Medication guide

MEDICATION GUIDE
See the section “What are the possible side effects of FACTIVE?” for
FACTIVE® [FAC-tiv]
more information about side ef ects.
(gemifloxacin)
320mg Tablets
What is FACTIVE?
FACTIVE is a fluoroquinolone antibiotic medicine used to treat certain Read the Medication Guide that comes with FACTIVE® before you start infections caused by certain germs called bacteria in adults 18 years or older. taking it and each time you get a refil . There may be new information. This It is not known if FACTIVE is safe and works in children under 18 years of Medication Guide does not take the place of talking to your healthcare age. Children have a higher chance of getting bone, joint, or tendon provider about your medical condition or your treatment. (musculoskeletal) problems such as pain or swelling while taking What is the most important information I should know about FACTIVE?
FACTIVE belongs to a class of antibiotics cal ed fluoroquinolones. FACTIVE Sometimes infections are caused by viruses rather than by bacteria. can cause side effects that may be serious or even cause death. If you get Examples include viral infections in the sinuses and lungs, such as the any of the following serious side effects, get medical help right away. Talk common cold or flu. Antibiotics including FACTIVE do not kil viruses. with your healthcare provider about whether you should continue to take Call your healthcare provider if you think your condition is not getting better 1. Tendon rupture or swel ing of the tendon (tendinitis)
• Tendon problems can happen in people of al ages who take Who should not take FACTIVE?
FACTIVE.
Do not take FACTIVE if you have ever had a severe allergic reaction to an Tendons are tough cords of tissue that connect muscles to bones. antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients • Symptoms of tendon problems may include: Pain, swelling, in FACTIVE. Ask your healthcare provider if you are not sure. See the list of tears and inflammation of tendons including the back of the ingredients in FACTIVE at the end of this Medication Guide. ankle (Achil es), shoulder, hand, or other tendon sites. • The risk of getting tendon problems while you take FACTIVE is What should I tell my healthcare provider before taking FACTIVE?
higher if you:
See “What is the most important information I should know about
FACTIVE?”
• are taking steroids (corticosteroids) • have had a kidney, heart or lung transplant. Tel your healthcare provider about al your medical conditions,
including if you:
Tendon problems can happen in people who do not have the above • have tendon problems
risk factors when they take FACTIVE.
• have a disease that causes muscle weakness (myasthenia gravis) • Other reasons that can increase your risk of tendon problems • have central nervous system problems (such as epilepsy)
can include:
• have or anyone in your family has an irregular heartbeat, especially a • tendon problems in the past, such as in people with • have low blood potassium (hypokalemia) or magnesium • Call your healthcare provider right away at the first sign of • have a slow heart beat (bradycardia)
tendon pain, swel ing or inflammation. Stop taking FACTIVE • have a history of seizures
until tendinitis or tendon rupture has been ruled out by your • have kidney problems. You may need a lower dose of FACTIVE if your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achil es tendon • have rheumatoid arthritis (RA) or other history of joint problems at the back of your ankle. This can also happen with other • are pregnant or planning to become pregnant. It is not known if • Talk to your healthcare provider about the risk of tendon • are breast-feeding or planning to breast-feed. It is not known if
rupture with continued use of FACTIVE. You may need a
FACTIVE passes into breast milk. You and your healthcare provider dif erent antibiotic that is not a fluoroquinolone to treat your should decide whether you wil take FACTIVE or breast-feed. • Tendon rupture can happen while you are taking or after you Tell your healthcare provider about all the medicines you take, including
have finished taking FACTIVE. Tendon ruptures have happened prescription and non-prescription medicines, vitamins, and herbal and dietary
up to several months after patients have finished taking their supplements. FACTIVE and other medicines can affect each other causing side effects. Especially tel your healthcare provider if you take: • Get medical help right away if you get any of the fol owing • an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common
signs or symptoms of a tendon rupture:
medicines for pain relief are NSAIDs. Taking an NSAID while you take • hear or feel a snap or pop in a tendon area FACTIVE or other fluoroquinolones may increase your risk of central • bruising right after an injury in a tendon area nervous system effects and seizures. See “What are the possible side
• unable to move the affected area or bear weight effects of FACTIVE?”
• a blood thinner (warfarin, Coumadin®, Jantoven®) 2. Worsening of myasthenia gravis (a disease which causes muscle • a medicine to control your heart rate or rhythm (antiarrhythmics) See
weakness). Fluoroquinolones like FACTIVE may cause worsening of
“What are the possible side effects of FACTIVE?”
myasthenia gravis symptoms, including muscle weakness and breathing • an anti-psychotic medicine problems. Call your healthcare provider right away if you have any • a tricyclic antidepressant worsening muscle weakness or breathing problems. • probenecid (Probalan, Col-Probenecid) • a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. See “What is the most
important information I should know about FACTIVE?”
o hear voices, see things, or sense things that are not there • Certain medicines may keep FACTIVE from working correctly. Take FACTIVE either 3 hours before or 2 hours after taking these products: • an antacid, multivitamin, or other product that contains magnesium, Ask your healthcare provider if you are not sure if any of your
medicines are listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. • Serious allergic reactions
Al ergic reactions can happen in people taking fluoroquinolones, How should I take FACTIVE?
including FACTIVE, even after only one dose. Stop taking FACTIVE • Take FACTIVE exactly as prescribed by your healthcare provider. and get emergency medical help right away if you get any of the • Take FACTIVE at about the same time each day. following symptoms of a severe allergic reaction: • FACTIVE tablets should be swallowed. • FACTIVE can be taken with or without food. • FACTIVE should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that • Drink plenty of fluids while taking FACTIVE. • Do not skip any doses, or stop taking FACTIVE even if you begin to feel Yellowing of the skin or eyes
better, until you finish your prescribed treatment, unless: Stop taking FACTIVE and tel your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark • you have tendon effects (see “What is the most important
urine. These can be signs of a serious reaction to FACTIVE (a liver information I should know about FACTIVE?”),
• you have a serious allergic reaction (see “What are the possible • Skin rash
side effects of FACTIVE?”), or your healthcare provider tells you
Skin rash may happen in people taking FACTIVE. Stop taking FACTIVE at the first sign of a skin rash and call your healthcare • This wil help make sure that all of the bacteria are kil ed and lower the provider. Skin rash may be a sign of a more serious reaction to chance that the bacteria wil become resistant to FACTIVE. If this FACTIVE. Rash happens more often with FACTIVE in: happens, FACTIVE and other antibiotic medicines may not work in the • women, especially women who take hormone replacement therapy • If you miss a dose of FACTIVE, take it as soon as you remember. Do not take more than 1 dose of FACTIVE in one day. people who take FACTIVE for longer than 5 days. • Serious heart rhythm changes (QT prolongation and torsades de
• If you take too much, call your healthcare provider or get medical help Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint. FACTIVE may What should I avoid while taking FACTIVE?
cause a rare heart problem known as prolongation of the QT interval. • FACTIVE can make you feel dizzy and lightheaded. Do not drive, This condition can cause an abnormal heartbeat and can be very operate machinery, or do other activities that require mental alertness or dangerous. The chances of this happening are higher in people: coordination until you know how FACTIVE affects you. • Avoid sunlamps, tanning beds, and try to limit your time in the sun. FACTIVE can make your skin sensitive to the sun (photosensitivity) and with a family history of prolonged QT interval the light from sunlamps and tanning beds. You could get severe • with low blood potassium (hypokalemia) sunburn, blisters or swelling of your skin. If you get any of these • who take certain medicines to control heart rhythm symptoms while taking FACTIVE, call your healthcare provider right away. You should use sunscreen and wear a hat and clothes that cover • Intestine infection (Pseudomembranous colitis)
your skin if you have to be in sunlight. Pseudomembranous colitis can happen with most antibiotics, including FACTIVE. Call your healthcare provider right away if you get watery What are the possible side effects of FACTIVE?
diarrhea, diarrhea that does not go away, or bloody stools. You may FACTIVE can cause side effects that may be serious or even cause death. have stomach cramps and a fever. Pseudomembranous colitis can See “What is the most important information I should know about
happen 2 or more months after you have finished your antibiotic. FACTIVE?”
• Changes in sensation and possible nerve damage (Peripheral
Other serious side effects of FACTIVE include: Neuropathy)
• Central Nervous System effects
Damage to the nerves in arms, hands, legs, or feet can happen in Seizures have been reported in people who take fluoroquinolone people taking fluoroquinolones, including FACTIVE. Talk with your antibiotics, including FACTIVE. Tell your healthcare provider if you have healthcare provider right away if you get any of the following symptoms a history of seizures. Ask your healthcare provider whether taking of peripheral neuropathy in your arms, hands, legs, or feet: FACTIVE wil change your risk of having a seizure. Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of FACTIVE. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior: FACTIVE may need to be stopped to prevent permanent nerve damage. • Sensitivity to sunlight (photosensitivity)
See “What should I avoid while taking FACTIVE?”
• Joint problems
The most common side effects of FACTIVE include: These are not all the possible side effects of FACTIVE. Tell your healthcare provider about any side effect that bothers you, or that does not go away. Call your doctor for medical advice about side effects. You may report side
How should I store FACTIVE?
• Store FACTIVE at 59º - 86ºF (15º to 30ºC)
Keep FACTIVE and al medicines out of the reach of children.

General Information about FACTIVE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FACTIVE for a condition for which it is not prescribed. Do not give FACTIVE 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 FACTIVE. If you would like more information about FACTIVE, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FACTIVE that is writ en for healthcare professionals. For more information go tr call 1-888-661-9260.
What are the ingredients in FACTIVE?
• Inactive ingredients: crospovidone, hydroxypropyl methycellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, This Medication Guide has been approved by the U.S. Food and Drug FACTIVE is a registered trademark of LG Life Sciences. Licensed from LG Life Sciences, Ltd. Seoul, Korea

Source: http://crtx.com/docs/Factive_Medication_Guide.pdf