CIPROFLOXACIN- ciprofloxacin tablet, film coated 
Actavis Pharma, Inc.

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Medication Guide

Ciprofloxacin (sipʺ roe flox' a sin)Tablets
for oral use

Read this Medication Guide before you start taking ciprofloxacin tablets and each time you get a refill. There may be new information. This information 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 ciprofloxacin tablets?

Ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.

If you get any of the following serious side effects while you take ciprofloxacin tablets, you should stop taking ciprofloxacin tablets immediately and get medical help right away.

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

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.

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 ciprofloxacin tablets. Stop taking ciprofloxacin 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   
 
  • numbness
 
  • burning     
 
  • weakness
 
  • tingling
 

Ciprofloxacin 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 antibacterial medicines, including ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin tablets. Stop taking ciprofloxacin 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        
  •  trouble sleeping
  •  hear voices, see things, or sense things
  •  nightmares

 that are not there (hallucinations)

  •  feel lightheaded or dizzy
  •  feel restless
  •  feel more suspicious (paranoia)
  •  tremors
  •  suicidal thoughts or acts
  •  feel anxious or nervous
  •  headaches that will not go away, with or
  •  confusion

 without blurred vision

  •  depression
 

4.  Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like ciprofloxacin 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 before you start taking ciprofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

What are ciprofloxacin tablets?

Ciprofloxacin tablets are a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
      • urinary tract infection
      • chronic prostate infection
      • lower respiratory tract infection
      • sinus infection
      • skin infection
      • bone and joint infection
      • nosocomial pneumonia
      • intra-abdominal infection, complicated
      • infectious diarrhea
      • typhoid (enteric) fever
      • cervical and urethral gonorrhea, uncomplicated
      • people with a low white blood cell count and a fever
      • inhalational anthrax
      • plague
• Studies of ciprofloxacin tablets for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
• Ciprofloxacin tablets should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
• Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.
Ciprofloxacin tablets are also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs.
• Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin tablets. Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine in children under 18 years of age.

Who should not take ciprofloxacin tablets?

Do not take ciprofloxacin tablets if you:

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

Before you take ciprofloxacin tablets, tell your healthcare provider if you:

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

•  Ciprofloxacin tablets and other medicines can affect each other causing side effects.

•  Especially tell your healthcare provider if you take:

•  Certain medicines may keep ciprofloxacin tablets from working correctly. Take ciprofloxacin tablets either 2 hours before or 6 hours after taking these      medicines, vitamins, or supplements:

Ask your healthcare provider for a list of these medicines if you are not sure.

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

How should I take ciprofloxacin tablets?

Taking all of your ciprofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your ciprofloxacin tablets doses will help lower the chance that the bacteria will become resistant to ciprofloxacin tablets. If you become resistant to ciprofloxacin tablets, ciprofloxacin tablets and other antibacterial medicines may not work for you in the future.

What should I avoid while taking ciprofloxacin tablets?

What are the possible side effects of ciprofloxacin tablets?

Ciprofloxacin tablets may cause serious side effects, including:

Skin rash may happen in people taking ciprofloxacin tablets even after only 1 dose. Stop taking ciprofloxacin 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 ciprofloxacin tablets.

○  nausea or vomiting
○  stomach pain
○  fever
○  weakness
○  abdominal pain or tenderness
○  itching
○  unusual tiredness
○  loss of appetite
○  light colored bowel movements
○  dark colored urine
○  yellowing of your skin or the whites of your eyes

Stop taking ciprofloxacin tablets and tell your healthcare provider right away if you have 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 ciprofloxacin tablets (a liver problem).

Changes in blood sugar

The most common side effects of ciprofloxacin tablets include:

Tell your healthcare provider about any side effect that bothers you, or that does not go away.

These are not all the possible side effects of ciprofloxacin tablets. For more information, ask your healthcare provider or pharmacist.

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

How should I store ciprofloxacin tablets?

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

General Information about the safe and effective use of ciprofloxacin tablets.

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

This Medication Guide summarizes the most important information about ciprofloxacin tablets. If you would like more information about ciprofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin tablets that is written for healthcare professionals.

For more information call 1-800-272-5525.

What are the ingredients in ciprofloxacin tablets?

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

Brands listed are the trademarks of their respective owners.

Manufactured In India By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. B 5/2019

Revised: 5/2019
Actavis Pharma, Inc.