Levofloxacin 500 mg. 7 tablets
Levofloxacin Accord contains an active substance called levofloxacin. Levofloxacin is an antibiotic which is used for the treatment of bacterial infections of:
lungs as pneumonia;
kidney and urinary tract;
skin and soft tissues (including fat and muscle).
2. BEFORE YOU TAKE levofloxacin ACCORD
Do not take Levofloxacin Accord if:
you are allergic (hypersensitive) to levofloxacin or any of the other ingredients in the tablets (see section 6) or are allergic to antibiotic drugs such as ciprofloxacin or ofloxacin;
before you received levofloxacin or similar medicine and have had problems with joints (eg. tendonitis);
you are a child or adolescent in the growth period (18 years);
you are pregnant, trying to become pregnant or breast-feeding.
Take special care with Levofloxacin Accord:
Before taking your medicine, tell your doctor if:
previously you had epilepsy or brain damage in the past (such as stroke), as it may increase the chances of having seizures (fits). Make sure you tell your doctor your entire medical history;
have rarely or inherited disease that affects the glucose-6-phosphate dehydrogenase (G-6-PD) as it is more likely to have problems with blood if you are given levofloxacin;
have kidney disease / damage, as your doctor may want to give you a lower dose of levofloxacin;
taking drugs to stop blood clotting (such as warfarin) because your doctor will want to monitor how well your blood is clotting while taking and levofloxacin;
you are diabetic and receive concomitant treatment with oral hypoglycemic agent;
have a history of mental illness;
You have heart problems, should be given caution when using this kind of medicine if you are born with or have a family history of prolonged QT-interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low of potassium or magnesium in the blood), you have a very slow heartbeat (called bradycardia) have a weak heart (heart failure) have a history of heart attack (myocardial infarction), if you are a woman or if you are elderly or are taking other medicines which lead to abnormal ECG changes (see Taking other medicines).
Levofloxacin may rarely cause pain and inflammation of tendons. Especially if you are elderly or are taking steroid medications (such as cortisone or hydrocortisone). If you have any problems with the tendon during or shortly after the adoption of levofloxacin, seek medical advice immediately and rest the affected limb (arm or leg). Do not take your next dose levofloxacin unless your doctor tells you. In such cases as these, you have swelling or pain in the affected tendon. You may need to stop treatment;
If you start experiencing severe, persistent and / or bloody diarrhea during or after treatment with levofloxacin, tell your doctor immediately. This may mean that you have a serious bowel inflammation (pseudomembranous colitis) that can sometimes occur after antibiotic treatment. You may need to stop taking levofloxacin and your doctor may give you another medicine;
While taking Levofloxacin Accord, we advise you to beware of strong sunlight and do not use a quartz lamp. This is because some patients may be more sensitive to light while taking the tablets and get a reaction similar to sunburn;
Levofloxacin should be discontinued if the patient has symptoms of burning, tingling, pain or numbness. These may be symptoms of a condition called "neuropathy";
Levofloxacin is the optimal therapy for the most severe cases of pneumococcal pneumonia;
During treatment, infections resulting from hospital for P.aeruginosa, may require combination therapy;
Levofloxacin is effective against infections caused by methicillin-resistant Staphylococcus aureus. Upon suspicion of infections caused by methicillin-resistant Staphylococcus aureus, levofloxacin is to be combined with a drug approved for the treatment of infections caused by methicillin-resistant Staphylococcus aureus.
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines, especially:
sucralfate or drugs containing iron salts, magnesium or aluminum, since they can interfere with the absorption of levofloxacin and should not be taken at the same time. You should take sucralfate two hours after levofloxacin and medicines containing iron, aluminum or magnesium or two hours before or two hours after levofloxacin;
nonsteroidal anti-inflammatory drugs (such as fenbufen, ibuprofen, or naproxen, which are frequently used for pain relief or treatment of joint problems);
theophylline because the risk of seizures (convulsions) may be increased;
probenecid and cimetidine may reduce the ability of the kidneys to get rid of levofloxacin from the body;
cyclosporine may prolong the effect of levofloxacin;
Vitamin K antagonists (such as warfarin) - are more likely to have bleeding. You may need your doctor to order regular blood tests to check how well can your blood clots;
You should tell your doctor if you take other medicines that can change your heart rhythm, medications that belong to the group of antiarrhythmics (eg. Quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobial substances (belonging to the macrolide), some antipsychotics.
Urine testing for opiates
Urine tests can show "false positive" results on strong painkillers called opioids in people taking Levofloxacin Accord. If you need your doctor to test your urine, tell that you are taking Levofloxacin Accord.
Taking Levofloxacin Accord with food and drink
Take the tablets without regard to food. Take the tablets with water. The adoption of this product with orange juice, may result in a reduction in plasma levels of quinolone.
Pregnancy and lactation
You should not take Levofloxacin Accord if you are pregnant, trying to become pregnant or breast-feeding.
Driving and using machines
Levofloxacin may cause dizziness, drowsiness, vision problems and confusion. If you are affected, do not drive, operate machinery or perform any activity that carries a potential hazard.
3. HOW TO TAKE levofloxacin ACCORD
Always take Levofloxacin Accord exactly as you have been told by your doctor. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets with a glass of water. The tablets can be taken with or without food.
Most individuals require 1 or 2 tablets per day.
Patients with kidney disease may require lower doses.
How long will take Levofloxacin Accord depends on what infection you have and how severe.
If you take more dose Levofloxacin Accord
If you accidentally take one tablet too many, nothing will happen. If you accidentally take a few more tablets, contact your doctor immediately or go to the nearest emergency unit. If possible, take your tablets or the box to show them to your doctor. If you take too many tablets, you may develop confusion, dizziness, loss of consciousness, seizures (convulsions) and cardiac disorders (irregular heart rhythm).
If you miss a dose of Levofloxacin Accord
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Levofloxacin Accord
It is important to take the full course of tablets. Do not stop until you have finished all the tablets even if you begin to feel better. If you stop taking the tablets too soon, the infection may return or get worse. If you feel that you must stop taking the tablets because of side effects, talk with your doctor before your next dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Accord Levofloxacin can cause side effects, although not everybody gets them.
If you experience any of the following rare side effects, contact your doctor.
Sudden wheezing, difficulty breathing or dizziness;
Swelling of eyelids, face, lips, tongue, or throat;
Peeling and blistering of the skin, mouth, eyes and genitals;
Rash that affects the whole body;
Bloody diarrhea (which may be a sign of a more serious illness, pseudomembranous colitis - see section 2);
Pain and swelling in the tendons (tendinitis).
Tell your doctor if you notice any of these side effects gets serious, or if you notice any side effects not listed.
Common (affects more than 1 to 10 users in 100):
increase blood levels of liver enzymes (which shall be established by blood tests);
Uncommon (affects 1 to 10 of 1000):
loss of appetite, vomiting;
growth of other bacteria and fungi, which are not destroyed by levofloxacin;
stomach pain, upset stomach;
drowsiness or sleep problems;
increase or decrease the number of white blood cells;
changes in blood tests due to damage to the liver or kidneys.
Rare (affects 1 to 10 users in 10,000):
mental problems such as hallucinations (seeing or hearing things that are not there) and / or delusions (unshakeable belief in something that is not true);
decrease the number of white blood cells;
itchy skin rash;
numbness in hands and feet;
muscle pain, joint pain;
tendency to easy bruising and bleeding due to low platelet count.
Very rare (affects less than 1 user in 10,000) and not known (frequency can not be estimated from available data):
sudden drop in blood pressure or collapse (shock);
low blood sugar (particularly in patients with diabetes);
rupture of tendons;
significant decrease in white blood cells, leading to symptoms such as fever, sore throat and again degraded state;
hepatitis (inflammation of liver);
severe renal dysfunction (including renal failure);
Abnormal rapid heartbeat, life-threatening irregular heartbeat, changes in heart rhythm (called prolongation of QT-interval seen on ECG, abnormal electrical activity of the heart);
increased skin sensitivity to light;
severe cases, blistering or destructive effects on the skin and mucous membranes (lining of the mouth or gut);
visual and hearing disorders;
changes in the sensations of taste and smell;
hallucinations (seeing or hearing things that are not there);
destruction of muscles;
decrease in red blood cells (anemia), or reducing the number of all types of blood cells;
allergic pulmonary responses.
Reported some adverse reactions that occur at like levofloxacin antibiotics. These include:
allergic inflammation of small blood vessels;
porfirichni attacks (in patients with porphyria).
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Levofloxacin Accord
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use Levofloxacin Accord after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Levofloxacin Tablets contain Accord
Each 250 mg tablet contains as active ingredient Levofloxacin, equivalent to 256.23 mg of levofloxacin hemihydrate.
Each tablet contains 500 mg Levofloxacin as an active substance, equivalent to 512.46 mg of levofloxacin hemihydrate.
Other ingredients are:
Core: povidone, crospovidone (Type B), cellulose, microcrystalline, magnesium stearate, silica colloidal anhydrous.
Tablet coating: hypromellose E5, talc, titanium dioxide (E171), macrogol 400, iron oxide red (E172) and iron oxide yellow (E172).
Levofloxacin Accord looks like and contents of the pack
Tablets 250 mg:
Pink, capsule-shaped, biconvex film-coated tablets, scored on both sides. Debossed "L" and "F" on both sides of the score on one side.
The tablets can be divided into two equal halves.
Tablets 500 mg:
Pink, capsule-shaped, biconvex film-coated tablets, scored on both sides. Debossed "L" and "V" on either side of the score on one side.
The tablets can be divided into two equal halves.
The tablets are packed in PVC / aluminum blisters.