Factive (Gemifloxacin)

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take FACTIVE at the same time each day with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking FACTIVE. You may take FACTIVE with or without food.

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 FACTIVE. They could make the medication less effective.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. FACTIVE will not treat a viral infection such as the common cold or flu.

Do not share this medicine with another person (especially a child), even if they have the same symptoms you have.

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

Seek emergency medical attention or call the Poison Help line.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, or the first sign of a skin rash; rapid heart rate, difficulty breathing; swelling of your face, lips, tongue, or throat.

FACTIVE may cause swelling or tearing of (rupture) a tendon. FACTIVE can also have serious effects on your nerves, and may cause permanent nerve damage. Stop taking this medicine and call your doctor at once if you have:

• 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); or
• nerve symptoms--numbness, tingling, burning pain, or being more sensitive to temperature, light touch, or the sense of your body position.

Stop using FACTIVE and call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• muscle weakness or trouble breathing;
• diarrhea that is watery or bloody;
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding;
• depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, insomnia, nightmares, thoughts of hurting yourself;
• seizure (convulsions); or
• increased pressure inside the skull-- severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

• nausea, vomiting, mild stomach pain, mild diarrhea;
• mild dizziness; or
• mild headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

You may not be able to use FACTIVE if you have a muscle disorder. Tell your doctor if you have a history of myasthenia gravis.

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 effect 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.

Stop taking FACTIVE and call your doctor at once if you have sudden pain, swelling, bruising, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

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

To make sure FACTIVE is safe for you, tell your doctor if you have:

• slow heartbeats or other heart rhythm disorder, especially if you take medication to treat it;
• a personal or family history of Long QT syndrome;
• tendon problems, arthritis or other joint problems (especially in children);
• a muscle or nerve disorder;
• liver or kidney disease;
• seizures or epilepsy;
• a history of head injury or brain tumor;
• a history of allergic reaction to an antibiotic;
• diabetes (especially if you use insulin or take oral diabetes medication);
• low levels of magnesium or potassium in your blood; or
• if you use a blood thinner (warfarin, Coumadin) and have "INR" or prothrombin time tests.

It is not known whether FACTIVE will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether FACTIVE passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

You may be taking certain other medicines that should not be taken at the same time as FACTIVE. Avoid taking the following medicines within 3 hours before or 2 hours after you take FACTIVE. These other medicines can make FACTIVE much less effective when taken at the same time:

• 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 iron or zinc.

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

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking FACTIVE and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

FACTIVE may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with FACTIVE, especially:

• probenecid;
• a diuretic or "water pill";
• heart rhythm medication--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others;
• medicine to treat depression or mental illness--amitriptylline, clomipramine, desipramine, iloperidone, imipramine, nortriptyline, ziprasidone, and others; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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