MOXIFLOXACIN HYDROCHLORIDE- moxifloxacin hydrochloride tablet 
Breckenridge Pharmaceutical, Inc.

----------

MEDICATION GUIDE



Moxifloxacin Tablets



(MOX-i-FLOX-a-sin)

Read the Medication Guide that comes with Moxifloxacin Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Moxifloxacin Tablets?

Moxifloxacin Tablets are in a class of antibiotics called fluoroquinolones. Moxifloxacin Tablets can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking Moxifloxacin Tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take Moxifloxacin Tablets.

1. Tendon rupture or swelling of the tendon (tendinitis).

   o Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.

   o Are over 60 years of age.
   o Are taking steroids (corticosteroids).
   o Have had a kidney, heart or lung transplant.
   o  Tendon problems can happen in people who do not have the above risk factors when they take Moxifloxacin Tablets.

   o Physical activity or exercise.
   o Kidney failure.
   o Tendon problems in the past, such as in people with rheumatoid arthritis (RA).

   o Hear or feel a snap or pop in a tendon area.
   o Bruising right after an injury in a tendon area.
   o Unable to move the affected area or put weight on the area.

2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Moxifloxacin Tablets. Stop taking Moxifloxacin Tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

  • pain
  • burning
  • tingling
  • numbness
  • weakness

Moxifloxacin Tablets may need to be stopped to prevent permanent nerve damage.

3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibiotic medicines, including Moxifloxacin Tablets. Tell your healthcare provider if you have a history of seizures before you start taking Moxifloxacin Tablets. CNS side effects may happen as soon as after taking the first dose of Moxifloxacin Tablets. Stop taking Moxifloxacin Tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless
  • tremors
  • feel anxious or nervous
  • confusion
  • depression
  • trouble sleeping
  • nightmares
  • feel lightheaded or dizzy
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts
  • headaches that will not go away (with or without blurred vision)

4. Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like Moxifloxacin Tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis. Moxifloxacin Tablets should not be used in people who have a history of myasthenia gravis. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

See the section " What are the possible side effects of Moxifloxacin Tablets?" for more information about side effects.

What are Moxifloxacin Tablets?

Moxifloxacin Tablets are a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. These bacterial infections include:

Moxifloxacin Tablets should not be used in people with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis if there are other treatment options available.

Studies of moxifloxacin for use in the treatment of plague were done in animals only, because plague could not be studied in people.

It is not known if Moxifloxacin Tablets are safe and work in people under 18 years of age. Children have a higher chance of getting bone, joint, and tendon (musculoskeletal) problems while taking fluoroquinolone antibiotic medicines.

Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including Moxifloxacin Tablets, do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking Moxifloxacin Tablets.

Who should not take Moxifloxacin Tablets?

Do not take Moxifloxacin Tablets if you have ever had an allergic reaction to moxifloxacin, other fluoroquinolone antibiotics, or any of the ingredients in Moxifloxacin Tablets. Ask your healthcare provider if you are not sure. See the end of this Medication Guide for a complete list of ingredients in Moxifloxacin Tablets.

What should I tell my healthcare provider before taking Moxifloxacin Tablets?

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal and dietary supplements. Moxifloxacin Tablets and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

   o An antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc
   o Sucralfate (Carafate)
   o Didanosine oral suspension or solution

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

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

How should I take Moxifloxacin Tablets?

   o 8 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time.
   o less than 8 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time.

   o You have tendon problems. See " What is the most important information I should know about Moxifloxacin Tablets?".
   o You have nerve problems. See " What is the most important information I should know about Moxifloxacin Tablets?"
   o You have central nervous system problems. See " What is the most important information I should know about Moxifloxacin Tablets?"
   o You have a serious allergic reaction (see " What are the possible side effects of Moxifloxacin Tablets?"), or your healthcare provider tells you to stop taking Moxifloxacin Tablets.

What should I avoid while taking Moxifloxacin Tablets?

What are the possible side effects of Moxifloxacin Tablets?

Moxifloxacin Tablets can cause side effects that may be serious or even cause death, including:

   o Who are elderly
   o With a family history of prolonged QT interval
   o With low blood potassium (hypokalemia)
   o Who take certain medicines to control heart rhythm (antiarrhythmics)

   o Hives
   oTrouble breathing or swallowing
   o Swelling of the lips, tongue, face
   o Throat tightness, hoarseness
   o Fast heartbeat
   o Faint
   o Yellowing of the skin or eyes. Stop taking Moxifloxacin Tablets and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to Moxifloxacin Tablets (a liver problem).

   The most common side effects of Moxifloxacin Tablets include:

   o nausea

   o diarrhea

   o headache

   o dizziness

These are not all the possible side effects of Moxifloxacin Tablets. Tell your healthcare provider about any side effect that bothers you or that does not go away. 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 Moxifloxacin Tablets?

Keep Moxifloxacin Tablets and all medicines out of the reach of children.

General Information about the safe and effective use of Moxifloxacin Tablets.

What are the ingredients in Moxifloxacin Tablets?

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Made in Switzerland

Distributed by:

Breckenridge Pharmaceutical, Inc.

Berlin, CT 06037

Manufactured by:

Rivopharm SA

6928, Manno, Switzerland

All trademarks are the property of their respective owners.

Revised 12/2020

Revised: 2/2021
Breckenridge Pharmaceutical, Inc.