LEVOFLOXACIN- levofloxacin tablet, film coated 
Mylan Institutional Inc.

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MEDICATION GUIDE
LEVOFLOXACIN TABLETS
(lee" voe flox' a sin)

Read the Medication Guide that comes with levofloxacin 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 levofloxacin tablets?

Levofloxacin tablets belong to a class of antibiotics called fluoroquinolones. Levofloxacin tablets can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take levofloxacin tablets.

  1. Tendon rupture or swelling of the tendon (tendinitis).
    • Tendon problems can happen in people of all ages who take levofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones.
      • Some tendon problems include pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand or other tendon sites.
    • The risk of getting tendon problems while you take levofloxacin tablets is higher if you:
      • are over 60 years of age
      • are taking steroids (corticosteroids)
      • have had a kidney, heart or lung transplant.
    • Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin tablets. Other reasons that can increase your risk of tendon problems can include:
      • physical activity or exercise
      • kidney failure
      • tendon problems in the past, such as in people with rheumatoid arthritis (RA).
    • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking levofloxacin tablets until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.
    • Talk to your healthcare provider about the risk of tendon rupture with continued use of levofloxacin tablets. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
    • Tendon rupture can happen while you are taking or after you have finished taking levofloxacin tablets. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
    • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
      • hear or feel a snap or pop in a tendon area
      • bruising right after an injury in a tendon area
      • unable to move the affected area or bear weight
  2. Worsening of myasthenia gravis (a disease that causes muscle weakness).

    Fluoroquinolones like levofloxacin tablets  may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. 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 levofloxacin tablets?” for more information about side effects.

What are levofloxacin tablets?

Levofloxacin tablets are a fluoroquinolone antibiotic medicine used in adults, 18 years or older, to treat certain infections caused by certain germs called bacteria.

Children have a higher chance of getting bone, joint or tendon (musculoskeletal) problems such as pain or swelling while taking levofloxacin tablets.

In children 6 months and older who have breathed the anthrax bacteria germ:

It is not known if levofloxacin tablets are safe and work in children under the age of 6 months.

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 levofloxacin tablets, do not kill viruses.

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

Who should not take levofloxacin tablets?

Do not take levofloxacin tablets if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in levofloxacin tablets. Ask your healthcare provider if you are not sure. See the list of the ingredients in levofloxacin tablets at the end of this Medication Guide.

What should I tell my healthcare provider before taking levofloxacin tablets?

See “What is the most important information I should know about levofloxacin 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 non-prescription medicines, vitamins, herbal and dietary supplements. Levofloxacin tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

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 levofloxacin tablets?

If you take too much, call your healthcare provider or get medical help immediately.

If you have been prescribed levofloxacin tablets after being exposed to anthrax:

What should I avoid while taking levofloxacin tablets?

What are the possible side effects of levofloxacin tablets?

Levofloxacin tablets can cause side effects that may be serious or even cause death. See “What is the most important information I should know about levofloxacin tablets?”

Other serious side effects of levofloxacin tablets include:

The most common side effects of levofloxacin tablets include:

In children 6 months and older who take levofloxacin tablets to prevent anthrax disease, vomiting is also common.

Levofloxacin tablets may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test.

These are not all the possible side effects of levofloxacin 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 levofloxacin tablets?

Store at 20° to 25°C (68° to 77°F).

Keep the container closed tightly.

Keep levofloxacin tablets and all medicines out of the reach of children.

General Information about Levofloxacin Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levofloxacin tablets for a condition for which it is not prescribed. Do not give levofloxacin tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about levofloxacin tablets. If you would like more information about levofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about levofloxacin tablets that is written for healthcare professionals. For more information contact Mylan Pharmaceuticals Inc. toll free at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in levofloxacin tablets?

The brand names mentioned in this Medication Guide are registered trademarks of their respective manufacturers.

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

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-11055 R1
12/11

Revised: 12/2011
 
Mylan Institutional Inc.