FACTIVE (Page 9 of 9)

What should I avoid while taking FACTIVE?

  • FACTIVE can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or 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 the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking FACTIVE, call your healthcare provider right away. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of FACTIVE?

FACTIVE can cause side effects that may be serious or even cause death. See “What is the most important information I should know about FACTIVE?

Other serious side effects of FACTIVE include:

  • Central Nervous System Effects. Seizures have been reported in people who take fluoroquinolone antibiotics, including FACTIVE. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking FACTIVE will change your risk of having a seizure.
    Central Nervous System (CNS) side effects may occur 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:

    • feel lightheaded

    • seizures

    • hear voices, see things, or sense things that are not there (hallucinations)

    • feel restless

    • tremors

    • feel anxious or nervous

    • confusion

    • depression

    • trouble sleeping

    • feel more suspicious (paranoia)

    • suicidal thoughts or acts

    • nightmares

  • Serious allergic reactions. Allergic reactions can happen in people taking fluoroquinolones, including FACTIVE, even after only one dose. Stop taking FACTIVE and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:

    • hives

    • trouble breathing or swallowing

    • swelling of the lips, tongue, face

    • throat tightness, hoarseness

    • rapid heartbeat

    • fain

    • yellowing of the skin or eyes. Stop taking FACTIVE and call your healthcare provider right away if you get 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 FACTIVE (a liver problem).

  • Skin rash. Skin rash may happen in people taking FACTIVE. Stop taking FACTIVE 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 FACTIVE. Rash happens more often with FACTIVE in:

    • women, especially women who take hormone replacement therapy

    • people under 40 years of age

    • people who take FACTIVE for longer than 5 days.

  • Serious heart rhythm changes (QTc prolongation and torsades de pointes).
    Tell your healthcare provider right away if you have a change in your heartbeat (get a fast or irregular heartbeat), or if you faint. FACTIVE may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:

    • who are elderly

    • with a family history of prolonged QT interval

    • with low blood potassium (hypokalemia)

    • who take certain medicines to control heart rhythm (antiarrhythmics).

  • Intestine infection (Pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including FACTIVE. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

  • Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including FACTIVE. Talk with 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

FACTIVE may need to be stopped to prevent permanent nerve damage.

  • Sensitivity to sunlight (photosensitivity)

See “What should I avoid while taking FACTIVE?

The most common side effects of FACTIVE include:

  • diarrhea

  • rash

  • nausea

  • headache

  • stomach pain

  • vomiting

  • dizziness

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 effects to FDA at 1-800-FDA-1088.

How should I store FACTIVE?

Store FACTIVE at 59º — 86ºF (15º to 30ºC).
Keep FACTIVE away from light.

Keep FACTIVE and all 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 written for healthcare professionals. For more information go to www.FACTIVE.com or call 1-866-432-2848.

What are the ingredients in FACTIVE?

Active ingredient: gemifloxacin

Inactive ingredients: crospovidone, hydroxypropyl methycellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Revised October 2008
© Oscient Pharmaceuticals Corporation 2008
FACTIVE is a registered trademark of LG Life Sciences.

Manufactured for:
Oscient PharmaceuticalsWaltham, MA 02451-1478 USA

Licensed from LG Life Sciences, Ltd. Seoul, Korea

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

FACTIVE gemifloxacin mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67707-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMIFLOXACIN mesylate (GEMIFLOXACIN) GEMIFLOXACIN 320 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone
hydroxypropyl methylcellulose
magnesium stearate
microcrystalline cellulose
polyethylene glycol
povidone
titanium dioxide
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code GE;320
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67707-320-05 5 TABLET (5 TABLET) in 1 BLISTER PACK None
2 NDC:67707-320-07 7 TABLET (7 TABLET) in 1 BLISTER PACK None
Labeler — Oscient Pharmaceuticals

Revised: 10/2008 Oscient Pharmaceuticals

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