What is the most important information I should know about FACTIVE?

FACTIVE belongs to a class of antibiotics called fluoroquinolones. FACTIVE can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your doctor about whether you should continue to take FACTIVE.

1. Tendon rupture or swelling of the tendon (tendinitis)

- Tendon problems can happen in people of all ages who take FACTIVE.

Tendons are tough cords of tissue that connect muscles to bones.

- Symptoms of tendon problems may include: Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.

-The risk of getting tendon problems while you take FACTIVE is higher if you:

- Are over 60 years of age.

- Are taking steroids (corticosteroids).

- Have had a kidney, heart or lung transplant.

Tendon problems can happen in people who do not have the above risk factors when they take FACTIVE.

- Other reasons that can increase your risk of tendon problems can include:

- Physical activity or exercise.

- Kidney failure.

- Tendon problems in the past, such as in people with rheumatoid arthritis (RA).

- Call your doctor right away at the first sign of tendon pain, swelling or inflammation. Stop taking FACTIVE until tendinitis or tendon rupture has been ruled out by your doctor. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.

- Talk to your doctor about the risk of tendon rupture with continued use of FACTIVE. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.

- Tendon rupture can happen while you are taking or after you have finished taking FACTIVE. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.

- Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:

- Hear or feel a snap or pop in a tendon area.

- Bruising right after an injury in a tendon area.

- Unable to move the affected area or bear weight.

2. Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like FACTIVE may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your doctor right away if you have any worsening muscle weakness or breathing problems.

1- Serious side effects

Fluoroquinolones, including FACTIVE, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:

- Tendinitis and tendon rupture

- Peripheral neuropathy

- Central nervous system effects

Discontinue FACTIVE immediately and avoid the use of fluoroquinolones, including FACTIVE, in patients who experience any of these serious adverse reactions.

Fluoroquinolones, including gemifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid gemifloxacin in patients with known history of myasthenia gravis.

Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions, reserve FACTIVE for use in patients who have no alternative treatment options for the following indications:

- Acute exacerbation of chronic bronchitis

1. What FACTIVE is and what it is used for

FACTIVE is a fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria in adults 18 years or older. It is not known if FACTIVE is safe and works in children under 18 years of age. Children have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking fluoroquinolone antibiotic medicines.

Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics including FACTIVE do not kill viruses.

Call your doctor if you think your condition is not getting better while you are taking FACTIVE.

2. Before you take FACTIVE

Do not take FACTIVE

Do not take FACTIVE if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in FACTIVE. Ask your doctor if you are not sure.

Tell your doctor about all your medical conditions, including if you:

- Have tendon problems.

- Have a disease that causes muscle weakness (myasthenia gravis).

- Have central nervous system problems (such as epilepsy).

- Have nerve problems.

- Have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”.

- Have low blood potassium (hypokalemia) or magnesium (hypomagnesemia).

- Have a slow heart beat (bradycardia).

- Have a history of seizures.

- Have kidney problems. You may need a lower dose of FACTIVE if your kidneys do not work well.

- Have rheumatoid arthritis (RA) or other history of joint problems.

Take special care with FACTIVE

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 doctor right away. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

Fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

Blood sugar disturbances, including high blood sugar and low blood sugar, and that hypoglycemia can lead to coma.

The mental health side effects are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities  called delirium.

Tell your health care professionals if you are taking a diabetes medicine when he is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone.

Early signs and symptoms of low blood sugar include: confusion, pounding heart or very fast pulse, dizziness, pale skin, feeling shaky, sweating, unusual hunger, trembling, headaches, weakness, irritability, unusual anxiety.

Take special care if you have any of the followings:

- Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects.

- Psychiatric Adverse Reactions.

- Central Nervous System Adverse Reactions.

- Exacerbation of Myasthenia Gravis.

- Blood Glucose Disturbances.

Taking other medicines

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal and dietary supplements. FACTIVE and other medicines can affect each other causing side effects. Especially tell your doctor if you take:

- An NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take FACTIVE or other fluoroquinolones may increase your risk of central nervous system effects and seizures.

- A blood thinner (warfarin, Coumadin®, Jantoven®).

- A medicine to control your heart rate or rhythm (antiarrhythmics).

- An anti-psychotic medicine.

- A tricyclic antidepressant.

- A water pill (diuretic).

- 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?”)..

- Certain medicines may keep FACTIVE from working correctly. Take FACTIVE either 2 hours before or 3 hours after taking these products:

- An antacid, multivitamin, or other product that contains magnesium, aluminum, iron, or zinc.

- Sucralfate (Carafate®).

- Didanosine (Videx®, Videx EC®).

Ask your doctor 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 doctor and pharmacist when you get a new medicine.

Taking FACTIVE with food and drink

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 contains these products.

Pregnancy and breastfeeding

Tell your doctor if you:

- Are pregnant or planning to become pregnant. It is not known if FACTIVE will harm your unborn child.

- Are breast-feeding or planning to breast-feed. It is not known if FACTIVE passes into breast milk. You and your doctor should decide whether you will take FACTIVE or breast-feed.

Driving and using machines

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.

3. How to take FACTIVE

- Take FACTIVE exactly as prescribed by your doctor.

- Take FACTIVE at about the same time each day.

- FACTIVE tablets should be swallowed.

- FACTIVE can be taken with or without food.

- Drink plenty of fluids while taking FACTIVE.

If you forget to take FACTIVE

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.

If you take more FACTIVE than you should

If you take too much, call your doctor or get medical help immediately.

If you stop taking FACTIVE

Do not skip any doses, or stop taking FACTIVE even if you begin to feel better, until you finish your prescribed treatment, unless:

- You have tendon effects (see “What is the most important information I should know about FACTIVE?”).

- You have a serious allergic reaction, or your doctor tells you to stop.

This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to FACTIVE. If this happens, FACTIVE and other antibiotic medicines may not work in the future.

4. Possible side effects

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 doctor if you have a history of seizures. Ask your doctor whether taking FACTIVE will 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 doctor right away if you get any of these side effects, or other changes in mood or behavior:

- Feel dizzy.

- 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.

- Faint.

- Yellowing of the skin or eyes

Stop taking FACTIVE and tell your doctor 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 doctor. 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 (QT prolongation and torsades de pointes)

Tell your doctor right away if you have a change in your heartbeat (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 doctor 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 doctor 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 “Take special care with FACTIVE”).

- Joint problems

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store FACTIVE

Keep out of reach of children.

Store below 30°C.

Do not use beyond the expiry date or if the product shows any sign of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.