ZANAFLEX CAPSULES® <small>(tizanidine HCl)</small>

Click here to see Important Safety Information below

ZANAFLEX CAPSULES is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with ZANAFLEX should be reserved for those daily activities and times when relief of spasticity is most important. Spasticity is a frequent and often significant consequence of injuries to the central nervous system, including multiple sclerosis (MS), spinal cord injury (SCI), brain trauma and stroke. People with spasticity can suffer severe, painful muscle spasms and/or rigidity during the day and night. ZANAFLEX CAPSULES are thought to reduce spasticity by blocking nerve impulses through pre-synaptic inhibition of motor neurons, which is thought to decrease spasticity without reducing muscle strength.

Food has a complex effect on how tizanidine is absorbed and processed in the body. A person’s experience taking ZANAFLEX CAPSULES may change depending on whether or not this medication is taken with or without food, including potential changes in efficacy and side effects. It is important that patients follow their doctor’s instructions on how to take this medication. Once a formulation has been chosen and the decision to take it with or without food has been made, this regimen should not be altered.

ZANAFLEX CAPSULES are available in 2-mg, 4-mg and 6-mg strengths.

Important Safety Information

  • ZANAFLEX (tizanidine hydrochloride) should not be taken with fluvoxamine or ciprofloxacin because of increased risk of serious adverse reactions such as severe lowering of blood pressure and sedation.
  • Patients should inform their healthcare provider when they start or stop taking any medication due to the risks associated with ZANAFLEX drug interactions.
  • Patients may experience low blood pressure and should be careful when standing up from a lying down or sitting position.
  • ZANAFLEX may cause liver injury. Liver function tests should be monitored and ZANAFLEX discontinued if liver injury is suspected. ZANAFLEX should be used with caution in patients with any liver injury.
  • ZANAFLEX may cause sedation or drowsiness, so care should be taken when performing activities that require alertness, such as driving a vehicle or operating machinery. The sedation may be additive when ZANAFLEX is taken with other drugs such as baclofen or benzodiazepines or substances such as alcohol that suppress the central nervous system.
  • Use of ZANAFLEX has been associated with hallucinations. Discontinuing ZANAFLEX should be considered in patients who develop hallucinations.
  • ZANAFLEX can cause severe allergic reactions. Patients should discontinue ZANAFLEX and seek immediate medical care if shortness of breath or trouble breathing, swelling of the throat or tongue, or hives occurs.
  • ZANAFLEX should be used with caution in patients with kidney impairment (creatinine clearance < 25 mL/min). Patients should be monitored closely for dry mouth, drowsiness, weakness, or dizziness as signs of potential overdose. Caution should be used in elderly patients.
  • ZANAFLEX should be taken exactly as prescribed (consistently either with or without food). Taking higher doses than prescribed increases the risk for adverse events. Patients should not switch between capsules and tablets. ZANAFLEX should not be suddenly stopped because rebound high blood pressure and rapid heart rate may occur.
  • If patients depend on their spasticity for posture and balance while moving, ZANAFLEX decreases spasticity and caution should be used.
  • The most common adverse reactions were dry mouth, drowsiness, weakness or fatigue or tiredness, dizziness, urinary tract infection, constipation, abnormal or increased liver function tests, vomiting, speech disorder, blurred vision, urinary frequency, flu syndrome, abnormal movement, nervousness, sore throat, and runny nose.
  • Before taking ZANAFLEX, patients should tell their healthcare provider if they are pregnant, planning to become pregnant, breast-feeding, or planning to breast-feed. It is not known if ZANAFLEX passes into breast milk.

For Full Prescribing Information, please click here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/, or call 1-800-FDA-1088.

ZANAFLEX CAPSULES® and ZANAFLEX® are registered trademarks of Acorda Therapeutics, Inc.

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