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Living with Fibromyalgia

A condition that's
often misunderstood

Recognizing the
full impact

The symptoms of fibromyalgia are challenging. With a well‑rounded support system, it's possible to find moments of progress, even on the worst days.

Fibromyalgia impacts over 10 million adults in the United States, 
but symptoms can vary widely from one person to the next. 
Some of the most common symptoms are:

  • Widespread pain

    of people with fibromyalgia experience pain across the body.

  • Disturbed sleep

    of people with fibromyalgia have trouble falling asleep, trouble staying asleep, or feel tired even after a long night's sleep.

  • Fatigue

    of people with fibromyalgia report feeling physically or mentally exhausted.

Fibromyalgia symptoms are strongly connected,
so you might find that when one symptom starts to flare up,
the others may get worse too.

Because fibromyalgia impacts multiple parts of the body, lasting improvement might require a broad-spectrum approach.

Tonmya™ is FDA‑approved for the
treatment of fibromyalgia in adults

See How TONMYA Works

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.

IMPORTANT SAFETY INFORMATION

WHO SHOULD NOT TAKE TONMYA?

Do not take TONMYA if you:

  • are allergic to cyclobenzaprine or any of the ingredients in TONMYA. Get medical help right away if you have symptoms of an allergic reaction, such as difficulty breathing, hives, swelling of your face or tongue, or itching
  • are taking an antidepressant medicine called a monoamine oxidase (MAO) inhibitor or if it has been 14 days or less since you stopped taking an MAO inhibitor
  • have had a recent heart attack, heart rhythm problems (arrhythmias), or heart failure
  • have an overactive thyroid (hyperthyroidism)

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE USING TONMYA?

Tell your healthcare provider 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
  • 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

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 the 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 dissolved.
  • 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 the Poison Help line at 1‑800‑222‑1222 or go to the nearest hospital emergency room right away.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF TONMYA?

Serious side effects may include:

  • Serotonin syndrome is a serious medical condition that may happen when TONMYA is taken with certain other medicines. Go to the nearest hospital emergency room right away if you develop any of the 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. Symptoms may include:
    • irregular or abnormal heartbeats (arrhythmias)
    • fast heartbeat (tachycardia)
    • dizziness
    • feeling faint or lightheaded
    • chest pain or discomfort
    • shortness of breath
  • TONMYA can cause side effects to the lining inside your mouth, including numbness, tingling, discomfort, pain, irritation, swelling (inflammation), and sores (lesions). 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

Call your healthcare provider right away or go to the emergency room if you have any serious side effects.

The most common side effects 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, and sores in your mouth (canker sores).

These are not all the possible side effects of TONMYA.

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. Do not drive, operate machinery, or do other dangerous activities until you know how TONMYA affects you.

HOW SHOULD I STORE TONMYA?

  • Store at room temperature (20°C to 25°C [68°F to 77°F]), but no lower than 15°C (59°F) and no higher than 30°C (86°F).
  • Keep the tablets in the original bottle with the desiccant (moisture absorber) canister, and keep the bottle closed to protect from moisture.
  • 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.
  • Keep out of reach of children.

WHAT ARE THE INGREDIENTS IN TONMYA?

Active ingredient: Cyclobenzaprine hydrochloride USP

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

Need help or have questions?

If you are exposed to TONMYA during pregnancy, contact Tonix Medicines, Inc. at 1‑888‑869‑7633 (1‑888‑TNXPMED).

Call your healthcare provider for medical advice about side effects. You may report side effects to Tonix Medicines, Inc. at 1‑888‑869‑7633 or to the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch.