250 mg and 500 mg tablets
levofloxacin
What Tavanic tablets are and what they are used for
The name of your medicine is Tavanic tablets. Tavanic tablets contain 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.
Tavanic tablets can be used to treat infection in:
- Nasal sinuses
- 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 under the skin, including muscle. These are sometimes called “soft parts”.
In some special situations, Tavanic tablets may be given to reduce the risk of getting a lung disease called anthrax, or a worsening of this disease, after you have been exposed to the bacteria that cause anthrax.
What you need to know before using Tavanic tablets
Do not use this medicine and tell your doctor 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, and swelling of the lips, face, throat, or tongue. - you have ever had epilepsy
- you have ever had problems with your tendons such as tendonitis in connection 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 are breastfeeding.
Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Tavanic.
Warnings and precautions
Talk to your doctor or pharmacist before using Tavanic if :
- you are 60 years of age or older
- you use corticosteroids, which are sometimes called steroids (see section “Other medicines and Tavanic”)
- you have undergone a transplant
- you have ever had a seizure (convulsions)
- you have had a brain injury due to a stroke or other brain injury
- you have problems with your kidneys
- you have something known as glucose -6-phosphate dehydrogenase deficiency. You are more likely to have serious problems with your blood if you use this medicine.
- you have ever had mental health problems
- you have ever had problems with the heart: caution should be taken when using this medicine if you have a congenital or family history of the prolonged QT interval (seen on ECG, electrical recording of the heart), have an imbalance of 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 female or elderly or use other medicines that cause abnormal ECG changes (see section “Other medicines and Tavanic”).
- you have diabetes
- you have ever had liver problems
- you have myasthenia gravis
- you have nerve problems ( peripheral neuropathy )
- you have been diagnosed with an enlargement or ‘bulging’ of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
- you have had an aortic dissection (a tear 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 (e.g. connective tissue diseases such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome (an inflammatory autoimmune disease) or vascular diseases such as Takayasu’s 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 ever developed a severe rash or scaly skin, blisters, and/or sores in your mouth after taking levofloxacin
Serious skin reactions
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin.
- Stevens-Johnson syndrome and toxic epidermal necrolysis may first appear as red, target-like spots or round spots, often with central blisters, on the trunk. In addition, sores in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may appear. These serious 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 facial rash, then widespread rash 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 contact your doctor or seek medical attention immediately.
You should not take fluoroquinolone /quinolone antibacterial medicines, including Tavanic if you have previously had a serious side effect associated with taking any quinolone or fluoroquinolone medicine. If this is the case, contact the doctor as soon as possible.
When using fluoroquinolones, talk to your doctor, nurse, or pharmacist about:
- If you feel a sudden, severe pain in your abdomen, chest, or back, visit an emergency room immediately as these may be symptoms of aortic aneurysm and aortic dissection. The risk of suffering from this may be increased if you are treated with systemic corticosteroids (“cortisone”).
- If you experience sudden shortness of breath, especially when lying down in bed, or notice swelling in your ankles, feet, or stomach, or new palpitations (feeling of fast or irregular heartbeats), see a doctor immediately.
In rare cases, pain and swelling of the joints and inflammation or rupture of the tendons may occur. The risk is greater if you are older (over 60), have undergone an organ transplant, have kidney problems, or if are being treated with cortisone ( corticosteroids ). Inflammation and ruptures of tendons can occur already within the first 48 hours after starting treatment, but also up to several months after treatment with Tavanic has ended. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking Tavanic, consult a doctor, and rest the painful area. Avoid unnecessary exertion as this can increase the risk of a tendon rupture.
In rare cases, you may have 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 Tavanic and contact your doctor immediately to prevent the development of a potentially permanent condition.
Long-term, disabling, and potentially permanent serious side effects
Antibacterial fluoroquinolone /quinolone drugs, including Tavanic, 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 sensory sensations such as crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disturbances in the form of impaired vision, taste, smell and hearing, depressed mood, impaired memory, extreme fatigue, and severe sleep problems.
If you experience any of these side effects after taking Tavanic, contact your doctor immediately before continuing with treatment. You and the doctor will decide whether to continue the treatment or consider whether to use a different type of antibiotic.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Tavanic.
Other medicines and Tavanic
Tell your doctor or pharmacist if you are using, have recently taken, or might use any other medicines. This is because Tavanic can affect how some other medicines work and some medicines can affect how Tavanic works.
In particular, tell your doctor if you are using any of the following medicines. This is important because it may increase the risk of side effects when using Tavanic:
- Corticosteroid er, which is sometimes called steroid er – is used for inflammation. You are more likely to get inflammation and/or a tear in your tendons.
- Warfarin – is used to thin the blood. You are more likely to bleed. It is possible that the doctor needs to take regular blood tests to check how well your blood can clot.
- Theophylline – is used for breathing problems. You are more likely to have fits (seizures) if this is taken with Tavanic.
- Non-steroidal anti-inflammatory drugs ( NSAIDs ) – such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin – are used for pain and inflammation. You are more likely to have seizures (convulsions) if these are taken with Tavanic.
- Cyclosporine – used after organ transplantation. You are more likely to have side effects from ciclosporin.
- Medicines are known to affect the way your heart beats. These include drugs used for abnormal heart rhythms (antiarrhythmics such as quinidine, hydroquinone, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone ), for depression ( tricyclic antidepressants such as amitriptyline and imipramine), for mental illness (antipsychotics) and bacterial infections ( 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 use a lower dose if you have kidney problems.
Talk to your doctor if any of the above applies to you.
Do not use Tavanic tablets together with the following medicines, as they may affect how Tavanic 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 using 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 using Tavanic. If your doctor has prescribed a urine test, tell the doctor that you are using Tavanic.
Tuberculosis tests
This medicine can give false negative results for some laboratory tests, which look for the bacteria that cause tuberculosis.
Pregnancy and breastfeeding
Do not use this medicine if:
- you are pregnant, may become pregnant, or think you may be pregnant
- you are breastfeeding or planning to breastfeed.
Driving ability and use of machinery
You may experience side effects after taking this medicine such as dizziness, sleepiness, feeling dizzy ( vertigo ) or visual disturbances. Some of these side effects can affect your ability to concentrate and your reaction speed. If this occurs, do not drive a motor vehicle or perform work that requires increased attention.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tavanic contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Tavanic tablets
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Use this medicine
- Use this medicine by mouth
- Swallow the tablets whole with water
- The tablets can be used with meals or at any time between meals
If you are already using iron tablets, zinc supplements, antacids, didanosine, or sucralfate
- Do not use these medicines together with Tavanic. Take a dose of one of these medicines at least 2 hours before or after Tavanic tablets.
How much to use
- The doctor will decide how many Tavanic tablets you should use
- The dose will depend on the type of infection you have and where the infection is in your body
- The length of treatment will depend on how serious the infection is
- If you feel that the effect of the drug is too weak or too strong, do not change the dosage yourself, but consult your doctor
Adults and the elderly
I infection in the nasal sinuses
- Two tablets of Tavanic 250 mg once daily
- or, one tablet of Tavanic 500 mg once daily
Lung infections in people with long-term breathing problems
- Two tablets of Tavanic 250 mg once daily
- or, one tablet of Tavanic 500 mg once daily
Pneumonia
- Two tablets of Tavanic 250 mg once or twice daily
- or, one tablet of Tavanic 500 mg once or twice daily
Infection in the urinary tract including your kidneys or bladder
- One or two tablets of Tavanic 250 mg once daily
- or, 1/2 or one tablets of Tavanic 500 mg once daily
Infection in the prostate gland
- Two tablets of Tavanic 250 mg once daily
- or, one tablet of Tavanic 500 mg once daily
Infection in the skin or under the skin including muscles
- Two tablets of Tavanic 250 mg once or twice daily
- or, one tablet of Tavanic 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 teenagers.
Protect your skin from sunlight
Avoid direct sunlight while using this medicine and for 2 days after you stop taking it. Your skin will become much more sensitive to the sun and may burn, sting or blister if you don’t take the following steps:
- Make sure you use sunscreen with a high sun protection factor
- Always wear a hat and clothing that covers your arms and legs
- Avoid tanning beds.
If you have used too many Tavanic tablets
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Take the medicine with you, so the doctor knows what you have taken.
The following symptoms may occur: convulsions, confusion, dizziness, reduced level of consciousness, tremors, and heart problems that may lead to irregular heartbeats as well as nausea.
If you forget to use Tavanic tablets
If you have forgotten to take a dose, take it as soon as you remember unless it is soon time for the next dose. Do not take a double dose to make up for a missed dose.
If you stop using Tavanic tablets
Do not stop using Tavanic just because you feel better. You must finish the course of tablets that your doctor has prescribed for you. If you stop using the tablets too soon, the infection may return, your condition may worsen or the bacteria may become resistant to the medicine.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 disappear after a short time.
Stop using Tavanic and contact a doctor or hospital immediately if you experience any of the following symptoms:
Very rare (affects less than 1 in 10,000 people)
- You have an allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue.
Stop using Tavanic and contact your doctor immediately if you experience any of the following serious side effects – you may need urgent medical treatment:
Rare (affects less than 1 in 1,000 people)
- Watery diarrhea, which may be bloody, possibly with stomach cramps and high fever. This could be a sign of a serious intestinal problem.
- Pain and inflammation in your tendons or ligaments, can lead to a rupture. The Achilles tendon is most commonly affected.
- Seizures (convulsions)
- Seeing or hearing things that are not there (hallucinations, paranoia ).
- Feeling depressed, mental health problems, feeling restless (restless), abnormal dreams or nightmares
- Lowering of blood sugar levels (hypoglycemia) or a lowering of blood sugar levels leading to coma (hypoglycaemic coma ). This is important for people with diabetes.
- Widespread skin 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 impaired water excretion and low sodium levels (SIADH)
Very rare (affects less than 1 in 10,000 people)
- Burning, stinging pain, or numbness. This can be a sign of something called “neuropathy”.
Frequency not known (frequency cannot be calculated from available data)
- Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These rashes can appear as red, target-like spots or round spots, often with blisters in the center, on the trunk, skin peeling, sores in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms. See also section 2.
- Loss of appetite, yellow-colored skin, and eyes, dark-colored urine, itching, or sore abdomen (stomach). This can be a sign of liver problems which can include fatal liver failure.
- Altered opinions or thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
If vision becomes impaired or any other visual disturbances are experienced while using Tavanic, consult an eye specialist immediately.
In very rare cases, long-term (up to several months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, pain in the arms and legs, difficulty walking, abnormal sensory sensations such as crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disorders, impaired memory and impaired hearing, vision and taste, and smell have been associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases independent of existing risk factors.
Cases of enlargement and weakening of an aortic wall or a 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 last longer than a few days:
Common (affects less than 1 in 10 people)
- Sleeping problems
- Headache, dizziness
- Feeling sick (nausea, vomiting) and diarrhea
- Increase in certain liver enzyme levels in the blood
Uncommon (affects less than 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 some blood tests can show ( leukopenia, eosinophilia )
- Feeling stressed (anxious), confused, nervous, sleepy, shaky, dizzy ( vertigo )
- Shortness of breath ( dyspnea )
- Taste changes, loss of appetite, upset stomach or problems with digestion ( dyspepsia ), pain in the stomach, bloating ( flatulence ), or constipation.
- Itching and rash, severe itching or hives ( urticaria ), abnormal sweating ( hyperhidrosis )
- Joint or muscle pain
- Blood tests may give unusual results due to problems with the liver (bilirubin increase) or kidney (creatinine increase)
- General weakness.
Rare (affects less than 1 in 1,000 people)
- Bruising or easy bleeding due to a reduced number of blood platelets ( thrombocytopenia )
- Low white blood cell count ( neutropenia ).
- Overactive 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).
- Change 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
- Memory impairment
- Well-defined, reddened patches with or without blisters that appear within a few hours of administration of levofloxacin and heal with residual hyperpigmentation (post-inflammatory). They usually return in the same place on the skin or mucous membrane if levofloxacin is given again at a later time.
Frequency not known (frequency cannot be calculated from available data)
- Decreased number of red blood cells (anemia), which can make the skin pale or yellow, due to the destruction of the red blood cells. Reduced number of all types of blood cells (pancytopenia).
- Fever, sore throat, and a general feeling of malaise, which does not go away. This may be due to a decrease in the number of white blood cells ( agranulocytosis ).
- Absence of circulation (similar to anaphylactic shock )
- Increase in blood sugar levels ( hyperglycemia ). This is important for people with diabetes.
- Change in how things smell, lost sense of smell, or how things taste ( parosmia, anosmia, ageusia )
- Trouble moving or walking ( dyskinesia, extrapyramidal disorders)
- Temporary loss of consciousness or posture ( syncope )
- Temporary loss of vision, eye inflammation
- Impaired hearing or hearing loss
- Abnormally fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, change in heart rhythm (called prolonged QT interval and seen on EKG, the 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 the sun and ultraviolet radiation (photosensitivity)
- Inflammation of the vessels that transport your blood around the body, due to an allergic reaction ( vasculitis )
- Inflammation of tissue inside the mouth ( stomatitis )
- Muscle tears and muscle wasting ( rhabdomyolysis )
- Red and swollen joints ( arthritis )
- Pain including back, chest, and extremity 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 )
How to store Tavanic tablets
Keep this medicine out of the sight and reach of children.
This medicine has no special storage instructions, but it is best to store Tavanic tablets in the original blister and carton in a dry place.
Use before 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 must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is levofloxacin. Each Tavanic 250 mg tablet contains 250 mg levofloxacin and each Tavanic 500 mg tablet contains 500 mg levofloxacin.
Other ingredients are:
- Tablet core: crospovidone, hypromellose, microcrystalline cellulose, and sodium stearyl fumarate
- Coating: hypromellose, titanium dioxide (E 171), talc, macrogol, yellow iron oxide (E 172), and red iron oxide (E 172)
Appearance and package sizes of the medicine
Tavanic tablets are film-coated and for oral use. The tablets are oblong and scored with a yellow-white to red-white color.
Tavanic 250 mg tablets are available in pack sizes of 1, 3, 5, 7, 10, 50, and 200 tablets.
Tavanic 500 mg tablets are available in pack sizes of 1, 5, 7, 10, 14, 50, 200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder
Sanofi AB
Box 30052
104 25 Stockholm
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
This medicine is approved in the European Economic Area under the name:
Tavanic