- Take ciprofloxacin extended-release tablets exactly as prescribed by your healthcare provider.
- Take ciprofloxacin extended-release tablets one time each day 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 extended-release tablets can be taken with or without food.
- Ciprofloxacin extended-release tablets 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 extended-release tablets.
- Do not skip any doses, or stop taking ciprofloxacin extended-release tablets even if you begin to feel better, until you finish your prescribed treatment, unless:
- You have tendon effects (see “What is the most important information I should know about ciprofloxacin extended-release tablets? ”),
- You have a serious allergic reaction (see “What are the possible side effects of ciprofloxacin extended-release tablets? ”), or
- Your healthcare provider tells you to stop.
This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to ciprofloxacin. If this happens, ciprofloxacin extended-release tablets and other antibiotic medicines may not work in the future.
- If you miss a dose of ciprofloxacin extended-release tablets, take it as soon as you remember. Do not take more than one dose in one day.
- If you take too much, call your healthcare provider or get medical help immediately.
- Ciprofloxacin extended-release tablets 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 extended-release tablets affect you.
- Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin extended-release tablets 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 taking ciprofloxacin extended-release tablets, 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 extended-release tablets?
Ciprofloxacin extended-release tablets can cause side effects that may be serious or even cause death. See “What is the most
important information I should know about ciprofloxacin extended-release tablets? ”
Other serious side effects of ciprofloxacin extended-release tablets include:
You may have serious seizure and breathing problems when you take theophylline with ciprofloxacin extended-release tablets. These problems may lead to death. Get emergency help right away if you have seizures or trouble breathing.
- Central Nervous System Effects
Seizures have been reported in people who take fluoroquinolone antibiotics including ciprofloxacin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking ciprofloxacin extended-release tablets will change your risk of having a seizure.
Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of ciprofloxacin extended-release tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
- Feel dizzy
- Hear voices, see things, or sense things that are not there (hallucinations)
- Feel restless
- Feel anxious or nervous
- Trouble sleeping
- Feel more suspicious (paranoia)
- Suicidal thoughts or acts
- Serious allergic reactions
Allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin extended-release tablets, even after only one dose. Stop taking ciprofloxacin extended-release tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
- Trouble breathing or swallowing.
- Swelling of the lips, tongue, face.
- Throat tightness, hoarseness.
- Rapid heartbeat.
- Yellowing of the skin or eyes. Stop taking ciprofloxacin extended-release 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 ciprofloxacin (a liver problem).
- Skin rash
Skin rash may happen in people taking ciprofloxacin extended-release tablets, even after only one dose. Stop taking ciprofloxacin extended-release 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.
- 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)
- Intestine infection (Pseudomembranous colitis)
Pseudomembranous colitis can happen with most antibiotics, 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 antibiotic.
- 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:
Ciprofloxacin extended-release tablets may need to be stopped to prevent permanent nerve damage.
- Low blood sugar (hypoglycemia)
People who take ciprofloxacin extended-release tablets and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance) can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with ciprofloxacin. Your antibiotic medicine may need to be changed.
- Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking ciprofloxacin extended-release tablets?”
- Joint Problems
Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin extended-release tablets.
The most common side effects of ciprofloxacin extended-release tablets include:
- Changes in liver function tests
- Vaginal yeast infection
- Pain or discomfort in the abdomen
These are not all the possible side effects of ciprofloxacin extended-release tablets. Tell your healthcare provider about any side effect that bothers you, or that does not go away.
To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical Companies, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep ciprofloxacin extended-release tablets and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin extended-release tablets for a condition for which it is not prescribed. Do not give ciprofloxacin extended-release 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 ciprofloxacin extended-release tablets. If you would like more information about ciprofloxacin extended-release tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin extended-release tablets that is written for healthcare professionals.
What are the ingredients in ciprofloxacin extended-release tablets?
- Active ingredient: ciprofloxacin
- Inactive ingredients: colloidal silicon dioxide, crospovidine, D&C Yellow #10, hydrogenated vegetable oil, lactitol, magnesium stearate, microcrystalline cellulose, and succinic acid. The coating contains: hypromellose, maltodextrin, polydextrose, polyethylene glycol, titanium dioxide, and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Par Pharmaceutical Companies, Inc.
Spring Valley, NY 10977
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