbeat): dizziness, light headedness, shortness of breath, racing heart | √ | ||
| RARE | |||
Allergic Reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | √ | ||
Acute Angle-closure Glaucoma: blurred vision, halos around lights, eye pain and redness, nausea and vomiting, severe headache | √ | ||
Serotonin Toxicity: agitation, hallucinations, confusion, or other changes in mental status; coordination problems, stiff muscles, uncontrolled muscle spasms, or muscle twitching (overactive reflexes); restlessness, shivering, racing or fast heartbeat, high or low blood pressure, sweating or fever, nausea, vomiting, or diarrhea | √ | ||
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
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or • Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice
Storage:
Store at room temperature between 15°C - 30°C in tightly sealed containers.
Keep out of reach and sight of children.
If you want more information about PRO-CYCLOBENZAPRINE:
- 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); or by contacting Pro Doc Ltée. : 1- 800-361-8559, www.prodoc.qc.ca , medinfo@prodoc.qc.ca
Laval, Quebec, H7L 3W9