Factive is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.

Factive is used to treat different types of bacterial infections in the lungs.

Fluoroquinolone antibiotics can cause serious or disabling side effects. Factive should be used only for infections that cannot be treated with a safer antibiotic.

Factive may also be used for purposes not listed in this medication guide.

Factive can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using this medicine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, Factive may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Factive with water, and drink extra fluids to keep your kidneys working properly while taking this medicine.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not chew it.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Factive will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

You should not use Factive if you are allergic to Factive or other fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, and others).

Factive may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop taking this medicine. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

Tell your doctor if you have ever had:

• tendon problems, arthritis or other joint problems;

• blood circulation problems, aneurysm, narrowing or hardening of the arteries;

• heart problems, high blood pressure;

• a genetic disease such as Marfan syndrome or Ehler's-Danlos syndrome;

• diabetes;

• a muscle or nerve disorder, such as myasthenia gravis;

• long QT syndrome (in you or a family member);

• trouble swallowing pills;

• liver or kidney disease;

• epilepsy or other seizure disorder; or

• low levels of magnesium or potassium in your blood.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using Factive.

Factive is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take Factive with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking this medicine. They could make the medication less effective.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Factive could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Avoid driving or hazardous activity until you know how Factive will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Factive can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking Factive and call your doctor at once if you have:

• low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;

• nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;

• serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or

• signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, Factive may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using Factive and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• the first sign of any skin rash, no matter how mild;

• muscle weakness, breathing problems;

• jaundice (yellowing of the skin or eyes);

• a seizure (convulsions); or

• increased pressure inside the skull--severe headaches, ringing in your ears, vision problems, pain behind your eyes.

Common side effects of Factive may include:

• nausea, vomiting, stomach pain, diarrhea;

• headache;

• dizziness; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make Factive much less effective when taken at the same time. If you take any of the following medicines, take your this medicine dose 2 hours before or 3 hours after you take the other medicine:

• antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);

• didanosine (Videx) powder or chewable tablets; or

• vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.

Factive can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• probenecid;

• a diuretic or "water pill";

• insulin or oral diabetes medicine (check your blood sugar regularly);

• a blood thinner--warfarin, Coumadin, Jantoven;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine--prednisone, methylprednisolone, and others.

This list is not complete. Other drugs may interact with gemifloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.