Tonmya: Uses, Side Effects and Dosage

What is TONMYA?

TONMYA is a prescription medicine used in adults for the treatment of fibromyalgia.

It is not known if TONMYA is safe and effective in children.

Do not use TONMYA if you:

• are allergic to cyclobenzaprine or any of the ingredients in TONMYA. See the end of the Patient Information leaflet for a complete list of ingredients in TONMYA.

  Stop taking TONMYA and call your healthcare provider or get medical help right away if you have symptoms of an allergic reaction such as:

• difficulty breathing
• hives

• swelling of your face or tongue
• itching

• are taking, or have stopped taking within the last 14 days, a medicine called monoamine oxidase (MAO) inhibitor. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
• have had a recent heart attack, have heart rhythm problems (arrhythmias) or heart failure
• have an overactive thyroid (hyperthyroidism)

Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.

Before taking TONMYA, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of seizures
• have trouble emptying your bladder (urinary retention)
• have a history of eye problems including glaucoma
• have liver problems

• are pregnant or plan to become pregnant. TONMYA may harm your unborn baby. You should not take TONMYA if you are planning to become pregnant or during the first trimester (first 12 weeks) of pregnancy.

  Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with TONMYA.
• Use effective birth control (contraception) during treatment with TONMYA and for 2 weeks after the final dose.
• Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you are pregnant during treatment with TONMYA.
• If you are exposed to TONMYA during pregnancy, contact Tonix Medicine, Inc., at 1-888-869-7633 (1-888-TNXPMED).

• are breastfeeding or plan to breastfeed. TONMYA may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with TONMYA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• a medicine to treat depression, mood, anxiety, psychotic, or thought disorders
• a pain medicine called tramadol or meperidine
• bupropion
• verapamil
• anticholinergic medicines
• barbiturates or other medicines that depress your central nervous system (CNS depressants)
• a blood pressure medicine called guanethidine

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take TONMYA with your other medicines.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider or pharmacist when you get a new medicine.

How should I take TONMYA?

• Take TONMYA exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much TONMYA to take.
• Your healthcare provider may change your TONMYA dose if needed.
• Take TONMYA 1 time a day at bedtime, around the same time each evening.
• Take TONMYA after brushing your teeth and other oral care is completed.
• Your mouth and area under your tongue (sublingual) should be moist when you take TONMYA. Drink a few sips of water before you take TONMYA.
• Place the prescribed number of TONMYA sublingual tablet(s) under your tongue until it dissolves.
• Do not swallow whole, cut, crush, or chew TONMYA sublingual tablets.
• Avoid eating or drinking for at least 15 minutes after the TONMYA sublingual tablet is completely dissolved. Avoid any hot, cold, or acidic beverages until the morning.
• Avoid talking for at least 5 minutes after taking TONMYA.
• If you miss a dose of TONMYA, take your next dose the following evening. Do not take a missed dose during the day. Do not take 2 doses to make up for a missed dose.
• If you take too much TONMYA, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while using TONMYA?

• You should not drink alcohol until you know how TONMYA affects you. Taking TONMYA with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times, and cause symptoms such as sleepiness.
• Do not drive, operate machinery, or do other dangerous activities until you know how TONMYA affects you.

What are possible side effects of TONMYA?

TONMYA may cause serious side effects, including:

• Serotonin syndrome. Serotonin syndrome is a serious condition that may be life-threatening and has happened when TONMYA is used with certain other medicines. Go to the nearest hospital emergency room right away if you develop any of following signs or symptoms of serotonin syndrome:

• confusion, agitation, seeing or hearing things that are not real (hallucinations), coma, or other changes in mental status
• high body temperature (hyperthermia)
• shaking (tremor), coordination problems, or muscle twitching (overactive reflexes)
• fast heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle stiffness or tightness

• TONMYA may cause serious side effects that may lead to heart attack or stroke. Stop taking TONMYA and go to the nearest hospital emergency room right away if you get:

• irregular or abnormal heartbeats (arrhythmias)
• fast heartbeat (tachycardia)
• dizziness

• lightheaded or feel faint
• chest pain or discomfort
• shortness of breath

• Side effects in your mouth. TONMYA can cause side effects to the lining inside your mouth, including numbness, tingling, discomfort, pain, irritation, swelling (inflammation), and sores (lesions). Side effects inside your mouth are common with TONMYA and can sometimes be severe. These side effects can happen within minutes of taking TONMYA, and most go away within 60 minutes. Drink a few sips of water before taking TONMYA to decrease your chance of getting numbness or reduced feeling in your mouth. Tell your healthcare provider right away if you have:

• trouble eating, drinking, breathing, or swallowing
• side effects that cover a large area in your mouth
• pain in your mouth that makes it difficult to do your normal activities

The most common side effects of TONMYA include:

• reduced feeling in your mouth
• mouth discomfort
• abnormal TONMYA taste
• feeling sleepy (somnolence)
• numbness or tingling in your mouth

• mouth pain
• tiredness
• dry mouth
• sores in your mouth (canker sores)

These are not all the possible side effects of TONMYA.

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

How should I store TONMYA?

• Store TONMYA at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep TONMYA in the original bottle. Protect from moisture.
• The TONMYA bottle contains a desiccant canister to help keep your medicine dry (protect it from moisture). Keep the desiccant canister in the bottle.
• The TONMYA bottle contains a polyester coil to help protect the sublingual tablets during shipping. Remove the polyester coil from the bottle and throw it away after opening the bottle for the first time.
• TONMYA comes in a child-resistant bottle.

Keep TONMYA and all medicines out of the reach of children.

General information about the safe and effective use of TONMYA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TONMYA for a condition for which it was not prescribed. Do not give TONMYA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TONMYA that is written for health professionals.

What are the ingredients in TONMYA?

Active ingredient: cyclobenzaprine hydrochloride

Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone (Type A), D&C Yellow No.10, dibasic potassium phosphate, mannitol, and sodium stearyl fumarate.

Distributed by: Tonix Medicines, Inc., 200 Connell Drive – Suite 3100, Berkeley Heights, NJ 07922

Manufactured for: Tonix Pharmaceuticals, Inc., 200 Connell Drive – Suite 3100, Berkeley Heights, NJ 07922

Manufactured by: Almac Pharma Services Limited, Craigavon, Northern Ireland BT63 5QD, United Kingdom and Almac Pharma Services LLC, 2661 Audubon Rd, Audubon, PA 19403-2413, USA and Patheon Inc., 111 Consumers Drive, Whitby, Ontario L1N 5Z5, Canada

For optional information, visit www.TONMYA.com or call 1-888-869-7633 (1-888-TNXPMED).