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US Brand Names

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Description

Cyclobenzaprine is used to help relax certain muscles in your body. It helps relieve the pain, stiffness, and discomfort caused by strains, sprains, or injuries to your muscles. However, this medicine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem. Cyclobenzaprine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of this medicine's side effects.

Cyclobenzaprine may also be used for other conditions as determined by your doctor.

Cyclobenzaprine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cyclobenzaprine is used in certain patients with fibromyalgia syndrome (also called fibrositis or fibrositis syndrome).

This product is available in the following dosage forms:

• Tablet
• Capsule, Extended Release

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Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cyclobenzaprine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cyclobenzaprine tablets in the elderly with use in other age groups.

Because of the possibility of higher blood levels in the elderly as compared to younger adults, use of cyclobenzaprine extended-release capsules is not recommended in the elderly .

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Toloxatone
• Tranylcypromine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma or
• Problems with urination—Cyclobenzaprine can make your condition worse.

• Heart or blood vessel disease or
• Overactive thyroid—The chance of side effects may be increased.

• Liver disease—Higher blood levels of cyclobenzaprine may occur, increasing the chance of side effects .

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Proper Use

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 serious side effects.

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 relaxing stiff muscles:
  • For the oral dosage form (tablets):
    • Adults and teenagers 15 years of age and older—The usual dose is 10 milligrams (mg) three times a day. The largest amount should be no more than 60 mg (six 10-mg tablets) a day.
    • Children and teenagers up to 15 years of age—Dose must be determined by your doctor.
  • For the oral dosage form (extended-release capsules):
    • Adults—The usual dose is 15 mg once a day. Some patients may require up to 30 mg (one 30 mg capsule or two 15 mg capsules) per day.
    • 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

You should NOT use the extended-release capsules if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days .

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. 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 dizzy or are not alert and able to see well.

Cyclobenzaprine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If your condition does not improve within two or three weeks, or if it becomes worse, check with your doctor .

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Side Effects

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

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

• Changes in the skin color of the face
• Fast or irregular breathing
• Large swellings that look like hives on the face, eyelids, mouth, lips, and/or tongue
• Puffiness or swelling of the eyelids or the area around the eyes
• Shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• Skin rash, hives, or itching

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

• Fainting

• Convulsions (seizures)
• Drowsiness (severe)
• Dry, hot, flushed skin
• Fast or irregular heartbeat
• Hallucinations (seeing, hearing, or feeling things that are not there)
• Increase or decrease in body temperature
• Troubled breathing
• Unexplained muscle stiffness
• Unusual nervousness or restlessness (severe)
• Vomiting (occurring together with other symptoms of overdose)

Check with your doctor as soon as possible if any of the following side effects occur:

• Clumsiness or unsteadiness
• Confusion
• Mental depression or other mood or mental changes
• Problems in urinating
• Ringing or buzzing in the ears
• Skin rash, hives, or itching occurring without other symptoms of an allergic reaction listed above
• Unusual thoughts or dreams
• Yellow eyes or skin

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:

• Blurred vision
• Dizziness or lightheadedness
• Drowsiness
• Dryness of mouth

• Bloated feeling or gas, indigestion, nausea or vomiting, or stomach cramps or pain
• Constipation
• Diarrhea
• Excitement or nervousness
• Frequent urination
• General feeling of discomfort or illness
• Headache
• Muscle twitching
• Numbness, tingling, pain, or weakness in hands or feet
• Pounding heartbeat
• Problems in speaking
• Trembling
• Trouble in sleeping
• Unpleasant taste or other taste changes
• Unusual muscle weakness
• Unusual tiredness

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

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