500 mg film-coated tablets
levofloxacin
What Levofloxacin Orion is and what it is used for
The name of your medicine is Levofloxacin Orion.
Levofloxacin Orion 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 Orion tablets can be used to treat infections in :
- sinuses of the nose
- the lungs, in people with long-term breathing problems or pneumonia
- urinary tract, including kidneys and bladder
- 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 Orion tablets can 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 Orion 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 Orion
Do not take Levofloxacin Orion 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 Orion.
Warnings and cautions
Talk to your doctor or pharmacist before taking your medicine:
- You should not take antibacterial fluoroquinolone / quinolone medicines, including levofloxacin, 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
- if you are 60 years or older
- if you are taking corticosteroids , sometimes called steroids (see section “Other medicines and Levofloxacin Orion”)
- if you have had a transplant
- if you have ever had a seizure (seizures)
- if you have had a brain injury due to a stroke or other brain injury
- if you have kidney problems
- if 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
- if you have ever had mental health problems
- if 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 Orion”)
- if you have diabetes
- if you have ever had liver problems
- if you have myasthenia gravis
- if you have nerve problems ( peripheral neuropathy )
- if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel)
- if you have had an aortic dissection (a rupture in the aortic wall)
- if you have been diagnosed with leaky heart valves
- if 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’s syndrome, or Ehlers-Danlos syndrome , Turner syndrome , Sjögren’s syndrome (en 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)).
- if you have ever developed severe rash or scaly skin, blisters and / or sores in your mouth after taking levofloxacindu.
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 .
Talk to your doctor or pharmacist when taking fluoroquinolone if:
- If you develop a severe skin rash or any of these other skin symptoms, stop taking levofloxacin and consult a doctor or seek medical attention immediately.
- If you feel a sudden, severe pain in the abdomen, chest or back, you should immediately go to 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 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 stopping treatment with Levofloxacin Orion. At the first sign of pain or inflammation of a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Orion, 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 Orion and contact your doctor immediately to prevent the development of any lasting condition.
Long-term, debilitating, and potentially lasting serious side effect s
Antibacterialfluoroquinolone/quinolone drugs, including Levofloxacin Orio,n have been linked to very rare but serious side effects. Some of these have been long-lasting (up to months or years), disabling,g and possibly permanent. This includes pain in the tendons, muscle,s, 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,e, and severe sleep disorders.
If you get any of these side effects after taking Levofloxacin Orion, talk to your doctor immediately before continuing with this treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Levofloxacin Orion.
Other medicines and Levofloxacin Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is due to that Levofloxacin Orion may affect the way some other medicines work and some medicines may affect how Levofloxacin Orion 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 Orion:
- 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 Orion.
- 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 if you take Levofloxacin Orion.
- cyclosporine – 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.
Talk to your doctor if any of the above apply to you.
Do not take Levofloxacin Orion with the following medicines, as they may affect the way Levofloxacin Orion works.
- iron tablets (for anemia ), zinc supplements, antacids containing magnesium or aluminum (for acid reflux 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 can give false-positive results for strong painkillers called “opiates” in people taking Levofloxacin Orion. If your doctor has prescribed a urine test, tell your doctor that you are taking Levofloxacin Orion.
Tuberculosis tests
This medicine may give false-negative results for some laboratory tests, which look for the bacterium that causes tuberculosis.
Pregnancy and breastfeeding
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.
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 effect. Description of these effects and side effects 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 Orion
Always take this medicine exactly as your doctor 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 tablet can be divided into equal doses .
If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate
- Do not take these medicines with Levofloxacin Orion. Take the dose of these medicines at least 2 hours before or after Levofloxacin Orion.
How much to take
- your doctor will decide how many Levofloxacin Orion 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 dosage yourself, but consult your doctor.
Adults and the elderly
Infection of the sinuses of the nose
One tablet of Levofloxacin Orion 500 mg once daily.
Lung infections in people with long-term respiratory problems
One tablet of Levofloxacin Orion 500 mg once daily.
Pneumonia
One tablet of Levofloxacin Orion 500 mg once or twice daily.
Urinary tract infection including your kidneys or bladder
1/2 or one Levofloxacin Orion 500 mg tablet once daily.
Infection of the prostate gland
One tablet of Levofloxacin Orion 500 mg once daily.
Infection of the skin or under the skin including muscles
One tablet of Levofloxacin Orion 500 mg once or twice daily.
Adults and the elderly with kidney problems
Your doctor may want to give you a lower dose.
A dose lower than 250 mg is not possible with this product, but there are products with lower strengths than 250 mg available.
Children and young people
This medicine must not be given to children or teenagers.
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 take more Levofloxacin Orion then you should
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 Orion 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 Orion and contact a doctor immediately if you experience any of the following serious side effects are – you may need urgent medical treatment:
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)
- see or hear things that are not there (hallucinations, paranoia )
- feeling depressed, mental problems, feeling restless (hurried), abnormal dreams or nightmares
- widespread skin rash, high body temperature, elevated liver enzymes, blood disorders ( 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 associated with decreased water excretion and low sodium levels (SIADH)
- lowering of blood sugar levels ( hypoglycaemia ) or a lowering of blood sugar levels leading to coma (hypoglycaemic coma ). This is important for people with diabetes .
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.
- changed opinions or thoughts (psychotic reactions) with the risk of suicidal thoughts or actions.
If your vision becomes impaired or if you experience any other visual disturbances while taking Levofloxacin Orion, consult an ophthalmologist immediately.
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.
Tell your doctor if any of the following side effects get worse or lasts longer than a few days :
Common (may affect up to 1 in 10 people) :
- sleeping problems
- headache, dizziness
- malaise (nausea, vomiting) and diarrhea
- increase in certain liver enzyme levels in the blood.
Uncommon (may affect up to 1 in 100 people) :
- change in 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 digestive problems ( dyspepsia ), abdominal pain, 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 bleeding due to decreased platelet count ( thrombocytopenia )
- low white blood cell count ( neutropenia )
- excessively active immune system (hypersensitivity)
- tingling in the 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 impairment.
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 malaise, 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 ( hyperglycaemia ). This is important for people with diabetes .
- change in how things smell, lost sense of smell or how things taste ( parosmia , anosmia , ageusi )
- difficulty moving or walking ( dyskinesia , extrapyramidal diseases)
- temporary loss of consciousness or posture ( syncope )
- temporary loss of vision, eye inflammation
- hearing loss or hearing loss
- abnormally fast heartbeat, life-threatening irregular heartbeat including cardiac arrest, change of heartbeat (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 in vessels one that carries around your blood in the body, due to an allergic reaction ( vasculitis )
- inflammation of tissue inside the mouth ( stomatitis )
- muscle strain 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 ).
Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se
How to store Levofloxacin Orion
Keep this medicine out of the sight and reach of children.
This medicine has no special storage instructions, but it is best to store Levofloxacin Orion 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. 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
Content declaration
- The active substance is levofloxacin. Each Levofloxacin Orion 500 mg tablet contains levofloxacin hemihydrate equivalent to 500 mg levofloxacin.
- Other ingredients are:
- Tablet core: crospovidone (E1202), hypromellose (E464), microcrystalline cellulose (E460), talc (E553B) and magnesium stearate (E470b).
- The coating: hypromellose (E464), titanium dioxide (E171), talc (E553B), macrogol, yellow iron oxide (E172) and red iron oxide (E172).
What the medicine looks like and contents of the pack
Levofloxacin Orion 500 mg film-coated tablets are light peach-colored, film-coated tablets, approximately 16.2 mm long and approximately 8.1 mm wide, with a notch on both sides and imprinted with “J” and “500” on each side of the notch on one side of the tablet.
The tablets are supplied in pack sizes of 7, 10, or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com