Tavaloxx Tablets

• TAVALOXX 250, 500 & 750 belong to a class of medicines called broad and medium spectrum antibiotics (antibacterial substances).

• TAVALOXX 250, 500 & 750 are used to treat bacterial infections caused by micro-organisms susceptible to levofloxacin (i.e. community acquired pneumonia, sinusitis, complicated/uncomplicated urinary tract infections, complicated skin and skin structure infections etc.).

• TAVALOXX 750 is used to treat hospital acquired pneumonia caused by micro-organisms susceptible to levofloxacin.

Do not take TAVALOXX:

• If you are a patient with known hypersensitivity to this medicine or any of its components.
• If you have epilepsy.
• If you have a history of tendon disorders related to fluoroquinolone administration.
• In children or adolescents.
• During pregnancy and lactation because animal studies have shown that levofloxacin may affect joint development in growing organisms.
• If you have kidney function impairment and are currently using medicine to lower your blood pressure, including angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, captopril) or renin-angiotensin blockers (e.g. valsartan, losartan).
• If you have mitral valve or aortic valve regurgitation (when your heart's mitral or aortic valve does not close tightly, causing blood to flow back into the heart instead of pumping out).

Take special care with TAVALOXX

Tell your doctor if you have any of the following as you may then require a lower dose or special precautions:

• Allergic reactions, which may include a skin rash, difficulty breathing, wheezing, hives, itching or swelling of the lips, tongue or whole body may occur with TAVALOXX, sometimes after the first dose. If you experience any of these symptoms during treatment, report to your doctor immediately. You may be required to stop the treatment.
• Porphyria.
• If you have ever had a fit (seizure).
• If you ever had a problem with your tendons such as tendonitis that was related to treatment with a quinolone antibiotic, such as TAVALOXX.
• If you have kidney problems.
• If you have heart problems or if you were born with or have a family history of prolonged QT-interval (seen on ECG, electrical recording of the heart), have a salt imbalance in the blood (especially low level of potassium or magnesium) have a history of heart attack, have a very slow heart rhythm, or are elderly, caution should be taken when taking quinolone antibiotics, such as TAVALOXX.
• If you have been diagnosed with mitral valve or aortic valve regurgitation (when your heart's mitral or aortic valve does not close tightly, causing blood to flow back into the heart instead of pumping out). Your doctor will perform a thorough examination of your heart, including an echocardiogram (see Do not take TAVALOXX).
• If you have a condition known as glucose-6-phosphate dehydrogenase deficiency.
• If you have been diagnosed with depression or any psychiatric disease, as you may develop psychiatric reactions even after the first dose of TAVALOXX. In some people such reactions have progressed to suicidal thoughts and self-endangering behaviour or suicide.
• If you have been diagnosed with myasthenia gravis. TAVALOXX may affect your blood sugar (glucose) levels (see POSSIBLE SIDE EFFECTS). It may increase or decrease your blood sugar levels and is more likely to affect people that have been diagnosed with diabetes mellitus and are taking oral antidiabetic medicine(s) or are using insulin. Very high or low blood glucose levels may result in coma and death. If you have been diagnosed with diabetes mellitus, you (in conjunction with your doctor) will have to monitor your blood glucose levels carefully while you are taking TAVALOXX. Report to your doctor if you develop excessive hunger or thirst, frequent urination, blurred vision, fatigue, sweating, shaking or trembling, or if you feel faint or dizzy. If you start having severe, bloody diarrhoea during or after treatment with TAVALOXX tell you doctor immediately. This could mean you have serious inflammation of your bowel which can sometimes occur after antibiotic treatment. TAVALOXX should be discontinued if you experience burning, tingling, pain or numbness. Urine tests may show “false-positive” results for strong painkillers called opiates in people taking TAVALOXX. If your doctor has prescribed a urine test, tell your doctor you are taking TAVALOXX.
• TAVALOXX may cause “false-positive” results for some tests used to test for the tuberculosis bacteria. Whilst taking TAVALOXX you are advised to stay out of strong sunlight and not to use a sun lamp as some patients may become more sensitive to light whilst taking TAVALOXX and get a sunburn-like reaction.
• Before you start taking TAVALOXX, tell your doctor if you are taking blood pressure lowering medicines called ACE inhibitors (such as enalapril, lisinopril, perindopril), or renin-angiotensin receptor blockers (such as losartan, valsartan) as taking TAVALOXX with these medicines may cause damage to your kidneys, especially if you have an existing kidney problem (see Do not take TAVALOXX). If your doctor has approved the use of these medicines with TAVALOXX your kidney function will be monitored before and during treatment.
• If you experience blurred vision or other problems with your eyesight, you should report to your doctor immediately. If you are taking TAVALOXX for a lengthy period it can lead to overgrowth of non-responsive organisms. Consult your doctor to ensure appropriate action is taken.

Do not share medicines prescribed for you with any other person. Always take TAVALOXX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Please consult your doctor before abruptly discontinuing TAVALOXX.

If you take more TAVALOXX than you should

In the event of an overdosage (if you take too many tablets), or if someone else has taken your medicine by mistake, you, or this other person, may experience confusion, dizziness, impairment of consciousness and convulsive seizures. General and supportive measures are recommended. In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take TAVALOXX

Take TAVALOXX as prescribed. If you miss a dose of this medicine, take it as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to compensate for the forgotten individual dose.

TAVALOXX can have side effects. As with any medicine, TAVALOXX may have unintended or undesirable effects. If any of the following happens, stop taking TAVALOXX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swallowing or breathing problems, hives, itching, skin rash, swelling of the lips, tongue or face, or any other symptom you think may be due to an allergic reaction. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TAVALOXX. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• Those that occur less frequently:
• Fits (seizures).
• Pain and inflammation in your tendons or ligaments, which could lead to rupture. The Achilles tendon is affected most often.
• Watery diarrhoea which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel infection.
• Pain, swelling or redness over a tendon (e.g. the Achilles tendon), torn tendon.
• Muscle weakness (especially in patients diagnosed with myasthenia gravis).
• Those that occur with unknown frequency:
• Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching or tender stomach. These may be signs of liver problems.
• Shortness of breath.
• Burning, tingling, pain and numbness. These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:
• Those that occur frequently:
• Sleeping problems.
• Headache, feeling dizzy.
• Nausea, vomiting and diarrhoea.
• Those that occur less frequently:
• Feeling stressed, feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling.
• Feeling depressed, abnormal dreams or nightmares, seeing or hearing things that are not there.
• Changes in the way things taste, loss of appetite, stomach upset or indigestion, pain in your stomach area, feeling bloated, or constipation.
• Sweating too much.
• Problems with your eyesight or hearing.
• Unusual fast beating of your heart, awareness of your heartbeat or low blood pressure, chest pain, fainting spells, light-headedness, fatigue or shortness of breath with or without exercise, or coughing when lying down, or swollen ankles.
• Muscle weakness.
• Lowering of your blood sugar levels especially if you are diabetic.
• Fungal infections and fungal infections resistant to usual treatment.
• Those that occur with unknown frequency:
• Pale or yellow skin, fever, sore throat and a general feeling of being unwell.
• Increase in your blood sugar levels, especially if you are diabetic.
• Risk of having suicidal thoughts or actions.
• Temporary loss of vision.
• Impairment or loss of hearing.
• Difficulty breathing or wheezing.
• Increased sensitivity of your skin to sun and ultraviolet light.

Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store below 25 °C. Protect from light. Keep the blister strips in the outer carton until required for use. Do not use after the expiry date stated on the packaging material. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems, for example toilets.