LEVOFLOXACINA 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. Levofloxacina ABC 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Levofloxacina ABC and what it is used for
   2. What you need to know before taking Levofloxacin ABC
   3. How to take Levofloxacina ABC
   4. Possible side effects
   5. How to store Levofloxacina ABC
   6. Contents of the pack and other information
2. levofloxacin (equivalent to 512.46 mg of levofloxacin hemihydrate).
3. Levofloxacina ABC 250 mg film-coated tablets

Levofloxacina ABC 250 mg film-coated tablets, 500 mg film-coated tablets

levofloxacin

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levofloxacina ABC is and what it is used for
• 2. What you need to know before you take Levofloxacina ABC
• 3. How to take Levofloxacina ABC
• 4. Possible side effects
• 5. How to store Levofloxacina ABC
• 6. Contents of the pack and other information

1. What is Levofloxacina ABC and what it is used for

Levofloxacina ABC contains the active substance called levofloxacin. This medicine
belongs to a group of medicines called antibiotics. Levofloxacina is a “quinolone” antibiotic.
This medicine works by killing the bacteria that cause infections
in the body.

Levofloxacina ABC can be used for the treatment of infections:

• of the sinuses
• of the lungs, in patients with chronic respiratory problems or pneumonia
• of the urinary tract, including kidneys and bladder
• of the prostate, where a persistent infection can develop
• of the skin and subcutaneous tissue, including muscles. These are sometimes called “soft tissues”.

In some special situations, Levofloxacina ABC can be used to decrease the likelihood of
contracting a lung disease called anthrax or the worsening of the disease after you have
been exposed to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacin ABC

Do not take this medicine and tell your doctor if:

• you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other ingredients of this medicine (listed in section 6)
• the signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• you have had epilepsy
• you have had problems affecting your tendons, such as tendinitis, related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to the skeleton
• you are a child or adolescent during the growth period
• you are pregnant, may become pregnant or think you may be pregnant
• you are breastfeeding

Do not take this medicine if the above applies to you in any way. If you have any
doubts, ask your doctor, nurse or pharmacist before taking Levofloxacin ABC.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:

• you are 60 years old or older
• you are taking corticosteroids, sometimes called steroids (see “Other medicines and Levofloxacin ABC”)
• you have undergone a transplant
• you have had seizures
• you have suffered brain damage following a stroke or other brain damage
• you have kidney problems
• you suffer from a disease known as “glucose-6-phosphate dehydrogenase deficiency”. Giving you this medicine makes it more likely to develop serious blood problems
• you have suffered from mental problems
• you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on an electrocardiogram, the electrical trace of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are a woman or elderly, or are taking other medicines that can alter the electrocardiogram (see section “Other medicines and Levofloxacin ABC”)
• you have diabetes
• you have had liver problems
• you have myasthenia gravis
• you have problems with your nerves (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 previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
• you have been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation)
• you have a family history of aortic aneurysm, aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet’s syndrome, high blood pressure or known atherosclerosis] rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [an inflammation of the heart])
• you have developed a severe skin reaction or peeling of the skin, blisters and/or ulcers in the mouth after taking any medicine containing levofloxacin.

Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of levofloxacin.

• SJS and TEN can initially appear on the body as reddish spots or as circular patches often with central blisters. Ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread peeling of the skin and life-threatening or fatal complications.
• DRESS initially presents as flu-like symptoms and a skin rash on the face, then a widespread rash with fever, increased levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes.

If you develop a severe skin rash or any other of these skin symptoms, stop
taking levofloxacin and contact your doctor or seek medical attention immediately.
You must not take antibacterial medicines based on quinolones/fluoroquinolones, including
Levofloxacin ABC if you have previously had any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

When you are taking this medicine:

• If you experience severe, sudden abdominal, chest or back pain, which may be a symptom of aneurysm and aortic dissection, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroid medicines.
• Immediately tell your doctor if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of a rapid or irregular heartbeat).
• If you begin to experience sudden involuntary jerks, fasciculations or muscle contractions - seek medical attention immediately as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate treatment.
• If you experience nausea, a general feeling of unwellness, severe or persistent abdominal discomfort or worsening abdominal pain, or vomiting, contact your doctor immediately as these may be a sign of inflammation of the pancreas (acute pancreatitis)
• In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and a severe worsening of your general condition, or if you feel that your resistance to infections has decreased - seek medical attention immediately as these may be signs of a blood disease. Your doctor must monitor your blood with a blood count. If the blood count is abnormal, your doctor may need to stop treatment.

Pain and swelling in the joints and inflammation or rupture of the
tendons can rarely occur. The risk is greater if you are elderly (over 60 years of age), if you have received an organ
transplant, if you have kidney problems or if you are being treated with corticosteroids. Inflammation and
tendon rupture can occur within the first 48 hours of treatment and up to several months after
the end of therapy with Levofloxacin ABC. At the first signs of pain or inflammation in a tendon
(for example in the ankle, wrist, elbow, shoulder or knee), stop treatment
with Levofloxacin ABC, see your doctor and keep the painful part at rest. Avoid any
unnecessary movement, as the risk of tendon rupture may increase.
Pain and swelling in the joints and inflammation or rupture of the
tendons can rarely occur. The risk is greater if you are elderly (over 60 years of age), if you have received an organ
transplant, if you have kidney problems or if you are being treated with corticosteroids. Inflammation and
tendon rupture can occur within the first 48 hours of treatment and up to several months after
the end of therapy with Levofloxacin ABC. At the first signs of pain or inflammation in a tendon
(for example in the ankle, wrist, elbow, shoulder or knee), stop treatment
with Levofloxacin ABC, see your doctor and keep the painful part at rest. Avoid any
unnecessary movement, as the risk of tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, can occur. If this happens, stop treatment with Levofloxacin ABC and inform your doctor immediately, to prevent nerve damage from becoming permanent.

Serious, prolonged, disabling and potentially irreversible side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Levofloxacin ABC,
have been associated with very rare but serious side effects, some of which are prolonged (lasting months or
years), disabling or potentially irreversible. These include pain in the tendons, muscles and
joints of arms and legs, difficulty walking, unusual sensations such as tingling, prickling, itching, numbness or burning (paresthesia), sensory disturbances such as
altered vision, taste, smell and hearing, depression, impaired
memory, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Levofloxacin ABC, contact
your doctor immediately before continuing treatment. The doctor will decide together with
you whether to continue treatment and will also consider using an antibiotic from another
class.
If you have any doubts that the above may apply to you in any way, ask your doctor or
pharmacist before taking Levofloxacin ABC.

Other medicines and Levofloxacin ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This is because Levofloxacin ABC can affect the mechanism
of action of other medicines. Also, some medicines can affect the mechanism of action of
Levofloxacin ABC.

In particular, tell your doctor if you are taking any of the following medicines. This
is because taking Levofloxacin ABC in combination with other medicines may
increase the possibility that you experience side effects:

• Corticosteroids, sometimes called steroids - used to treat inflammation. The possibility that you develop inflammation and/or tendon rupture is greater.
• Warfarin - used to thin the blood. The possibility that you experience bleeding is greater. Your doctor may ask you to have regular blood tests to check your blood clotting.
• Theophylline - used for breathing problems. The possibility that you experience a seizure (fit) is greater if you take theophylline in combination with Levofloxacin ABC.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that you experience a seizure (fit) if taken in combination with Levofloxacin ABC is greater.
• Cyclosporine - used for organ transplants. The possibility that you experience the typical side effects of cyclosporine is greater.
• Medicines known for their effects on the heartbeat. These include medicines used to treat irregular heartbeat (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics) and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin).
• Probenecid - used to treat gout. Your doctor may prescribe you a lower dose if you have kidney problems.
• Cimetidine - used for ulcers and heartburn. Your doctor may prescribe you a lower dose if you have kidney problems.

Talk to your doctor if the above applies to you in any way.

Do not take Levofloxacin ABC at the same time as the following medicines. This is because
the mechanism of action of Levofloxacin ABC may be affected:

• iron supplements in tablets, zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine or sucralfate (for stomach ulcers). See section 3 “If you are taking iron supplements in tablets, zinc supplements, antacids, didanosine or sucralfate”.

Urine test for opioids
In patients taking Levofloxacin ABC, urine tests may give “false-positive” results for strong painkillers called “opioids”. If your doctor considers it necessary to have urine tests, tell them that you are taking Levofloxacin ABC.

Tuberculosis test
This medicine may cause “false negative” results in some laboratory tests that look for
bacteria that cause 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 plan to breastfeed

Driving and using machines
Some side effects may occur after taking this medicine that
include dizziness, drowsiness, a subjective sensation of movement (vertigo) or visual disturbances.
Some of these side effects may impair your ability to concentrate and your reaction time.
If this happens, do not drive vehicles or perform activities that require a high level of
attention.

3. How to take Levofloxacina ABC

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth
• Swallow the tablets whole with some water
• The tablets can be taken with or without food.

If you are already taking iron salts in tablets, zinc supplements, antacids, didanosine or
sucralfate

• Do not take these medicines at the same time as Levofloxacina ABC. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacina ABC.

How much medicine to take

• The doctor will decide how much Levofloxacina ABC you need to take
• The dose will depend on the type of infection you have and the location of the infection in the body
• The duration of treatment will depend on the severity of the infection
• If you think that the effect of the medicine is too weak or too strong, do not change the dosage yourself but consult your doctor

Adults and the elderly
Sinus infections

• two Levofloxacina ABC 250 mg tablets once a day
• or, one Levofloxacina ABC 500 mg tablet once a day Lung infections, in patients with chronic respiratory problems
• two Levofloxacina ABC 250 mg tablets once a day
• or, one Levofloxacina ABC 500 mg tablet once a day Pneumonia
• two Levofloxacina ABC 250 mg tablets one or two times a day
• or, one Levofloxacina ABC 500 mg tablet one or two times a day Urinary tract infections including kidneys or bladder
• one or two Levofloxacina ABC 250 mg tablets once a day
• or, half or one Levofloxacina ABC 500 mg tablet once a day Prostate infections
• two Levofloxacina ABC 250 mg tablets once a day
• or, one Levofloxacina ABC 500 mg tablet once a day Skin and subcutaneous tissue infections, including muscles
• two Levofloxacina ABC 250 mg tablets one or two times a day
• or, one Levofloxacina ABC 500 mg tablet one or two times a day

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dosage.

Children and adolescents
This medicine should not be given to children or adolescents.

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days
after the end of treatment. This is because the skin will become much more sensitive to the sun and can
burn, itch or blister severely if you do not observe the following precautions:

• Make sure you use a high protection factor sunscreen
• Always wear a hat and clothes that cover your arms and legs
• Avoid sunbeds

If you take more Levofloxacina ABC than you should
If you accidentally take more tablets than you should, inform your doctor immediately or
seek medical advice elsewhere. Bring the medicine packaging with you. This will allow the
doctor to know what you have taken.
The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling of fainting, tremor and heart problems that can lead
to irregular heartbeat and a feeling of unwellness (nausea) or heartburn.

If you forget to take Levofloxacina ABC
If you forget to take a dose, take it as soon as you remember unless it is time to
take the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Levofloxacina ABC
Do not stop taking Levofloxacina ABC just because you feel better. It is important that you
complete the cycle of tablets prescribed by your doctor. If you stop taking the tablets too
early, the infection may return and the condition may worsen or the
bacteria may develop resistances to the medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Usually, these effects are mild or moderate and often disappear after a short time.

Stop taking Levofloxacina ABC and seek immediate medical attention or go to hospital
if you notice the following side effect:
Very rare(may affect up to 1 in 10,000 people)

• You have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking Levofloxacina ABC and seek immediate medical attention if you notice any
of the following side effects – you may need to receive urgent medical treatment:
Rare(may affect up to 1 in 1,000 people)

• Watery diarrhoea with possible blood, possibly accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
• Pain and inflammation of tendons or ligaments which may rupture in some cases. The Achilles tendon is most commonly affected
• Convulsions
• Seeing or hearing things that are not there (hallucinations, paranoia)
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• Widespread rash, fever, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with insufficient water excretion and low sodium levels (SIADH)
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people who have diabetes.

Very rare(may affect up to 1 in 10,000 people)

• Burning, tingling, pain or numbness. These signs may be indicative of a disease called “neuropathy”.

Not known(frequency cannot be estimated from the available data )

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or as circular patches often with blisters in the centre, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems which may include fatal liver failure (liver failure that can cause death).
• Changes in opinion and thoughts (psychotic reactions) with the risk of having suicidal thoughts or actions.
• Nausea, general feeling of unwellness, discomfort or pain in the stomach area or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or if you experience any discomfort in your eyes while taking
Levofloxacina ABC, consult an ophthalmologist immediately.
Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent,
such as inflammation of the tendons, tendon rupture, joint pain, arm or leg pain,
difficulty walking, abnormal sensations such as prickling, tingling, itching, burning,
numbness or pain (neuropathy), fatigue, impaired memory and
concentration, effects on mental health (which may include sleep disorders, anxiety,
panic attacks, depression and suicidal ideation), changes in hearing, vision, taste and
smell, have been associated with the use of antibiotics of the quinolone and fluoroquinolone type, in some
cases independently of pre-existing risk factors.
Cases of dilation and weakening of the aortic wall or of dissection of the aortic wall
(aneurysms and dissections), with possible ruptures that can cause death, as well as cases of regurgitation
of blood from the heart valves, have been reported in patients treated with fluoroquinolones. See
also section 2.

Tell your doctor if any of the following side effects worsen or last for more than a few
days:
Common(may affect up to 1 in 10 people)

• trouble sleeping
• headache, dizziness
• feeling unwell (nausea, vomiting) and diarrhoea
• increased levels of liver enzymes in the blood

Uncommon(may affect up to 1 in 100 people)

• changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require the initiation of treatment
• change in the number of white blood cells shown in some blood tests (leukopenia, eosinophilia)
• feeling of stress (anxiety), feeling of confusion, feeling of nervousness, drowsiness, tremor, dizziness
• shortness of breath (dyspnoea)
• change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), pain in the stomach area, feeling of fullness (flatulence), constipation
• itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint pain or muscle pain
• blood tests may show abnormal results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• general weakness

Rare(may affect up to 1 in 1,000 people)

• bruising and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• low number of white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• feeling of tingling in the hands and feet (paresthesia)
• problems with hearing (tinnitus) or vision (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system)
• changes in kidney function and occasional kidney failure which may be caused by an allergic reaction to the kidneys called interstitial nephritis
• fever
• clearly defined, erythematous patches, with or without blister formation that develop within a few hours of levofloxacin administration and heal leaving the reddened area; usually reappear at the same site of the skin or mucosa after subsequent exposure to levofloxacin
• insufficient memory.

Not known(frequency cannot be estimated from the available data)

• decrease in red blood cells (anemia). This can lead to paleness or yellowish skin due to damage to red blood cells and a decrease in the number of all types of cells in the blood (pancytopenia)
• the bone marrow stops producing new blood cells, which can cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• fever, sore throat and a general feeling of unwellness that does not go away. This may be due to a decrease in the number of white blood cells in the blood (agranulocytosis)
• lack of blood flow (anaphylactic shock)
• increased blood sugar levels (hyperglycaemia). This is important for those who suffer from diabetes
• change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• feeling very excited, euphoric, agitated or exhausted (mania)
• difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision, inflammation of the eyes
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening including cardiac arrest, changes in heartbeat (called “prolongation of the QT interval” seen on the electrocardiogram, heart electrical activity)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions to the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
• inflammation of the vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
• inflammation of the inner tissues of the mouth (stomatitis)
• rupture and destruction of muscles (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back pain, chest pain and limb pain
• sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
• attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Levofloxacina ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the package and on the blister foil after “Expiry.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levofloxacina ABC contains
Levofloxacina ABC 250 mg film-coated tablets

• The active ingredient is levofloxacin. Each film-coated tablet contains 250 mg of levofloxacin (equivalent to 256.23 mg of levofloxacin hemihydrate).
• The other ingredients are: Inside the tablet: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate. Coating: hypromellose, macrogol 400, titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172).

Levofloxacina ABC 500 mg film-coated tablets

• The active ingredient is levofloxacin. Each film-coated tablet contains 500 mg of

levofloxacin (equivalent to 512.46 mg of levofloxacin hemihydrate).

• The other components are: Inside the tablet: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate. Coating: hypromellose, macrogol 400, titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Levofloxacina ABC and contents of the pack
Pack containing 5 tablets.

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. - Corso Vittorio Emanuele II, 72 - 10121 Turin- Italy.

Manufacturer
PSI Supply nv - Axxes Business Park, Guldensporenpark 22, Block C - 9820 Merelbeke – Belgium
SPECIAL PRODUCT’S LINE S.p.A. Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

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Levofloxacina ABC 250 mg film-coated tablets

LevofloxacinaABC 500 mg film-coated tablets
Levofloxacin hemihydrate

Generic medicine
The following information is intended for healthcare professionals only:
Clinical information
Before prescribing Levofloxacina ABC, national and/or local guidelines on the appropriate use of fluoroquinolones should be considered.

Posology
The following doses of Levofloxacina ABC are recommended:

Dosage in patients with normal renal function(Creatinine clearance > 50 ml/min)

Special populations

Impaired renal function(Creatinine clearance ≤ 50 ml/min)

* No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis

For further information, see the Summary of Product Characteristics.