Patient Medication Information: uses, side effects, how to take - PMS-Cyclobenzaprine - Tab 10mg
What is pms-CYCLOBENZAPRINE used for?
pms-CYCLOBENZAPRINE is used in adults and children (age 15 and older) to treat muscle spasm due to acute, painful musculoskeletal conditions. pms-CYCLOBENZAPRINE is for use in combination with rest and physical therapy.
How does pms-CYCLOBENZAPRINE work?
pms-CYCLOBENZAPRINE relieves skeletal muscle spasm without interfering with muscle function. The way that pms-CYCLOBENZAPRINE works is not known.
What are the ingredients in pms-CYCLOBENZAPRINE?
Medicinal ingredients: cyclobenzaprine hydrochloride.
Non-medicinal ingredients: Colloidal Silicon Dioxide, Hydroxypropyl Cellulose, Hypermellose, Lactose, Magnesium Stearate, Polyethylene Glycol, Polysorbate 80, Pregelatinized Starch, Purified Water, Titanium Dioxide and Yellow Iron Oxide.
pms-CYCLOBENZAPRINE comes in the following dosage forms:
Tablets; 10 mg
Do not use pms-CYCLOBENZAPRINE if:
- 1. you are allergic to cyclobenzaprine hydrochloride or to any other ingredient in Teva- Cyclobenzaprine.
- 2. you have an overactive thyroid (hyperthyroidism).
- 3. you recently had a heart attack.
- 4. you have heart problems or heart failure.
- 5. you have any problems with your heart rhythm.
- 6. 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 pms-CYCLOBENZAPRINE. Talk about any health conditions or problems you may have,
including if you:
- 1. have a history of eye problems including glaucoma
- 2. have liver problems
- 3. have trouble emptying your bladder (urinary retention)
- 4.
are pregnant or plan to become pregnant.
- 5. 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 pms-CYCLOBENZAPRINE affects you.
Serotonin Toxicity: if you take pms-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 pms-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 pms-CYCLOBENZAPRINE:
Serious Drug Interactions Do not take pms-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:
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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 pms-CYCLOBENZAPRINE:
- pms-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 pms-CYCLOBENZAPRINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Talk to your healthcare professional if you miss a dose.
What are possible side effects from using pms-CYCLOBENZAPRINE?
These are not all the possible side effects you may have when taking pms-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
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| 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:
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 |
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Storage:
Store at room temperature between 15°- 30°C.
Keep out of reach and sight of children.
If you want more information about pms-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 Pharmascience Inc. at 1-888-550-6060.