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MEDICATION GUIDE Ciprofloxacin Tablets USP (sip-roh-flok-suh-sin)

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 youÂget 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).

• Tendon problems can happen in people of all ages who take ciprofloxacin tablets .ÂTendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:

○ Pain

○ swellingÂ

○ tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites.

• The risk of getting tendon problems while you take ciprofloxacin 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 ciprofloxacin 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)

• S top  t a k i n g  ciprofloxacin tablets imm e dia te l y a n d g et m e di c a l  h e l p  r ig h t a w a y at t h e f i r s t  s ig n of t e nd on pai n , s we lli n g  or i n f lamma t i o n .

The mostÂcommon areaÂof painÂandÂswellingÂis the Achilles tendon at the backÂofÂyourÂankle.ÂThis canÂalso happenÂwithÂother tendons.

•ÂÂT e n d o n r u p t ur e c a n  h app en w h il e y o u a r e t a k i n g or a fter you h a ve f i n is h ed t a k i n g ciprofloxacin tablets. Tendon rupturesÂcan happen within hours or days of takingÂciprofloxacin tablets andÂhave happened up to severalÂmonths afterÂpeople haveÂfinished taking theirÂfluoroquinolone.

•ÂÂS top t a k i n g  ciprofloxacin tablets imm e dia te l y a n d g et m e di c a l  h e l p  r ig h t a w a y if  you g et a n y of t h e  f o ll ow i n g  s ig n s or s y mp to m s of a  te n d on r u p t u r e:

○ hearÂor feelÂaÂsnapÂorÂpopÂinÂa tendon area

○ bruisingÂrightÂafter anÂinjuryÂinÂa tendon area

○ unable to move the affected areaÂor bear weight

The tendon problems may be permanent.

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:

• Âpain	• Ânumbness
• Âburning	• Âweakness
• Âtingling	Â

Ciprofloxacin tablets mayÂneedÂtoÂbe stoppedÂtoÂpreventÂpermanentÂnerveÂdamage.

3. C en t ral N er v ous  S y s t em  ( CNS )  e ff e c t s. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, includingÂciprofloxacin 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:

• Âseizures
• Âhear voices, see things, or sense thingsÂthat are not there (hallucinations)
• ÂfeelÂagitated
• Âtremors
• Âfeel anxious or nervous
• Âconfusion
• Âdepression
• Âreduced awareness of surroundings
• Âtrouble sleeping
• Ânightmares
• Âfeel light-headed or dizzy
• Âfeel more suspiciousÂ(paranoia)
• Âsuicidal thoughts or acts
• Âheadaches that will not go away, with or without blurred vision
• Âmemory problems
• Âfalse or strange thoughts or beliefs (delusions)

These changes may be permanent.

4. Worsening of myasthenia gravis (a problem that causes muscle weakness).

Fluoroquinolones likeÂciprofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems.ÂTell 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.

W hat are ciprofloxacin t ablets ?

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 jointÂinfection

○ 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 ofÂciprofloxacin tablets for use in the treatment of plague and anthrax wereÂdone in animals only, because plague and anthrax could not be studied in people.

•ÂCiprofloxacin tablets should not beÂusedÂin people withÂacute exacerbationÂofÂchronicÂbronchitis,Âacute uncomplicatedÂcystitis,ÂandÂsinusÂinfections, ifÂthere are otherÂtreatmentÂoptions available.

•ÂCiprofloxacin tablets should not beÂused as the firstÂchoice of antibacterial medicine toÂtreat lower respiratoryÂtractÂinfections caused by aÂcertainÂtype of bacterialÂcalledÂS tr e pt oco c c u s pn e u m o n i a e.Â

• Ciprofloxacin t ablets are also used in children younger than 18 years of age to treatÂcomplicated 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 ciprofloxacinÂtablets. Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine inÂchildren under 18 years of age.

Who should not take ciprofloxacin tablets?

Do not take ciprofloxacin tablets if you:

• Have ever had a severe allergic reaction to an antibacterial medicine known as aÂfluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin tablets. See the end of this Medication Guide for a complete ul of ingredients in ciprofloxacin tablets.
• 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 tablets?

Before you take ciprofloxacin tablets, tell your healthcare provider about all your medical conditions, including if you:

• have tendon problems; ciprofloxacin tablets should not be used in people who have a history of tendon problems

• have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin tablets should not be used in people whoÂhave a known history of myasthenia gravis

• have liver problems

• have central nervous system problems (such as epilepsy)

• have nerve problems. Ciprofloxacin tablets should not be used in people who have a history of a nerve problem called peripheral neuropathy have or anyone in your family has an irregular heartbeat, or heart attack, especially a condition called “QT prolongation”.

• have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).

• 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 diabetes or problems with low blood sugar (hypoglycemia).

• have joint problems including rheumatoid arthritis (RA)

• have trouble swallowing pills.

• are pregnant or plan to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn baby.

• are breastfeeding or plan to breastfeed. Ciprofloxacin passes into your breast milk.

o You should not breastfeed during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets. You may pump your breast milk and throw it away during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets.

o If you are taking ciprofloxacin tablets for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin tablets.

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:Â

o a steroid medicineo an anti-psychotic medicineo a tricyclic antidepressanto a water pill (diuretic)o theophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)o a medicine to control your heart rate or rhythm (antiarrhythmics)o an oral anti-diabetes medicineo phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin® , Extended Phenytoin Sodium®, Prompt Phenytoin Sodium®, Phenytek®)o cyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®).o a blood thinner (such as warfarin, Coumadin®, Jantoven®)o methotrexate (Trexall®)o ropinirole (Requip®)o clozapine (Clozaril®, Fazaclo® ODT®)o a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin tablets or other fluoroquinolones may increase your risk of central nervous system effects and seizures.o sildenafil (Viagra®, Revatio®)o duloxetineo products that contain caffeineo probenecid (Probalan®, Col-probenecid ®)

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

o an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinco sucralfateÂ(Carafate^®)o didanosine (Videx^®, Videx EC^®)Â

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

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

How should I take ciprofloxacin tablets ?

• Take ciprofloxacin tabletsÂexactly as your healthcare provider tells you to take them.
• Your healthcare provider will tell you how much ciprofloxacin tabletsÂto take and whenÂto takeÂthem.
• Ciprofloxacin tablets can be taken with or without food.
• Ciprofloxacin 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 tablets.
• Do not skip any doses of ciprofloxacin tablets, or stop taking them, 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 tablets ?” ○ you have nerve problems. See “What is the most important informat ion I should know about ciprofloxacin tablets ?” ○ you have centralÂnervous systemÂproblems. See “ W h a t i s t h e m o st imp o r t a n t i n f o r ma t i on I sh o u l d k n ow ab o u t ciprofloxacin tablets ?” ○ you have a serious allergic reaction. See “What are the possible side effects of ciprofloxacin tablets ? ” ○ your healthcare provider tells you to stop taking ciprofloxacin tablets.

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

• If you take too much ciprofloxacin tablets, call your healthcare provider or get medical help right away.
• 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.
• If you miss a dose of ciprofloxacin tablets and it is:

 Â○Â6 hours or moreÂuntil your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time. Â○Âless than 6 hoursÂuntil your next scheduled dose, do not take the missed dose. Take the next dose at your regular time.

• 
  Do not take 2 doses of Ciprofloxacin Tablets atÂ1 time to make up for a missed dose. If you are not sure about when to take Ciprofloxacin Tablets after a missed dose, ask your healthcare provider or pharmacist.
  

What should I avoid while taking ciprofloxacin tablets ?

• Ciprofloxacin tablets can make you feel dizzy and light-headed. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin tabletsÂaffects you.
• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get a severe sunburn, bulers or swelling of your skin. If you get any of these symptoms while you take ciprofloxacin 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.

W h a t a r e t h e p o s s ibl e s id e  effects of ciprofloxacin tablets ?

Ciprofloxacin t ablets ma y c a us e s e r i o u s s id e effec t s , i n c l u di n g :

• See “What is the most important information I should know about ciprofloxacin tablets ?”
• Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin tablets, even after only 1 dose. Stop taking ciprofloxacin tabletsÂand 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 tabletsÂeven after only 1 dose. Stop taking ciprofloxacin tabletsÂat 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.

• Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin tablets. Call your healthcare provider right away if you have unexplained symptoms such as:○ nauseaÂor vomiting○ stomach pain○ fever○ weakness○ abdominal painÂor tenderness○ itching○ unusualÂtiredness○ loss of appetite○ lightÂcolored bowelÂmovements○ darkÂcolored urine○ yellowingÂof the skin and whites of yourÂeyes

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 tabletsÂ(a liver problem).

• 
  Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
  

• Intestine infection (Clostridioides difficile – associated diarrhea). Clostridioides difficile-associated diarrhea (CDAD) can happen with many antibacterial medicines, including ciprofloxacin 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. CDAD can happen 2 or more months after you have finished your antibacterial medicine
• 
  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 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 event are higher in people:
  

○ who are elderly.○ withÂa familyÂhistory of prolonged QTÂinterval.○ withÂlowÂblood potassiumÂ(hypokalemia)Âor low magnesium (hypomagnesemia).○ who take certain medicines to controlÂheartÂrhythmÂ(antiarrhythmics).

• Joint Problems. Increased chance of problems with joints and tissues around joints in Âchildren 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 tablets.

• Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking  ciprofloxacin tablets ?”Â

5. Changes in blood sugarÂPeople who take ciprofloxacin tablets and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking ciprofloxacin tablets, stop taking ciprofloxacin tablets and call your healthcare provider right away. Your antibiotic medicine may need to be changed.ÂÂÂÂÂ

The most common side effects of ciprofloxacin tablets 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 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 1-800-FDA-1088.

How should I store ciprofloxacin tablets ?

• Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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

General in formation about the safe and effective use of ciprofloxacin tablets .

Medicines are sometimes prescribed for purposes other than those uled in a Medication Guide. Do not use ciprofloxacin tablets for a condition for which it is not prescribed. Do not give ciprofloxacin 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 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 health professionals.

For more Information contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001.

What are the ingredients in ciprofloxacin tablets ? Â

• Active ingredient: ciprofloxacin hydrochloride
• Inactive ingredients: colloidal silicon dioxide, corn starch, hydrogenated vegetable oil,Âmagnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate. The film-coating suspension (Opadry white 321A180025) contains the following inactive ingredients: glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcoholÂgraft copolymer, polyvinyl alcohol, talc and titanium dioxide.

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

Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922

Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400Amman 11118 – Jordan

Revised November 2021