Evox (Levofloxacin) is a fluoroquinolone antibiotic medicine used in adults’ age 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

• Sinuses.

• Lungs, in people with long-term breathing problems or pneumonia.

• Urinary tract, including your kidneys or bladder.

• Prostate gland, where you have a long lasting infection.

• Skin and underneath the skin, including muscles. this is sometimes called “soft tissue”.

Before you take Levofloxacin, tell your healthcare provider if you:

• have tendon problems.

• have a problem that causes muscle weakness (myasthenia gravis).

• have central nervous system problems such as seizures (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).

• have bone problems.

• have joint problems including rheumatoid arthritis (RA).

• have kidney problems. You may need a lower dose of Levofloxacin if your kidneys do not work well.

• have liver problems.

• have diabetes or problems with low blood sugar (hypoglycemia).

• are pregnant or plan to become pregnant. It is not known if levofloxacin will harm your unborn child.

• are breastfeeding or plan to breastfeed. It is not known if Levofloxacin passes into your breast milk. You and your healthcare provider should decide if you will take Levofloxacin or breastfeed. You should not do both.

• have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).

•  have experienced a previous episode of aortic dissection (a tear in the aorta wall).

•  have a family history of aortic  aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).

If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Levofloxacin and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

• a steroid medicine.

• an anti-psychotic medicine.

• a tricyclic antidepressant.

• a water pill (diuretic).

• certain medicines may keep Levofloxacin from working correctly. Take Levofloxacin Tablets either 2 hours before or 2 hours after taking these medicines or supplements:

- an antacid, multivitamin, or other medicines or supplements that have magnesium, aluminum, iron, or zinc.

- sucralfate.

- didanosine.

• a blood thinner (Warfarin, Coumadin, Jantoven).

• an oral anti-diabetes medicine or insulin.

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

• theophylline.

• a medicine to control your heart rate or rhythm (antiarrhythmics).

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

HOW SHOULD I TAKE EVOX ?

• Take Evox exactly as your healthcare provider tells you to take it.

• Take this medicine by mouth.

• Swallow the tablets whole with a drink of water

• Take Evox at about the same time each day.

• Evox Tablets can be taken with or without food.

HOW MUCH TO TAKE:

• Your doctor will decide on how many tablets you should take.

• The dose will depend on the type of infection you have and where the infection is in your body

• the length of your treatment will depend on how serious your infection is.

• if you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.

• The scoring line on Evox 250 and 500 is for differentiation only and the tablet cannot be break into two halfs.

• Adults and the elderly.

Dosage for Evox 250 and 500 mg

- Sinuses: Two tablets of Evox 250 mg, once each day or one tablet of Evox 500 mg once each day.

- Lungs, in people with long-term breathing problems: One or two tablets of Evox 250 mg, once each day or one tablet of Evox 500 mg once each day.

- Pneumonia: Two tablets of Evox 250 mg once or twice each day, or one tablet of Evox 500 mg once or twice each day.

- Urinary tract, including your kidneys or bladder: One tablet of Evox 250 mg each day.

- Prostate gland: Two tablets of Evox 250 mg once each day. Or one tablet of Evox 500 mg once each day.

- Skin and underneath the skin, including muscles: One or two of tablets of Evox 250 mg  once or twice each day or one tablet of Evox 500 mg once or twice each day.

Dosage for Evox 750 mg:

- Sinuses: One tablet of Evox 750 mg, once each day.

- Pneumonia: One tablet of Evox 750 mg once each day.

- Skin and underneath the skin, including muscles: One tablet of Evox 750 mg once each day.

• Adults with Kidney problems: Your doctor may need to give you a lower dose.

• Children and Teenagers: this medicine must not be given to children or teenagers.

• If you miss a dose of Evox, take it as soon as you remember. Do not take more than 1 dose in 1 day.

• If you accidentally take more tablets than you should, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious and heart problem leading to uneven heart beats as well as feeling sick (nausea).

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

- you have tendon problems. See “What is the most important information I should know about Levofloxacin?”.

- you have a serious allergic reaction. See “What are the possible side effects of levofloxacin?”.

- your healthcare provider tells you to stop taking Levofloxacin.

Taking all of your Levofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your Levofloxacin doses will help you lower the chance that the bacteria will become resistant to Levofloxacin. If your infection does not get better while you take Levofloxacin, it may mean that the bacteria causing your infection may be resistant to Levofloxacin. If your infection does not get better, call your healthcare provider. If your infection does not get better, Levofloxacin and other similar antibiotic medicines may not work for you in the future.

• If you take too much Levofloxacin, call your healthcare provider or get medical help right away.

WHAT SHOULD I AVOID WHILE TAKING LEVOFLOXACIN?

• Levofloxacin 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 Levofloxacin affects you.

• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin 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 you take Levofloxacin, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

Levofloxacin can cause serious side effects, including:

• See “What is the most important information I should know about Levofloxacin?”

• Serious allergic reactions.

Allergic reactions can happen in people taking fluoroquinolones, including Levofloxacin, even after only 1 dose. Stop taking Levofloxacin and get emergency medical help right away if you have 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.     - skin rash.

Skin rash may happen in people taking Levofloxacin, even after only 1 dose. Stop taking Levofloxacin 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 Levofloxacin.

• Liver damage (hepatotoxicity): Hepatotoxicity can happen in people who take Levofloxacin. Call your healthcare provider right away if you have unexplained symptoms such as:

- nausea or vomiting.      - stomach pain.      - fever.     - weakness.      - abdominal pain or tenderness.

- itching.      - unusual tiredness.      - loss of appetite.      - light colored bowel movements.

- dark colored urine.      - yellowing of your skin or the whites of your eyes.

Stop taking Levofloxacin and tell your healthcare provider right away if you have 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 Levofloxacin (a liver problem).

• Central Nervous System Effects: Seizures have been reported in people who take fluoroquinolone antibiotics including Levofloxacin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Levofloxacin 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 Levofloxacin. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

- seizures.      - hear voices, see things, or sense things that are not there (hallucinations).

- feel restless.      - tremors.      - feel anxious or nervous.      - confusion.      - depression.

- trouble sleeping.      - nightmares.      - feel lightheaded.      - feel more suspicious (paranoia).

- suicidal thoughts or acts.      - a headache that will not go away, with or without blurred vision.

• Intestine infection (Pseudomembranous colitis) Pseudomembranous colitis can happen with many antibiotics, including Levofloxacin. 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 nerve damage (Peripheral Neuropathy)

Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including Levofloxacin. Stop Levofloxacin and 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 and should be switched to another non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk:

- pain.      - burning.      - tingling.      - numbness.

- weakness The nerve damage may be permanent.

- change in sensation to light touch, pain or temperature.

Peripheral neuropathy can occur at any time during treatment with fluoroquinolones (may occur soon after these drugs are taken) and can last for months to years after the drug is stopped or be permanent.

• Serious heart rhythm changes (QT prolongation and torsades de pointes)

Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Levofloxacin 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).

• Joint Problems

Increased chance of problems with joints and tissues around joints in children can happen. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with Levofloxacin.

• Changes in blood sugar

People who take Levofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking Levoflxoacin, stop taking Levofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

• Sensitivity to sunlight (photosensitivity) See “What should I avoid while taking Levofloxacin?” The most common side effects of Levofloxacin include:

- nausea.      - headache.      - diarrhea.      - insomnia.      - constipation.      - dizziness.

In children 6 months and older who take Levofloxacin to treat anthrax disease or plague, vomiting is also common.

Levofloxacin may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test.

These are not all the possible side effects of Levofloxacin. Tell your healthcare provider about any side effect that bothers you or that does not go away.

• Store below 30°C.

Keep all medicines out of the reach of children.