Comfort Pac w/Tizanidine (Oral)

Tizanidine is used to help relax specific muscles in your body. It eases spasms, cramping, and tightness of the muscles that are caused by medical conditions, such as multiple sclerosis or certain spine injuries. Tizanidine does not cure these conditions, but it may make other treatments, like physical therapy, more effective in improving your condition.

Tizanidine works on the central nervous system (CNS) to produce its muscle relaxant effects. Its effects on the CNS may also lead to some side effects of the medicine.

This medicine is available only with a doctor's prescription.

It is important for your doctor to check your progress at regular visits, especially during the first few weeks of treatment with this medicine. This will help your doctor see if the medicine is working correctly and check for unwanted effects. Blood tests may be needed to monitor for unwanted effects.

Do not use this medicine with ciprofloxacin or fluvoxamine. Using these medicines together may cause serious unwanted effects.

Dizziness, lightheadedness, or fainting may happen when you get up suddenly from a lying or sitting position. Getting up slowly may help reduce this issue.

Contact your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that cause drowsiness or lower alertness). Some examples of CNS depressants include antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, barbiturates, medicines for seizures, other muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while using tizanidine.

This medicine may cause dizziness, drowsiness, lightheadedness, clumsiness or unsteadiness, or vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see clearly.

Hallucinations (seeing things that are not there) may occur while using this medicine. Contact your doctor right away if you experience hallucinations.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually decrease the amount you are taking before stopping completely. This may help prevent a possible worsening of your condition and reduce the risk of withdrawal symptoms.

Tizanidine may cause dryness of the mouth. For temporary relief, try sugarless candy or gum, melting bits of ice in your mouth, or using a saliva substitute. However, if dry mouth lasts more than 2 weeks, contact your medical doctor or dentist. Ongoing dry mouth may increase the risk of dental issues, including tooth decay, gum disease, and fungal infections.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it will provide. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of tizanidine in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of tizanidine. However, older patients are more likely to have kidney issues, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to change the dose, or other precautions may be necessary. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may adjust your other medications.

• Ciprofloxacin
• Fluvoxamine
• Potassium Citrate
• Viloxazine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Alfentanil
• Alprazolam
• Amantadine
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Capmatinib
• Cetirizine
• Cimetidine
• Clonazepam
• Clozapine
• Codeine
• Daridorexant
• Deferasirox
• Desogestrel
• Dexmedetomidine
• Dienogest
• Dihydrocodeine
• Doxylamine
• Drospirenone
• Escitalopram
• Esketamine
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Famotidine
• Fentanyl
• Fexinidazole
• Flibanserin
• Gabapentin
• Gabapentin Enacarbil
• Gestodene
• Givosiran
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Hydrocodone
• Hydromorphone
• Ketamine
• Lacosamide
• Lemborexant
• Leniolisib
• Levocetirizine
• Levoketoconazole
• Levonorgestrel
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meperidine
• Mestranol
• Methacholine
• Methadone
• Methotrexate
• Metoclopramide
• Mexiletine
• Midazolam
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Olanzapine
• Oxycodone
• Oxymorphone
• Pacritinib
• Peginterferon Alfa-2b
• Pentazocine
• Periciazine
• Phenobarbital
• Pixantrone
• Ponesimod
• Potassium Oxybate
• Pregabalin
• Primidone
• Propafenone
• Quetiapine
• Remifentanil
• Remimazolam
• Revefenacin
• Ritlecitinib
• Rofecoxib
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secretin Human
• Sodium Oxybate
• Sufentanil
• Tacrolimus
• Tapentadol
• Taurursodiol
• Ticlopidine
• Tiotropium
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Vemurafenib
• Verapamil
• Voclosporin
• Zileuton
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Fosphenytoin
• Lisinopril
• Phenytoin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine or give you special instructions regarding food, alcohol, or tobacco.

• Tobacco

Other Medical Problems

Having other medical conditions may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain or discomfort
• fever or chills
• nausea or vomiting
• nervousness
• pain or burning while urinating
• unusual tiredness

Less common

• Blurred vision
• flu-like symptoms
• irregular heartbeat
• itching skin
• kidney stones
• right upper stomach tenderness
• seeing things that are not there
• shortness of breath
• weight gain

Incidence not known

• Continuing vomiting
• general feeling of tiredness or weakness
• headache
• light-colored stools

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision
• change in consciousness
• chest pain or discomfort
• confusion
• decreased awareness or responsiveness
• difficult or troubled breathing
• dizziness, faintness or lightheadedness when getting up from a lying position
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• loss of consciousness
• pale or blue lips, fingernails, or skin
• severe sleepiness
• sleepiness or unusual drowsiness
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness or lightheadedness, especially when getting up from a lying or sitting position
• drowsiness
• dry mouth
• fatigue
• sleepiness
• weakness

Less common

• Constipation
• nervousness
• sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Comfort Pac w/Tizanidine
• Zanaflex
• Zanaflex Capsule

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. To do so may increase the chance of side effects.

When you take the different dosage forms (tablets, capsules, capsule contents sprinkled over applesauce) of tizanidine with food, it affects the amount of the medicine absorbed into your blood differently. Follow your doctor's instructions for when to take this medicine and whether or not you should take it with food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or tablets): For muscle relaxation: Adults—At first, 2 milligrams (mg) every 6 to 8 hours. Your doctor may adjust your dose as needed. Do not take more than 36 mg within a 24-hour period. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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