Levofloxacin Mylan Generics Italia: detailed information

Package Leaflet: Information for the Patient

Levofloxacina Mylan Generics Italia 250 mg film-coated tablets, 500 mg film-coated tablets

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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levofloxacina Mylan Generics Italia is and what it is used for

Levofloxacina Mylan Generics Italia contains the active substance levofloxacin. Levofloxacin belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. This medicine works by killing the bacteria responsible for infections in the body.
Levofloxacina may be used to treat the following infections:

sinusitis
of the lungs, in patients with chronic respiratory disorders or pneumonia
of the urinary tract, including kidneys or bladder
of the prostate
of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues".

In certain special situations, Levofloxacina Mylan Generics Italia 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 Levofloxacin Mylan Generics Italia

Do not take Levofloxacin Mylan Generics Italia if:

you are allergic 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: 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, 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 or pharmacist before taking Levofloxacin Mylan Generics Italia.
Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Levofloxacin Mylan
Generics Italia, if you have previously experienced any serious adverse reaction during treatment with a quinolone
or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Consult your doctor or pharmacist before taking Levofloxacin Mylan Generics Italia if:
you are 60 years old or older
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 heart valve insufficiency (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 suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, known atherosclerosis, rheumatoid arthritis (an autoimmune inflammatory disease), or endocarditis (inflammation of the heart).
you are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin
Mylan Generics Italia”)
you have undergone an organ transplant
you have had epileptic seizures (epileptic episodes)
you have suffered brain damage due to stroke or other brain injuries
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 electrical tracing 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 female or elderly, or are taking other medicines that can alter the electrocardiogram (see section “Taking other medicines”).
you have diabetes
you have had liver problems
you have myasthenia gravis
you have previously developed a severe skin reaction, skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.
If you have any doubts whether any of the above could apply to you, consult your doctor or pharmacist before taking Levofloxacin Mylan Generics Italia.
When taking this medicine
Rarely, joint pain and swelling, tendon inflammation or tendon 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 Levofloxacin Mylan Generics Italia. At the first signs of pain or inflammation in a tendon (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Mylan Generics Italia, consult your doctor and rest the affected area. Avoid unnecessary movements, 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 taking Levofloxacin Mylan Generics Italia and inform your doctor immediately to prevent permanent nerve damage.
If you experience sudden abdominal, chest or back pain, which may be a symptom of aortic aneurysm or dissection, seek immediate emergency care. The risk may be higher if you are taking systemic corticosteroid medications.
Inform your doctor immediately if you notice sudden 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 experience nausea, general malaise, severe or persistent stomach pain or worsening pain in the stomach area, or vomiting, contact your doctor immediately, as these may be signs of inflammation of the pancreas (acute pancreatitis).
Avoid strong sunlight and do not use sunlamps or tanning beds during treatment and for 48 hours after treatment with Levofloxacin Mylan Generics Italia (see also section 3. Protect your skin from sunlight).
Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Mylan Generics Italia, 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 prickling, tingling, itching, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell or hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Levofloxacin Mylan Generics Italia, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Severe skin reactions
Serious 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 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 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 help.

Other medicines and Levofloxacin Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. This is because levofloxacin may affect the action of other medicines. Some medicines may also affect the action of levofloxacin.
In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration with Levofloxacin Mylan Generics Italia may increase the likelihood of
you 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 (epileptic episodes) is higher if you take theophylline together with levofloxacin.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures (epileptic episodes) is higher when taken together with levofloxacin.
cyclosporine – used for organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
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), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and 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 use a lower dose if you have kidney problems.

Do not take Levofloxacin Mylan Generics Italia together with the following medicines.
This is because the mechanism of action of Levofloxacin Mylan Generics Italia may be
affected:

iron salts in 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 already taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate”.

Urine testing for opioids
In patients taking Levofloxacin Mylan Generics Italia, urine tests may give “false-positive” results for strong painkillers called “opioids”. If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacin Mylan Generics Italia.
Tuberculosis testing
This medicine may cause “false-negative” results in certain laboratory tests used to detect the bacterium that causes 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 your ability to concentrate and your reaction speed. If this occurs, do not drive or operate machinery requiring high attention.

3. How to take Levofloxacin Mylan Generics Italia

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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
the tablets may be divided into equal doses

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 will become much more sensitive to sunlight and you may get sunburn, itching, or serious skin lesions if you do not follow these precautions:

make sure you use a sunscreen with high protection factor
always wear a hat and clothing covering your arms and legs
avoid sunbeds (solariums)

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

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

How much medicine to take

your doctor will decide how much Levofloxacin Mylan Generics Italia 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 but consult your doctor

Adults and elderly
Sinusitis

two 250 mg tablets of Levofloxacin Mylan Generics Italia once daily
or, one 500 mg tablet of Levofloxacin Mylan Generics Italia once daily
Lung infections in patients with chronic respiratory problems
two 250 mg tablets of Levofloxacin Mylan Generics Italia once daily
or, one 500 mg tablet of Levofloxacin Mylan Generics Italia once daily
Pneumonia
two 250 mg tablets of Levofloxacin Mylan Generics Italia once or twice daily
or, one 500 mg tablet of Levofloxacin Mylan Generics Italia once or twice daily
Urinary tract infections, including kidneys or bladder
one or two 250 mg tablets of Levofloxacin Mylan Generics Italia once daily
or, half or one 500 mg tablet of Levofloxacin Mylan Generics Italia once daily
Prostate infections
two 250 mg tablets of Levofloxacin Mylan Generics Italia once daily
or, one 500 mg tablet of Levofloxacin Mylan Generics Italia once daily
Skin and subcutaneous tissue infections, including muscles
two 250 mg tablets of Levofloxacin Mylan Generics Italia once or twice daily
or, one 500 mg tablet of Levofloxacin Mylan Generics Italia once or twice daily

Adults and elderly with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacin Mylan Generics Italia than you should
If you accidentally take more tablets than you should, contact your doctor immediately or seek medical advice. Take the medicine pack with you. This will allow the doctor to see 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 Mylan Generics Italia
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 forgotten dose.
If you stop taking Levofloxacin Mylan Generics Italia
Do not stop taking Levofloxacin Mylan Generics Italia 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 become resistant to the medicine.
If you have any doubts about how to use 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 to moderate in severity and often disappear after a short time.

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

Rare (may affect up to 1 in 1,000 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 Mylan Generics Italia 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)

pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected.
seizures
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).
decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes.

Not known (frequency cannot be estimated from 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.
changes in thinking and mood, with possible development of suicidal thoughts or suicidal behaviour.
loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or stomach pain (abdomen). These may be signs of liver problems, which may include potentially fatal liver failure.
watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may indicate a serious intestinal problem
a rash with circular, measles-like spots. These may be associated with high fever and joint pain.
rapid drop in blood pressure with symptoms such as shortness of breath, dizziness and weak pulse (anaphylactic shock).
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (called “prolongation of the QT interval” seen on electrocardiogram, electrical activity of the heart)
nausea, general feeling of illness, discomfort or pain in the stomach area or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2
inflammation of the liver (hepatitis) with symptoms such as nausea, vomiting, loss of appetite, fever, itching, yellowing of the skin and whites of the eyes.
burning, tingling, pain or numbness. These may be signs of a condition called “neuropathy”.

If your vision becomes blurred or if you experience any eye discomfort while taking Levofloxacina Mylan Generics Italia, 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)
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 tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropenia)
exaggerated immune response (hypersensitivity)
changes in mental health such as seeing or hearing things that are not there (hallucinations) or feeling threatened (paranoia)
feeling depressed, mental disturbances, feeling restless (agitation), unusual 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 erythematous patches, with or without blistering, developing within hours of levofloxacin administration and healing with residual redness; these usually recur at the same skin or mucosal site upon subsequent exposure to levofloxacin.
memory disturbances

Not known (frequency cannot be estimated from 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)
fever, sore throat and a general feeling of illness that does not go away. This may be due to a decrease in white blood cells in the blood (agranulocytosis)
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)
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
difficulty breathing or wheezing (bronchospasm)
allergic reactions affecting the lungs
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 rupture and destruction of muscle tissue (rhabdomyolysis)
redness and swelling of the 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 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, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment and 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 effect, including those not listed in this leaflet, talk to your doctor or visit 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 Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is preferable to store
Levofloxacina Mylan Generics Italia in the original blister pack and in a dry place.
Do not use this medicine after the expiry date stated on the carton, bottle, and aluminium sheet after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Mylan Generics Italia contains

The active substance is levofloxacin hemihydrate.
Each film-coated tablet contains 250 mg/500 mg of levofloxacin (as levofloxacin hemihydrate).
The other components are: Microcrystalline cellulose, Crospovidone, Hydroxypropylcellulose, Magnesium stearate. The tablet coating contains: Hydroxypropylcellulose, Macrogol 400, Macrogol 3350 and Titanium dioxide (E171).

Description of the appearance of Levofloxacina Mylan Generics Italia and contents of the pack
Levofloxacina Mylan Generics Italia tablets are film-coated.
The 250 mg tablets are white to off-white, capsule-shaped, biconvex tablets, engraved with “LVO” – breakline – “250” on one side and “G” – breakline – “G” on the other side.
The 500 mg tablets are white to off-white, capsule-shaped, biconvex tablets, engraved with “LVO” – breakline – “500” on one side and “G” – breakline – “G” on the other side.
Levofloxacina Mylan Generics Italia is packaged in blister packs containing 1, 2, 3, 5, 7, 8, 10, 14, 16, 50 and 200 tablets per pack, and in bottles containing 50 and 500 tablets per bottle.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano, Italy

Manufacturers:
McDermott Laboratories Limited (t/a Gerard Laboratories), 35/36 Baldoyle Industrial Estate, Grange Road, Dublin, Ireland
Mylan Hungary Kft., H-2900 Komárom, Mylan utca, Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Levofloxacina Mylan Generics Italia 250 mg, 500 mg film-coated tablets