CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated 
Chartwell RX, LLC.

----------

Medication Guide

CIPROFLOXACIN TABLETS, USP

(sip'' roe flox' a sin)

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 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:

● pain
● burning
● tingling
● numbness
● weakness

Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage.

3.       Central Nervous System (CNS) effects. Mental health problems and 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
● hear voices, see things, or sense things that are not there (hallucinations)
● feel restless or agitated
● tremors
● feel anxious or nervous
● confusion
● depression
● reduced awareness of surroundings
● 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
● memory problems
● false or strange thoughts or beliefs (delusions)

The CNS changes may be permanent.

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 is 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

Who should not take ciprofloxacin tablets?

Do not take ciprofloxacin tablets if you:

Ask your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking ciprofloxacin?

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

◦ 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.

◦ 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.

◦ 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 tablets 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 ®).

◦ 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?

Taking all of your ciprofloxacin tablet doses will help make sure that all of the bacteria are killed. Taking all of your ciprofloxacin tablet 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:

◦ 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 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 the skin and 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. People who take ciprofloxacin 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, stop taking ciprofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

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?

Ciprofloxacin tablets

Keep ciprofloxacin 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 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 healthcare professionals.

For more information call 1-845-232-1683.

What are the ingredients in ciprofloxacin tablets?

Ciprofloxacin tablets

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

All registered trademarks in this document are the property of their respective owners.

Manufactured for:
Chartwell RX, LLC
Congers, NY 10920

L70425

Rev: 04/2021

Revised: 4/2021
Chartwell RX, LLC.