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TAVANIC 500 mg. film coated tablets Levofloxacin
COMPOSITION
Each tablet of TAVANIC 500 mg. contains 500 mg. levofloxacin as active substance.
The tablets also contain the following excipients: crospovidone, hypromellose, microcrystalline cellulose and sodium stearyl fumarate. The film coating contains hypromellose, titanium dioxide (E 171), talc, polyethylene glycol, yellow ferric oxide (E 172) and red ferric oxide (E 172).
PHARMACEUTICAL FORM AND CONTENTS OF PACKAGE
TAVANIC 500 mg. film coated tablets are reddish-yellow, oblong, with a score line.
The tablets are packed in blister strips, and are available in pack sizes of 10 and 5 tablets.
ACTIVITY
Levofloxacin, the active ingredient of TAVANIC 500 mg. tablets, is a synthetic antibacterial agent of the fluoroquinolone class (antibiotic) for oral administration.
INDICATIONS
This medication is used to treat infections due to bacteria against which the medicine is active. Some infections which the tablets can be used to treat are: infections of the sinuses, chest infections in patients with long standing breathing difficulties, pneumonia, urinary tract infections and skin infections.
CONTRAINDICATIONS
Do not take TAVANIC if you have ever had an allergic reaction to levofloxacin, any other quinolone antibiotic or to any of the other ingredients (which are listed above under point COMPOSITION). Otherwise you could have a similar reaction to TAVANIC.
Do not take the tablets if you suffer from epilepsy, otherwise, your risk of getting "fits" (convulsions) is increased.
Do not take TAVANIC if you have ever had tendon problems (for example, tendinitis) related to treatment with an antibiotic of the fluoroquinolone class. This is because there is a risk of getting similar problems with TAVANIC, including tendon rupture.
Do not take the tablets if you are pregnant or breastfeeding a baby. TAVANIC could harm your baby.
TAVANIC tablets are only intended for adults and must not be given to children or growing teenagers. They could harm the cartilage of their growing bones.
Tell your doctor if you have had any problems with taking medicines in the past.
PRECAUTIONS
The risk of getting "fits" may also 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 take these tablets if you suffer from epilepsy). Make sure your doctor knows about your medical history, so he / she can give you appropriate advice. Do not stay out in strong sunlight for unnecessarily long periods and do not use a sun lamp or solarium while you are taking TAVANIC. This is because some patients may become more sensitive to light whilst taking the tablets (sunburn-like reactions).
Tell your doctor immediately if you have severe, persistent and / or bloody diarrhoea during or after treatment with TAVANIC. This may be a sign of a serious bowel inflammation (pseudomembranous colitis) which can occur following treatment by antibiotics, and it may be necessary to stop treatment and start specific therapy. TAVANIC may in rare cases cause pain and inflammation in tendons (tendinitis), which frequently involves the Achilles tendon and may lead to tendon rupture, particularly in elderly patients or in patients taking corticosteroids (cortisone and similar medicines). If you experience any tendon complaints whilst or shortly after taking the tablets, seek medical advice immediately and rest the affected limb to avoid tendon damage. Do not take the next dose of TAVANIC unless your doctor tells you to, as it may be necessary to discontinue treatment (see also under CONTRAINDICATIONS).
Patients with some abnormalities of an enzyme called glucose-6-phosphate dehydrogenase (G6-PD) (a rare hereditary disease) may be prone to destruction of red blood cells (hemolysis) when treated with quinolone antibacterial agents, and so levofloxacin should be used with caution in these patients.
INTERACTIONS
Tell your doctor about all medicines you are taking including any that you bought without a prescription, as some of them could have an interaction with TAVANIC. Furthermore, do not take any new medicine without consulting your doctor.
When taking TAVANIC with medicines used to treat anaemia (iron salts), medicines against heartburn and stomach pain (magnesium or aluminium containing antacids) or medicines for protecting the stomach wall (sucralfate), the efficacy of TAVANIC may be reduced (see also under INSTRUCTIONS FOR USE).
With other medicines the risk of getting "fits" may be increased (with fenbufen or similar medicines against rheumatic pain and inflammation, or with medications used to treat respiratory problems like theophylline).
Vitamin K antagonists
Increased coagulation tests (PT/INR) and / or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists.
WARNING
Pregnancy and lactation: You should not take TAVANIC if you are pregnant or breastfeeding a baby. TAVANIC could harm your baby.
Use in children: TAVANIC must not be given to children or growing teenagers. It could harm the cartilage of their growing bones.
Use in the elderly: TAVANIC may cause pain and inflammation in tendons.
Effects on the ability to drive and use machinery: Some side effects like dizziness, drowsiness, visual disturbances (see also under SIDE EFFECTS) may impair your ability to concentrate and react. Do not drive, operate dangerous machinery or carry out similar activities if you feel that your ability to concentrate and react is impaired.
Patients with reduced kidney activity (renal insufficiency): may need lower doses than patients with normal kidney activity.
POSOLOGY
Your doctor will tell you how many TAVANIC tablets to take, at what time and for how long (but not longer than 14 days).
Most people need a dose of one or two tablets per day.
Patients with reduced kidney activity (renal insufficiency) may need lower doses than patients with normal kidney activity.
Duration of treatment
The duration of treatment depends on the type and severity of your infection. It is important to finish your course of tablets as prescribed by your doctor. Do not stop, even if you begin to feel better before you have finished them all. If you stop the tablets too soon your condition may get worse. If you feel you have to stop because of a side effect, tell a doctor immediately to get advice before taking the next dose.
INSTRUCTIONS FOR CORRECT ADMINISTRATION
TAVANIC may be taken during meals or at any time between meals. The tablets should be swallowed, without chewing, with a glass of water. If you take medicines against heartburn and stomach pain (magnesium or aluminium containing antacids), medicines for protecting the stomach wall (sucralfate) or medicines used to treat anaemia (iron salts), do not take them at the same time as TAVANIC. Take these medicines at least 2 hours before or after TAVANIC. Otherwise, they may reduce the absorption and efficacy of TAVANIC.
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not double-up on the next dose to make up for the one missed.
OVERDOSE
If you accidentally take one tablet too many, nothing is likely to happen.
If you accidentally take several tablets too many, contact your doctor or pharmacist. If possible, take your tablets or the box with you to show the doctor. The consequences of an overdose include central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and (convulsive) fits. In the event of overdose treatment is according to symptoms. Levofloxacin is not removed from the body by dialysis. No specific antidote exists.
SIDE EFFECTS
General allergic reactions, skin reactions
Uncommon: itching and skin rash.
Rare: general allergic reactions (anaphylactic / anaphylactoid reactions) (which may sometimes occur even after the first dose and which may develop fast within minutes or hours of intake) with symptoms such as wheals (urticaria), cramping of the bronchi and possibly severe breathing problems, as well as in very are cases swelling of the skin and mucous membranes (for example, in the face and throat).
Very rare: sudden drop in blood pressure or collapse (shock). Such general allergic reactions may sometimes be preceded by, for example, mild skin reactions.
Increased sensitivity of the skin to sun and ultraviolet light may also occur.
Isolated cases: severe blistering reactions of the skin and mucous membranes (Steven's Johnson syndrome), toxic epidermal necrolysis (Lyells' syndrome) and erythema exsudativum multiforme.
Gastrointestinal, metabolism
Common: nausea, diarrhoea.
Uncommon: loss of appetite, stomach upset (dyspepsia), vomiting or pain in the abdominal region.
Rare: bloody diarrhoea which in very rare cases may be indicative of enterocolitis (inflammation of the bowel), including pseudomembranous colitis.
Very rare: decrease in blood sugar to a too low level (hypoglycaemia) which may be of special importance in patients treated for diabetes.
Some medicines of this class may trigger attacks of porphyria in patients with porphyria (a very rare metabolic disease). This might therefore also occur with TAVANIC.
Nervous system
Uncommon: headache, dizziness, drowsiness, sleeping problems.
Rare: feeling like tingling, for example in the hands (paraesthesia), trembling, restlessness (agitation), anxiety, depression, psychotic reactions, "fits" (convulsions) and confusion may be experienced.
Very rare: vision and hearing disorders, disturbances of taste and smell, numbness, psychiatric problems including hallucinations and depressive mood changes. Disorders of movement, including walking difficulties may also be experienced.
Cardiovascular system
Rare: abnormally rapid beating of the heart, abnormally low blood pressure.
Very rare: circulatory collapse (anaphylactic like shock).
Muscles, tendon, bones
Rare: tendon pain and inflammation including tendinitis (for example, Achilles tendon), joint pain or muscle pain.
Very rare: tendon rupture (for example, Achilles tendon). As with other fluoroquinolones, this side effect may occur within 48 hours after starting treatment and may be bilateral. Muscular weakness, which may be of special importance in patients with myasthenia gravis (a rare disease of the nervous system).
Isolated cases: muscle reactions with muscle cell damage (rhabdomyolysis).
Blood
Uncommon: increase or decrease in the number of white blood cells.
Rare: decrease in the number of blood platelets leading to a tendency to bruise and bleed easily.
Very rare: severe decrease in the number of white blood cells (agranulocytosis) leading to symptoms such as recurrence or persistence of fever, sore throat and feeling more ill again.
Isolated cases: decrease in red blood cells (anaemia) due to blood cell damage; decrease in the number of all types of blood cells.
Liver, kidney
Common: increase in blood levels of liver enzymes.
Uncommon: blood test abnormalities due to liver or kidney problems.
Very rare: inflammation of the liver. Disturbances of kidney function and occasional kidney failure which may be due to allergic kidney reactions (interstitial nephritis).
Other reactions
Uncommon: general weakness.
Very rare: fever, allergic inflammation of small blood vessels or allergic lung reactions.
Any antibacterial treatment that kills certain germs may lead to a disturbance of the microorganisms (bacteria / fungi) that are normally found in humans. Consequently, the number of other bacteria or fungi may increase, which in rare cases requires treatment.
Tell your doctor or pharmacist if you experience any of these side effects. If you experience any other adverse reaction not mentioned above, consult your doctor or pharmacist. As with all medicines, to prevent serious reactions contact a doctor immediately when you experience a severe side effect or a side effect with sudden onset or fast progression.
STORAGE
No special precautions are required but it is best to keep TAVANIC tablets in the original strips and box in a dry place.
EXPIRY
Do not use this medicine after the expiry date shown on the packaging. If the tablets go out of date, take them to your pharmacist so that he / she can get rid of them safely.
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