Patient Medication Information: uses, side effects, how to take - Pal-Tizanidine
ABOUT THIS MEDICATION
What the medication is used for:
pal-TIZANIDINE (tizanidine hydrochloride, house standard) is a drug used to reduce the spasticity which may be caused by medical conditions such as spinal cord injury or multiple sclerosis.
What it does:
Tizanidine presumably reduces spasticity by decreasing the activity of nerves that cause muscle spasticity. The overall effect is muscle relaxation.
When it should not be used:
Do not use pal-TIZANIDINE if you:
Are allergic to it or to any of the nonmedicinal ingredients (see
below). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
- Are currently taking fluvoxamine or ciprofloxacin.
Need spasticity to maintain upright posture and balance for your
movements.
What the medicinal ingredient is:
Tizanidine hydrochloride
What the important nonmedicinal ingredients are: Anhydrous lactose.
Other non-medicinal ingredients include: microcrystalline cellulose, silicon dioxide colloidal, and stearic acid.
What dosage forms it comes in:
4 mg tablets
WARNINGS AND PRECAUTIONS
BEFORE you use pal-TIZANIDINE , talk to your doctor or pharmacist if any of the following conditions apply to you:
history of an unusual or allergic reaction to Pal-
TIZANIDINE or to any other substances, such as foods, preservatives or dyes
pregnancy or breast-feeding
- liver disease
- kidney disease
- low blood pressure
presently receiving treatment with antihypertensives
(high blood pressure medicine), oral contraceptives (birth control pills), fluvoxamine, ciprofloxacin, or phenytoin.
Do not drive or operate hazardous machinery if you are unsure how this medication will affect you or if you experience drowsiness, coordination problems, or blurred vision.
It is important to tell your doctor or pharmacist about all medicines that you are taking including other medicines that a doctor has prescribed, medicines that you buy yourself without a prescription, and any herbal remedies that you are taking.While on pal-TIZANIDINE, do not start taking a new medicine or herbal remedy before checking with your doctor.
INTERACTIONS WITH THIS MEDICATION
Do not use pal-TIZANIDINE if you are taking fluvoxamine or ciprofloxacin.
Alcohol and other central nervous system depressants (medicines causing drowsiness or decreased alertness such as antihistamines, sedatives, tranquilizers, sleeping medicines, prescription pain medicines, narcotics, anti-epileptics, other muscle relaxants, and anaesthetics) may increase the drowsiness experienced with pal-TIZANIDINE.
Other drugs that may interact with pal-TIZANIDINE include: acetaminophen, oral contraceptives, blood pressure lowering drugs, antiarrythmic heart medications (e.g. amiodarone, mexiletine, propafenone), cimetidine (to reduce stomach acid), fluoroquinolone-type antibiotics (e.g. norfloxacin, moxifloxacin), and ticlopidine (to prevent blood clotting).
PROPER USE OF THIS MEDICATION
Usual dose:
Take pal-TIZANIDINE as directed by your doctor. Do not take larger or more frequent doses than your doctor has prescribed. During the first weeks of treatment, your doctor may want to adjust your dose to meet your individual needs.
If you need to stop taking pal-TIZANIDINE, follow your doctor's instruction on how to gradually reduce your dose.
Food can affect the absorption of pal-TIZANIDINE in your body - so it is important to take it in the same way all the time. For example, if you normally take pal-TIZANIDINE with a meal, you should take it with food each time. If you normally take pal-TIZANIDINE on an empty stomach, then you should always take it before you eat.
Overdose:
The majority of the cases of tizanidine overdose reported in post-marketing experience involved sleepiness, very long or deep sleeplike state from which a person can be awakened only briefly by vigorous stimulation (stupor) or cannot be at all (coma), heart beat at an unusually slow rate, fall in blood pressure, and difficulty breathing.
In case of overdose, contact your doctor or nearest hospital emergency department, even though you may not feel sick.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
pal-TIZANIDINE may cause dry mouth, drowsiness, weakness, fatigue, hallucinations, or dizziness in some patients.
pal-TIZANIDINE may cause a decrease in your blood pressure. In some cases, decreased blood pressure may result in dizziness, light headedness, or fainting when a person rises suddenly from a sitting or lying position. Rising slowly may decrease the risk of these problems.
Rare cases of liver damage have been reported in patients receiving pal-TIZANIDINE. Monitoring of liver function tests (ALT/SGPT and AST/SGOT) during treatment with pal-TIZANIDINE may be required by your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Hallucination | T | ||
| Hypotension (feeling dizzy, lightheaded, or faint) | T | |||
| Uncommon | Liver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine] | T* | ||
| Allergic reactions (red and lumpy skin, rash, hives, swelling, trouble breathing) | T* | |||
Breakdown of muscle fibers [symptoms include abnormal urine color (dark, red, or cola colored), muscle tenderness, weakness of the affected muscle(s), generalized weakness or muscle stiffness or aching] | T | |||
*If you think you have these side effects, it is important that you seek medical advice from your doctor straight away.
This is not a complete list of side effects. For any unexpected effects while taking pal-TIZANIDINE, contact your doctor or pharmacist.
HOW TO STORE IT
Pal-TIZANIDINE should be stored out of the reach of children and away from heat and direct light.
REPORTING SUSPECTED 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 www.healthcanada.gc.ca/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, ON K1A 0K9
Postage paid label, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/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
Please read this before you start taking pal-TIZANIDINE. It may answer some of the questions you have and help you to understand how to take pal-TIZANIDINE to obtain the best results. However, this leaflet does not contain all available information about pal-TIZANIDINE and does not take the place of your doctor’s instructions. If you need more information or advice about pal-TIZANIDINE, talk to your doctor or pharmacist.
Paladin Labs Inc.
6111 Royalmount Avenue, Suite 102
Montréal, Québec, H4P 2T4
1-800-550-6060