MEDICATION GUIDE

Medication Guide for
Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg

Read this Medication Guide before you start taking ciprofloxacin 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?

Ciprofloxacin a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects could result in death.

If you get any of the following serious side effects while you take ciprofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin.

1. Tendon rupture or swelling of the tendon (tendinitis).
   • Tendon problems can happen in people of all ages who take ciprofloxacin. Tendons are tough cords of tissue that connect muscles to bones.
     Symptoms of tendon problems may 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 ciprofloxacin 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 ciprofloxacin.
   • 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 ciprofloxacin 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 ciprofloxacin. 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 ciprofloxacin. Tendon ruptures have happened up to several months after people 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 problem that causes muscle weakness).

   Fluoroquinolones like ciprofloxacin 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 “What are the possible side effects of ciprofloxacin?”

What is ciprofloxacin?

Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infection 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 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 is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infectionsand 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 chances of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin. Ciprofloxacin should not be used as the first choice of antibacterial medicine in children under 18 years of age.

Who should not take ciprofloxacin?

Do not take ciprofloxacin if you:

• Have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin. See the end of this Medication Guide for a complete list of ingredients in ciprofloxacin.
• Also take a medicine called tizanidine (Zanaflex ®).
  Ask your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking ciprofloxacin?

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

• have tendon problems
• have a disease that causes muscle weakness (myasthenia gravis)
• have liver problems
• have central nervous system problems (such as epilepsy)
• have nerve problems
• have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
• have or have had seizures
• have kidney problems. You may need a lower dose of ciprofloxacin tablets if your kidneys do not work well.
• have joint problems including rheumatoid arthritis (RA)
• have trouble swallowing pills
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if ciprofloxacin will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Ciprofloxacin passes into breast milk. You and your healthcare provider should decide whether you will take ciprofloxacin or breastfeed. You should not do both.

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

Especially tell your healthcare provider if you take:

• a steroid medicine
• an anti-psychotic medicine
• a tricyclic antidepressant
• a water pill (diuretic)
• theophylline (such as Theo-24 ®, Elixophyllin ®, Theochron ®, Uniphyl ®, Theolair ®)
• a medicine to control your heart rate or rhythm (antiarrhythmics)
• an oral anti-diabetes medicine
• phenytoin (Fosphenytoin Sodium ®, Cerebyx ®, Dilantin-125 ®, Dilantin ® , Extended Phenytoin Sodium ®, Prompt Phenytoin Sodium ®, Phenytek ®)
• cyclosporine (Gengraf ®, Neoral ®, Sandimmune ®, Sangcya ®).
• a blood thinner (such as warfarin, Coumadin ®, Jantoven ®)
• methotrexate (Trexall ®)
• ropinirole (Requip ®)
• clozapine (Clozaril ®, Fazaclo ® ODT ®)
• a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
• sildenafil (Viagra ®, Revatio ®)
• duloxetine
• products that contain caffeine
• probenecid (Probalan ®, Col-probenecid ®)
• certain medicines may keep ciprofloxacin from working correctly. Take ciprofloxacin either 2 hours before or 6 hours after taking these medicines, vitamins, or supplements:
  • an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinc
  • sucralfate (Carafate ®)
  • didanosine (Videx ®, Videx EC ®)

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?

• Take ciprofloxacin tablets exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much ciprofloxacin to take and when to take it.
• Take ciprofloxacin tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you cannot swallow the tablet whole.
• Ciprofloxacin can be taken with or without food.
• Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
• Drink plenty of fluids while taking ciprofloxacin.
• Do not skip any doses of ciprofloxacin, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:
  • you have tendon problems. See “What is the most important information I should know about ciprofloxacin?”
  • you have a serious allergic reaction. See “ What are the possible side effects of ciprofloxacin?”
  • your healthcare provider tells you to stop taking ciprofloxacin
  Taking all of your ciprofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your ciprofloxacin doses will help lower the chance that the bacteria will become resistant to ciprofloxacin. If you become resistant to ciprofloxacin, ciprofloxacin and other antibacterial medicines may not work for you in the future.
• If you take too much ciprofloxacin, call your healthcare provider or get medical help right away.

What should I avoid while taking ciprofloxacin?

• Ciprofloxacin can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin affects you.
• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take ciprofloxacin, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of ciprofloxacin?

Ciprofloxacin may cause serious side effects, including:

• See, “What is the most important information I should know about ciprofloxacin ?”
• Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin, even after only 1 dose. Stop taking ciprofloxacin and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
  • hives
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faint
  • Skin rash
  Skin rash may happen in people taking ciprofloxacin even after only 1 dose. Stop taking ciprofloxacin 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.
• Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin. Call your healthcare provider right away if you have unexplained symptoms such as:
  • 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 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 (a liver problem).

• Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking ciprofloxacin will change your risk of having a seizure.
  CNS side effects may happen as soon as after taking the first dose of ciprofloxacin. 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
• Intestine infection (Pseudomembranous colitis). Pseudomembranous colitis can happen with many antibacterial medicine, including ciprofloxacin. 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 antibacterial medicine.
• 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. 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:
  • pain
  • burning
  • tingling
  • numbness
  • weakness
  Ciprofloxacin may need to be stopped to prevent permanent nerve damage.
• Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin 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 event are higher in people:
  • who are elderly
  • with a family history of prolonged QT interval
  • with low blood potassium (hypokalemia)
  • who take certain medicines to control heart rhythm (antiarrhythmics)
• Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old can happen. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin.
• Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking ciprofloxacin?”
  The most common side effects of ciprofloxacin include:
  • nausea
  • diarrhea
  • changes in liver function tests
  • vomiting
  • rash

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. 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 1-800-FDA-1088 or Rising Pharmaceuticals,Inc.at 1-866-562-4597.

How should I store ciprofloxacin tablets?

• Store ciprofloxacin tablets at 20° to 25°C (68° to 77°F).

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

General Information about the safe & effective use of ciprofloxacin.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin for a condition for which it is not prescribed. Do not give ciprofloxacin 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 ciprofloxacin. If you would like more information about ciprofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin that is written for healthcare professionals.

For more information, call 1-866-562-4597

What are the ingredients in ciprofloxacin tablets?

• Active ingredient: Ciprofloxacin Hydrochloride USP
• Inactive ingredients: pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water

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

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd)
Mumbai 400 030, India

Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401

Revised: April 2015 xxxxxx