Cyclobenzaprine Sublingual Tablets

What is this medication?

CYCLOBENZAPRINE (sye kloe BEN za preen) treats fibromyalgia. It works by calming overactive nerves in your body. This helps reduce pain and improve sleep. It belongs to a group of medications called muscle relaxants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TONMYA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Glaucoma
• Have had a heart attack
• Heart failure
• High thyroid levels
• Irregular heartbeat or rhythm
• Liver disease
• Seizures
• Trouble passing urine
• An unusual or allergic reaction to cyclobenzaprine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Take your dose after you brush your teeth and other oral care is complete. Drink a few sips of water to make sure your mouth and tongue are moist. Place the tablet(s) under your tongue until it dissolves. Then, swallow. Do not swallow the tablets whole. Do not cut, crush, or chew this medication. Keep taking this medication unless your care team tells you to stop.

Do not eat or drink for at least 15 minutes after you take your dose. Do not drink hot, cold, or acidic drinks, such as orange juice or soda, until the morning. Try not to talk for at least 5 minutes after you take your dose.

Talk to your care team about the use of this medication in children. Special care may be needed.

People 65 years and older may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs, such as Marplan, Nardil, and Parnate
• Rasagiline
• Safinamide

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough, and cold
• Atropine
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Guanethidine
• Linezolid
• Medications that help you fall asleep
• Medications that relax muscles
• Methylene blue
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Some medications for bladder problems, such as oxybutynin or tolterodine
• Some medications for depression, anxiety, or other mental health conditions
• Some medications for Parkinson disease, such as benztropine or trihexyphenidyl
• Some medications for seizures, such as phenobarbital or primidone
• Some medications for stomach problems, such as dicyclomine or hyoscyamine
• Some medications for travel sickness, such as scopolamine
• Verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication is a CNS depressant. This is a type of medication or substance that slows down your brain and nervous system. Taking it with other CNS depressants can make you too sleepy. This can make it hard to breathe and stay awake. In some cases, it can cause coma and death. CNS depressants include opioids, benzodiazepines, muscle relaxants, medications for sleep, alcohol, and street drugs. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake.

Serotonin syndrome is when your body has too much serotonin in it. This happens when this medication is used with other ones that increase serotonin levels. Common medications that increase serotonin levels are antidepressants, some medications for migraines, and some antibiotics. The symptoms of serotonin syndrome include irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, and diarrhea. Contact your care team right away if you think you have serotonin syndrome.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

Talk to your care team if you may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 2 weeks after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 2 weeks after the last dose. Your care team can help find the option that works for you.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Pain, redness, or swelling with sores inside the mouth or throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Numbness or tingling of the tongue or mouth
• Dry mouth
• Drowsiness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. When you first open the bottle, remove the coil and throw it away. The coil helps protect the medication when it is shipped. Do not throw out the canister in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.