Levaquin^®

Levofloxacin 500 mg

Film Coated Tablets for Oral Use

Product leaflet summary

Therapeutic Indications

Levaquin tablets can be used to treat infections of the:

• 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’.

In some special situations, Levaquin tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.

Dosage and Administration

Sinuses infection

• One tablet of Levaquin 500 mg, once each day

Lungs infection, in people with long-term breathing problems

• One tablet of Levaquin 500 mg, once each day

Pneumonia

• One tablet of Levaquin 500 mg, once or twice each day

Infection of urinary tract, including your kidneys or bladder

• Half or one tablet of Levaquin 500mg, once each day

Prostate gland infection

• One tablet of Levaquin 500 mg, once each day

Infection of skin and underneath the skin, including muscles

• One tablet of Levaquin 500 mg, once or twice each day

Contraindications

• You are allergic to Levofloxacin, any other quinolone antibiotic such as Moxifloxacin,

Ciprofloxacin or Ofloxacin or any of the other ingredients of this medicine

• Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have ever had epilepsy
• You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton
• You are a child or a growing teenager
• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding

Using it to treat infections that might get better without treatment or are not severe (such as throat infections)

Using it to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;

Using it for preventing traveler’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder)

Using it to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used

Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Levaquin.

Pregnancy and Lactation

Do not take this medicine if:

• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding or planning to breast-feed

Ability to Drive and Use Machinery

You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.

Package Presentation:

Levaquin 500 mg is provided in pack size of 5 film coated tablets.