500 mg film-coated tablets
levofloxacin
What Levofloxacin Mylan is and what it is used for
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 Mylan can be used to treat infections 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
- Skin and inside the skin, including muscles. These are sometimes called “soft parts”.
In some special situations, Levofloxacin Mylan 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 Mylan 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 take Levofloxacin Mylan tablets
Do not take Levofloxacin Mylan if:
- 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, think you may be pregnant or are planning to have a baby.
- 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 Mylan.
Warnings and cautions
Before taking this medicine
You should not take antibacterial fluoroquinolone / quinolone medicines, including Levofloxacin Mylan, if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.
Talk to your doctor or pharmacist before taking Levofloxacin Mylan if:
- you are 60 years or older
- 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)
- if you have been diagnosed with leaky heart valves
- someone in your family has or has had an aortic aneurysm or 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 syndrome, or Ehlers-Danlos syndrome , Turner 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 use corticosteroids , sometimes called steroids (see section “Other medicines and Levofloxacin Mylan”)
- you have undergone a transplant
- 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 Mylan”).
- 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
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Levofloxacin Mylan.
When you take this medicine
In rare cases, joint pain and swelling and inflammation or tendon rupture may occur. The risk increases 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 of treatment but also up to several months after stopping treatment with Levofloxacin Mylan. At the first sign of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Mylan, consult a doctor and let the painful area rest. 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 and stinging sensation, numbness and / or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Levofloxacin Mylan and contact a doctor immediately to prevent the development of a possible permanent condition.
Avoid direct sunlight and do not use a tanning bed while taking this medicine and 2 days after stopping taking Levofloxacin Mylan (see also section 3 “Protecting your skin from sunlight”).
Long-term, debilitating and potentially lasting serious side effect s
Antibacterial fluoroquinolone / quinolone drugs, including Levofloxacin Mylan, have been linked to very rare but serious side effects . Some of these have been long-lasting (up to months or years), disabled or possibly permanent. This includes pain in tendons, muscles and joints in 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 and smell and hearing , depression, memory loss, extreme fatigue and severe sleep disorders.
If you get any of these side effects after taking Levofloxacin Mylan, 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 experience a sudden severe pain in the abdomen, chest or back, visit an emergency room immediately 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.
Other medicines and Levofloxacin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin Mylan may affect the way some other medicines work and some medicines may affect how Levofloxacin Mylan 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 you take Levofloxacin Mylan:
- 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 if you take Levofloxacin Mylan.
- 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 Mylan.
- 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 . Your doctor may want to give you a lower dose if you have kidney problems.
- Cimetidine – used for stomach ulcers and heartburn. Your doctor may want to give you a lower dose if you have kidney problems.
Do not take Levofloxacin Mylan with the following medicines, as they may affect the way Levofloxacin Mylan works.
- 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.
Urine tests for opiates
Urine tests may give false positive results for strong painkillers called “opiates” in people taking Levofloxacin Mylan. If your doctor has prescribed a urine test, tell your doctor that you are taking Levofloxacin Mylan.
Tuberculosis tests
This drug may give false negative results for certain tests, which are used in laboratories to look for the bacterium that causes tuberculosis .
Pregnancy and breastfeeding
Do not take this medicine if:
- you are pregnant, think you may be pregnant or are planning to have a baby
- you are breastfeeding or planning to breastfeed.
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.
How to take Levofloxacin Mylan
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
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 Mylan. Take dose of these drugs for at least 2 hours before or after Levofloxacin Mylan tablets.
How much to take
- Your doctor will decide how many Levofloxacin Mylan 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
- one tablet of Levofloxacin Mylan 500 mg once daily
Lung infections in people with long-term respiratory problems
- one tablet of Levofloxacin Mylan 500 mg once daily
Pneumonia
- one tablet of Levofloxacin Mylan 500 mg once or twice daily
Urinary tract infection including your kidneys or bladder
- 1/2 or one tablet Levofloxacin Mylan 500 mg daily
Infection of the prostate gland
- one tablet of Levofloxacin Mylan 500 mg once daily
Infection of the skin or under the skin including muscles
- one tablet of Levofloxacin Mylan 500 mg once or twice daily
Adults and the elderly with kidney problems
Your doctor may want to give you a lower dose .
Children and young people
This medicine must not be given to children or adolescents.
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 Mylan and contact a doctor immediately or see a hospital if you get any of the following symptoms:
Rare (may affect up to 1 in 1,000 people)
- You get an allergic reaction . Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, rapid decrease in blood pressure (drop in blood pressure) with symptoms such as shallow breathing, dizziness and weak pulse .
Stop taking Levofloxacin Mylan 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)
- 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)
- Decreased blood sugar levels ( hypoglycemia ) or a decrease in your blood sugar levels, leading to coma (hypoglycemic coma ). This is important for people with diabetes .
Has been reported (occurs in an unknown number of people)
- 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.
- Changed opinions or thoughts with risk of suicidal thoughts or actions.
- Loss of appetite, nausea, vomiting, yellowing of the skin and eyes, dark-colored urine, fever, itching or sore stomach (stomach). This can be a sign of liver problems that can include fatal liver failure.
- Watery diarrhea, which may be bloody, possibly with stomach cramps and high fever. This can be a sign of a serious intestinal problem.
- 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)
- Burning sensation, tingling, pain or numbness. These can be signs of something called “neuropathy”.
If your vision becomes impaired or if you experience any other visual disturbances while taking Levofloxacin Mylan, 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 can cause unusual results due to problems with the liver (bilirubin increase) or kidneys (creatine increase).
- General weakness.
Rare (may affect up to 1 in 1,000 people)
- Bruising or easy bleeding due to a decreased number of platelets ( thrombocytopenia ).
- Low white blood cell count ( neutropenia ).
- Excessive active immune system (hypersensitivity).
- Changes in your mental health such as seeing or hearing things that are not there (hallucinations), or that you think you are or feel threatened ( paranoia ).
- 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.
- Memory disorder.
Has been reported (occurs in an unknown number of people)
- 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 ).
- Increase in blood sugar levels ( hyperglycaemia ). 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, eye inflammation.
- Hearing loss or hearing loss.
- Difficulty breathing and wheezing ( bronchospasm ).
- Allergic reactions in the lungs.
- Upper abdominal and back pain, nausea or vomiting caused by inflammation of the pancreas ( pancreatitis ).
- 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, chest and limb pain .
- 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 impaired hearing, vision, taste and smell associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-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 Mylan
Keep this medicine out of the sight and reach of children.
This medicine does not have any specific storage instructions, but it is best to store Levofloxacin Mylan tablets in the original blister and carton in a dry place.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified 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.
Contents of the package and other information
Content declaration
- The active substance is levofloxacin hemihydrate. One film-coated tablet contains 500 mg levofloxacin (as levofloxacin hemihydrate)
- The other ingredients are microcrystalline cellulose (E 460), crospovidone (E 1202), hydroxypropylcellulose (E 463), magnesium stearate (E 470b). The film coating contains: hydroxypropylcellulose (E 463), macrogol 3350, macrogol 400 and titanium dioxide (E 171).
What the medicine looks like and contents of the pack
Levofloxacin Mylan tablets are film-coated.
The 500 mg tablet is white to off-white, capsule-shaped, curved, film-coated, marked with “LVO” breaker notch “500” on one side and “G” breaker notch “G” on the other side. The tablets can be divided into two equal halves.
Levofloxacin Mylan is packaged in blisters, in packs containing 1, 2, 3, 5, 7, 8, 10, 14, 16, 50 and 200 tablets and cans of 50 and 500 tablets.
Not all packaging may be marketed.
Marketing Authorisation Holder
Manufacturer
McDermott Laboratories Ltd to Gerard Laboratories, Baldoyle Industrial Estate, Grange Road, Dublin, Ireland.
Mylan Hungary Kft, Mylan utca 1, Komarom 2900, Hungary
Pharma Pack Hungary Kft., 2040 Hungary, Budaörs, Vasút u. 13, Hungary
Mylan Germany GmbH, Benzstrasse 1, Bad Homburg vd, Hoehe, Hessen, 61352, Germany