IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TIZANIDINE - ORAL

(tye-ZAN-i-deen)

COMMON BRAND NAME(S): Zanaflex

USES: This medication is used to treat muscle tightness and cramping (spasm) caused by conditions such as multiple sclerosis or spinal injury. Decreasing spasms can reduce pain and improve your ability to move around. Tizanidine is a short-acting muscle relaxant that works by blocking certain nerve signals from the spine to the brain (alpha adrenergic agonist).

HOW TO USE: Take this medication by mouth as directed. When you start this medication, your dosage will probably need to be increased slowly by your doctor to reduce side effects, especially dizziness and/or drowsiness. Ask your doctor or pharmacist how to use this medication correctly, and follow all instructions carefully. This medication usually starts to work in 1 to 2 hours and wears off after 6 to 8 hours. Tizanidine can be taken every 6 to 8 hours, but you should not take more than 36 milligrams a day or more than 3 doses in 24 hours. The dosage is based on your medical condition and response to therapy.

Your body will absorb this medication differently depending on whether you take it as a tablet or capsule, whether you take it with food or on an empty stomach, or if you sprinkle the contents of the capsule on food. Be sure to discuss this with your doctor to determine the best way to take your dose, especially when changes to your dose are being considered or if your doctor prescribes a different form of tizanidine (e.g., tablet or capsule).

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, tremor, increased blood pressure, heart rate and muscle tenseness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

SIDE EFFECTS: Constipation, dry mouth, drowsiness, dizziness, weakness and fatigue may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes including seeing things that aren't there, frequent/burning urination, hearing or vision changes such as blurred vision.

Tell your doctor immediately if any of these rare but very serious side effects occur: black stool, slow or irregular heartbeat.

Tizanidine rarely has caused very serious (possibly fatal) liver disease. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tizanidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure or heart disease, kidney disease, liver disease.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness, stand up slowly when arising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and drowsiness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug is excreted into human milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: ciprofloxacin, fluvoxamine.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting tizanidine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antiarrhythmics (e.g., amiodarone, mexiletine, propafenone, verapamil), birth control pills, blood pressure drugs (e.g., ACE inhibitors such as lisinopril, beta blockers such as propranolol, clonidine, methyldopa, guanabenz, guanfacine), cimetidine, drugs affecting liver enzymes that remove tizanidine from your body (e.g., zileuton, ticlopidine, acyclovir, fluoroquinolone antibiotics such as norfloxacin), "water pills" (e.g., furosemide, thiazides).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

Do not use non-prescription medications that contain cimetidine for relief of upset stomach or heartburn.

Do not start or stop any medicine without doctor or pharmacist approval.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe drowsiness, fainting, trouble breathing, and unconsciousness.

NOTES: Laboratory and/or medical tests (e.g., blood pressure, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store away from light and moisture at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep this and all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.