Tavanic Tablets

TAVANIC belongs to the class of medicines known as antibiotics. It is used to treat bacterial infections in many parts of the body. It works by killing bacteria or preventing their growth. Some infections which TAVANIC can be used to treat are: infections of the sinuses, chest infections in patients with long standing breathing difficulties, pneumonia, intra-abdominal (stomach and intestinal) infections, urinary tract infections (bladder and kidney) and skin infections.

Your doctor will consider the risks of taking TAVANIC before prescribing it for you. The following will be considered: Tell your doctor if you have ever had an allergic reaction to levofloxacin, any other quinolone antibiotic or to any substance listed under ‘What TAVANIC contains’. Tell your doctor if you suffer from epilepsy (fits or convulsions). Your risk of getting convulsions is increased when taking TAVANIC. Tell your doctor if you have ever had tendon problems such as pain, inflammation or rupture of a tendon with treatment with an antibiotic for the fluoroquinolone class.

This is because there is a risk of getting similar problems with TAVANIC, including tendon rupture. Tell your doctor if you are pregnant or breast feeding. TAVANIC is only intended for adults and must not be given to children or growing teenagers. It could harm the cartilage of their growing bones. Tell your doctor if you have had any problems with medicines in the past.

Take special care with TAVANIC:

• If you have a test for the diagnosis of tuberculosis, TAVANIC may give false-negative results.
• TAVANIC may cause some people to become dizzy, light-headed, drowsy or less alert than they are normally. Do not drive or operate machines if you are dizzy or not alert.
• When you use TAVANIC you may become more sensitive to sunlight than normally. Exposure to sunlight, even for brief periods may cause severe sunburn or skin rash, redness, itching or discolouration. Take precautions when exposed to sunlight and do not use a sun lamp or tanning bed.
• The risk of getting convulsions or fits may be increased if in the past you have experienced brain damage (such as stroke or severe brain injury) and are now treated with TAVANIC. (You should not be administered with TAVANIC if you suffer from epilepsy). Make sure your doctor knows about your medical history, so he can give you appropriate advice.
• Contact your doctor or healthcare professional immediately, if you develop watery diarrhoea, especially if the diarrhoea is persistent and/or bloody.
• You may develop tendinitis (inflammation of the tendon) with the use of TAVANIC.
• You may experience change in blood glucose levels (low blood sugar / high blood sugar) if you are diabetic and are taking medication for the diabetes.

The dose of TAVANIC is determined by the type and severity of the infection. Always take TAVANIC tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. TAVANIC tablets may be taken during meals or any time between meals. Swallow the tablets without crushing with a full glass of water. They may be taken on an empty stomach or with meals. This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. Your doctor will tell you how many TAVANIC tablets to take, at what time and for how long. Also, the number of doses you take each day, the time allowed between doses and the length of time you take the medicine depends on the medical problem for which you are taking levofloxacin. Most people need a dose of one or two tablets per day. Your doctor or a nurse will administer TAVANIC by infusion into a vein. It will take at least 30 minutes for 250mg or 60 minutes for 500mg TAVANIC solution for infusion.

Dosage in patients with normal kidney function:

(creatinine clearance above 50ml/min):

Indication

Daily dosage regimen (according to severity)

• Sinusitis 500mg once daily
• Acute exacerbation of chronic bronchitis 500mg once daily
• Community acquired pneumonia 500mg once or twice daily
• Chronic bacterial prostatitis 500mg once daily
• Complicated urinary tract infections 250mg once daily including pyelonephritis
• Skin and soft tissue infections 500mg twice daily
• Intra-abdominal infections 500mg once daily

1 consideration should be given to increasing the dose in cases of severe infection. Elderly patients and patients with impaired liver function (but normal kidney function) should receive the same dosage as normal adult. If your kidney function is below normal your doctor will reduce the dose of TAVANIC accordingly. The duration of treatment is determined according to your condition and your response to treatment. If you miss a dose of TAVANIC tablets, take it as soon as you remember. However, if you don’t remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take double doses.

TAVANIC can have side effects. Check with your doctor immediately if any of the following side effects occur: Very rare You have an allergic reaction i.e. rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Shortness of breath. Also, check with your doctor as soon as possible if any of the following side effects occur: Rare Watery diarrhoea which may have blood in it, possible with stomach cramps and a high fever; pain and inflammation of the tendons; fits. Very Rare Burning, tingling, pain or numbness; loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine and abdominal pain, coma due to low blood sugar level. Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor is any of the following side effects continue or are bothersome: Common Nausea, diarrhoea, local irritation and pain at site of injection. Uncommon Itching, rash, loss of appetite, vomiting, stomach pain, indigestion, headache, dizziness, drowsiness, unable to sleep, a spinning feeling, general weakness. Rare Depressed, anxious, mental problems, restlessness, confused, unusual fast beating of your heart, low blood pressure, joint and muscle pain. Very rare including isolated cases Increased sensitivity of your skin to sun and UV light, lowering of blood sugar levels symptoms: sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat. (hypoglycaemia), high sugar (glucose) levels in the blood, problems with your hearing or eyesight or changes in the way things taste and smell, suicidal thoughts or actions, muscle weakness, liver and kidney problems, fever.

Store at or below 25 °C, in a dry place. Protect from light. Keep product in the outer carton until required. Once the single dose infusion vial has been opened, the infusion solution must be used within three hours, stored at 25 °C. Any unused infusion must be discarded. The infusion vial can be refrigerated at 2 °C to 8 °C. Do not use later than the date of expiry. KEEP OUT OF SIGHT AND REACH OF CHILDREN. Return all unused medicine to your pharmacist.