PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacina Alter 500 mg film-coated tablets

Levofloxacin
Generic medicine
Please read all of 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, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levofloxacina Alter is and what it is used for
What you need to know before taking Levofloxacina Alter
How to take Levofloxacina Alter
Possible side effects
How to store Levofloxacina Alter
Contents of the pack and other information

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

Levofloxacina Alter contains the active substance called levofloxacin. This
medicine belongs to a group of medicines known as antibiotics. Levofloxacin is a
"quinolone" antibiotic. This medicine works by killing bacteria responsible for
infections in the body.
Levofloxacina Alter 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 Alter may be used to reduce the
risk 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 Alter

Do not take this medicine and inform your doctor if:

you are allergic (hypersensitive) to levofloxacina, to any other quinolone antibiotic such as moxifloxacina, ciprofloxacin or ofloxacin, or to 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 had epilepsy
you have previously experienced tendon problems such as tendinitis related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting muscles to the skeleton
you are a child or adolescent during the growth period
you are pregnant, may become pregnant, or think you might be pregnant
you are breastfeeding

Do not take this medicine if any of the above applies to you. If you have any doubts, consult your doctor, nurse or pharmacist before taking Levofloxacina Alter.

Warnings and precautions

Before taking this medicine

You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacina Alter, if in the past you have had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.

Talk to your doctor or pharmacist before taking Levofloxacina Alter if:

you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacina
you are aged 60 years or older
you are taking corticosteroids, sometimes called steroids (see "Other medicines and Levofloxacina Alter")
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 tracing), 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 can alter the electrocardiogram (see section "Taking other medicines").
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 or 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 vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
you have diabetes
you have had liver problems
you have myasthenia gravis

While taking Levofloxacina Alter:

If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or 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 sudden 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).

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 levofloxacina.

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, swollen eyes) may also occur. These serious 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 may result in death.
DRESS initially presents as 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 skin symptoms, stop taking levofloxacina and contact your doctor or seek immediate medical help.

When taking this medicine

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years of age), have received 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 Alter. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with Levofloxacina Alter, consult your doctor, and keep the affected area 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, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Levofloxacina Alter and inform your doctor immediately to prevent permanent nerve damage.

If your vision deteriorates or your eyes are otherwise affected in any way, consult an ophthalmologist immediately.

If you begin to experience sudden involuntary jerks, fasciculations or muscle contractions – consult a doctor immediately as these may be signs of myoclonus. Your doctor may need to discontinue levofloxacina treatment and start appropriate therapy.

If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and severe 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.

If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Levofloxacina Alter.

Serious, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacina Alter, 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, itching, 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 Alter, 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.

Other medicines and Levofloxacina Alter

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Levofloxacina Alter may affect the way other medicines work. Some medicines may also affect the way Levofloxacina Alter works.

In particular, inform your doctor if you are taking any of the following medicines. This is because concomitant administration with Levofloxacina Alter may increase the likelihood of experiencing side effects:

corticosteroids – sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is higher.
warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for respiratory problems. The risk of seizures is higher if you take theophylline together with Levofloxacina Alter.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is higher when taken together with Levofloxacina Alter.
ciclosporin – used for organ transplants. The risk of experiencing typical ciclosporin side effects is higher.
medicines known for their effects on 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, and cimetidine – used for ulcers and heartburn. Particular caution is required when using any of these medicines together with Levofloxacina Alter. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacina Alter together with the following medicines. This is because the mechanism of action of Levofloxacina Alter may be affected:

iron salts in tablet form (for anemia), 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 salts in tablet form, zinc supplements, antacids, didanosine or sucralfate".

Urine testing for opiates

In patients taking Levofloxacina Alter, 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 Alter.

Tuberculosis testing

This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium causing tuberculosis.

Pregnancy and breastfeeding

Do not take this medicine if:

you are pregnant, may become pregnant, or think you might be pregnant
you are breastfeeding or think you might 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 impair concentration and reaction speed. If this occurs, do not drive or perform activities requiring high attention.

3. How to take Levofloxacin Alter

Take this medicine exactly as prescribed by your doctor or pharmacist. 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

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after stopping treatment. This is because your skin may become much more sensitive to sunlight and you may experience sunburn, itching, or serious skin lesions 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 (tanning beds)

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

Do not take these medicines at the same time as Levofloxacin Alter. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacin Alter tablets.

Dosage

your doctor will decide how much Levofloxacin Alter 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 dose yourself; consult your doctor

Adults and elderly patients
Sinus infections

two tablets of Levofloxacin Alter 250 mg once daily
or, one tablet of Levofloxacin Alter 500 mg once daily

Lung infections in patients with chronic respiratory problems

two tablets of Levofloxacin Alter 250 mg once daily
or, one tablet of Levofloxacin Alter 500 mg once daily

Pneumonia

two tablets of Levofloxacin Alter 250 mg once or twice daily
or, one tablet of Levofloxacin Alter 500 mg once or twice daily

Urinary tract infections, including kidneys or bladder

one or two tablets of Levofloxacin Alter 250 mg once daily
or, half or one tablet of Levofloxacin Alter 500 mg once daily

Prostate infections

two tablets of Levofloxacin Alter 250 mg once daily
or, one tablet of Levofloxacin Alter 500 mg once daily

Skin and soft tissue infections, including muscles

two tablets of Levofloxacin Alter 250 mg once or twice daily
or, one tablet of Levofloxacin Alter 500 mg once or twice daily

Adults and elderly patients with kidney problems
Your doctor may decide that a lower dose is necessary.
Use in children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacin Alter 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 – which may lead to irregular heartbeat and feelings of discomfort (nausea) or stomach burning.

If you forget to take Levofloxacin Alter
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 Levofloxacin Alter
Do not stop taking Levofloxacin Alter 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, your condition may worsen, or the bacteria may develop resistance to the medicine.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Levofloxacina Alter and go immediately to the doctor or hospital if you notice the following side effect:

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

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

Stop taking Levofloxacina Alter and go immediately to the 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 may be a sign of a serious intestinal problem.
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected.
seizures.
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.
widespread rash, fever, elevated 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).

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

burning, tingling, pain or numbness. These signs may indicate a condition called “neuropathy”.

Other:

loss of appetite, yellowing of the skin and eyes, dark urine, itching or abdominal pain. These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death).

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

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)

difficulty 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, 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)
altered taste, loss of appetite, stomach upset 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 tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropenia)
exaggerated immune response (hypersensitivity)
decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
seeing or hearing things that are not there (hallucinations, paranoia), changes in thinking and indecisiveness (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
feeling depressed, mental disturbances, restlessness (agitation), abnormal dreams or nightmares
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 red patches, with or without blistering, developing within a few hours of taking levofloxacin and healing with redness; these usually recur at the same skin or mucosal site after subsequent exposure to levofloxacin

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

Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
Feeling very excited, euphoric, agitated or enthusiastic (mania)
darker areas of skin (hyperpigmentation)

Sudden involuntary jerks, muscle twitching or contractions (myoclonus)

Other side effects include:

reduction 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)
fever, sore throat and a general feeling of being unwell 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) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia), difficulty in moving and walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as “prolongation of the 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)
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
attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder)
Persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as tingling, pricking, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), as well as 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 tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Alter

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is advisable to store Levofloxacina Alter in its original blister and packaging, in a dry place.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp." 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. Pack contents and other information

What Levofloxacina Alter contains
The active substance is levofloxacin. Each Levofloxacina Alter 500 mg tablet contains 500 mg of levofloxacin.
The excipients are:

core: microcrystalline cellulose, hypromellose, crospovidone, sodium stearyl fumarate
coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Levofloxacina Alter and pack contents
Levofloxacina Alter tablets are film-coated tablets for oral use.
Levofloxacina Alter 500 mg tablets are available in packs of 5, 7, and 10 divisible tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l
Via Egadi, 7 – 20144 Milan, Italy

Manufacturer
Laboratorios Alter, S.A.
C/Mateo Inurria, 30 - 28036 Madrid, Spain