Levofloxacin 500 mg. 5 tablets
The name of your medicine is Levofloxacin Teva 500 mg film-coated tablets. These tablets contain a medicine called levofloxacin. It belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic. It works by killing bacteria that cause infections in your body.
Levofloxacin Teva 500 mg film-coated tablets can be used in adults to treat infections of:
Lungs, in people with long-term breathing problems or pneumonia;
Urinary system, including kidney or bladder;
Prostate gland, in the case of long-term infection;
Skin and underlying tissues, including muscle. This is sometimes called "soft tissue".
2. BEFORE YOU TAKE TEVA levofloxacin 500 mg tablets
Do not take Levofloxacin Teva 500 mg film-coated tablets:
If you are allergic to levofloxacin or other quinolone antibiotics (such as moxifloxacin, ciprofloxacin or ofloxacin) or any of the other ingredients of Levofloxacin Teva 500 mg (listed in section 6 below);
If you have ever had epilepsy;
If you've ever had a problem with your tendons associated with the use of "quinolone antibiotics";
If you are pregnant or breast-feeding.
Children and adolescents under 18 years of age should not take levofloxacin.
Do not take this medicine if any of the above applies to you. If you are unsure, talk to your doctor or pharmacist before you start taking Levofloxacin Teva 500 mg film-coated tablets.
Take special care with Levofloxacin Teva 500 mg film-coated tablets
Consult your doctor or pharmacist before taking this medicine if:
You are aged 65 or older;
Using corticosteroids, sometimes called steroids (see "Taking other medicines" below);
You have ever had seizures (convulsions);
Have brain damage due to stroke or other brain injury;
Have kidney problems;
You have glucose-6-phosphate dehydrogenase (a rare hereditary disease);
Ever had mental problems;
You have ever had heart problems;
You have ever had liver problems.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you start taking Levofloxacin Teva 500 mg film-coated tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal. This is required since levofloxacin can change the way some other medicines work. In addition, some drugs can change the modus operandi of Levofloxacin Teva.
It is particularly important to tell your doctor if you are taking any of these drugs. It is because they may increase the likelihood get side effects when taking levofloxacin tablets:
Corticosteroids, sometimes called steroids - used for inflammation. More likely to have inflammation and / or breakage of your tendons;
Warfarin - used to thin the blood. More likely to receive bleeding. You may need your doctor to conduct regular tests to check how your blood clots;
Theophylline - used for breathing problems. More likely to have seizures (convulsions) if you take it with levofloxacin tablets;
Non-steroidal anti-inflammatory drugs (NSAIDs) - used to treat pain and inflammation, eg. aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. Increase your chances of getting fits (convulsions) if you take them with levofloxacin tablets;
Cyclosporin - used after organ transplantation. More likely to get side effects of cyclosporine;
Drugs that affect heart rhythm. These drugs are used for irregular heart rhythm (antiarrhythmics such as quinidine and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine) and for bacterial infections ( 'macrolide' antibiotics such as erythromycin, azithromycin and clarithromycin);
Probenecid - used for gout and cimetidine - used for ulcers and heartburn. When you are taking any of these medicines together with levofloxacin tablets, special attention is required. If you have kidney problems, your doctor may prescribe a lower dose.
Do not take Levofloxacin Teva 500 mg tablets at the same time with the following medicines as they may alter the modus operandi of Levofloxacin Teva:
Tablets containing iron (for anemia), magnesium or aluminum-containing antacids (for acids) or sucralfate (for ulcers of the stomach). See section 3 "If you take iron-containing tablets, antacids or sucralfate" below.
Urine tests for opiates
Urine tests may show 'false positive' results for strong painkillers called 'opiates' in people taking levofloxacin tablets. If you need your doctor to test your urine, tell him that you are taking levofloxacin.
Pregnancy and lactation
Do not take this medicine if:
You are pregnant, may become pregnant or think you are pregnant;
If you are breastfeeding or you are breast-feeding. Ask your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.
Ask your doctor or pharmacist before taking any medicine.
Driving or operating machinery
After taking this medication may experience side effects include dizziness, sleepiness, dizziness or vision changes. Some of these side effects may change your ability to concentrate and speed of reaction. If this happens, do not drive or perform any activities that require a high level of attention.
3. HOW TO TAKE TEVA levofloxacin 500 mg tablets
Always take Levofloxacin Teva 500 mg film-coated tablets, just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Taking this medicine
Take this medicine by mouth.
Swallow the tablets whole with water.
The tablets can be taken during meals or between meals.
Protecting skin from sunlight
Beware of direct sunlight while taking this medicine. This is because your skin can become more sensitive to the sun and can burn to get large blisters or irritation if you do not follow these precautions:
Use sunscreen with a high factor.
Always wear a hat and clothes that cover arms and legs.
If you are already taking iron-containing tablets, antacids or sucralfate
Do not take these medications at the same time with levofloxacin tablets. Take the dose of these medicines at least 2 hours before or after you take levofloxacin tablets.
How much to take
Your doctor will decide the dose of levofloxacin should be taking.
The dose depends on the type of infection and where in your body's infection.
The duration of treatment will depend on the severity of the infection.
If you think the effect of this medicine is too weak or too strong do not change the dose on your own judgment and consult your doctor.
Adults and elderly patients
One tablet levofloxacin 500 mg once a day, every day.
Lungs, in people with prolonged breathing problems:
1/2 or one tablet levofloxacin 500 mg once a day, every day.
One tablet 500 mg levofloxacin once or twice a day, every day.
Excretory system, including kidneys or bladder:
1/2 tablet levofloxacin 500 mg each day.
One tablet levofloxacin 500 mg once a day, every day.
Skin and underlying tissues, including muscles:
1/2 or one tablet levofloxacin 500 mg once or twice a day, every day.
Adults with kidney problems:
Your doctor can prescribe a lower dose.
Children and adolescents
This drug should not be given to children and adolescents.
If you take a large dose of Levofloxacin Teva 500 mg film-coated tablets required
If you accidentally take a larger amount of your medicine, tell your doctor or get other medical advice immediately. Take the medicine pack with you. This is necessary so the doctor knows what you have taken. It may experience the following effects: seizures (convulsions), confusion, dizziness, impaired consciousness and heart problems leading to irregular heartbeats and nausea.
If you forget to take Levofloxacin Teva 500 mg film-coated tablets
If you forget to take a dose, take it as soon as you remember unless it is nearly time for the next. Do not take a double dose to make up for a missed dose.
If you stop taking Levofloxacin Teva 500 mg film-coated tablets
Do not stop taking Levofloxacin Teva 500 mg film-coated tablets just because you feel better. It is important to complete the course of treatment with tablets that your doctor has prescribed. If you stop taking the tablets too soon, the infection is likely to recur, worsen your condition or the bacteria may become resistant to the drug.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, levofloxacin can cause side effects, although not everybody gets them. These reactions are usually mild to moderate and often disappear after a short period of time.
Stop taking Levofloxacin Teva 500 mg film-coated tablets and call your doctor or go to the hospital immediately if you notice any of the following:
Very rare (affects less than 1 in 10,000 users):
If you have an allergic reaction. The signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
Stop taking Levofloxacin Teva 500 mg film-coated tablets and call your doctor or go to the hospital immediately if you notice any of the following serious side effects - you may need urgent medical treatment:
Rare (affects less than 1 in 1000 users):
Watery diarrhea which may have blood, possibly accompanied by stomach cramps and fever. This may be a sign of severe bowel problem;
Pain and inflammation of tendons. Achilles tendon prejudice in most cases and in some cases may occur tendon rupture;
Very rare (affects less than 1 in 10,000 users):
Burning, stinging, pain or numbness in the extremities. These are signs of the so-called. "Neuropathy"
Severe skin rashes that can occur with blistering or peeling of the skin around the lips, eyes, mouth, nose or genitals;
Loss of appetite, skin and eyes turn yellow, dark colored urine, itching or tender stomach (abdomen). These may be signs of liver problems.
Tell your doctor if any of these side effects become severe or last longer than a few days:
Common (affects less than 1 user in 10) are:
Feeling sick (nausea) and diarrhea;
Increasing the level of certain liver enzymes in the blood.
Uncommon (affects less than 1 in 100 users) are:
Itching, skin rash;
Loss of appetite, upset stomach and indigestion (dyspepsia), being sick (vomiting) or pain in the stomach area, bloating or constipation;
Headache, dizziness, drowsiness, trouble sleeping or nervous tension;
Blood tests may show unusual results due to problems with the kidneys or liver;
Changes in the number of white blood cells that are found in some blood tests;
Changes in the numbers of other bacteria or fungi increased, which may require treatment.
Rare (affects less than 1 in 1000 users) are:
Tingling sensation of hands and feet (paresthesia) or trembling;
Feeling of anxiety, depression, mental health problems, agitation or confusion;
Unusually fast heartbeat or low blood pressure;
Pain in joints or muscles;
Easy bruising or bleeding due to low platelet count (platelets);
Low white blood cells (called neutropenia);
Difficulty breathing or wheezing (bronchospasm);
Shortness of breath (dyspnoea);
Intense itching or rash (also called urticaria).
Very rare (affects less than 1 in 10 000 users) are:
Increased skin sensitivity to sunlight and ultraviolet light;
Decreased levels of blood sugar (hypoglycemia). It is important for people with diabetes;
Problems with hearing or vision or change in taste and smell;
You see or hear things that are not there (hallucinations), change in opinion or thoughts (psychotic reactions) and likelihood of suicidal thoughts or actions;
Loss of circulation (similar to anaphylactic shock);
Muscle weakness. This is important for people with myasthenia gravis (a rare disease of the nervous system);
Inflammation of the liver, changes in kidney function and in some instances, renal failure, which may be due to an allergic reaction of the kidney called interstitial nephritis;
Fever, sore throat and general malaise. This condition may be due to low white blood cell counts;
Fever and allergic pulmonary reaction.
Other side effects include:
Reduced number of red blood cells (anemia). This may result in white or yellowish leather, as a result of damage to red blood cells and decrease the number of all types of blood cells;
Enhanced immune response (hypersensitivity);
Profuse sweating (hyperhidrosis);
Pain including back pain, chest and limbs;
Problems with movement and walking;
Attacks of porphyria in people who suffer from porphyria (a very rare metabolic disease);
Blood vessel inflammation due to an allergic response (allergic vasculitis).
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 TEVA levofloxacin 500 mg tablets
Keep out of reach of children.
Do not use Levofloxacin Teva 500 mg film-coated tablets after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of in 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 Teva 500 mg film-coated tablets
The active substance is levofloksatsinov hemihydrate, which corresponds to 500 mg of levofloxacin.
Other ingredients are:
Core: silica (colloidal anhydrous), hydroxypropylcellulose, sodium starch glycolate, talc, croscarmellose sodium, magnesium stearate.
Film coat: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate, iron oxide red (E172).
Additional 500 mg tablets contain black and yellow iron oxide (E172).