Patient Medication Information: uses, side effects, how to take - Mylan-Tizanidine
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-TIZANIDINE (tizanidine hydrochloride) 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 MYLAN-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 MYLAN-TIZANIDINE, talk to your doctor or pharmacist if any of the following conditions apply to you:
history of an unusual or allergic reaction to
MYLAN-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 MYLAN-TIZANIDINE, do not start taking a new medicine or herbal remedy before checking with your doctor.
INTERACTIONS WITH THIS MEDICATION
Do not use MYLAN-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 MYLAN-TIZANIDINE.
Other drugs that may interact with MYLAN-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 MYLAN-TIZANIDINE as directed by your doctor. Do not take larger or more frequent doses
| IMPORTANT: PLEASE READ |
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 MYLAN-TIZANIDINE, follow your doctor's instruction on how to gradually reduce your dose.
Food can affect the absorption of MYLAN-TIZANIDINE in your body - so it is important to take it in the same way all the time. For example, if you normally take MYLAN-TIZANIDINE with a meal, you should take it with food each time. If you normally take MYLAN-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 drug overdose, contact a health care practitioner , hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
MYLAN-TIZANIDINE may cause dry mouth, drowsiness, weakness, fatigue, hallucinations, or dizziness in some patients.
MYLAN-TIZANIDINE may cause a decrease in your blood pressure. In some cases, decreased blood pressure may result in dizziness, lightheadedness, 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 Tizanidine Hydrochloride. Monitoring of liver function tests (ALT/SGPT and AST/SGOT) during treatment with MYLAN-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 seek immediate emergency medical attention | ||||
| Only if severe | In all cases | |||||
| Common | Hallucination | √ | ||||
| Hypotension (feeling dizzy, lightheaded, or faint) | √ | |||||
| Uncommon | Liver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine] | √* | ||||
| Allergic reactions (red and lumpy skin, rash, hives, swelling, trouble breathing) | √* | |||||
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] | √ | |||||
*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 MYLAN-TIZANIDINE, contact your doctor or pharmacist.
| IMPORTANT: PLEASE READ |
HOW TO STORE IT
MYLAN-TIZANIDINE should be stored between 15 oC and 30oC 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 0701E
Ottawa, ON K1A 0K9
Postage paid labels, 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
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-
Prepared on/Revised on: April 19, 2013
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca