250 mg and 500 mg film-coated tablets
levofloxacin
What Levofloxacin Krka is and what it is used for
The name of your medicine is Levofloxacin Krka. Levofloxacin Krka contains a substance called levofloxacin. Levofloxacin belongs to a group of medicines called antibiotics . Levofloxacin is a “quinolone”. It works by killing the bacteria that caused the infection in your body.
Levofloxacin Krka can be used to treat infection you in :
- The sinuses of the nose
- The lungs, in people with long-term breathing problems or pneumonia
- The urinary tract, including the kidneys and bladder
- The prostate gland, when you have had a long-term infection
- Skin and inside the skin, including muscles. These are sometimes called “soft parts”.
In some special situations, Levofloxacin Krka may be given to reduce the risk of getting a lung disease called anthrax or an exacerbation of this disease, after you have been exposed to the bacterium that causes anthrax.
Levofloxacin contained in Levofloxacin Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Levofloxacin Krka
Do not take this medicine and tell your doctor about:
- you are allergic to levofloxacin or any other quinolone such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6).
- Signs of an allergic reaction include rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
- you have ever had epilepsy
- you have ever had problems with your tendons such as tendonitis associated with treatment with a quinolone . The tendon is the string that connects the muscle to your skeleton.
- you are a child or a growing teenager
- you are pregnant, may become pregnant or think you may be pregnant
- you breastfeed
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin Krka.
Warnings and cautions
Talk to your doctor or pharmacist before taking Levofloxacin Krka if:
- you are 60 years or older
- you use corticosteroids , sometimes called steroids (see section “Other medicines and Levofloxacin Krka”)
- you have ever had a seizure (seizures)
- you have had a brain injury due to a stroke or other brain injury
- you have kidney problems
- You have something known as glucose -6-phosphate dehydrogenase deficiency. If you are taking this medicine, you are more likely to have serious blood problems.
- you have ever had mental health problems
- you have ever had heart problems: caution should be exercised when taking this medicine if you have a congenital or family history of prolonged QT interval (seen on ECG , electrical recording of the heart), have an imbalance in the salts in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rhythm (called “bradycardia”), have a weak heart ( heart failure ), previous heart attack ( myocardial infarction ), you are a woman or elderly or taking other drugs that cause abnormal ECG changes (see section “Other medicines and Levofloxacin Krka”).
- you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel).
- you have had an aortic dissection (a rupture in the aortic wall).
- you have been diagnosed with leaky heart valves.
- someone in your family has or has had an aortic aneurysm, aortic dissection or congenital heart valve disease, or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan’s syndrome, Ehlers-Danlos’ syndrome , Turner’s syndrome , Sjögren’s syndrome (an inflammatory autoimmune disease) or vascular diseases such as Takayasus arteritis, giant cell arteritis, Behçet’s disease, high blood pressure , or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (an infection of the heart)).
- you have diabetes
- you have ever had liver problems
- you have myasthenia gravis
- you have ever developed severe rash or scaly skin, blisters and / or sores in your mouth after taking levofloxacin.
Before taking this medicine
You should not take antibacterial fluoroquinolone / quinolone drugs, including Levofloxacin Krka, if you have ever had a serious side effect associated with that you’ve taken any quinolone or fluorokinolonläkemedel. If this is the case, contact your doctor as soon as possible.
When you take this medicine
If you experience a sudden, severe pain in the abdomen, chest or back, you should immediately visit an emergency room as this may be a symptom of aortic aneurysm and aortic dissection. The risk of developing this may be increased if you are being treated with systemic corticosteroids (“cortisone”).
If you experience sudden shortness of breath, especially when you lie down in bed, or notice swelling in your ankles, feet or stomach, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately.
In rare cases, joint pain and swelling and inflammation or tendon rupture may occur. The risk is greater if you are older (over 60 years), have undergone an organ transplant, have kidney problems or if you are being treated with cortisone ( corticosteroids ). Inflammation and tendon rupture can occur within the first 48 hours after starting treatment but also up to several months after treatment with Levofloxacin Krka has ended. At the first sign of pain or inflammationin a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Krka, consult a doctor and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
In rare cases, you may experience symptoms of nerve damage ( neuropathy ) such as pain, a burning sensation, tingling, numbness and / or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Levofloxacin Krka and contact your doctor immediately to prevent the development of a possible permanent condition.
Long-term, debilitating and potentially lasting serious side effect s
Antibacterial fluoroquinolone / quinolone drugs, including Levofloxacin Krka have been linked to very rare but serious side effects . Some of these have been long-lasting (up to months or years), disabling and possibly permanent. This includes pain in the tendons, muscles and joints of the arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disorders in the form of impaired vision, taste, smell and hearing, depression, memory loss, extreme fatigue and severe sleep disorders.
If you get any of these side effects after taking Levofloxacin Krka, talk to a doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic .
Severe skin reactions
Severe skin reactions including Stevens Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with levofloxacin.
- Stevens Johnson syndrome and toxic epidermal necrolysis may first appear as red, target-like spots or round spots, often with blisters in the center, on the torso. In addition, sores in the mouth, throat, nose, genitals and eyes (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and / or flu-like symptoms . The rash can develop into widespread skin peeling and life-threatening complications or can be life-threatening.
- DRESS first appears as flu-like symptoms and rashes on the face and then widespread rashes with high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes .
If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and consult a doctor or seek medical attention immediately.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Levofloxacin Krka.
Urine tests for opiates
Urine tests can give “false positive” results for strong painkillers, so-called “opiates”, in people taking Levofloxacin Krka. If your doctor has prescribed a urine test, tell your doctor that you are taking Levofloxacin Krka.
Tuberculosis tests
This medicine may give “false negative” results to some laboratory tests, which look for the bacterium that causes tuberculosis .
Children and young people
This medicine should not be given to children or teenagers.
Other medicines and Levofloxacin Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is due to that Levofloxacin Krka may affect the way some other medicines work and some medicines may affect how Levofloxacin Krka works.
In particular, tell your doctor if you are taking any of the following medicines. This is important because it may increase the risk of side effects when taking Levofloxacin Krka:
- Corticosteroids , sometimes called steroids – are used for inflammation . You are more likely to get inflammation and / or a rupture in your tendons.
- Warfarin – used to thin the blood. You are more likely to bleed. Your doctor may need to take regular blood tests to check how well your blood can coagulate.
- Theophylline – used for breathing problems. You are more likely to have seizures (seizures) if this is taken with Levofloxacin Krka.
- Non-steroidal anti-inflammatory drugs ( NSAIDs ) – used for pain and inflammation , such as acetylsalicylic acid , ibuprofen , fenbufen, ketoprofen and indomethacin. You are more likely to have seizures (seizures) if they are taken with Levofloxacin Krka.
- Ciclosporin – used after organ transplantation. You are more likely to get side effects from cyclosporine.
- Drugs that are known to affect how your heart beats. These include drugs used to abnormal heart rhythm ( antiarrhythmics such as quinidine , hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone ), in depression ( tricyclic antidepressants such as amitriptyline and imipramine), for mental disorders (antipsychotics), and the bacterial infection s ( antibiotics – “macrolides” such as erythromycin, azithromycin and clarithromycin)
- Probenecid – used for gout , and cimetidine – used for stomach ulcers and heartburn. Particular caution should be exercised when taking any of these medicines with Levofloxacin Krka. If you have kidney problems, your doctor may want to give you a lower dose .
Do not take Levofloxacin Krka tablets with the following medicines, as they may affect the way Levofloxacin Krka tablets work.
- Iron tablets (for anemia ), zinc supplements, antacids containing magnesium or aluminum (for hydrochloric acid or heartburn), didanosine or sucralfate (for stomach ulcers ). See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate” below.
Pregnancy, breastfeeding and fertility
Do not take this medicine if:
- you are pregnant, may become pregnant or think you may be pregnant
- you are breastfeeding or planning to breastfeed
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may experience side effects after taking this medicine such as dizziness, drowsiness, vertigo or visual disturbances. Some of these side effects may affect your ability to concentrate and your reaction rate. If this happens, do not drive motor vehicles or perform work that requires sharp attention.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Levofloxacin Krka contains para-orange
May cause allergic reactions.
How to use Levofloxacin Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Take this medicine
- Take this medicine by mouth
- Swallow the tablets whole with water
- The tablets can be taken with a meal or at any time between meals
- The tablets can be divided into two equal doses .
Protect your skin from sunlight
Avoid direct sunlight while taking this medicine and 2 days after you stop taking it. Your skin will be much more sensitive to the sun and may get burned, sting or get blisters, if you do not take the following measures:
- Make sure you use a sunscreen with a high sun protection factor
- Always wear a hat and clothing that covers your arms and legs
- Avoid solarium.
If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate
- Do not take these medicines with Levofloxacin Krka. Take dose of these drugs for at least 2 hours before or after Levofloxacin Krka tablets.
How much to take
- Your doctor will decide how many Levofloxacin Krka tablets to take
- Dose one will depend on what kind of infection you have and what infection one is in your body
- The duration of treatment will depend on the severity of infection one is
- If you have the impression that the effect of this medicine is too weak or too strong, do not change the dose yourself, but consult your doctor.
Adults and the elderly
Infection of the sinuses of the nose
- Two tablets Levofloxacin Krka 250 mg once daily
- or, one tablet of Levofloxacin Krka 500 mg once daily
Lung infections in people with long-term respiratory problems
- Two tablets Levofloxacin Krka 250 mg once daily
- or, one tablet of Levofloxacin Krka 500 mg once daily
Pneumonia
- Two tablets Levofloxacin Krka 250 mg once or twice daily
- or, one tablet of Levofloxacin Krka 500 mg once or twice daily
Urinary tract infection including your kidneys or bladder
- One or two tablets Levofloxacin Krka 250 mg once daily
- or, 1/2 or one tablet Levofloxacin Krka 500 mg once daily
Infection of the prostate gland
- Two tablets Levofloxacin Krka 250 mg once daily
- or, one tablet of Levofloxacin Krka 500 mg once daily
Infection of the skin or under the skin including muscles
- Two tablets Levofloxacin Krka 250 mg once or twice daily
- or, one tablet of Levofloxacin Krka 500 mg once or twice daily
Adults and the elderly with kidney problems
Your doctor may want to give you a lower dose .
Use for children and adolescents
This medicine must not be given to children or teenagers.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. These side effects are usually mild or moderate and often go away after a short time.
Stop taking Levofloxacin Krka and contact a doctor immediately or see a hospital if you get any of the following symptoms:
Very rare (may affect up to 1 in 10,000 people):
- You get an allergic reaction . Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
Stop taking Levofloxacin Krka and contact a doctor immediately, if you get any of the following serious side effects – you may need urgent medical attention:
Rare (may affect up to 1 in 1,000 people):
- Watery diarrhea, which may be bloody, possibly with stomach cramps and high fever. This can be a sign of a serious intestinal problem.
- Pain and inflammation in your tendons or ligaments, which can lead to a rupture. The Achilles tendon is most often affected.
- Seizures (convulsions)
- Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes and effects on other body organs (drug reaction with eosinophilia and systemic symptoms called DRESS or drug hypersensitivity syndrome). See also section 2.
- Syndrome linked to decreased water excretion and low sodium levels (SIADH)
Very rare (may affect up to 1 in 10,000 people):
- Burning, stabbing pain or numbness. This may be a sign of something called “neuropathy”.
Has been reported (occurs in an unknown number of users):
- Severe skin rash including Stevens Johnson syndrome and toxic epidermal necrolysis . These rashes may appear as red, target-like spots or round spots, often with blisters in the middle, trunk, skin rash, sores in the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms . See also section 2.
- Loss of appetite, yellow skin and eyes, dark urine, itching or sore stomach (stomach). This can be a sign of liver problems that can include fatal liver failure.
If your vision becomes impaired or if you experience any other visual disturbances while taking Levofloxacin Krka, consult an ophthalmologist immediately.
Tell your doctor if any of the following side effects gets worse or lasts longer than a few days :
Common (may affect up to 1 in 10 people):
- Sleeping problems
- Headache, dizziness
- Feeling sick (nausea, vomiting) and diarrhea
- Increase in certain liver enzyme levels in the blood
Uncommon (may affect up to 1 in 100 people):
- Changing the number of other bacteria or fungi, a fungal infection called Candida , which may need to be treated
- Change in the number of white blood cells , which certain blood tests can show ( leukopenia , eosinophilia )
- Feeling stressed (anxious), confused, nervous, sleepy, shaky, dizzy ( vertigo )
- Shortness of breath ( dyspnoea )
- Taste changes, loss of appetite, upset stomach or problems with digestion ( dyspepsia ), pain in the stomach area, bloating ( flatulence ) or constipation.
- Itching and rash, severe itching or hives ( urticaria ), abnormal sweating ( hyperhidrosis )
- Joint or muscle pain
- Blood tests may cause unusual results due to liver problems (bilirubin increase) or kidneys (creatine increase)
- General weakness.
Rare (may affect up to 1 in 1,000 people):
- Bruising or easy to bleed due to decreased platelet count ( thrombocytopenia )
- Low white blood cell count ( neutropenia ).
- Excessive active immune system (hypersensitivity)
- Decreased blood sugar levels ( hypoglycaemia ). This is important for people with diabetes .
- See or hear things that are not there (hallucinations, paranoia ), Changed opinions or thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
- Feeling depressed, mental problems, feeling restless (hurried), abnormal dreams or nightmares
- Tingling in hands or feet ( paresthesias )
- Problems with hearing ( tinnitus ) or vision (blurred vision)
- Unusually fast heartbeat ( tachycardia ) or low blood pressure ( hypotension )
- Muscle weakness. This is important for people with myasthenia gravis (a rare disease of the nervous system).
- Changes in the way the kidneys work and temporary kidney failure , which may be due to an allergic reaction in the kidneys called interstitial nephritis.
- Fever.
- Clearly defined, reddened spots with or without blisters that appear within a few hours after administration of levofloxacin and that heal with persistent hyperpigmentation (post-inflammatory). They usually reappear in the same place on the skin or mucous membrane if levofloxacin is given again at a later time.
Has been reported (occurs in an unknown number of users):
- Decreased number of red blood cells ( anemia ), which can make the skin pale or yellow, due to the destruction of the red blood cells . Decreased number of all kinds of blood cells (pancytopenia).
- Fever, sore throat and a general feeling of illness, which does not go away. This may be due to a decrease in the number of white blood cells ( agranulocytosis ).
- Lack of circulation (similar to anaphylactic shock )
- Increase in blood sugar levels ( hyperglycemia ) or a decrease in your blood sugar levels, leading to coma (hypoglycemic coma ). This is important for people with diabetes .
- Change in how things smell, lost sense of smell or how things taste ( parosmia , anosmia , ageusi )
- Problems moving or walking ( dyskinesia , extrapyramidal diseases)
- Temporary loss of consciousness or posture ( syncope )
- Temporary vision loss
- Hearing loss or hearing loss
- Abnormally fast heartbeat, life-threatening irregular heartbeat including cardiac arrest, change in heart rate (called prolonged QT interval and seen on ECG , electrical activity of the heart)
- Difficulty breathing and wheezing ( bronchospasm )
- Allergic reactions in the lungs
- Pancreatitis
- Inflammation of the liver ( hepatitis )
- Increased sensitivity of the skin to sun and ultraviolet radiation (light sensitivity)
- Inflammation of vessels one that carries around your blood in the body, due to an allergic reaction ( vasculitis )
- Inflammation of tissue inside the mouth ( stomatitis )
- Muscle stretching and muscle wasting ( rhabdomyolysis )
- Red and swollen joints ( arthritis )
- Pain including back pain, chest and limb s
- Attacks of porphyria in people who already have porphyria (a very rare metabolic disease)
- Persistent headache with or without blurred vision ( benign intracranial hypertension )
In very rare cases, long-term (up to several months or years) or permanent side effects , such as tendinitis, tendonitis, joint pain, pain in the arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disturbances, impaired memory and hearing loss, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.
Cases of enlargement and weakening of an aortic wall or rupture of an aortic wall ( aneurysms and dissections), which can rupture and be life-threatening, as well as cases of leaking heart valves, have been reported in patients receiving fluoroquinolones . See also section 2.
How to store Levofloxacin Krka
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
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.
Contents of the package and other information
Content declaration
The active substance is levofloxacin. One film-coated tablet contains 250 mg or 500 mg of levofloxacin as levofloxacin hemihydrate.
The other ingredients are microcrystalline cellulose, hydroxypropylcellulose, crospovidone (type A) and magnesium stearate in the tablet core and hypromellose, indigo carmine (E132), para-orange (E110), macrogol 4000, titanium dioxide (E171), red iron oxide (E172) and yellow iron (E172) (yellow17) only for 500 mg ) in the film coating.
What the medicine looks like and contents of the pack
250 mg film-coated tablets are pink, oblong, biconvex film-coated tablets with a score score of 13.7 mm x 6.7 mm and a thickness of 3.8 mm. The tablet can be divided into two equal doses .
500 mg film-coated tablets are orange, oblong, biconvex film-coated tablets with a score score of 19.3 mm x 7.8 mm and a thickness of 5.0 mm. The tablet can be divided into two equal doses .
250 mg and 500 mg film-coated tablets are available in packs of 1, 5, 7, 10 and 14 tablets in blisters.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
Krka, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia