Gemifloxacin tablets

What is this medication?

GEMIFLOXACIN (gem ah FLOX a sin) is a quinolone antibiotic. It is used to treat certain kinds of bacterial infections. It will not work for colds, flu, or other viral infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Factive

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bone problems
• diabetes
• heart disease
• high blood pressure
• history of irregular heartbeat
• history of low levels of potassium in the blood
• joint problems
• kidney disease
• liver disease
• mental illness
• myasthenia gravis
• seizures
• tendon problems
• tingling of the fingers or toes, or other nerve disorder
• an unusual or allergic reaction to gemifloxacin, other quinolone antibiotics, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Avoid taking didanosine, sucralfate, antacids, or iron or zinc products within 2 hours of taking this medicine.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• antacids
• birth control pills
• certain medicines for diabetes, like glipizide, glyburide, or insulin
• certain medicines that treat or prevent blood clots like warfarin
• didanosine buffered tablets or powder
• dofetilide
• multivitamins
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• probenecid
• sucralfate
• ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery.

Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not sit or stand up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use a sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue
• anxious
• bloody or watery diarrhea
• breathing problems
• confusion
• depressed mood
• dizziness
• fast, irregular heartbeat
• feeling faint or lightheaded
• fever
• hallucination, loss of contact with reality
• joint, muscle, or tendon pain or swelling
• loss of memory
• muscle weakness
• pain, tingling, numbness in the hands or feet
• seizures
• signs and symptoms of aortic dissection such as sudden chest, stomach, or back pain
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low blood sugar such as feeling anxious; confusion; dizziness; increased hunger; unusually weak or tired; sweating; shakiness; cold; irritable; headache; blurred vision; fast heartbeat; loss of consciousness; pale skin
• suicidal thoughts or other mood changes
• sunburn
• unusually weak

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dry mouth
• headache
• nausea
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.