Levofloxacin ABC

Package leaflet: Information for the user

Levofloxacina ABC 500 mg film-coated tablets

Levofloxacin
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Levofloxacina ABC is and what it is used for

Levofloxacina ABC contains the active substance called levofloxacina. This medicine
belongs to a group of medicines known as antibiotics. Levofloxacina is a
"quinolone" antibiotic. This medicine works by killing the bacteria responsible for infections
in the body.
Levofloxacina ABC can be used to treat the following infections:

• of the sinuses
• of the lungs, in patients with chronic respiratory conditions or pneumonia
• of the urinary tract, including kidneys and bladder
• of the prostate, where a persistent infection may develop
• of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues".

In certain special situations, Levofloxacina ABC may be used to reduce the likelihood of developing a lung disease called anthrax or to prevent worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you should know before taking Levofloxacina ABC

Do not take this medicine and inform 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)
• 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 previously experienced tendon problems, 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, could become pregnant, or think you may be pregnant
• you are breastfeeding

Do not take this medicine if any of the above apply to you. If you have any
doubts, consult your doctor, nurse or pharmacist before taking Levofloxacina ABC.
Warnings and precautions
Consult 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 Levofloxacina ABC")
• you have undergone an organ transplant
• you have had seizures
• you have suffered brain damage due to stroke or other brain injury
• you have kidney problems
• you suffer from a condition known as "glucose-6-phosphate dehydrogenase deficiency". Administration of this medicine increases the likelihood of developing serious blood-related problems
• you have had mental health 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 QT interval prolongation (seen on electrocardiogram, the heart's electrical trace), 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 female or elderly, or are taking other medicines that may alter the electrocardiogram (see section "Other medicines and Levofloxacina ABC")
• you have diabetes
• you have 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 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 or mitral regurgitation)
• you have a family history of aortic aneurysm, aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's syndrome, known high blood pressure or atherosclerosis), rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart])
• you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

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

• SJS and TEN may initially appear on the body as reddish spots or circular patches often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening complications or even death.
• DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin rash or any of these other skin symptoms, stop taking
levofloxacin and contact your doctor or seek immediate medical assistance.
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Levofloxacina ABC, if you have previously experienced any severe adverse reaction during
treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.
While taking this medicine:

• If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aneurysm or aortic dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
• Inform your doctor immediately 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 (sensation of rapid or irregular heartbeat).
• If you suddenly develop involuntary jerks, muscle fasciculations or contractions – consult a doctor immediately as these may be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and start appropriate therapy.
• If you develop nausea, general malaise, severe discomfort or persistent or worsening stomach pain, or vomiting, contact your doctor immediately, as these may be signs of pancreas inflammation (acute pancreatitis).
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat and a significant worsening of your general condition, or if you feel your resistance to infections has decreased – consult a doctor immediately as these may be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have undergone an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Levofloxacina ABC. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with Levofloxacina ABC, consult your doctor and rest the affected area. Avoid 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, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Levofloxacina ABC and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacina ABC, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Levofloxacina ABC, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking Levofloxacina ABC.
Other medicines and Levofloxacina ABC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This is because Levofloxacina ABC may affect the way other medicines work. Likewise, some medicines may affect the way Levofloxacina ABC works.
In particular, inform your doctor if you are taking any of the following medicines. This
is because taking Levofloxacina ABC together with other medicines may increase the risk of
experiencing side effects:

• Corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is increased.
• Warfarin – used to thin the blood. The risk of bleeding is increased. Your doctor may ask you to have regular blood tests to monitor blood clotting.
• Theophylline – used for respiratory problems. The risk of seizures is increased if you take theophylline together with Levofloxacina ABC.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is increased if taken together with Levofloxacina ABC.
• Cyclosporine – used for organ transplants. The risk of experiencing typical cyclosporine side effects is increased.
• Medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (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 a lower dose if you have kidney problems.
• Cimetidine – used for ulcers and heartburn. Your doctor may prescribe a lower dose if you have kidney problems.

Consult your doctor if any of the above apply to you.
Do not take Levofloxacina ABC together with the following medicines. This is because the
mechanism of action of Levofloxacina ABC may be affected:

• iron salt tablets (for anaemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine or sucralfate (for gastric ulcers). See section 3 "If you are taking iron salt tablets, zinc supplements, antacids, didanosine or sucralfate".

Urine testing for opiates
In patients taking Levofloxacina ABC, urine tests may give "false-positive" results for strong painkillers called "opiates". If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacina ABC.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests that detect the bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, could become pregnant, or think you may be pregnant
• you are breastfeeding or think you may breastfeed

Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo) or visual disturbances. Some of these side effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive or operate machinery or perform any activity requiring high attention.

3. How to take Levofloxacina ABC

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
How to take this medicine

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

If you are already taking iron supplements, 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

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

Levofloxacina ABC is not available in all the dosages described below. Other medicines are available
on the market for these dosages. Ask your doctor or pharmacist for advice.
Adults and elderly patients
Sinus infections
One tablet of Levofloxacina ABC 500 mg once daily
Lung infections in patients with chronic respiratory problems
One tablet of Levofloxacina ABC 500 mg once daily
Pneumonia
One tablet of Levofloxacina ABC 500 mg once or twice daily
Urinary tract infections, including kidneys or bladder
Half or one tablet of Levofloxacina ABC 500 mg once daily
Prostate infections
One tablet of Levofloxacina ABC 500 mg once daily
Skin and subcutaneous tissue infections, including muscles
One tablet of Levofloxacina ABC 500 mg once or twice daily
Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dosage.
Children and adolescents
This medicine must not be given to children or adolescents.
Protect your skin from sunlight
Avoid direct exposure to sunlight during treatment with this medicine and for 2 days
after the end of treatment. This is because your skin will become much more sensitive to sunlight and may
burn, itch, or develop severe blistering if you do not follow these precautions:

• Make sure to use a high-protection sunscreen
• Always wear a hat and clothing covering 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. Take the medicine pack with you. This will allow the
doctor to know what you have taken.
The following side effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems that may lead to irregular heartbeat and feelings of discomfort (nausea) or stomach burning.
If you forget to take Levofloxacina ABC
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed 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 full course of tablets prescribed by your doctor. If you stop taking the tablets too
early, the infection may return or worsen, and bacteria may develop resistance to the medicine.
If you have any questions about the use of this medicine, consult 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 go immediately to a doctor or 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: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking Levofloxacina ABC and go immediately to a doctor if you notice any of the
following side effects – you may need urgent medical treatment:

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

• Watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This could be a sign of a serious bowel problem
• Pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
• Seizures
• Seeing or hearing things that do not exist (hallucinations, paranoia)
• Feeling depressed, mental disturbances, feeling restless (agitation), abnormal dreams or nightmares
• Widespread rash, fever, increased liver enzymes, blood abnormalities (eosinophilia), swollen 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 inadequate water excretion and low sodium levels (SIADH)
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important for people with diabetes.

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

• Burning, tingling, pain or numbness. These signs may indicate a condition 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 circular patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or stomach pain (abdomen). These may be signs of liver problems, including fatal liver failure (liver failure that may lead to death).
• Changes in thoughts and mood (psychotic reactions) with risk of suicidal thoughts or actions.
• Nausea, general feeling of unwellness, stomach discomfort or pain, or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or you experience any eye discomfort while taking Levofloxacina ABC, consult an ophthalmologist immediately.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, unusual sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of aortic wall dilation and weakening or aortic wall rupture (aneurysms and dissections), with possible fatal rupture, as well as cases of blood regurgitation from 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 longer than a few days:

Common (may affect up to 1 in 10 people)

• Trouble sleeping
• Headache, dizziness
• Feeling unwell (nausea, vomiting) and diarrhoea
• Increased liver enzyme levels in the blood

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
• Changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
• Feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
• Shortness of breath (dyspnoea)
• Change in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
• Itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalised weakness

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

• Bruising and increased bleeding due to reduced platelet count in the blood (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Tingling sensation in hands and feet (paraesthesia)
• Hearing problems (tinnitus) or vision problems (blurred vision)
• Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
• Changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
• Fever
• Clearly defined erythematous patches, with or without blistering, developing within a few hours of levofloxacin administration and healing with redness; usually reappear at the same skin or mucosal site after subsequent exposure to levofloxacin
• Poor memory

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

• Decrease in red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia)
• Bone marrow stops producing new blood cells, which may 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 reduced number of white blood cells in the blood (agranulocytosis)
• Lack of blood flow (anaphylactic shock)
• Increased blood sugar levels (hyperglycaemia). This is important for people with diabetes
• Change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely excited, euphoric, agitated or exhausted (mania)
• Difficulty moving or walking (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Worsening or loss of hearing
• Unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (known as “prolongation of QT interval” seen on electrocardiogram, electrical activity of the heart)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic reactions affecting the lungs
• Pancreatitis
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the internal tissues of the mouth (stomatitis)
• Muscle breakdown and destruction (rhabdomyolysis)
• Redness and swelling of joints (arthritis)
• Pain, including back, chest and limb pain
• Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
• Porphyria attacks in patients who already suffer from porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Levofloxacin ABC

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and aluminium sheet after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levofloxacina ABC contains
The active substance is levofloxacin. Each film-coated tablet contains 500 mg of
levofloxacin (equivalent to 512.46 mg of levofloxacin hemihydrate).
The other ingredients are:
Tablet core: 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 pack contents
Pack containing 5 tablets.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. - Corso Vittorio Emanuele II, 72 - 10121 Turin - Italy.
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

Package leaflet: information for the physician

Levofloxacin ABC 500 mg film-coated tablets

Levofloxacin hemihydrate
Generic medicine

The following information is intended exclusively for healthcare professionals:

Clinical information
Before prescribing Levofloxacina ABC, national and/or local guidelines on the appropriate use of fluoroquinolones should be taken into consideration.
Levofloxacina ABC is not available in all the dosage strengths described below. Other medicinal products are available on the market for these dosage strengths.
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.