Mylan-Levofloxacin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MYLAN-LEVOFLOXACIN is from a group of antibiotics known as quinolones. Mylan-Levofloxacin is used to treat adults with certain lung, sinus, skin and urinary tract infections caused by certain germs called bacteria.

What it does:

MYLAN-LEVOFLOXACIN has been shown, in a large number of clinical trials, to be effective for the treatment of bacterial infections. MYLAN-LEVOFLOXACIN interferes with bacterial enzymes to prevent bacterial growth, thereby killing many types of bacteria that can infect the lungs, sinus, skin, and urinary tract.

Sometimes, viruses rather than bacteria may infect the lungs and sinuses (for example, the common cold). MYLAN-LEVOFLOXACIN, like other antibiotics, does not kill viruses.

When it should not be used:

You should not take MYLAN-LEVOFLOXACIN if you have had an allergic reaction to any of the group of antibiotics known as quinolones, or to any of the nonmedicinal ingredients (see What the nonmedicinal ingredients are). This includes antibiotics such as ofloxacin, ciprofloxacin, moxifloxacin hydrochloride, gatifloxacin and norfloxacin. If you have had any reaction to quinolones, you should discuss this with your doctor.

You should not take MYLAN-LEVOFLOXACIN if you have had tendinitis or tendon rupture while taking quinolone antibiotics.

What the medicinal ingredient is:

MYLAN-LEVOFLOXACIN contains the active (medicinal) ingredient levofloxacin.

What the nonmedicinal ingredients are:

250 mg: Black iron oxide, Croscarmellose sodium, erythrosine aluminium lake, Hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, corn starch and titanium dioxide.

500 mg: Croscarmellose sodium, FD&C yellow # 5/Tartrazine Aluminium Lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, titanium dioxide and yellow iron oxide.

What dosage forms it comes in:

MYLAN-LEVOFLOXACIN tablets come in 250 mg and 500 mg strengths. MYLAN-LEVOFLOXACIN tablets are pink coloured for the 250 mg tablet, peach coloured for the 500 mg tablet.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

BEFORE you use MYLAN-LEVOFLOXACIN talk to your doctor or pharmacist if:

• you have decreased kidney function
• you have epilepsy or have a history of seizures (convulsions)
• you have had any problems with your heart rhythm, heart rate, or problems with low potassium
• you are taking anti-diabetic medications as MYLAN-LEVOFLOXACIN may interfere with blood sugar levels
• you have a disease that causes muscle weakness (myasthenia gravis)
• you experience any symptoms of muscle weakness, including breathing difficulties (e.g., shortness of breath)

INTERACTIONS WITH THIS MEDICATION

Before taking MYLAN-LEVOFLOXACIN, make sure you tell your doctor and pharmacist all the medications you are taking. Do not start a new medicine without first consulting a doctor or pharmacist.

It is important to let your doctor know all of the medicines you are using including some medications for arthritis (non-steroidal anti-inflammatory drugs), blood sugar medicines, drugs for any heart condition, and non-prescription drugs, because MYLAN-LEVOFLOXACIN may react with certain medications.

Taking warfarin and MYLAN-LEVOFLOXACIN together can further predispose you to the development of bleeding problems. If you take warfarin, be sure to tell your doctor.

Many multi-vitamin/mineral combinations and antacids, containing calcium, magnesium, aluminum, iron, zinc and sucralfate may interfere with the absorption of MYLAN-LEVOFLOXACIN and may prevent it from working properly. You should take MYLAN-LEVOFLOXACIN either two hours before or two hours after taking these products.

Some medicines such as erythromycin, clarithromycin, quinidine, procainamide, amiodarone, sotalol, cisapride^¶, antipsychotics, tricyclic antidepressants, and other medications may produce an effect on the electrocardiogram test. The risk of developing abnormal heartbeat may be increased when MYLAN-LEVOFLOXACIN is taken with any of these medications. Do not take any of these medications with MYLAN-LEVOFLOXACIN unless your doctor tells you that it is alright.

^¶ No longer marketed in Canada.

PROPER USE OF THIS MEDICATION

Usual adult dose:

MYLAN-LEVOFLOXACIN tablets should be taken once a day for 3, 5, 7, 10, 14 or 28 days depending on your condition.

Each tablet should be swallowed whole and may be taken with or without food. Try to take the tablet at the same time each day and drink fluids liberally, to maintain a hydrated condition.

You may begin to feel better quickly; however, in order to make sure that you are getting the full, sustained benefits from your medication so that your infection does not return, you should complete the full course of medication.

Overdose:

Missed dose:

Do not take more than the prescribed dose of MYLAN-LEVOFLOXACIN tablets even if you missed a dose by mistake. You should not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Levofloxacin is generally well tolerated. The most common side effects caused by levofloxacin, which are usually mild, include nausea, vomiting, diarrhea, abdominal pain, constipation, dizziness, flatulence, rash, headache, difficulty in sleeping, and vaginitis in women. However, allergic reactions have been reported in patients receiving quinolones, including levofloxacin tablets, even after just one dose. If you develop hives, itching, skin rash, difficulty breathing or swallowing, swelling in the face, tongue or throat, or other symptoms of an allergic reaction, you should stop taking this medication and call your doctor.

MYLAN-LEVOFLOXACIN may be associated with dizziness. You should know how you react to this drug before you operate an automobile, or machinery, or perform other activities requiring mental alertness or co-ordination.

Pain, swelling and tears of shoulder, hand, or Achilles tendons have been reported in patients receiving quinolones, including levofloxacin tablets. The risk of tendon effects is higher if you are over 65 years old, and especially if you are taking corticosteroids. If you develop pain, swelling, or rupture of a tendon you should stop taking MYLAN-LEVOFLOXACIN, rest, avoid exercise and strenuous use of the affected area and contact your doctor.

Convulsions have been reported in patients receiving quinolone antibiotics including levofloxacin tablets. If you have experienced convulsions in the past, be sure to let your physician know that you have a history of convulsions.

Quinolones, including MYLAN-LEVOFLOXACIN, may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia and, rarely, suicidal thoughts or acts. If you have suicidal thoughts, contact your doctor.

Neuropathy (problems in the nerves) has been reported in patients receiving quinolones, including levofloxacin. Peripheral neuropathy may be irreversible. If neuropathy symptoms occur such as pain, burning, tingling, numbness, weakness, or other alterations of sensation (including feelings of vibration, temperature or touch sensitivity), you should stop taking MYLAN-LEVOFLOXACIN tablets and contact your doctor immediately.

Sun sensitivity (photosensitivity), which can appear as skin eruption or severe sunburn, can occur in some patients taking quinolone antibiotics after exposure to sunlight or artificial ultraviolet (UV) light (e.g., tanning beds). Levofloxacin tablets have been infrequently associated with phototoxicity. You should avoid excessive exposure to sunlight or artificial ultraviolet light while you are taking MYLAN-LEVOFLOXACIN. Use sunscreen and wear protective clothing if out in the sun. If photosensitivity develops, contact your doctor.

If you have diabetes and you develop a hypoglycemic reaction (low blood sugar) while taking MYLAN-LEVOFLOXACIN tablets, you should stop taking MYLAN-LEVOFLOXACIN tablets and call your doctor. Hypoglycemic coma has been observed in diabetic patients and deaths have occurred. Hyperglycemic and hypoglycemic (high and low blood sugar respectively) reactions have also been reported in patients without diabetes. Common symptoms of hyperglycemia (high blood sugar) include excessive thirst or excessive urination. Common symptoms of hypoglycemia (low blood sugar) include dizziness, excessive hunger, lack of coordination, headache, fatigue, or fainting. You should call your doctor if you experience any of these symptoms.

Problems with the liver, including fatal cases, have been reported in patients taking levofloxacin. The symptoms of hepatic impairment are non-specific and include nausea, vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, loss of appetite, itching, unusual or unexplained tiredness, light coloured bowel movements and dark coloured urine. In more severe cases, these symptoms are followed by jaundice (yellowing of the skin) and/or icterus (yellowing of the eyes). Call your doctor if you experience these symptoms.

Some quinolones have been associated with lengthening of the heartbeat on an electrocardiogram test, and with abnormal heart rhythm. Very rare cases of abnormal heartbeat have been reported in patients while on levofloxacin, but these reports generally involved patients who had conditions that predisposed them to abnormal heartbeat, or who have been taking other medicines that increase the risk of developing abnormal heartbeat. If you develop heart palpitations (fast beating) or have fainting spells, you should stop taking MYLAN-LEVOFLOXACIN and call your doctor.

Eye abnormalities and abnormal vision have been reported in patients being treated with quinolones. The relationship of the drugs to these events has not been established.

Diarrhea that usually ends after treatment is a common problem caused by antibiotics. A more serious form of diarrhea can occur during or up to 2 months after the use of antibiotics. This has been reported with all antibiotics including with levofloxacin. If you develop a watery and bloody stool with or without stomach cramps and fever, contact your doctor as soon as possible.

Fluoroquinolones like MYLAN-LEVOFLOXACIN may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. If you have or have had myasthenia gravis, do not use MYLAN-LEVOFLOXACIN.

These are not all the side effects that have been reported with levofloxacin. If you notice any side effects not mentioned in this leaflet, or you have concerns about the side effects you are experiencing, please inform your doctor.

This is not a complete list of side effects. For any unexpected effects while taking MYLAN-LEVOFLOXACIN, contact your doctor or pharmacist.

HOW TO STORE IT

Store MYLAN-LEVOFLOXACIN at room temperature (15°C - 30°C) in well-closed containers.

Keep out of the reach and sight of children.

Do not use after the expiry date. Generally, all expired medications should be returned to your pharmacist.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Last revised: April 17, 2015

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

www.mylan.ca