OFLOXACIN- ofloxacin tablet, film coated 
Teva Pharmaceuticals USA Inc

----------

MEDICATION GUIDE

OFLOXACIN TABLETS

Rx only

Read the Medication Guide that comes with ofloxacin 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 ofloxacin tablets?

Ofloxacin belongs to a class of antibiotics called fluoroquinolones. Ofloxacin 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 ofloxacin tablets.

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

2. Worsening of myasthenia gravis (a disease that causes muscle weakness).

Fluoroquinolones like ofloxacin 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 ofloxacin tablets?" for more information about side effects.

What is ofloxacin?

Ofloxacin tablets are a fluoroquinolone antibiotic medicine used in adults to treat certain infections caused by certain germs called bacteria. It is not known if ofloxacin tablets are safe and work in people under 18 years of age. Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ofloxacin tablets.

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 ofloxacin tablets, do not kill viruses.

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

Who should not take ofloxacin tablets?

Do not take ofloxacin 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 ofloxacin. Ask your healthcare provider if you are not sure. See the list of the ingredients in ofloxacin tablets at the end of this Medication Guide.

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

See "What is the most important information I should know about ofloxacin 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. Ofloxacin 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 ofloxacin tablets?

What should I avoid while taking ofloxacin tablets?

What are the possible side effects of ofloxacin tablets?

Ofloxacin tablets can cause side effects that may be serious or even cause death. See "What is the most important information I should know about ofloxacin tablets?"

Other serious side effects of ofloxacin tablets include:

Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of ofloxacin tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

Allergic reactions can happen in people taking fluoroquinolones, including ofloxacin tablets, even after only one dose. Stop taking ofloxacin tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:

Skin rash may happen in people taking ofloxacin tablets, even after only one dose. Stop taking ofloxacin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ofloxacin.

Pseudomembranous colitis can happen with most antibiotics, including ofloxacin tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including ofloxacin tablets. Stop ofloxacin and talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

The nerve damage may be permanent.

Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:

The most common side effects of ofloxacin tablets include:

Ofloxacin 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 ofloxacin 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 ofloxacin tablets?

General Information about ofloxacin tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ofloxacin tablets for a condition for which it is not prescribed. Do not give ofloxacin 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 ofloxacin tablets. If you would like more information about ofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ofloxacin tablets that is written for healthcare professionals. For more information call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in ofloxacin tablets?

Active ingredient: ofloxacin, USP

Inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol 400, polysorbate 80, sodium starch glycolate, and titanium dioxide. Additionally, the 200 mg tablets contain iron oxide yellow and the 400 mg tablets contain iron oxide yellow and iron oxide red.

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

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. E 7/2013

Revised: 04/2014
 
Teva Pharmaceuticals USA Inc